Lindsey Wilson College Human Subject Policies.docx by liuqingyan

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									              Lindsey Wilson College
      School of Professional Counseling (SPC)

          Human Subjects Protection Program
              Policies and Procedures




The Lindsey Wilson College SPC Human Subjects Protection Program gratefully acknowledges the University of
Arizona and the permission granted to glean from their policies and procedures. Their policy and procedures were
also the result of other universities sharing resources primarily that of Vanderbilt University.
                         Lindsey Wilson College SPC
                      Human Subjects Protection Program
                           Policies and Procedures
                            TABLE OF CONTENTS
SECTION I      AUTHORITY AND INSTITUTIONAL COMMITMENT
     I.A       Institutional Oversight of Human Subject Research
     I.A.1     Procedure for Institutional Oversight of Human Subject Research
     I.B       Activities Subject to IRB Jurisdiction
     I.B.1     Procedure for Activities Subject to IRB Jurisdiction
     I.C       Research Involving Performance Sites
     I.C.1     Procedure for Research Involving Performance Sites
     I.D       Knowledge of Local Research Context
     I.D.1     Procedure for Knowledge of Local Research Context
     I.E       Cooperative Agreements
     I.E.1     Procedure for Cooperative Agreements
     I.F       IRB of Record
     I.F.1     Procedure for Memorandum of Understanding (MOU)

SECTION II     IRB COMPLIANCE ACTIVITIES
     II.A      IRB Compliance Activities
     II.A.1    Procedure for IRB Compliance Activities
     II.B      Suspension, Termination, or Reinstatement of IRB Approval
     II.B.1    Procedure for Suspension, Termination, or Reinstatement of IRB Approval
     II.C      Investigating any Non-compliance, Serious or Continuing Non-Compliance
     II.C.1    Procedure for Investigating and Managing Potential Issues of Non-
               Compliance
      II.D     Reporting to the Appropriate Institutional Officials, and the Department or
               Agency Head(s)
      II.D.1   Procedure for Reporting to the Appropriate Institutional Officials, and the
               Department or Agency Head(s)
      II.E     Complaints Regarding Human Subjects Research
      II.E.1   Procedure for Complaints Regarding Human Subjects Research
      II.F     Protocol Deviation/Violation Reporting
      II.F.1   Procedure for Protocol Deviation/Violation Reporting

SECTION III    IRB REVIEW PROCEDURES
     III.A     Institutional Review Board Committee Review Responsibilities
     III.A.1   Procedure for Institutional Review Board Committee Review Responsibilities
     III.B     IRB Committee Determinations/Motions
     III.B.1   Procedure for IRB Committee Determinations/Motions
     III.C     Composition of IRB Committees
     III.C.1   Procedure for Composition of IRB Committees
     III.D     IRB Review of Human Subjects Research – Full Committee
     III.D.1   Procedure for IRB Review of Human Subjects Research – Full Committee
     III.D.2   Initial Application Materials to be Reviewed by the Full IRB Committee
      III.E     IRB Review of Human Subjects Research - Expedited Review
      III.E.1   Procedure for IRB Review of Human Subjects Research - Expedited Review
      III.F     IRB Review of Human Subjects Research – Exempt Review
      III.F.1   Procedure for IRB Review of Human Subjects Research – Exempt Review
      III.G     IRB Continuing Review Requirements
      III.G.1   Procedure for IRB Continuing Review
      III.G.2   Procedure for Processing the Continuing Review Application
      III.H     Amendments to Previously Approved Applications or Exempt Projects
      III.H.1   Procedure for Amendments to Previously approved Applications or Exempt
                Projects
      III.I     Reporting of Serious Adverse Events or Unanticipated Problems Involving
                Risks to Participants or Others
      III.I.1   Procedure for Reporting of Serious Adverse Events or Unanticipated
                Problems Involving Risks to Participants or Others
      III.J     Research with Human Tissue, Blood, Genetic Material and Data
      III.J.1   Procedure for Research with Human Tissue, Blood, Genetic Material and Data
      III.K     Human Subject Research/Non-Human Subject Research Determination
      III.K.1   Procedure for Human Subject Research/Non-Human Subject Research
                Determination

SECTION IV          IRB INFORMED CONSENT PROCESS
     IV.A       Legally Effective and Prospectively Obtained Informed Consent
     IV.A.1     Procedure for Obtaining Legally Effective and Prospectively Obtained
                Informed Consent
      IV.A.2    Procedure for Incorporating the Elements of Informed Consent
      IV.B.     Documentation of Informed Consent for Human Subjects Research
      IV.B.1    Procedure for Documentation of Informed Consent for Human Subjects
                Research
      IV.C      Waiver of Informed Consent for Human Subject Research or Exception of
                Informed Consent for Emergency Research
      IV.C.1    Procedure for Waiver of Informed Consent for Human Subject Research or
                Exception of Informed Consent for Emergency Research
      IV.D      Assent/Dissent by Children or Cognitively Impaired Adults Who Lack
                Decision-Making Capacity
      IV.D.1    Procedure for Assent/Dissent by Children or Cognitively Impaired Adults
                Who Lack Decision-Making Capacity
      IV.E      Approval and Expiration Dates on Informed Consent Documents
      IV.E.1    Stamping IRB Approval and Expiration Dates on Informed Consent
                Documents

SECTION V. RECORDS, DOCUMENTATION, AND FEES
     V.A     IRB Office Records
     V.A.1   Procedure for Documentation of IRB Committee Meeting Minutes
     V.A.2   Procedure for IRB Committee Meeting Agendas
     V.A.3   Procedure for Anatomy of the IRB File
     V.B     IRB Fee Policy for Industry-Sponsored Application
      V.B.1     Processing Industry-Sponsored IRB Applications
      V.C       Development, Approval, and Maintenance of IRB Policies Procedures
      V.C.1     Procedure for Development, Approval, and Maintenance of Policies and
                Procedures

SECTION VI      INVESTIGATOR RESPONSIBILITIES
     VI.A       Investigator Qualifications
     VI.A.1     Procedure for Assuring Investigator Qualifications
     VI.B       General Responsibilities of Investigators
     VI.B.1     Procedure for General Responsibilities of Investigators
     VI.C       Investigator and Study Personnel Disclosure of Conflict of Interest
     VI.C.1     Procedure for Investigator and Study Personnel Disclosure of Conflict of
                Interest
      VI.D      Certificate of Confidentiality
      VI.D.1    Procedure for Certificate of confidentiality
      VI.E      Data and Safety Monitoring Plans
      VI.E.1    Procedure for Data and Safety Monitoring Plans

SECTION VII. IRB MEMBERSHIP
     VII.A    Policy for Payment of Voting Community
     VII.A.1 Procedure for Payment of Voting Community Committee Members
     VII.B    Committee Member Compensation and Recognition
     VII.B.1 Procedure for Committee Member Compensation and Recognition
     VII.C    IRB Committee Member Conflict of Interest
     VII.C.1 Procedure for IRB Committee Member Conflict of Interest Disclosure
     VII.D.   Procedure for Requesting Legal Counsel Opinion

SECTION VIII    HSPP EDUCATION AND TRAINING
     VIII.A     Investigator and Study Personnel Training
     VIII.A.1   Procedure for Investigator and Study Personnel Training
     VIII.B     IRB Committee Member Training
     VIII.B.1   Procedure for IRB Committee Member Training
     VIII.C     HSPP Staff Member Education, Training and Evaluation
     VIII.C.1   Procedure for HSPP Staff Member Education, Training and Evaluation
     VIII.D     Community Outreach
     VIII.D.1   Procedure for Community Outreach

SECTION IX      VULNERABLE POPULATIONS
     IX.A       Special Categories of Research: Children in Research
     IX.A.1     Procedure for Special Categories of Research: Children in Research
     IX.A.2     Review of Non-Federally Funded Research Meeting 45 CRF 46.407
     IX.B       Special Categories of Research: Prisoners in Research
     IX.B.1     Procedure for Special Categories of Research: Prisoners in Research
     IX.C       Special Categories of Research: The Fetus, Pregnant Women and Human
                Neonates and Transplantation of Fetal Tissue
     IX.C.1   Procedure for Special Categories of Research: The Fetus, Pregnant Women
              and Human Neonates and Transplantation of Fetal Tissue
     IX.D     Special Categories of Research: Cognitively Impaired
     IX.D.    Procedure for Special Categories of Research: Cognitively Impaired

SECTION X     CONDUCT OF RESEARCH
     X.A      Health Insurance Portability and Accountability Act (HIPAA) Policy
     X.A.1    Procedure for Addressing Health Insurance Portability and Accountability Act
              (HIPAA) Policy
     X.B      Modifications to HIPAA Authorization Language for Lindsey Wilson College
              SPC Covered Entity Participants
     X.B.1    Procedure for Modifications to HIPAA Authorization Language for Lindsey
              Wilson College SPC Covered Entity Participants
     X.C      Compensation or Medical Treatment if Injury Occurs During Participation in
              Research
     X.C.1    Procedure for Compensation or Medical Treatment if Injury Occurs During
              Participation in Research
     X.D      Screening for Diseases Reportable to the State Health Department and/or
              Public Health Services
     X.D.1    Procedure for Screening for Diseases Reportable to the State Health
              Department and/or Public Health Services
     X.E      Payments to Research Participants
     X.E.1    Procedure for Payments to Research Participants
     X.F      Recruitment/Advertising
     X.F.1    Procedure for Recruitment/Advertising
     X.F.2    Procedure for Recruitment of Students and Employees as Research
              Participants
     X.G      Research Conducted at International Performance Sites
     X.G.1    Procedure for Research Conducted at International Performance Sites
     X.H      Research Involving the Use of the Internet
     X.H.1    Procedure for Research Involving the Use of the Internet
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.A Institutional Oversight of Human Subject Research
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.A Institutional Oversight of Human Subject Research
       1. Definitions:
                a. Assurance: A contract or agreement between the Lindsey Wilson College
                    SPC and the Office for Human Research Protections (OHRP) that establishes
                    standards for human subjects research as approved by OHRP.
                b. Department of Health and Human Services (DHHS): The United States
                    government's agency for protecting the health of all Americans and providing
                    essential human services, especially for those who are least able to help
                    themselves.
                c. Institutional Review Board (IRB): A specifically constituted review body
                    established or designated by an entity to protect the rights and welfare of
                    human subjects recruited to participate in biomedical or behavioral/social
                    science research.
                d. IRB of Record: An IRB is considered the IRB of record when it assumes IRB
                    responsibilities for another institution and is designated to do so through an
                    approved Assurance with OHRP. A Memorandum of Understanding is
                    required, designating the relationship, for the Lindsey Wilson College SPC to
                    serve as the IRB of Record.
                e. Memorandum of Understanding (MOU): A formal agreement between
                    Lindsey Wilson College SPC and another institution that identifies Lindsey
                    Wilson College SPC Institutional Review Board as the IRB of record for that
                    institution (agreement may also be referred to as an Authorization
                    Agreement).
                f. Office for Human Research Protections (OHRP): The office under the
                    Department of Health and Human Services responsible for implementing
                    DHHS regulations (45 CFR 46) governing biomedical and behavioral/social
                    science research involving human subjects.
       2. Policy:
       It is the policy of Lindsey Wilson College SPC IRB to uphold its policies and procedures
       for human subject research. These policies and procedures are consistent with a potential
       future filing of an Assurance with the Office for Human Research Protections (OHRP).
       Lindsey Wilson College SPC policies and procedures will be maintained with the Dean
       of LWC SPC, and a copy will be available to the entire Lindsey Wilson College SPC
       community via the Lindsey Wilson College SPC Human Subjects Protection Program
       website at (www.lindsey.edu). Lindsey Wilson College SPC Assurance is based on the
       following principles:
                a. Safeguarding the rights and welfare of human participants in research and
                    other research activities is a general Institutional policy delegated by the
                    President through the academic departments. It is the responsibility of these
                    individuals to exercise appropriate administrative oversight to ensure that
                    Lindsey Wilson College SPC‟s policies and procedures designed for
           protecting the rights and welfare of human participants are consistently and
           effectively applied.
       b. Lindsey Wilson College SPC faculty, staff, and students, which comprise its,
           divisions, and facilities, are subject to these policies. This includes any
           research for which an research agreement (e.g., MOU) identifies Lindsey
           Wilson College SPC Institutional Review Board (IRB) as the IRB of record.
       c. Safeguarding the rights and welfare of human participants in research is the
           responsibility of the Institutional Review Board (IRB). Evaluating and
           assessing whether each protocol provides the necessary resources to protect
           participant‟s rights and welfare is the responsibility of the Supervising
           Official.
       d. Lindsey Wilson College SPC agrees to uphold the ethical principles of the
           Belmont Report and apply DHHS regulations (45 CFR 46, including Subparts
           A, B, C, & D) and state and local laws to all proposed research protocols
           involving human subjects regardless of sponsorship. The ethical principles set
           forth in the Belmont Report are:
               i. Respect for Persons: Recognition of the personal dignity and
                    autonomy of individuals and special protection of those persons with
                    diminished autonomy;
               ii. Beneficence: Obligation to protect persons from harm by maximizing
                    benefits and minimizing possible risk of harm; and
               iii. Justice: Fairness in the distribution of research benefits and burdens.
       e. Lindsey Wilson College SPC further agrees to apply additional regulations
           such as, the U.S. Food and Drug Administration Regulations (21 CFR 50 and
           56, 312 and 812), the Health Insurance Portability and Accountability Act of
           1996 (HIPAA), the Veterans Affairs Regulations (38 CFR 16) Privacy Act of
           1974 when applicable, to research involving human subjects under review.
3. Structure of the Institutional Review Board.
       a. The IRB Committee is appointed as a Committee. As such, the IRB
           Committee serve Lindsey Wilson College SPC as a whole, rather than a
           particular department, and any institution for which Lindsey Wilson College
           SPC IRB is designated as the IRB of record.
       b. Lindsey Wilson College presently designates two IRB Committees.
           i. LWC IRB #1 performs initial and continuing review of studies designed to
               contribute to behavioral, educational, and social science research at the
               undergraduate level and are under a separate policy and procedure manual.
           ii. LWC SPC IRB performs initial and continuing review of studies designed
               to contribute to behavioral, educational, and social science research at the
               undergraduate and graduate level representing the School of Professional
               Counseling.
       c. The IRB functions independently of other organizational entities in its role in
           protecting research participants.
       d. Lindsey Wilson College SPC will provide the appropriate number of IRBs for
           the volume and type of human research reviewed.
4. Responsibilities of the IRB to Provide Oversight for its Assurance Agreement.
             a. Review of the IRB is required prior to the initiation of all human subjects‟
                research. Through the review process, the IRB has the authority to exempt,
                approve, require modifications, suspend, disapprove, or terminate all research
                activities that fall within its jurisdiction. Projects that may meet the
                requirements for an exemption, will be verified, by a qualified person or
                persons other than the investigator or research team, to determine whether
                proposed human subject research activities qualify for exemption from the
                requirements of the Common Rule.
             b. Research reviewed and approved by the IRB may be subject to review and
                disapproval by other compliance units, department heads, or departmental
                review committees for reasons determined by those persons or committees or
                other compliance units of Lindsey Wilson College SPC, or any institution for
                which Lindsey Wilson College SPC IRB is designated as the IRB of record.
                However, non IRB college officials may not approve research previously
                disapproved by the Lindsey Wilson College SPC IRB.
References:
The Belmont Report
21 CFR 50
21 CFR 56
21 CFR 312
21 CFR 812
38 CFR 16
45 CFR 46
45 CFR 160
45 CFR 164
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.A Institutional Oversight of Human Subject Research
SUB-PART: I.A.1 Procedure for Institutional Oversight of Assurance
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.A.1 Procedure for Institutional Oversight of Human Subject Research
        1. Procedure:
This procedure outlines Lindsey Wilson College SPC Investigator, Institutional Review Board,
Supervising Official (Dean, Department Head, or Comparable Authority), Human Subjects
Protection Program staff, and HSPP Administration responsibilities in maintaining the Lindsey
Wilson College SPC Assurance.
               a. Investigator Responsibilities:
                  i. The PI is responsible for acquiring the appropriate knowledge regarding
                       human subjects protections, ethics, federal regulations, training, and
                       monitoring to conduct his/her proposed research.
                  ii. The PI must assure that his/her key study personnel are adequately trained
                       and knowledgeable regarding human subjects protections, ethical
                       considerations, and federal regulations applicable to the proposed
                       research.
                  iii. The PI is responsible for complying with the training, monitoring, and
                       human subjects research guidance as outlined in the Assurance and IRB
                       policies and procedures.
               b. IRB Committee Responsibilities:
                  i. The IRB Committee is to review all research activities and document its
                       findings regarding ethical considerations, scientific merit, adherence to
                       federal regulations and IRB policies and procedures.
               c. Supervising Official (Deans, Department Heads, or Comparable Authorities)
                  Responsibilities:
                  i. Supervising Officials will assure that each research study has the resources
                       necessary to protect human participants. Examples of resources include
                       staffing and personnel, (e.g., availability, number, expertise, and
                       experience) psychological, social, or medical services, including
                       counseling or social support services that may be required because of
                       research participation; psychological, social, or medical monitoring,
                       ancillary care, equipment needed to protect participants, and resources for
                       participant communication, such as language translation services.
               d. HSPP Staff Responsibilities:
                  i. HSPP staff will confer with and advise LWC staff, students and others and
                       provide technical advice, problem-solving assistance and policy
                       interpretation with regard to the Human Subjects Protection Program.
                  ii. HSPP staff will draft correspondence that conveys IRB committee
                       members‟ deliberations and contingencies for approval of research
                       activities involving human subjects.
                  iii. HSPP staff will assist with review of research applications eligible for
                       expedited review.
   iv. HSPP staff will evaluate program effectiveness in order to improve
        program processes, analyze results and recommend appropriate action for
        improvement.
   v. HSPP staff will develop and facilitate IRB Committee meetings.
e. IRB Administration Responsibilities:
   i. The Director of the Human Subjects Protection Program (HSPP) or
        Research Director will determine whether a Federalwide Assurance with
        OHRP is necessary or whether the Assurance is up to date every
        36months, even if no changes have occurred.
   ii. The HSPP Director will promptly report amendments to an Assurance to
        OHRP. This includes changes to IRB Committee rosters and the addition
        or deletion of an IRB Chairperson or the Institutional Official of Lindsey
        Wilson College SPC.
   iii. If an Assurance is obtained, Lindsey Wilson College SPC will seek
        approval of OHRP prior to entering into Cooperative Agreements.
   iv. Lindsey Wilson College SPC will maintain policies and procedures
        reflecting the current practices of the IRB in conducting reviews and
        approvals. These policies and procedures will be maintained and kept
        current by Lindsey Wilson College SPC HSPP. They will be re-reviewed
        at least every 36 months. All revision dates will be listed under the
        revision date for each policy and procedure.
   v. Policies and procedures are to be developed and revised by the HSPP in
        conjunction with the IRB Committee.
   vi. All policies and procedures are to be approved by the appropriate
        signatories as applicable to each individual policy and procedure.
   vii. All policies and procedures will be made available to the LWC research
        community.
   viii.The IRB budget will be reviewed by the Dean of the School of
        Professional Counseling and the Research Director/Director of the Human
        Subjects Protection Program annually, and modified as necessary to
        provide the resources needed to protect participants‟ rights and welfare
        and accommodate the volume and type of research reviewed. This
        includes but is not limited to space, facilities and staff. The number of
        IRBs will be evaluated systematically, by polling IRB members/Chairs,
        Investigators, research personnel, and HSPP staff to determine whether the
        number of IRBs is appropriate to the volume and types of human research
        reviewed.
   ix. New information will be disseminated to research community through the
        website, list serve, or another media device.
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.B Activities Subject to IRB Jurisdiction
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.B Activities Subject to IRB Jurisdiction
       1. Definitions:
                a. Agent: An individual employed by Lindsey Wilson College SPC or affiliated
                    with the Lindsey Wilson College SPC who is authorized to act on its behalf.
                b. Human Subject: A living individual about whom an Investigator (whether
                    professional or student) conducting research obtains data through intervention
                    or interaction directly with the individual or with his/her identifiable private
                    information or an individual who is or becomes a participant in research,
                    either as a recipient of the test article or as a control
                c. Intervention: Includes both physical procedures by which data are gathered
                    (e.g., venipuncture) and manipulations of the subjects‟ environment that are
                    performed for research purposes.
                d. Interaction: Includes communication or interpersonal contact with a subject
                    or their private identifiable information.
                e. Private Information: (As opposed to HIPAA regulations) includes
                    information about behavior that occurs in a setting in which an individual can
                    reasonably expect that no observation or recording is taking place. It includes
                    information, which has been provided for specific purposes by an individual,
                    and the individual can reasonably expect will not be made public (e.g., a
                    medical record). Private information must be individually identifiable in order
                    to be considered information to constitute research involving human subjects.
                    This may include identifiable private information obtained from a primary
                    subject about a third party.
                f. Memorandum of Understanding (MOU): A formal agreement between the
                    Lindsey Wilson College SPC and another institution or organization that
                    identifies the Lindsey Wilson College SPC Institutional Review Board as the
                    IRB of record for that institution or organization.
                g. Office for Human Research Protections (OHRP): The office under the
                    Department of Health and Human Services responsible for implementing
                    DHHS regulations (45 CFR46) governing biomedical and behavioral/social
                    science research involving human subjects.
                h. Research: Any systematic investigation (including research development,
                    testing and evaluation) designed to develop or contribute to generalizable
                    knowledge
                i. Human Subjects Research: Any research that involves humans as subjects
                    and any clinical investigation.
       2. Policy:
       It is the policy of Lindsey Wilson College SPC Institutional Review Board to have
       jurisdiction over all research involving human subjects.
       3. Review and Approval of Human Subject Research.
        a. All research involving human subjects, and all other activities, which in part
           involve such research, regardless of sponsorship, must be reviewed and
           approved by a Lindsey Wilson College SPC IRB.
           i. No intervention or interaction with human subjects in research, including
                advertising, recruitment and/or screening, may begin until the IRB has
                reviewed and approved the research.
           ii. It is the responsibility of the IRB Chairperson, his/her designee or the full
                IRB Committee to determine what activities constitute “research”
                involving “human subjects” as defined by the Federal regulations.
                Investigators will be notified verbally or in writing of this determination.
        b. Lindsey Wilson College SPC, along with the Federal government, defines its
           jurisdiction over the review of research activities involving human subjects.
           Regardless of sponsorship, the IRB must review all research if one or more of
           the following apply:
           i. The research is sponsored by Lindsey Wilson College SPC;
           ii. The research is conducted by or under the direction of any employee,
                faculty, staff, student, or agent of Lindsey Wilson College SPC in
                connection with his/her institutional responsibilities;
           iii. The research is conducted by or under the direction of any employee or
                agent of this institution using any of its property or facilities;
           iv. The research involves the use of non-public information maintained by
                Lindsey Wilson College SPC to identify or contact human subjects or
                prospective subjects;
           v. Lindsey Wilson College SPC receives a direct Federal award to conduct
                human subject research, even where all activities involving human
                subjects are carried out by a subcontractor or collaborator;
           vi. Lindsey Wilson College SPC is designated as a subcontractor to a Federal
                award from another institution to conduct human subject research;
           vii. The research is conducted in accordance with an Assurance filed with the
                Office of Human Research Protections (OHRP) in which Lindsey Wilson
                College SPC IRB is designated as the IRB of record through an
                established MOU.
        c. The IRB must review and approve the use of data collected for non-research
           purposes, if it will now be used in a research context.
        d. If an Investigator begins a non-research project and later finds that the data
           gathered could contribute to generalizable knowledge, the Investigator must
           submit an application form to the IRB for review and approval prior to
           publication or presentation of the data (e.g., journal article, poster session,
           public speech or presentation, or project report).
4. Failure to Submit a Project for IRB Review.
        a. The implications of engaging in activities that qualify as research that are
           subject to IRB review without obtaining such review are significant and
           considered noncompliance. Results from such studies may not be published,
           presented publicly, or the data used to satisfy thesis or dissertation
           requirements unless IRB approval had been obtained prior to collecting the
           data.
              b. If an Investigator begins a project and later finds that the data gathered could
                 contribute to generalizable knowledge or that he or she may wish to publish or
                 present the results of the activities, it is required that the Investigator submit a
                 proposal to the IRB for review and approval prior to release of such
                 information.
              c. Investigators who request approval to continue research that was not
                 previously reviewed or to use data that was collected without IRB approval
                 face the possibility that the IRB will reject his/her application, as the IRB
                 cannot give post-hoc approval to such research activities and appropriate
                 research officials of the College will be notified. This activity is considered
                 noncompliance
              d. The IRB may not approve applications where the Investigator has attempted
                 to circumvent IRB policies and procedures regarding human subjects research
                 by collecting data as non-research and then applying to use them as existing
                 data. This activity is considered noncompliance. It is therefore in the
                 Investigator‟s best interest to consider carefully the likelihood that he or she
                 will want to use the data for research purposes in the future, and to err on the
                 side of inclusion and seek IRB approval prior to commencing the work.

References:
45 CFR 46
21 CFR 50 and 56
IRB Management and Function; Amdur, R. and Bankert, E.; 2002 Jones and Bartlett Publishers,
Inc.
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.B Activities Subject to IRB Jurisdiction
SUB-PART: I.B.1 Procedure for Activities Subject to IRB Jurisdiction
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.B.1 Procedure for Activities Subject to IRB Jurisdiction
       Procedure:
       This procedure provides guidance on types of research activities that are subject to
       review and approval by Lindsey Wilson College SPC Institutional Review Board.
              a. Investigator Responsibilities:
                     i. The Investigator will submit to the HSPP office his/her research for
                         review and determination of jurisdiction, exemption, non-human
                         subject, non-research, etc. prior to the initiation of research activities.
                     ii. Below is a table that identifies typical activities that may require
                         Lindsey Wilson College SPC IRB review and approval, prior to
                         initiation of such activities:
                                                                                      IRB
   SPECIAL
                                           DESCRIPTION                              REVIEW
CONSIDERATIONS
                                                                                   REQUIRED
                       Experiments using a test article on one or more human
                       subjects that are regulated by the Food and Drug
                       Administration or support applications for research or
                       marketing permits for products regulated by the Food
                                                                                     YES
Clinical Investigation and Drug Administration. Products regulated include
                       food and color additives, drugs for human use, medical
                       devices for human use, biological products for human
                       use, and electronic products.

                        The collection of data about a series of established and
                        accepted diagnostic, therapeutic procedures, or
                                                                                     YES
                        instructional methods for dissemination or contribution
                        to generalizable knowledge.
                        An alteration in patient care or assignment for research
Standard Diagnostic                                                                  YES
                        purposes.
        or
                        A diagnostic procedure added to a standard treatment
    Therapeutic                                                                      YES
                        for the purpose of research.
    Procedures
                        An established and accepted diagnostic, therapeutic
                        procedure or instructional method, performed only for
                                                                                     NO
                        the benefit of a patient or student but not for the
                        purposes of research.

                        A systematic investigation of innovations in diagnostic,
                        therapeutic procedure or instructional method in
                        multiple participants in order to compare to standard
                        procedure. The investigation is designed to test a           YES
                        hypothesis, permit conclusions to be drawn, and
                        thereby develop or contribute to generalizable
                        knowledge.
    Innovative
    Procedures,
                        The use of innovative interventions of
   Treatment, or
                        noninvestigational drug or device that are designed
   Instructional
                        solely to enhance the well being of an individual
     Methods
                        patient or client and have a reasonable expectation of
                        success, but are not being done for research purposes.
                                                                                     NO
                        The intent of the medical or behavioral science
                        practitioner is to provide diagnosis, preventive
                        treatment, or therapy to the particular individual and
                        the intervention does not include investigational drug
                        device or biologics.
                                                                                        IRB
   SPECIAL
                                            DESCRIPTION                               REVIEW
CONSIDERATIONS
                                                                                     REQUIRED
                        Preliminary activities typically designed to help the
                                                                                       YES
                        Investigator refine data collection procedures. This data
                        is to be included in the publication.
                        A storage site or mechanism by which identifiable
Repositories (e.g.,
                        human tissue, blood, genetic material or data are stored       YES
data, specimen, etc.)
                        or archived for research by multiple Investigators or
                        multiple research projects.
                        Storage of human tissue, blood, genetic material or data
                                                                                       YES
                        that has been de-identified at the time of collection.
                        LWC is NOT an enrolling site and the Lindsey Wilson
                        College SPC PI has agreed to serve as the coordinating
                        center for a multi-center trial, which may include
                                                                                       YES
                        activities such as data collection, data analysis,
LWC functioning as
                        reporting of adverse events to regulatory authorities,
the Coordinating
                        and/or oversight of the research at participating sites.
Center for a
                        Lindsey IS an enrolling site and the Lindsey Wilson
Multicenter
                        College SPC PI has agreed to serve as the coordinating
Research Project
                        center for the multi-center trial, which may include
                                                                                       YES
                        activities such as data collection, data analysis,
                        reporting of adverse events to regulatory authorities,
                        and/or oversight of the research at participating sites.
                        Institutional Policies do not permit research activities
                        to be started, even in an emergency, without prior IRB
                        acknowledgement.
                        1. This does not limit the physician‟s ability to deliver
                        emergency care. The physician may deliver such care,
Emergency Use of an     but the data derived from such care may not be used in         YES
Investigational Drug    any manner of research.
or Device               2. Emergency care involving investigational drugs,
                        devices or biologics must meet the Food and Drug
                        Administration (FDA) requirements and data from such
                        use may not be used in any manner of research.

                        Sponsor requires IRB approval to release drug/device           YES
                        in emergency use situation.
                        Activities designed for educational purposes only. The
                        data will not contribute to generalizable knowledge or
      Research
                        be published outside the classroom, will not result in an
Practicums/Research                                                                    NO
                        article, master‟s thesis, doctoral dissertation, poster
  Methods Classes
                        session, abstraction or result in any other publication or
                        presentation.
                                                                                          IRB
   SPECIAL
                                             DESCRIPTION                                REVIEW
CONSIDERATIONS
                                                                                       REQUIRED
                         A single subject study with clear intent, before
                         recruiting or interacting with the participant, to use data
                                                                                          YES
                         that would not ordinarily be collected in the course of
                         daily life. The intent is to report and publish the case
                         study.
Case Studies
                                                                                           YES
                         Retrospective review of a patient‟s medical record with
                                                                                       may qualify
                         the intent to report and/or publish the summary.
                                                                                       as “exempt”
                         Retrospective review of a patient‟s medical records for
                                                                                           NO
                         use in an educational setting. The data will be de-
                         identified.
                         The Investigator or his/her staff will participate, overtly
                         or covertly, in people‟s daily lives for an extended
Ethnographic             period of time. They will be watching what happens,              YES
Research                 listening to what is said, asking questions and
                         collecting data to create a broader understanding of a
                         particular environment, ethnic group, gender, etc.
                         Online websites are set up for the purposes of
                         collecting data regarding a particular topic. This may           YES
Internet Research
                         include the completion of questionnaires/surveys,
                         personal data, etc.
Quality Assurance
and Quality              Quality improvement projects where users of a service
Improvement              are asked to give their opinions about the satisfaction           NO
Activities               with the service received.

                         Evaluations of a specific project, process, or resource
                         utilization review, etc. where the primary intent
                         (design) of the activity is for internal assessment or
Evaluation                                                                                 NO
                         improvement. There are no plans for publication or
                         presentation outside Lindsey Wilson College SPC /
                         College Medical Center.


                     iii. When the proposed research is determined to be under IRB
                          jurisdiction, the proposed research must be submitted to the IRB for
                          review and approval prior to initiation of human subjects research.
                     iv. It is in the Investigator‟s best interest to consider carefully the
                          likelihood that he or she will want to use clinical or routinely collected
                          data for research purposes in the future. If it is likely the Investigator
                          should err on the side of inclusion and seek IRB approval prior to
                          commencing the work.
               b. IRB Committee Responsibilities:
      i. The IRB will review the proposed research in accordance with
           applicable IRB policies and procedures.
      ii. If a study has been completed without prior IRB approval, the IRB
           Committee will reject and return the application, will notify the
           Investigator of the regulatory requirements regarding prospective IRB
           approval of human subjects research and that the data cannot be used
           for any publications, presentations, or to meet thesis or dissertation
           requirements.
      iii. If the IRB Committee determines that an Investigator has attempted to
           circumvent IRB policies and procedures regarding human subjects
           research by collecting data as nonresearch and then applying to use
           them as existing data the IRB Committee will reject and return the
           application, will notify the Investigator of the regulatory requirements
           regarding prospective IRB approval of human subjects research and
           that the data cannot be used for any publications, presentations, or to
           meet thesis or dissertation requirements. School administrators will be
           notified for further determinations and actions.
c. IRB Staff Responsibilities:
      i. The HSPP staff will conduct an initial pre-review of the research
           proposal to verify that Lindsey Wilson College SPC IRB has
           jurisdiction.
      ii. If Lindsey Wilson College SPC IRB has jurisdiction the staff will
           process the research in accordance with applicable IRB policies and
           procedures. If Lindsey Wilson College SPC IRB does not have
           jurisdiction the research proposal will be returned to the PI with
           notification of such.
      iii. If staff receive a completed publication (e.g., thesis, manuscript) as
           part of an initial IRB submission, the IRB Chair will be notified. A
           notice will be sent to the Investigator indicating that the submission is
           being returned and will not be accepted for review by the IRB.
           Because the research was not prospectively approved by the IRB, it
           cannot be used for publications, presentations, or to satisfy thesis or
           dissertation requirements.
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.C Research Involving Performance Sites
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.C Research Involving Performance Sites
       1. Definitions:
                a. Institutional Review Board (IRB): A specially constituted review body
                    established or designated by an entity to protect the rights and welfare of
                    human subjects recruited to participate in biomedical or behavioral/social
                    science research.
                b. IRB of Record: An IRB is considered the IRB of record when it assumes IRB
                    responsibilities for another institution and is designated to do so through an
                    approved Assurance with OHRP. A Memorandum of Understanding is
                    required, designating the relationship, for Lindsey Wilson College SPC to
                    serve as the IRB of Record.
                c. Memorandum of Understanding (MOU): A formal agreement between
                    Lindsey Wilson College SPC and another institution that identifies Lindsey
                    Wilson College SPC Institutional Review Board as the IRB of record for that
                    institution and defines the responsibilities for both Lindsey Wilson College
                    SPC IRB and the other institution.
                d. Office for Human Research Protections (OHRP): The office under the
                    Department of Health and Human Services responsible for implementing
                    DHHS regulations (45 CFR 46) governing biomedical and behavioral/social
                    science research involving human subjects.
                e. Performance Site: A site where research is performed.
                f. Performance Site(s) Engaged in Research: A performance site becomes
                    "engaged” in human subjects research when its employees or agents:
                        1) intervene or interact with living individuals for research purposes
                        2) obtain individually identifiable private information for research
                             purposes. Further, a performance site is considered to be "engaged” in
                             human subjects research when it receives a direct Federal award to
                             support the research.
                g. Performance Sites Not Engaged in Research: A performance site is "not
                    engaged” in human subjects research if its employees or agents do not:
                        1) intervene or interact with living individuals for research purposes
                        2) obtain individually identifiable private information for research
                             purposes. If a Lindsey Wilson College SPC Investigator or his/her
                             staff, (including site personnel contracted by Lindsey Wilson College
                             SPC), performs all research related activities at the performance site.
                             The performance site is not considered to be “engaged” in research.
       2. Policy:
       It is the policy of Lindsey Wilson College SPC IRB to assure that appropriate approvals
       and/or written agreements are completed when human subjects research involves
       performance sites. Performance sites must obtain a Federal-Wide Assurance when the
       research project is federally funded and the site is considered to be “engaged” in research.
       3. Performance Sites “Engaged” in Research.
             a. Regardless of financial support or funding, Lindsey Wilson College SPC IRB
                 must assure that all performance sites “engaged” in research have approval
                 from the IRB of Record for the proposed research to be conducted at the site.
             b. It is the responsibility of the IRB of Record and the Assurance holding
                 institution to assure that the resources and facilities are appropriate for the
                 nature of the research under its jurisdiction.
      4. Performance Sites "Not engaged" in Research.
             a. When performance sites are "not engaged" in research, a letter of cooperation
                 or site authorization must be obtained demonstrating that the appropriate
                 institutional officials are permitting the research to be conducted at the
                 performance site.
             b. Lindsey Wilson College SPC IRB approval to conduct research at a
                 performance site is contingent upon receiving a letter of cooperation or site
                 authorization, as applicable.
             c. It is the responsibility of Lindsey Wilson College SPC Principal Investigator
                 and the performance site “not engaged” in research to assure that the resources
                 and facilities are appropriate for the nature of the research.
             d. It is the responsibility of Lindsey Wilson College SPC PI and/or the
                 performance site “not engaged” in research to notify Lindsey Wilson College
                 SPC IRB promptly if a change in research activities alters the performance
                 site‟s engagement in the research (e.g., performance site “not engaged” begins
                 consenting research participants, etc.).
References:
45 CFR 46
21 CFR 50 and 56
OHRP Guidance Document: Assurance of Performance Sites, September 1998
OHRP Guidance Document: Engagement of Institutions in Research, January 1999
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.C Research Involving Performance Sites
SUB-PART: I.C.1 Procedure for Research Involving Performance Sites
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.C.1 Procedure for Research Involving Performance Sites
       Procedure:
       This procedure outlines the process for assuring approval for "engaged" and "not
       engaged" performance sites associated with Lindsey Wilson College SPC human subject
       research.
              a. Investigator Responsibilities:
                  i. The Investigator will obtain documentation that approval has been granted
                       for sites "engaged" and "not engaged" in human subjects research with
                       Lindsey Wilson College SPC .
                  ii. The Investigator will include this documentation in the initial submission
                       to the IRB. If all approvals/letters of cooperation are not available at the
                       time of initial submission, they may be submitted to the IRB as they are
                       received by the Investigator. The Investigator may begin research
                       activities at each site as it is approved by Lindsey Wilson College SPC
                       IRB.
                  iii. Performance sites may be added to the research study with the submission
                       of an amendment and the appropriate documents to the IRB for review and
                       approval prior to beginning research activities at the new performance site.
                  iv. The IRB is to be notified of closures of performance sites, if they occur.
                       The Investigator will obtain the IRB approval letters or letters of
                       cooperation for each performance site.
                  v. It is the Investigator‟s responsibility to assist performance sites that do not
                       have an IRB and are “engaged” in research in securing the appropriate
                       Assurance and IRB approvals.
                  vi. It is the responsibility of the Investigator to maintain current IRB
                       documentation, (e.g. approvals, continuing reviews, FDA 1572, updated
                       assurance, investigator qualifications, etc.), throughout the course of the
                       research.
              b. IRB Committee Responsibilities:
                  i. The Committee needs to verify the Investigator‟s determination of
                       “engaged” versus “not engaged” in research. Lindsey Wilson College SPC
                       IRB is to keep a copy of the initial approval letter or letter of cooperation
                       in the study file.
                  ii. Additions or closures of study sites may be reviewed and approved in an
                       expedited manner by the Chairperson or his/her designee, when
                       appropriate documentation (e.g. IRB approval letter, Letter of
                       Cooperation, Site Authorization etc.) is provided by the Investigator.
                  iii. For performance sites “engaged” in research where Lindsey Wilson
                       College SPC has agreed to serve as the IRB of Record through an
                       MOU/Authorization Agreement, the IRB will maintain a current
                      MOU/Authorization Agreement in the office of the Director of the Human
                      Subjects Protection Program.
              c. Director of Human Subjects Protection Program (HSPP) and HSPP Staff
                 Responsibilities:
                 i. The HSPP staff member will verify that the appropriate documentation for
                      performance sites has been submitted to the IRB for approval. If omissions
                      in documentation are found, the staff member will contact the Investigator
                      specifying the required documentation needed from the performance
                      site(s).
                 ii. The Director of the HSPP will verify the institution‟s OHRP Assurance
                      number and IRB registration number for performance sites "engaged" in
                      research when required. These numbers are located on the OHRP website.
                      For those performance sites “engaged” in research where Lindsey Wilson
                      College SPC has agreed to serve as the IRB of Record through an
                      executed MOU/Authorization Agreement, the Director of the HSPP will
                      verify and enter the information in the appropriate field of the database
                      and/or study folder
                 iii. The HSPP staff member will provide Committee reviewers with a copy of
                      the performance site‟s IRB approval letter(s) or letter(s) of cooperation
                      demonstrating performance site agreement that Lindsey Wilson College
                      SPC may conduct research at each site.
                 iv. The SPP staff member will process all documents notifying the IRB of
                      closure of the performance site(s) for expedited approval by the
                      Chairperson or his/her designee. A corresponding database entry and/or
                      note to study file will be made noting the closure of the performance
                      site(s).

Examples of Research Activities Meeting Requirements for "Engaged" vs. "Not Engaged."
An institution is automatically considered to be "engaged" in human subjects‟ research whenever
it receives a direct HHS award to support such research. In such cases, the awardee institution
bears ultimate responsibility for protecting human subjects under the award.

A. Institutions would be considered "engaged" in human subjects research if their nonexempt
   involvement includes the following:
               (1) Institutions whose employees or agents intervene with living individuals by
                   performing invasive or noninvasive procedures for research purposes (e.g.,
                   drawing blood; collecting other biological samples; dispensing drugs;
                   administering other treatments; employing medical technologies; utilizing
                   physical sensors; utilizing other measurement procedures).
               (2) Institutions whose employees or agents intervene with living individuals by
                   manipulating the environment for research purposes (e.g., controlling
                   environmental light, sound, or temperature; presenting sensory stimuli;
                   orchestrating environmental events or social interactions; making voice,
                   digital, or image recordings).
               (3) Institutions whose employees or agents interact with living individuals for
                   research purposes (e.g., engaging in protocol-dictated communication or
      interpersonal contact; conducting research interviews; obtaining informed
      consent).
(4)   Institutions whose employees or agents release individually identifiable
      private information, or permit investigators to obtain individually identifiable
      private information, without subjects' explicit written permission (e.g.,
      releasing patient names to investigators for solicitation as research subjects;
      permitting investigators to record private information from medical records in
      individually identifiable form). (However, see Example (B)(5) regarding
      release of such information with subjects' prior, written permission, and
      Example (B)(6) regarding release of such information to State Health
      Departments.)
(5)   Institutions whose employees or agents obtain, receive, or possess private
      information that is individually identifiable (either directly or indirectly
      through coding systems) for research purposes (e.g., obtaining private
      information from medical records in an individually identifiable form).
      (However, see Examples (B)(7) and B(8) for certain activities involving the
      release of information and/or specimens to investigators in nonidentifiable
      form.)
(6)   Institutions whose employees or agents obtain, receive, or possess private
      information that is individually identifiable (either directly or indirectly
      through coding systems) for the purpose of maintaining "statistical centers"
      for multi-site collaborative research. Where institutional activities involve no
      interaction or intervention with subjects, and the principal risk associated with
      institutional activities is limited to the potential harm resulting from breach of
      confidentiality, the Institutional Review Board (IRB) need not review each
      collaborative protocol. However, the IRB should determine and document that
      the statistical center has sufficient mechanisms in place to ensure that (i) the
      privacy of subjects and the confidentiality of data are adequately maintained,
      given the sensitivity of the data involved; (ii) each collaborating institution
      holds an applicable OHRP-approved Assurance if necessary; (iii) each
      protocol is reviewed and approved by the IRB at the collaborating institution
      prior to the enrollment of subjects; and (iv) informed consent is obtained from
      each subject in compliance with HHS regulations.
(7)   Institutions whose employees or agents maintain "operations centers" or
      "coordinating centers" for multi-site collaborative research. Where
      institutional activities involve no interaction or intervention with subjects, the
      IRB need not review each collaborative protocol. However, the IRB should
      determine and document that the operations or coordinating center has
      sufficient mechanisms in place to ensure that (i) management, data analysis,
      and Data Safety and Monitoring (DSM) systems are adequate, given the
      nature of the research involved; (ii) sample protocols and informed consent
      documents are developed and distributed to each collaborating institution; (iii)
      each collaborating institution holds an applicable OHRP-approved Assurance
      if necessary; (iv) each protocol is reviewed and approved by the IRB at the
      collaborating institution prior to the enrollment of subjects; (v) any
      substantive modification by the collaborating institution of sample consent
                   information related to risks or alternative procedures is appropriately justified;
                   and (vi) informed consent is obtained from each subject in compliance with
                   HHS regulations.
               (8) Institutions receiving a direct HHS award to conduct human subjects research,
                   even where all activities involving human subjects are carried out by a
                   subcontractor or collaborator (e.g., a small business receives a HHS award to
                   design a medical device at its own facility and contract with a medical clinic
                   to test the device with human subjects; a foundation receives a HHS award on
                   behalf of an affiliated institution that will actually conduct the human subjects
                   research).
B. Institutions would not be considered "engaged" in human subjects research (and would not
   need an Assurance) if their involvement is limited to the following:
               (1) Institutions whose employees or agents act as consultants on research but at
                   no time obtain, receive, or possess identifiable private information (e.g., a
                   consultant analyzes data that cannot be linked to individual subjects, either
                   directly or indirectly through coding systems, by any member of the research
                   team).
                   (a) Should a consultant access or utilize individually identifiable private
                       information while visiting the research team's institution, the consultant's
                       activities become subject to the oversight of the research team's
                       Institutional Review Board (IRB). However, the consultant's institution is
                       not considered to be "engaged" in the research and would not need an
                       Assurance.
                   (b) Should a consultant obtain "coded" data for analysis at the consultant's
                       institution, the consultant's institution is considered "engaged" in human
                       subjects research, and would need an Assurance, unless a written
                       agreement unequivocally prohibits release of identifying codes to the
                       consultant.
               (2) Institutions whose employees or agents (i) perform commercial services for
                   the investigators (or perform other genuinely non-collaborative services
                   meriting neither professional recognition nor publication privileges), and (ii)
                   adhere to commonly recognized professional standards for maintaining
                   privacy and confidentiality (e.g., an appropriately qualified laboratory
                   performs analyses of blood samples for investigators solely on a commercial
                   basis).
               (3) Institutions whose employees or agents (i) inform prospective subjects about
                   the availability of research; (ii) provide prospective subjects with written
                   information about research (which may include a copy of the relevant
                   informed consent document and other IRB-approved materials) but do not
                   obtain subjects' consent or act as authoritative representatives of the
                   investigators; (iii) provide prospective subjects with information about
                   contacting investigators for information or enrollment; or (iv) obtain and
                   appropriately document prospective subjects' permission for investigators to
                   contact them (e.g., a clinician provides patients with literature about a research
                   study, including a copy of the informed consent document, and tells them how
                   to contact the investigator if they want to enroll; a clinician provides
     investigators with contact information about potential subjects after receiving
     explicit permission from each potential subject).
(4) Institutions (e.g., schools, nursing homes, businesses) that permit use of their
     facilities for intervention or interaction with subjects by research investigators
     (e.g., a school permits investigators to test students whose parents have
     provided written permission for their participation; a business permits
     investigators to solicit research volunteers at the worksite).
(5) Institutions whose employees or agents release identifiable private
     information to investigators with the prior written permission of the subject
     (e.g., with written permission of the subject, a clinician releases the subject's
     medical record to investigators).
(6) Institutions whose employees or agents release identifiable private
     information or specimens to a State or Local Health Department or its agent
     for legitimate public health purposes within the recognized authority of that
     Department. However, utilization of such information or specimens by
     Department investigators for research purposes would constitute engagement
     in research, and would require an Assurance from the Department.
 (7) Institutions whose employees or agents release information and/or specimens
     to investigators in non-identifiable (i.e., non-linkable) form, where such
     information/specimens have been obtained by the institution for purposes
     other than the investigators' research (e.g., nursing home employees provide
     investigators with a data set containing medical record information, but the
     data set contains no direct or indirect identifiers through which the identity of
     individual subjects could be ascertained, either by the investigators or by
     nursing home personnel; a hospital pathology department releases excess
     tissue specimens and relevant medical record information to investigators, but
     these materials include no direct or indirect identifiers through which the
     identity of individual subjects could be ascertained, either by investigators or
     by hospital personnel, including the pathology department; consistent with
     applicable law or recognized authority, local hospitals or health departments
     permit State or Local Health Department investigators to access information
     for research purposes, but the investigators record no direct or indirect
     identifiers through which the identity of individual subjects could be
     ascertained, either by the investigators or by local hospital or health
     department personnel.)
(8) Institutions whose employees or agents receive information or specimens for
     research from established repositories operating in accordance with (i) an
     applicable OHRP approved Assurance; (ii) OHRP guidance (see
     http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm); and (iii)
     written agreements unequivocally prohibiting of release of identifying
     information to recipient investigators.
(9) Institutions (or private practitioners) whose clinical staff provide protocol-
     related care and/or follow-up to subjects enrolled at distant sites by clinical
     trial investigators in OHRP-recognized Cooperative Protocol Research
     Programs (CPRPs). In such cases, (i) the CPRP clinical trial investigator
     (consistent with a registered investigator as defined in Section 14.1 of the NCI
            Investigator's Handbook) retains responsibility for oversight of protocol
            related activities; (ii) clinical staff may not accrue subjects or obtain informed
            consent for research participation; (iii) clinical staff may only provide data to
            the investigator in accord with the terms of informed consent; and (iv) the
            informed consent document should state that such data are to be provided by
            clinical staff as directed by the investigator.


PERFORMANCE SITES *ENGAGED IN RESEARCH AND NOT ENGAGED IN
RESEARCH”


                                Performance Sites
                               Engaged in Research,
                               WITH Federal Research
                                 Support or Direct
                                  Award for Study




                                         Must
                                have a Registered IRB




               Use Lindsey Wilson                        Use Other
                 College SPC IRB
              registered with OHRP                 OHRP-registered IRB




              Negotiate MOU with
             Lindsey Wilson College                 Obtain copy of IRB
                      SPC                               Approval
                       IRB
                                             Performance Sites Not
                                              Engaged in Research




                                            Letter of Cooperation or
                                          Site Authorization from the
                                           appropriate institutional
                                          official allowing research to
                                                 be conducted at
                                                performance site




*Engaged in Research. A performance site becomes “engaged” in human subject research when its employees or
agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable
private information for research purposes. Further, an institution is automatically considered to be “engaged” in
human subject research whenever it receives a direct federal award to support such research. In this case, the
awardee institution bears ultimate responsibility for protecting human subjects under the award.
      Examples of Research Meeting Requirements for "Engaged" vs. "Not Engaged"
                                  Behavioral Science
                EXAMPLE                            IRB DECISIONS BASED ON
                                                        REGULATIONS
Lindsey Wilson College SPC Investigators are
allowed to come into the classroom to observe,
                                                        The school would be considered "not engaged" in
audio/video tape, or distribute
                                                        research. The students and teachers of the school
surveys/questionnaires for research purposes. The
                                                        are participants in a study for which they have
students and teachers of the school have consented
                                                        consented.
by Lindsey Wilson College SPC Investigator to
participate.
A psychologist is administering a standardized test     The agency would be considered “not engaged” in
at his/her agency. The test is part of the              research. The psychologist is functioning as a
psychologist realm of professional practice. The        contract provider and is performing a
psychologist is not administering the informed          noncollaborative service that they are trained and
consent or performing data analysis.                    qualified to perform.
                                                        The school would be considered "engaged" in
A teacher conducts his/her own research program
                                                        research as the intervention is not part of the
in his/her classroom. The intervention is not part of
                                                        standard curriculum performed in the everyday
the curriculum.
                                                        activities of the teacher.
The school system performs its own research,
                                                        The school system and Lindsey Wilson College
which is completed by school personnel.
                                                        SPC would be "engaged" in research. Although
Investigators at Lindsey Wilson College SPC will
                                                        Lindsey Wilson College SPC is contracted to
analyze the data. The data will not have identifiers.
                                                        perform a service, it will be included in the
However, the Lindsey Wilson College SPC
                                                        publication and therefore, considered “engaged.”
Investigator will be included in the publication.
In a trend toward collaboration, Lindsey Wilson
College SPC Investigators and Investigators from        Both organizations would be "engaged in research”
another academic institution may be paired together     as both would be collecting data and involved in
to provide faculty with new training tools and          the publication of the results.
provide Investigators access to field experience.
Lindsey Wilson College SPC receives an award
and obtains a letter of cooperation from a              Lindsey Wilson College SPC would be considered
community-based clinic to perform research, which       "engaged in research" as Lindsey Wilson College
involves young adults. The counselor does not           SPC received funding to conduct the research. The
obtain consent from the participants but will be        clinic is "engaged" in research as the counselor is
administering surveys to the participants as part of    performing a task that is part of the research.
the research.
     Examples of Research Meeting Requirements for "Engaged" vs. "Not Engaged"
                                   Health Science

EXAMPLE                                            IRB DECISIONS BASED ON
                                                   REGULATIONS
                                                   The local clinic is "not engaged" in research as
                                                   they are considered to be a "contract" provider
                                                   and the participant requested use of the local
                                                   clinic. A contract provider may only perform
A Lindsey Wilson College SPC Investigator is
                                                   commercial services in which they are
consenting subjects and conducting research.
                                                   appropriately qualified (e.g., an appropriately
Subjects may have their blood and tissue
                                                   qualified laboratory performs analyses of blood
samples collected at a local clinic instead of a
                                                   samples for Investigators solely on a
Lindsey Wilson College SPC site, because of
                                                   commercial basis) or perform other genuinely
convenience.
                                                   noncollaborative services meriting neither
                                                   professional recognition nor publication
                                                   privileges. Lindsey Wilson College SPC is
                                                   “engaged” in research.
                                                   The local doctor would be considered "not
                                                   engaged” in research as they are providing a
A Lindsey Wilson College SPC Investigator          service that is considered standard practice.
has a 5-year research study, which requires a      Lindsey Wilson College SPC is “engaged” in
hearing evaluation as part of follow-up. A         research. A Lindsey Wilson College SPC
subject chooses to see his/her local doctor to     Investigator has a study that involves a rare
obtain the hearing evaluation.                     genetic mutation that may be identified at any
                                                   institution in the world. Lindsey Wilson
                                                   College SPC
                                                   The referring institutions are considered "not
                                                   engaged" in research, as they are not
                                                   participating in study procedures (e.g.,
                                                   consenting). A contract provider may only
Investigator will obtain consent via telephone     perform commercial services in which they are
and standard of care blood samples will be sent    appropriately qualified (e.g., an appropriately
to Lindsey Wilson College SPC with the             qualified laboratory performs analyses of blood
participant's permission.                          samples for Investigators solely on a
                                                   commercial basis) or perform other genuinely
                                                   non-collaborative services meriting neither
                                                   professional recognition nor publication
                                                   privileges. Lindsey Wilson College SPC is
                                                   “engaged” in research.
                                                   The independent MRI center is considered "not
A Lindsey Wilson College SPC Investigator
                                                   engaged" in research. The MRI center is
will contract with an independent MRI center
                                                   considered a contract provider and providing a
to conduct MRI procedures for research
                                                   service for which they are qualified to perform
purposes. The MRI center will then send all
                                                   outside of the research context. Lindsey
reports to the Investigator.
                                                   Wilson College SPC is “engaged” in research.
An external clinic (outside Lindsey Wilson
College SPC ) has written permission from the     The external site is "not engaged" in research
participants to disclose Protected Health         because they have obtained explicit written
Information to a Lindsey Wilson College SPC       permission from the participants to release
Investigator for research purposes. The data      PHI. Lindsey Wilson College SPC is
was collected at the external clinic solely for   “engaged” in research.
the purpose of routine clinical care.

                                                  The Health department would be considered
                                                  "engaged" in research. The VA is "engaged" in
The VA receives grant funding from the
                                                  research as the recipient of the funding and as
Federal government. The research is conducted
                                                  such, Lindsey Wilson College SPC IRB must
at the Health Department with the assistance of
                                                  also approve the research. The Health
Health Department employees.
                                                  Department IRB must also review and approve
                                                  the research study.
A Lindsey Wilson College SPC Investigator is      Both Lindsey Wilson College SPC and non
conducting an oncology study in which             Lindsey Wilson College SPC sites would be
additional non-Lindsey Wilson College SPC         considered "engaged" in research as they will
sites would follow the protocol and administer    be obtaining consent and performing research
the                                               procedures. All sites require IRB approval
chemotherapy.                                     from each site‟s IRB.
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.D Knowledge of Local Research Context
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.D Knowledge of Local Research Context
      1. Definitions:
               a. Assurance: A contract or agreement that establishes standards for human
                   subjects research as approved by the Office for Human Research Protections
                   (OHRP).
               b. Department of Health and Human Services (DHHS): The United States
                   Government's agency for protecting the health of all Americans and providing
                   essential human services, especially for those who are least able to help
                   themselves.
               c. Greater than Minimal Risk: Where the research involves greater than
                   minimal risk (defined below) to subjects, the mechanism of obtaining local
                   research context differs depending on whether the local research context
                   involves intervention or interaction with subjects and whether the principal
                   risk associated with the local research context is limited to the potential harm
                   resulting from a breach of confidentiality.
               d. IRB of Record: An IRB is considered the IRB of record when it assumes IRB
                   responsibilities for another institution and is designated to do so through an
                   approved Assurance with OHRP. A Memorandum of Understanding or
                   Authorization Agreement is required, designating the relationship, for Lindsey
                   Wilson College SPC to serve as the IRB of Record.
               e. Local Research Context: Knowledge of the institution and community
                   environment in which human subjects research will be conducted.
               f. Minimal Risk: The probability and magnitude of harm or discomfort
                   anticipated in the research are not greater in and of themselves than those
                   ordinarily encountered in daily life or during the performance of routine
                   physical or psychological examinations or tests. An example of minimal risk
                   is the risk of drawing a small amount of blood from a healthy individual for
                   research purposes (because the risk of doing so is no greater than the risk of
                   doing so as part of a routine physical examination).
               g. Office for Human Research Protections (OHRP): The office under the
                   Department of Health and Human Services responsible for implementing
                   DHHS regulations (45 CFR 46) governing biomedical and behavioral/social
                   science research involving human subjects.
      2. Policy:
      It is the policy of Lindsey Wilson College SPC Institutional Review Board to obtain
      sufficient
      knowledge of the local research context to fulfill its responsibilities,
      regardless of the geographical location of the research.
               a. Lindsey Wilson College SPC IRB must fulfill the responsibilities toward
                   human research subjects regardless of its geographic location relative to the
                   Institution and the research. This is particularly critical when the research
                involves greater than minimal risk to participants or involves vulnerable
                categories of participants.
             b. When Lindsey Wilson College SPC IRB is geographically removed from the
                site at which the research will be conducted, Lindsey Wilson College SPC
                IRB is serving as another institution‟s IRB of Record, or when the research
                involves a distinct subject population (e.g. Veterans, Amish, etc.), the IRB
                must demonstrate that it has obtained the necessary information about the
                local research context through compliance with required standards. These
                standards reflect minimal levels of adequacy. Standards that are more
                stringent may be required, depending on the nature of the proposed research
                or the relevant research context.
             c. When the IRB wishes to avoid duplication of effort, in accordance with
                DHHS regulations at 45 CFR 46.114, the IRB may rely on the review of
                another OHRP Assurance-holding institution. The review arrangement must
                be approved in writing by OHRP and by appropriate officials of the
                institutions involved. When relying on another IRB‟s review, Lindsey Wilson
                College SPC IRB has a responsibility to ensure that the particular
                characteristics of the local research context are considered, either through
                knowledge of the local research context by the reviewing IRB (See IRB
                Procedure I.D.1); or through subsequent review by appropriate designated
                institutional officials, such as the Chairperson and/or other members of its
                local IRB.
References:
45 CFR 46
OHRP Guidance Document: Knowledge of Local Research Context, July 21, 2000
PROGRAM: Human Subjects Protection Office
SECTION: I IRB Authority and Institutional Commitment
POLICY NUMBER: I.D Knowledge of Local Research Context
SUB-PART: I.D.1 Procedure for Knowledge of Local Research Context
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.D.1 Procedure for Knowledge of Local Research Context
       Procedure:
       This procedure outlines the process for the collection, submission, and review of
       sufficient information regarding local research context for research within the jurisdiction
       of the Lindsey Wilson College SPC Institutional Review Board.
               a. Investigator Responsibilities:
                   i. The Investigator will obtain documentation of the necessary information
                       required under the DHHS regulations for verification of local research
                       context when the proposed research will be conducted in an area
                       geographically removed from the Lindsey Wilson College SPC IRB,
                       Lindsey Wilson College SPC IRB is serving as another institution‟s IRB
                       of Record, or when the research involves a distinct subject population (e.g.
                       Veterans, Amish, etc.). This documentation should include:
                       • The anticipated scope of the institution‟s or population‟s involvement
                           in the research activities
                       • The types of participant populations likely to be involved
                       • The size and complexity of the institution or population
                       • Any Institutional commitments, regulations, and/or applicable laws
                           specific to the institutions or population
                       • Standards of professional conduct and practice at the institution
                       • The method for equitable selection of subjects
                       • Method for protection of privacy of subjects
                       • Method for maintenance of confidentiality of data
                       • Language(s) understood by prospective participants
                       • Method for minimizing the possibility of coercion or undue influence
                           in seeking consent
                       • Safeguards to protect the rights and welfare of vulnerable participants
                       • Determination and specifically, documentation that provisions to
                           protect the privacy of participants and maintain confidentiality of data
                           are adequate
                   ii. The Investigator is responsible for addressing local research context at
                       each continuing review interval. The Investigator must promptly report to
                       the IRB any changes in the local research context that may influence or
                       alter the risk/benefit ratio.
               b. IRB Committee Responsibilities:
                   i. The IRB Committee must have the experience and expertise necessary to
                       review and make determinations regarding local research context. This
                       may be achieved through:
                       • Submission of sufficient documented information regarding local
                           research context by the Investigator
   •    Personal knowledge of the local research context on the part of one or
        more IRB members, such knowledge having been obtained through
        extended, direct experience with the research institution, its subject
        populations, and its surrounding community
    • The Committee may request a written review by a consultant(s)
        knowledgeable of the local research context. The consultant may then
        be invited to participate (either physically or through audiovisual or
        telephone conference) in the convened meeting of the IRB.
ii. The IRB must demonstrate that it has obtained the necessary information
    about the local research context through compliance with required
    standards. These standards include the following:
    Minimal risk. When the research involves minimal risk to the subjects,
        the IRB should demonstrate that it has obtained necessary information
        about the local research context through written materials or
        discussion with appropriate consultants.
    Greater than minimal risk without intervention/interaction with
        participants. When the research involves greater than minimal risk to
        the participants but the local research context involves no intervention
        or interaction with participants and the principal risk associated with
        the local research context is limited to the potential harm resulting
        from a breach of confidentiality, the IRB should:
        • Demonstrate that it has obtained necessary information about the
            local research context through written materials or discussions with
            appropriate consultants and necessary information under DHHS
            regulations.
        • Determine and specifically document that provisions to protect the
            privacy of subjects and maintain confidentiality are adequate.
    Greater than minimal risk with intervention/interaction with
        participants. When the research involves greater than minimal risk
        and the Investigator and/or key study personnel will have interaction
        or intervention with the participants or the risk associated with the
        local research context is broader than the potential harm resulting from
        a breach of confidentiality, the IRB should demonstrate that it has
        obtained necessary information about the local research context
        through one or more of the following mechanisms or through other
        mechanisms deemed appropriate by OHRP for the proposed research
        and local research context:
        • Personal knowledge of the local research context on the part of one
            or more IRB members, such knowledge having been obtained
            through extended, direct experience with the research institution,
            its subject populations, and its surrounding community
        • Participation (either physically or through audio conference) by
            one or more appropriate consultants in a convened IRB meeting.
            Such consultant(s) should have personal knowledge of the local
            research context, such knowledge having been obtained through
            extended, direct experience with the research institution, its subject
                populations, and its surrounding community. The consultant(s)
                may participate in the discussion and provide a recommendation
                but they are not a voting member.
            • Prior written review of proposed research by one or more
                appropriate consultant(s), in conjunction with participation (either
                physically or through audiovisual conference) by the consultant(s)
                in convened IRB meetings, when such participation is deemed
                warranted either by the consultant(s) or by any member of the IRB.
                The consultant(s) may participate in the discussion and provide a
                recommendation but they are not a voting member.
            • Systematic, reciprocal, and documented interchange between the
                IRB and elements of the local research context. Such interchanges
                could include:
                1) Periodic visits to the research site, occurring annually, by either
                    one or more IRB members or HSPP staff in order to obtain and
                    maintain knowledge of the local research context, including the
                    research institution, its subject populations, and its surrounding
                    community;
                2) Periodic discussion with appropriate consultants
                    knowledgeable about the local research context;
                3) Regular interaction with one or more designated institutional
                    liaisons
                4) Review of relevant written materials from the local site
   iii. Local research context must also be reviewed at the time of continuing
        review of the proposal.
c. HSPP Staff Member Responsibilities:
   i. The staff member will pre-review the submitted research proposal to
        assure that local research context has been addressed, when applicable
   ii. The staff member will assist the Committee with identifying a
        consultant(s) and will assure distribution of the appropriate review
        materials, when applicable.
   iii. The staff member will maintain documentation of local research context
        and will update the database and/or study file accordingly.
PROGRAM: Human Subjects Protection Office
SECTION: I IRB Authority and Institutional Commitment
POLICY NUMBER: I.E Cooperative Agreements
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


I.E Cooperative Agreements
      1. Definitions:
              a. Cooperative Agreement: A joint agreement, in which multiple institutions
                  agree to participate in a research project while relying on the review of one
                  primary IRB‟s review and approval in order to avoid duplication of effort. The
                  primary IRB responsibilities may be rotated among the participating
                  institutions.
              b. Primary Reviewing Institution: The institution serving as the IRB of record
                  in a Cooperative Agreement.
              c. Other Participating Institution: A collaborating institution that has chosen
                  to participate in a research study under the Cooperative Agreement that will
                  rely on the Primary Reviewing Institution as the IRB of record in order to
                  avoid duplication of effort.
      2. Policy:
         It is the policy of Lindsey Wilson College SPC IRB to permit research activities
         under an established Cooperative Agreement in which Lindsey Wilson College SPC
         IRB has granted approval.
              a. When the IRB wishes to avoid duplication of effort, the IRB may rely on
                  another approved institution. The review arrangement between the institutions
                  must be approved in writing by appropriate officials of the institutions
                  involved. In addition, the following criteria must be met:
                  • The arrangement may not contain disincentives, impediments, or conflicts
                      of interest that may hamper the exercise of the IRB function or objectivity.
                  • IRB members may not hold an equity interest in the organization
                      providing IRB review.
                  • No IRB member may receive compensation or benefits under
                      arrangements that could impede, discourage, or encourage objective
                      decision-making on behalf of human subjects. Lindsey Wilson College
                      SPC IRB is responsible for ensuring that the particular characteristics of
                      its local research context are considered by the reviewing institution.
                      When relying on this arrangement for IRB approval, Lindsey Wilson
                      College SPC must continue to ensure the appropriate safeguards
                      protecting the rights and welfare of human subjects are integrated into the
                      research.
              b. Lindsey Wilson College SPC IRB acting as the Primary Reviewing Institution
                  under a Cooperative Agreement Lindsey Wilson College SPC IRB as the
                  primary reviewing institution (IRB of record) agrees to assume responsibility
                  for initial and ongoing review and conduct for the study or studies under the
                  Cooperative Agreement. Prior to reviewing research for the other participating
                  institution, Lindsey Wilson College SPC IRB must assure it has sufficient
                  knowledge regarding local research context. Lindsey Wilson College SPC
                 IRB approval of research activities applies to all participating research sites;
                 therefore, approvals must be conveyed to all participating sites in accordance
                 with the Cooperative Agreement.
              c. Responsibility for Site Conduct Regardless of whether Lindsey Wilson
                 College SPC IRB serves as the primary reviewing institution or as an
                 institution relying on a designated IRB through a Cooperative Agreement, the
                 Principal Investigator retains the responsibility for the conduct of the study at
                 his/her site.
References:
21 CFR 56.114
45 CFR 46.114
U.S. Food and Drug Administration Information Sheets: Guidance for Institutional Review
Boards and Clinical Investigators, 1998.
OHRP Guidance Document: IRB Knowledge of Research Context, August 27, 1998
OHRP Guidance Document: Institutional Review Board‟s Reliance on Another Institution‟s
IRB, July 9, 1991
PROGRAM: Human Subjects Protection Office
SECTION: I IRB Authority and Institutional Commitment
POLICY NUMBER: I.E Cooperative Agreements
SUB-PART: I.E.1 Procedure for Cooperative Agreements
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.E.1 Procedure for Cooperative Agreements
       Procedure:
       This procedure outlines the procedures for multi-site research carried outside of Lindsey
       Wilson College SPC
              a. Investigator Responsibilities.
                  i. The PI is responsible for the incorporation of local research context within
                       the initial study application and at the time of continuing review or any
                       time there are changes in the local research context that may influence or
                       alter the risk/benefit ratio.
                  ii. Amendments to ongoing research may not be implemented unless
                       submitted for IRB Committee for review and approval.
                  iii. The PI is responsible for assuring that the forms/documents for multi-site
                       research are sent to the LWC IRB office and that copies of all
                       forms/documents are maintained.
                  iv. The PI will maintain training records indicating that site PIs and key study
                       personnel have completed requirements for human research protections
                       training.
                  v. Information from alternate sites will be communicated promptly in writing
                       to the IRB Committee that is relevant to the protection of research
                       participants including but not limited to unanticipated problems involving
                       risks to participants or others, interim results from Data Safety Monitoring
                       Committees/Boards, suspension of site PI, serious or continuing
                       noncompliance.
                  vi. Information from among the sites, relevant to the protection of research
                       participants, will be communicated promptly in writing to the various
                       sites. This information includes but is not limited to unanticipated
                       problems involving risks to participants or others, interim results from
                       Data Safety Monitoring Committees/Boards, study suspensions, or serious
                       or continuing noncompliance.
              b. IRB Committee Responsibilities.
                  i. The IRB Chairperson, designee or IRB Committee will review initial
                       research proposals to assure sufficient local research context has been
                       provided.
                  ii. The IRB Chairperson, designee or IRB Committee will review
                       amendments to ongoing research
                  iii. The IRB Committee will review information from among the sites
                       relevant to the protection of research participants. This information
                       includes but is not limited to unanticipated problems involving risks to
                       participants or others, interim results from Data Safety Monitoring
                       Committees/Boards, study suspensions, or serious or continuing
                       noncompliance.
c. HSPP Staff Responsibilities.
   i. HSPP staff will pre-review the submission and assure that all forms and
       documents required for multi-site research have been submitted.
   ii. HSPP staff will review training records and assure that site PIs and key
       study personnel have completed requirements for human research
       protections training.
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.F IRB of Record
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.F IRB of Record
       1. Definitions:
           a. Coordinating Center: An institution, department, or center, which agrees to be
               responsible for the conduct, administrative, or coordinating functions of a multi-
               center research project.
           b. IRB of Record: An IRB is considered the IRB of record when it assumes IRB
               responsibilities for another institution. A Memorandum of Understanding is
               required designating the relationship.
           c. Memorandum of Understanding (MOU): A formal agreement between the
               Lindsey Wilson College SPC and another institution that identifies Lindsey
               Wilson College SPC Institutional Review Board as the IRB of record for that
               institution.
           d. Performance Site(s) Engaged in Research: A performance site becomes
               "engaged” in human subjects research when its employees or agents 1) intervene
               or interact with living individuals for research purposes, or 2) obtain individually
               identifiable private information for research purposes. Further, a performance site
               is considered to be "engaged” in human subject‟s research when it receives a
               direct Federal award to support the research.
           e. Site Authorization: A letter from an appropriate official of the site/sites at which
               recruitment and/or study conduct will be performed outside the supervising
               department (e.g., in another department, off-campus agency or organizational
               location) granting approval for conduct of specific study activities.
       2. Policy:
           The policy establishes the provisions under which Lindsey Wilson College SPC
           (LWC) Institutional Review Board (IRB) will serve as the IRB of Record for an
           external site engaged in research.
           a. IRB of Record.
               i. Differences between “coordinating center” and “IRB of Record.” When the
                    LWC IRB serves as the IRB of Record, it is accepting the responsibility of
                    oversight of the conduct of the research for a particular site. The details of
                    such an agreement are outlined in an MOU.
               ii. A “coordinating center” of a multi-center trial is responsible for assuring that
                    IRB approval is granted at the participating sites prior to the initiation of the
                    research at that site. The coordinating center assumes responsibility for
                    assuring that the participating site has received IRB approval at its sites.
               iii. Under rare circumstances, the LWC IRB may be requested to serve as the IRB
                    of Record for a participating site of a multi-center trial in which a LWC
                    Investigator is serving as the “coordinating center.” The participating site may
                    either not have an IRB of Record, or due to other circumstances, may request
                    the LWC IRB to serve as their IRB of Record for that particular study at that
                    particular site.
           b. Memorandum of Understanding (MOU).
              i.   An executed MOU is one method by which the LWC IRB serves as the IRB
                   of Record for a site, which is not a legal entity of the LWC.
              ii. The LWC IRB will also accept an “IRB Authorization Agreement” or an
                   MOU. All agreements for the LWC IRB to serve as the IRB of Record for a
                   performance site “engaged” in research must be detailed in either an executed
                   MOU or an “IRB Authorization Agreement”.
              iii. A MOU between the relevant parties will outline specific provisions and
                   responsibilities for each party entering into the agreement.
         c.   Basis for LWC IRB to serve as the IRB of Record.
              i. The performance site engaged in research may or may not have an IRB and
                   will rely solely on the LWC IRB for review of human subjects research
                   activities; or
              ii. The performance site engaged in research may or may not have an IRB of
                   Record, but will rely on the LWC IRB for a specific research project.
         d.   Conditions for LWC IRB to serve as the IRB of Record.
              i. The research shall be conducted in collaboration with LWC; and
              ii. The Principal Investigator must be a faculty member at the LWC.
         e.   The performance site engaged in research requesting the LWC IRB to serve as the
              IRB of Record must:
              i. File a Federalwide Assurance (FWA); and
              ii. Conduct the research in accordance with the terms and conditions specified in
                   the MOU or the IRB Authorization Agreement”.
         f.   The Investigator must provide all necessary information pertaining to local
              research activities conducted at external sites in accordance with LWC IRB
              policies and procedures.
         g.   The LWC IRB and external site will maintain an approved Federalwide
              Assurance (FWA) and provide verification of such during the negotiation of the
              MOU or “IRB Authorization Agreement”.
         h.   The Investigator will be responsible for payment of the negotiated fees as
              established in the MOU.
         i.   The Investigator and external sites will abide by all LWC IRB policies and
              procedures including accessing the Lindsey Wilson IRB Website at
              http://www.lindsey.edu to view any revisions and/or updates.
         j.   Investigators will comply with all oversight activities deemed appropriate by the
              IRB, Federal oversight agencies and/or Federal funding agencies at all sites (e.g.,
              monitoring, auditing).
References:
45 CFR 46
PROGRAM: Human Subjects Protection Program
SECTION: I. IRB Authority and Institutional Commitment
POLICY NUMBER: I.F IRB of Record
SUB-PART: I.F.1 Procedure for Memorandum of Understanding (MOU)
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


I.F.1 Procedure for Memorandum of Understanding (MOU)
       Procedure:
       This procedure outlines the process for establishing and maintaining a Memorandum of
       Understanding for sites where Lindsey Wilson College SPC (LWC) Institutional Review
       Board (IRB) serves as the IRB of Record for all research activity at the site or for a
       specific research project.
       1. Investigator Responsibilities.
           a. The Investigator will complete the initial MOU template and submit to the HSPP
               for processing.
           b. The following documentation will be submitted with the template:
               i. A certificate of insurance for general comprehensive liability and professional
                    liability for Investigators and staff involved in the conduct of research;
               ii. A list of all research staff identifying their role in the study with correct titles
                    and degrees;
               iii. Verification of the Investigator‟s and/or key study personnel‟s LWC
                    employment status;
               iv. Curriculum Vitae for all Investigators and key study personnel involved in the
                    conduct of the study;
               v. Completed Verification of Training Form for all Investigators and key study
                    personnel, verifying successful completion of the LWC IRB Human Subjects
                    Protection Program Training program;
               vi. Names of the local contacts, Institutional Signatory Official, and Human
                    Protections Administrator for the site requesting the LWC IRB to serve as the
                    IRB of Record;
           c. The Investigator must provide all necessary information regarding local research
               context including the following:
               i. Local contacts for IRB questions;
               ii. Local contacts for research participants;
               iii. Local subject injury language; and
               iv. Local HIPAA language.
           d. The Investigator or representative from the external site must provide to the IRB
               and keep current the names, addresses, and phone numbers of local contact
               persons who can make decisions regarding IRB issues.
           e. The LWC IRB may conduct their own audit of the external site‟s conduct of
               research depending on several factors, including but not limited to, the following:
               i. The level of risk of the research study;
               ii. The number of reported unanticipated problems involving risk to participants
                    or others or serious adverse events (e.g., this could be an inordinate low
                    number of reports in a high risk study);
               iii. The degree of local oversight provided;
               iv. The involvement of a Data Safety Monitor, Committee, or Board;
      v. An increased number of protocol deviations;
      vi. Complaints from participants; or
      vii. Any issues of noncompliance.
   f. When applicable, site authorization letters from all external research sites must
      be submitted to the LWC IRB before the research may be conducted.
   g. A copy of an approved Federal wide Assurance (FWA), if necessary, must be
      submitted to the HSPP. If a FWA has been applied for, but not yet granted
      approval, a copy of the FWA with OHRP approval must submitted to the HSPP
      within 30 days of receipt.
   h. An original signature on the MOU of the Institutional Official with the authority
      to sign contracts is required.
   i. The Investigator will provide payment of the following fees determined at the
      time of the MOU negotiations:
      (i.a) IRB Review Fee(s) - Due for each industry sponsored human subjects
           research project reviewed by the LWC IRB.
   j. The Investigator will agree to abide by all LWC HSPP policies and procedures
      including accessing the HSPP website at http://www.lindsey.edu to view any
      revisions and/or updates.
   k. The Investigator will assure adherence to the agreements outlined in the MOU.
   l. The Investigator will fully inform the HSPP of all locations in which human
      subjects will be recruited into the research project.
   m. All Investigators and key study personnel at the external site must participate in
      human research protections continuing education and provide documentation to
      the HSPP office.
   n. The Investigator will comply with all oversight activities deemed appropriate by
      the IRB Committee, Federal oversight agencies and/or Federal funding agencies
      at all sites (e.g., monitoring, auditing).
   o. The Signatory Official or administrator must notify the HSPP immediately if a
      local Investigator or key study personnel receives a suspension or restriction of
      any duties, clinical or research related. In addition, they must notify the HSPP if
      any Investigator or key study personnel have received a determination of serious
      or continuing noncompliance. Failure to do so may result in cancellation of the
      MOU.
   p. All IRB-related communication and documents will be submitted by the
      Investigator to the HSPP office.
2. HSPP Director Responsibilities.
   a. The Director will draft the MOU with consultation from other school
      administrators.
   b. The HSPP Director will make all final determinations regarding the LWC IRB‟s
      willingness to serve as the IRB of Record for a performance site “engaged” in
      research.
   c. With the approved MOU, the HSPP office agrees to:
      i. Maintain and provide a copy of an approved Federal wide Assurance (FWA);
      ii. Provide a copy of the MOU to the Office of Research and Contract Analysis;
      iii. Inform the HSPP staff of the conditions of the MOU; and
      iv. Keep the MOU on file in the HSPP office.
   d. The HSPP Director will register with the OHRP, if necessary, and the HSPP will
      serve as the IRB of record for the external site only for the human subjects
      research activities that are (a) conducted in collaboration with the LWC, (b)
      where the Investigator is a LWC employee, or (c) where the Principal
      Investigators or research personnel are employees of the external site.
   e. The HSPP office will report promptly (within 21 days) to the appropriate
      institutional officials of the external site all actions taken by the IRB regarding (a)
      any serious or continuing noncompliance by Investigators and (b) any suspension
      for cause or termination for cause of IRB approval in accordance with the HSPP
      policies and procedures.
   f. If necessary, the HSPP office will contact Legal Counsel and/or Risk
      Management for advice on indemnification language and insurance limits.
   g. If the external sites require inclusion of local context such as local contact
      names/numbers, subject injury language, HIPAA language, conflict of interest,
      etc., the HSPP suggests the use of one informed consent form and one HIPAA
      authorization form with each site that is modified to include the local information
      that varies from site to site.
3. IRB Committee Responsibilities.
   a. The IRB Committee must determine if Principal Investigators are qualified to
      conduct the research in relationship to their specific roles.
   b. The IRB Committee must assess if the external site has the appropriate resources
      to safely and ethically conduct the study. Items to be considered include, but are
      not limited to, the following:
      i. The number and composition of staff;
      ii. The facilities, e.g. resources available to handle emergency situations, etc.;
      iii. The mechanism of recruitment utilized;
      iv. The process of informed consent; and
   c. The IRB Committee must review the following for adherence to State Law
      including, but not limited to:
      i. Age of consent;
      ii. Capacity to consent;
      iii. HIV status reporting;
      iv. Screening consent;
      v. Child Assent;
      vi. Confidentiality of patient records;
      vii. HIPAA;
      viii.Mentally and physically handicapped; and
      ix. Surrogate Consent.
   d. Each informed consent form will be compared for consistency. In addition, the
      Committee Members must verify the appropriateness of each site‟s contact
      names/numbers, subject injury language, HIPAA language, conflict of interest,
      etc.
4. HSPP Staff Responsibilities.
   a. The HSPP staff will verify that the Investigator and key study personnel have
      completed the education requirements in human research protections.
b. The HSPP staff will assure that the appropriate documentation of local research
   context has been submitted for review and consideration.
c. If needed, the HSPP staff will verify the institution‟s OHRP Assurance number
   from the OHRP website and assure that the approval is current. Appropriate
   documentation of this verification will be entered into the database.
d. At the time of pre-review, the HSPP staff will review the research for adherence
   to State Law including, but not limited to:
   i. Age of consent;
   ii. Capacity to consent;
   iii. HIV status reporting;
   iv. Screening consent;
   v. Child Assent;
   vi. Confidentiality of patient records;
   vii. HIPAA; and
   viii.Mentally and physically handicapped.
e. At the time of pre-review, the HSPP staff will review each informed consent
   document and other study-related documents to assure consistency and addition of
   site-specific information. In addition, staff will assure that the Committee
   Members discussion regarding the appropriateness of each site‟s contact
   names/numbers, subject injury language, HIPAA language, conflict of interest,
   etc. is reflected in the IRB Committee Minutes.
f. If there are questions that the PI cannot answer, the HSPP staff will contact the
   IRB contact at the local site for additional information.
g. At the time of pre-review the HSPP staff will reference the MOU for the external
   site to verify if any additional requirements need to be met. If clarification is
   required, HSPP staff will consult with the HSPP Director and will convey
   additional requirements to the IRB Committee at the time of its review.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.A IRB Compliance Activities
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


II.A IRB Compliance Activities
       1. Definitions:
          a. Continuous Quality Improvement (CQI): A methodology employed, for
               routine assessment of current practice and when needed, to improve existing
               processes by identifying the root cause of a problem, developing and
               implementing an action plan, and evaluating the outcome to assure problem
               resolution.
          b. Directed Audit: These audits are conducted by the HSPP staff, or other
               designated individuals to assess the Investigator‟s compliance with federal
               regulations, state and local laws, and Lindsey Wilson College SPC IRB policies
               and procedures. These audits of IRB approved research studies are in response to
               identified concern(s). Concerns may be identified by an IRB Committee, an
               external source (e.g. OHRP, FDA or Sponsor), or an internal source (e.g.
               participant, family member, or Institutional personnel).
          c. Periodic Compliance Review: Random assessments of the internal IRB
               department and external departments or sites involved in the conduct of human
               subjects research at Lindsey Wilson College SPC are conducted by the HSPP
               staff. These reviews are used to evaluate proper execution and accurate
               documentation of an IRB approved research project. Internal compliance reviews
               monitor the adherence to federal regulations, state and local law, and IRB policies
               and procedures as well as accurate documentation between the IRB database and
               the IRB paper files. External compliance reviews monitor the adherence to federal
               regulations, state and local law, Lindsey Wilson College SPC IRB policies and
               procedures, adherence to the study protocol, accurate documentation and
               reporting of study related activities, and evaluation/observation of the informed
               consent process.
          d. Quality Assurance Reviews: Quality Assurance reviews are performed by the
               HSPP staff, or other designated individuals to verify that the electronic database is
               consistent with the IRB paper files and the paper files are organized in accordance
               with IRB policy and procedure.
       2. Policy:
          It is the policy of Lindsey Wilson College SPC Institutional Review Board to oversee
          all internal and external compliance reviews and/or auditing efforts in order to assure
          the protection of human research participants and compliance with federal
          regulations, state and local law as well as Lindsey Wilson College SPC IRB policies
          and procedures.
          a. Initiation of Audit/Review. The Director of the HSPP, and/or the Chairs of the
               IRB Committees may direct the HSPP staff or designee to initiate periodic
               compliance reviews and/or directed audits when deemed necessary. The IRB and
               HSPP have the authority to observe or appoint a designee to observe the informed
               consent process and IRB approved research.
          b. External Consultant. Lindsey Wilson College SPC IRB may engage an external
              consultant with a specific area of expertise to perform or assist with any of the
              above defined auditing and reviewing activities.
          c. External Sites. Directed audits and periodic compliance reviews may also be
              conducted by the HSPP staff at non-Lindsey Wilson College SPC sites where
              Lindsey Wilson College SPC IRB serves as the IRB of Record.
          d. Reporting of Monitoring and/or Auditing Results. The results of any monitoring
              or auditing activity by the IRB will be reported in writing to the Director of the
              Human Subjects Protection Program, and the Chair of the IRB Committee
              responsible for the review of the study. The IRB Chair will determine the need for
              full IRB Committee review. If the monitoring or auditing activity finds that a
              human subject participating in a research project has been exposed to unexpected,
              serious harm, the IRB Compliance Team will promptly report such findings to the
              Director of the Human Subjects Protection Program, and the Chair of the IRB
              Committee that reviewed and approved the study. In addition, the audit findings
              from the study in question will be placed on the agenda of the next regularly
              scheduled meeting for discussion.
          e. IRB May Suspend or Terminate Research. If the information, gained during the
              monitoring or auditing process, indicates that human subjects of a research project
              were exposed to unexpected serious risk or harm, or that the policies of the IRB
              were not met, the IRB will suspend or terminate the research.
          f. Safety Monitoring. The IRB may request additional safety monitoring, as it deems
              necessary.
          g. Additional Requirements For Activities Involving Vulnerable Populations. For
              activities involving vulnerable populations such as fetuses, pregnant women,
              human in vitro fertilization, prisoners, children, or the cognitively impaired, the
              IRB should determine that adequate provisions have been made by the
              Investigator for protection of these vulnerable populations, which may include the
              monitoring of the actual informed consent process requiring a witness to oversee
              the consenting process or have other specific instructions.
          h. The HSPP staff will conduct continuous quality improvement (CQI) and quality
              assurance (QA) activities to assure the best possible practice is conducted in IRB
              operations.
References:
45 CFR 46
21 CFR 50 & 56
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.A IRB Compliance Activities
SUB-PART: II.A.1 Procedure for IRB Compliance Activities
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


II.A.1 Procedure for IRB Compliance Activities
       Procedure:
       The purpose of this procedure is to outline the processes for conducting compliance
       reviews and audits by Lindsey Wilson College SPC IRB and Human Subjects Protection
       Program Office.
              a. Investigator Responsibilities:
                  i. The Investigator will cooperate with the IRB by making him/herself
                     available for questions, having documents accessible, and responding to
                     any written requests within the time frame designated by the IRB in
                     association with a directed audit. Written preliminary audit results will be
                     provided to the Investigator to facilitate understanding of the process and
                     collaboration in resolving any outstanding issues/concerns. The PI, or
                     designee will be present for an exit interview that will occur following
                     each directed audit. Investigators will abide by all IRB Chair, or his/her
                     designee and/or full IRB Committee determinations. These determinations
                     may include developing and following a corrective action plan and/or an
                     educational plan and completing it in the time specified by the Committee.
                     The Investigator may request or may be requested to attend a full IRB
                     Committee meeting to present information addressing any concerns
                     resulting from a directed audit, as well as any determination rendered by
                     the full IRB Committee.
           b. IRB Committee Responsibilities:
              i. Directed audits may be requested by the Chair of the IRB to assess
                  compliance with local, State, and Federal laws, research participant safety,
                  and IRB policies and procedures.
              ii. Determining the need for such additional supervision or participation by the
                  IRB is made by the IRB on a case-by-case basis during the initial and
                  continuing review, or as new information is presented. Factors to be
                  considered by the IRB may include:
                  • Involvement of vulnerable populations;
                  • Research conducted internationally;
                  • The involvement of recombinant DNA or other types of gene transfer
                     protocols;
                  • The use of waiver or alteration of informed consent procedures, e.g.
                     surrogate consent;
                  • Research for which subjects would be exposed to additional risks, e.g.
                     breach of confidentiality, Phase 1 studies, disproportionate number or
                     severity of SAEs;
                  • Previous suspension of the research due to compliance issues, poor record-
                     keeping or other concerns;
                  • Recommendations from other institutional committees
           Upon receipt and review of the directed audit summary, the IRB Committee
           may:
           Accept the audit report with or without revisions to the currently approved
           study; or
           Impose additional measures for participant safety. These may include, but are
           not limited to:
           • Request status reports after each participant receives intervention;
           • Decrease the continuing review cycle (e.g. 3 months, 6 months, after a
               specific number of participants are enrolled);
           • Require an independent safety monitor or formation of a data safety
               monitoring board (DSMB) to monitor activities locally or nationally if
               Lindsey Wilson College SPC is a coordinating center;
           • Request an off-cycle DSMB review and written report;
           • Conduct a follow-up audit by the HSPP staff or designee;
           • Require oversight/signatures by superior on all research;
           • Replace the PI by a qualified Investigator who is not subordinate to the
               Investigator being replaced;
           • Limit Investigator‟s ability to submit new research studies to the IRB;
               and/or
           • Require an ombudsman or subject advocate to participate in or monitor the
               informed consent process;
           Create an education plan recommended by the IRB Chair or HSPP Director,
           these may include, but are not limited to:
               (ii.a) Participation of Investigator and/or research staff in IRB “101”:
                        additional training as designated by the IRB
               (ii.b) Attendance of Investigator and/or research staff at local, regional
                        or national conferences on human subjects protections;
               (ii.c) Review of additional regulatory documents or materials (e.g.
                        Belmont Report, 45 CFR 46, IRB policies and procedures, OHRP
                        determination letters);
               (ii.d) Additional web-based human subjects protection training (e.g.
                        OHRP, NIH, NCI); and/or
           Accept the audit report and place the study on “Suspension”, specifying the
           criteria for the suspension pending further investigation.

The Committee will outline any recommendations in a letter to the Investigator. At the
direction of the IRB Chair and the Director of the Human Subjects Protection Program,
or IRB Committee, the IRB may engage an expert consultant to perform or assist with
any of the auditing and reviewing activities.

   c. HSPP Staff:
      i. Directed Audit.
         (i.a) The HSPP staff will contact the Investigator to schedule the on-site visit
               via an e-mail.
   ii. The HSPP staff will conduct a focused or comprehensive audit contingent upon
        consideration of the request and preliminary evaluation, which may include, but is
        not limited to the following:
        (ii.a) A review of the inclusion/exclusion criteria, participant selection and
             recruitment methods to verify that subject selection is appropriate
        (ii.b) A review of the consent process and/or documentation. This may include an
             observation of the consent process and/or review of the documentation of
             consent
        (ii.c) A review of progress reports requested from the Investigator
        (ii.d) A review of all study documentation, regulatory documents, presentations,
             and monitoring reports
        (ii.e.) Monitoring the progress of the activity and intervening as necessary through
             such steps as visits to the activity site and continuing evaluation to determine
        if any unanticipated risks to participants or others have arisen
        (ii.f) Any other related documents as deemed appropriate by the Lindsey Wilson
             College SPC IRB
        (ii.g) A change in research or personnel not approved by IRB or protocol
             deviation
   iii. Conclusion of Audit Activities.
        The HSPP staff will document the preliminary findings in writing as well as
        specific recommendations. At the conclusion of the directed audit, an exit
        interview with the Investigator(s) or his/her designee and the auditors, HSPP staff,
        HSPP Director, and/or IRB Chair as needed will be conducted to discuss the
        preliminary findings to facilitate the Investigator‟s understanding of the process
        and collaborate in resolving any outstanding issues or concerns.
   iv. Reporting Activities.
        (iv.a) A memorandum and a summary of findings will be distributed to the
             Director of the Humans Subjects Protection Program, the Chair of the IRB
             Committee responsible for the study, and the Vice President for Research.
             Other individuals who may receive a memorandum and a summary of the
             findings include; Deans, Department Heads, Section Chiefs, Chief Executive
             Officers of involved institutions, and Veteran‟s Administration officials.
        (iv.b) A “Summary of Findings” report will be placed on an agenda for full
             Committee review and discussion.
   v. Documentation.
        (v.a) Compliance review hard-copy file will be created upon initiation of the
             review activities and kept in the HSPP project specific files.
        (v.b) A review history will be entered into the database and will reflect the type of
             review required.
        (v.c) A copy of the summary and signed report will be placed in the IRB project
             specific file.
d. Non-Lindsey Wilson College SPC Institutional Directed Audits:
   i. External directed audits are conducted by Lindsey Wilson College SPC IRB at
        Non- Lindsey Wilson College SPC sites where Lindsey Wilson College SPC IRB
        serves as the IRB of Record. These reviews will be conducted in accordance with
        the procedures detailed above. Additionally, assuring proper recruitment, space,
        facilities, qualified staff, enrollment, and execution of the consenting process will
        be reviewed.
e. General Responsibilities:
   i. If while conducting a directed audit the auditor finds an issue that potentially
        places participants at risk, they will report the findings immediately to the
        Director of the HSPP Office, the Chair of the IRB Committee responsible for the
        study, and the Vice President for Research.
   ii. In addition, the auditor will clearly document the reasons for this determination.
   iii. The Chair or his/her designee will review the study and determine if the study
        should be placed on “suspension” designating the specific criteria for suspension
        pending further information. If the Chair determines a study should be placed on
        suspension, the IRB Committee will be notified.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.B Suspension, Termination, or Reinstatement of IRB Approval
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.B Suspension, Termination, or Reinstatement of IRB Approval
       1. Definitions:
          a. Sponsor-Imposed Suspension: A determination from the sponsor of the study to
               place specific research activities on hold. This determination may be made for
               interim data analysis; inadequate drug availability; in response to a Data and
               Safety Monitoring Board (DSMB) report/recommendation; or a pre-planned
               stopping point.
          b. Study Expiration: When continuing review of the research does not occur prior to
               the end of the approval period specified by the IRB, IRB approval expires
               automatically if no response is received from Investigator, or if the IRB has not
               reviewed and approved the project prior to the expiration date, thereby ending the
               research activities.
          c. Suspension for Cause: An action initiated by the IRB to stop temporarily some or
               all research procedures pending future action by the IRB or by the Investigator or
               his/her study personnel.
          d Termination for Cause: An action initiated by the IRB to stop permanently some
               or all research procedures.
       2. Policy:
          It is the policy of Lindsey Wilson College SPC IRB that all currently approved
          research is subject to modification or change in approval status, as deemed necessary
          by Lindsey Wilson College SPC IRB.
          a. Suspension
               i. Conditions may exist in which the IRB requests additional information from
                    the Investigator in order to determine if a change in the risk/benefit ratio has
                    occurred, or if potential areas of non-compliance exist in a currently approved
                    research protocol. The IRB Committee, IRB Chair or his/her designee may
                    place specific research activities on suspension until a determination can be
                    made.
               ii. The IRB will notify the Investigator in writing of the Committee‟s
                    determination of suspension. The letter will include an explanation regarding
                    the suspension. request or make recommendations for additional education
                    and/or compliance interventions for the PI and his/her staff through the
                    Director of the HSPP.
               iv. If, when received, the additional information reveals a change in the
                    risk/benefit ratio or an issue of potential non-compliance has been identified,
                    the Chairperson or his/her designee will refer the study to the full Committee.
               v. If, when received by the IRB, the additional information is evaluated to
                    determine that no change to the risk/benefit ratio has occurred or the issue of
                    potential non- compliance has been ruled out, the study may return to active
                    status under the following conditions:
        (v.a) If the research was placed on Suspension via expedited review by the
             IRB Chair or his/her designee, then the study may be reinstated via
             expedited review;
        (v.b) If the research was placed on Suspension at full committee, then the
             study must be reinstated by the full committee
        (v.c) If the research was placed on Suspension by the IRB Chair or his/her
             designee due to concern for potential harm and then was reported to full
             committee at the next convened meeting, then the study must be reinstated
             by the full committee.
b. Sponsor-Imposed Suspensions:
   i. Notification of suspension by a sponsor “unrelated to risk” must be submitted
        to the IRB for review and acknowledgement.
   ii. Notification of suspension by a sponsor “possibly related to risk” must be
        submitted to the IRB for review by the full Committee.
c. Study Expiration:
   i. If an investigator has failed to provide continuing review information to the
        IRB or the IRB has not reviewed and approved a research study by the
        specified continuing review expiration date, the study expires.
   ii. The research must stop, unless the IRB finds that it is in the best interests of
        individual subjects to continue participating in the research interventions or
        interactions supported by a letter from the Principal Investigator justifying
        such a continuation. Under no circumstances may enrollment of new subjects
        occur after the expiration of IRB approval.
   iii. Once notified of the suspension, the Investigator must immediately submit to
        the IRB Chair, a list of research subjects for whom suspension of the research
        would cause harm.
        (iii.a) The full IRB Committee reviews this list and allows individual
             participants to continue participating in the research interventions or
             interactions only when the IRB determines that it is in their best interests.
        (iii.b) If the participants are covered by the Veterans Administration,
             additional consultation must be obtained from the VA Chief of Staff.
        (iii.c) Notification of the sponsoring agency, private sponsor, VA Office of
             Research and Development, and VA Office of Research Oversight must
             be notified for Veterans research.
   iv. The IRB notifies the Investigator in writing of Expiration.
        (iv.a) The letter indicates that after the expiration date:
        (iv.b) Enrollment of new participants must stop;
        (iv.c) All research activities must stop; and
        (iv.d) Any continuation research activity is a violation of Federal regulations
        (iv.e) The letter also indicates that the Investigator must immediately submit
             to the IRB, a list of research participants for whom suspension of the
             research would cause harm.
   v. Continuation of study interventions/procedures for previously enrolled
        subjects, if determined by the IRB Chair or designee as being in the best
        interest of the subjects, may occur only with prior written approval. VA
        projects can only continue after the IRB Chair or designee, in consultation
        with the VA Chief of Staff (COS), finds that it is in the best interest of
        individual subjects to do so.
   vi. There are no grace periods for continuing review. The federal regulations
        make no provision for any grace period extending the conduct of research
        beyond the expiration date of IRB approval. Therefore, continuing review and
        re-approval of research must occur on or before the date when IRB approval
        expires.
   vii. The IRB will notify the Investigator in writing with a first notification of
        expiration. The letter will state the specific research activities that must
        immediately cease.
   viii.Research studies not reviewed and approved within 30 days after the
        expiration period, will be administratively closed.
   ix. If a database error or error in processing has occurred within the HSPP office,
        the Chair may convene a Committee meeting to review the project(s) that
        would expire if reviewed on the regular meeting schedule.
   x. If the Investigator wishes to re-open a closed study they must submit a new
        Project Review Form or Project Approval Form.
d. Suspension Due to Cause:
   i. The IRB Committee may suspend research due to cause if the research is not
        being conducted in accordance with the IRB‟s requirements, the federal
        regulations or has been associated with unexpected serious harm to
        participants.
   ii. Examples of a suspension for cause might include: inappropriate involvement
        of human subjects in research, serious or continuing noncompliance with
        federal regulations or IRB policies, new information regarding increased risk
        to human subjects, mishandling of data, etc.
   iii. The IRB Committee will report in writing all suspensions due to cause
        promptly to the Investigator. The letter will include a statement of the reasons
        for the IRB's action. The letter will include the following:
        • Statement of the reasons for the IRB‟s actions
        • Requirement that the Investigator submit to the IRB proposed procedures
            for withdrawal of currently enrolled subjects that considers their rights and
            welfare. The IRB reviews the proposed procedures. The IRB may
            mandate oversight or transfer responsibility to another Investigator to
            assure implementation of these procedures;
        • Requirement that the Investigator submit to the IRB a proposed script or
            letter notifying all currently enrolled participants that are affected by the
            suspension. The IRB Committee reviews the proposed script or letter.
            If follow-up of subjects for safety reasons is permitted/required by the
            IRB, participants should be so informed. The IRB may directly
            contact participants to fulfill this notification; and
        • Requires the Investigator to report any adverse events to the IRB or
            sponsor that would have required reporting had the former participants
            continued to be enrolled in the research. The IRB may mandate
            oversight or transfer responsibility to another Investigator to ensure
            implementation of these procedures.
   iv. The IRB Chair responsible for the review of the research must report in a
        letter suspensions due to cause, to the Dean of the School of Professional
        Counseling and the Investigator‟s Department Head within 10 days of
        notification to the Investigator. IRB Committee members will be notified in
        the next Committee meeting agenda.
   v. When applicable, notification will also be forwarded Regional Directors and
        appropriate institutional officials at external sites where Lindsey Wilson
        College SPC IRB serves as their IRB of record.
   vi. Regulatory authorities such as the OHRP, FDA, NIH, VA Office or other
        Federal sponsoring departments or agencies will also be promptly notified by
        the Dean of the School of Professional Counseling, through the Director of the
        HSPP within 30 days notification to the Investigator.
        vii. Investigators receiving repeat suspensions due to cause will necessitate
        institutional actions for serious and continuing non-compliance.
e. Termination of IRB Approval for Cause:
   i. The IRB may terminate the approval of a project for cause if the research is
        not being conducted in accordance with the IRB Policies, is not in compliance
        with Federal regulations, or has been associated with unexpected serious harm
        to subjects.
   ii. Examples of a termination of approval for cause might include: inappropriate
        involvement of human subjects in research, serious or continuing
        noncompliance with federal regulations or IRB policies, failure to
        communicate new information regarding increased risk to human subjects,
        etc.
   iii. The IRB will report in writing all terminations of IRB approval for cause
        promptly to the Investigator. The letter of termination will include a statement
        of the reasons for the IRB's action. The letter will include the following:
        • Statement of the reasons for the IRB‟s actions
        • Requirement that the Investigator submit to the IRB proposed procedures
             for withdrawal of currently enrolled subjects that considers their rights and
             welfare. The IRB reviews the proposed procedures. The IRB may
             mandate oversight or transfer responsibility to another Investigator to
             assure implementation of these procedures;
        • Requirement that the Investigator submit to the IRB a proposed script or
             letter notifying all currently enrolled participants that are affected by the
             suspension. The IRB Committee reviews the proposed script or letter.
             If follow-up of subjects for safety reasons is permitted/required by the
             IRB, participants should be so informed. The IRB may directly
             contact participants to fulfill this notification; and
        • Requires the Investigator to report any adverse events to the IRB or
             sponsor that would have required reporting had the former participants
             continued to be enrolled in the research. The IRB may mandate
             oversight or transfer responsibility to another Investigator to ensure
             implementation of these procedures.
   iv. The IRB Chair responsible for the review of the research will also send a letter
        reporting terminations of approval for cause to the Dean of the School of
                  Professional Counseling and the Investigator‟s Department Head within 10
                  days notification to the Investigator. IRB Committee members will be notified
                  in the next Committee meeting agenda (as an information item).
             v. When applicable, notification will also be forwarded to regional directors, and
                  the appropriate institutional officials at the external sites where Lindsey
                  Wilson College SPC IRB serves as their IRB of record.
             vi. Regulatory authorities such as the OHRP, FDA, NIH, VA Office or other
                  Federal sponsoring departments or agencies will also be promptly notified by
                  the Dean of the School of Professional Counseling, through the Director of the
                  HSPP within 30 days notification to the Investigator.
             vii. Investigators receiving repeat suspensions due to cause may necessitate
                  institutional action for serious and continuing non-compliance.
References:
45 CFR 46.113; 42 CFR 50 Subpart A
OHRP Guidance Document, “Guidance on Continuing Review” dated July 11, 2002
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.B Suspension, Termination, or Reinstatement of IRB Approval
SUB-PART: II.B.1 Procedure for Suspension, Termination, or Reinstatement of IRB Approval
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.B.1 Procedure for Suspension, Termination, or Reinstatement of IRB Approval
        1. Procedure:
           This procedure outlines the mechanisms in which a study‟s approval status may be
           changed and subsequently reinstated.
           a. Investigator Responsibilities
              i. Sponsor-Imposed Suspension Unrelated to Potential Risk:
                   (i.a) The notice of suspension or removal of suspension is to be forwarded to
                        the IRB as soon as possible but no later than 10 working days after the
                        Investigator first learns of the notice of suspension or its removal.
                   (i.b) Research activities are to cease as specified in the sponsor‟s suspension
                        letter until notified by the sponsor that the study is re-opened and the IRB
                        has acknowledged this notification.
                   (i.c) Adverse events/unanticipated problems to participants or others must
                        continue to be reported to the IRB.
              ii. Sponsor-Imposed Suspension for Potential Risk:
                   (ii.a) Investigators will forward any correspondence from the sponsor,
                        indicating suspension or removal of suspension imposed for potential risk,
                        to the IRB as soon as possible, but no later than 10 working days after the
                        Investigator first learns of the notice of suspension or its removal for full
                        Committee review and approval.
                   (ii.b) Research activities are required to cease as specified in the suspension
                        letter imposed by the sponsor until the study is re-opened by the sponsor
                        and the full IRB Committee has reviewed and approved the study. Also,
                        the IRB may determine additional criteria for suspension that must be
                        followed
                   (ii.c) Adverse events/unanticipated problems to participants or others must
                        continue to be reported to the IRB.
              iii. Study Expiration:
                   (iii.a) The Investigator will complete all continuing review requirements
                        promptly.
                   (iii.b) Research activities are required to cease until notified that the IRB has
                        determined continuing review requirements are met and approval is
                        granted.
                   (iii.c) Under no circumstances may enrollment of new subjects occur after the
                        expiration of IRB approval.
                   (iii.d) Adverse events or unanticipated problems to participants or others must
                        continue to be reported to the IRB.
                   (iii.e) Continuation of study interventions/procedures for previously enrolled
                        subjects, if determined by the IRB Chair or designee as being in the best
                        interest of the subjects, may occur only with prior written approval.
              iv. Suspension for Cause:
        (iv.a) It is within the authority of the IRB to terminate the study if necessary.
             Research activities are required to cease, as specified in the suspension
             criteria, until the Investigator is notified that the full IRB Committee has
             granted approval of the study to resume.
        (iv.b) The Investigator will cooperate with the IRB in complying with all
             corrective actions as designated by the IRB Committee.
        (iv.c) The Investigator will notify the sponsor of Lindsey Wilson College SPC
             IRB imposed suspension/reinstatement.
        (iv.d) The Investigator is responsible for notifying all affected participants of
             the termination. The Investigator submits the script or letter to the IRB for
             approval prior to notification to participants.
        (iv.e) Adverse events or unanticipated problems to participants or others must
             continue to be reported to the IRB.
   v. Termination for Cause:
        (v.a) The Investigator will cease all study related activities and notify the
             sponsor of the termination of Lindsey Wilson College SPC IRB approval.
        (v.b) The Investigator is responsible for notifying all affected participants of
             the termination. The Investigator submits the script or letter to the IRB for
             approval prior to notification to participants.
        (v.c) Adverse events or unanticipated problems to participants or others must
             continue to be reported to the IRB.
b. IRB Committee Responsibilities
   i. Sponsor-Imposed Suspension Unrelated to Potential Risk:
        (i.a) Notification of suspension and the reinstatement of research by the
             sponsor for issues unrelated to risks may be reviewed by expedited
             procedures and approved by the IRB Chairperson or his/her designee.
   ii. Sponsor-Imposed Suspension for Potential Risk:
        (ii.a) Notification and re-instatement of a suspension imposed by the Sponsor
             possibly related to risk must be reviewed and approved by the full IRB
             Committee.
        (ii.b) The full IRB Committee will suspend the research study as determined
             by the Sponsor. However, the IRB Committee may impose additional
             restrictions upon research conducted under its jurisdiction.
        (ii.c) The IRB will notify the Investigator in writing of its determinations.
   iii. Lapse in Approval:
        (iii.a) The study will be terminated due to lapse in IRB approval at the level of
             review for which it qualifies (e.g., expedited, full committee).
        (iii.b) The IRB communicates in a letter to the Investigator that all study
             activities must stop.
        (iii.c) Studies that have lapsed may be granted approval after the continuing
             review requirements are completed and approved at the appropriate level
             of review for which the study currently qualifies. Investigators will be
             given a 30-day window in which to complete the continuing review
             requirements.
   iv. Suspension Due to Cause:
(iv.a) The IRB must review a study for suspension for cause at a full IRB
    Committee meeting.
(iv.b) Examples of these types of circumstances include:
    1. Falsification of study safety data
    2. Failure to comply with conditions imposed by the IRB under a prior
        suspension notice.
    3. Repeated or deliberate failure to obtain or document informed consent
        from human participants, which may include:
        • Repeated or deliberate omission of a description of serious risks of
            the experimental therapy when obtaining informed consent.
        • Repeated or deliberate failure to provide informed consent in a
            language understandable to the subject
        • Repeated or deliberate failure to limit administration of the
            investigational drug or device to those participants under the
            Investigator‟s supervision
        • Repeated or deliberate failure to comply with conditions placed on
            the study by the College, IRB, sponsor, or FDA
        • Failure of approved study staff to be part of the consenting process
        • Repeated or deliberate failure to obtain prior review and approval
            of new protocols and on-going human subjects research by the IRB
        • Repeated or deliberate failure to follow the signed Investigator
            agreement or protocol, e.g., by enrolling participants who should
            have been excluded because of concomitant illnesses that put those
            participants at greater risk
        • Repeated or deliberate failure to maintain accurate study records or
            submit required adverse event reports to the IRB
        • Failure to maintain report unanticipated problems involving risks
            to subjects or others accurate study records or others
        • Repeated or deliberate falsification or concealment of study
            records, e.g., by substituting in study records the results of
            biological samples from participants who met the inclusion criteria
            for samples of participants who did not meet the inclusion criteria,
            or by fabricating participants.
(iv.c) The Committee may request an ad hoc review from an independent
    source with expertise in the type of research being conducted or expertise
    in the specific area of concern.
(iv.d) The extent of suspension may include the following:
        • recruitment
        • screening/enrollment
        • interaction/intervention
        • follow-up
        • prohibitions on data use
(iv.e) The IRB will notify the Investigator in writing via hand delivery or
    certified receipt of its decision to suspend the study for cause and provide
    a rationale for its actions. This letter should include an opportunity for the
    PI to respond to the Committee‟s determinations and to attend an IRB
        Committee meeting to discuss the suspension and provide clarification of
        the issues.
    (iv.f) The Committee may request the development of an education plan
        and/or the completion of a directed audit by the Director of the HSPP.
    (iv.g) Suspensions for cause will be reinstated for approval after corrective
        actions are completed to the IRB Committee‟s satisfaction. The
        Committee may approve the study with or without additional restrictions
        (e.g., mandating a data and safety monitoring committee to oversee the
        research at designated intervals, increase in the frequency of IRB
        Committee review, observation of the consent process).
v. Termination for Cause:
    (v.a) The IRB must review a study for Termination for Cause at a full IRB
        Committee meeting.
    (v.b) In addition, the Committee may request an ad hoc review from an
        independent source with expertise in the type of research being conducted
        or expertise in the specific area of concern.
    (v.c) The IRB will notify the Investigator in writing via hand delivery or
        certified receipt of the decision to terminate the study for cause and
        provide a rationale for its actions. This letter should include an opportunity
        for the PI to respond to the Committee‟s determinations and to attend an
        IRB Committee meeting to discuss the termination and provide
        clarification of the issues.
vi. Reporting of Suspensions for Cause or Terminations for Cause:
    (vi.a) All Suspensions or Terminations for Cause must be promptly reported
        to the Director of the Human Subjects Protection Office and the IRB
        Committee responsible for the review of the research. The Director will
        notify the Dean of the School of Professional Counseling and the
        Department Head.
    (vi.b) When applicable, notification will also be forwarded to the regional
        directors, and the appropriate Institutional officials at external sites where
        Lindsey Wilson College SPC IRB serves as their IRB of Record.
    (vi.c) Regulatory authorities such as the OHRP, FDA, NIH, VA Office or
        other Federal sponsoring departments or agencies will also be promptly
        notified by the Dean of the School of Professional Counseling, through the
        IRB Chair and the Director of the Human Subjects Protection Program.
    (vi.d) The institution may determine that suspensions or terminations
        associated with a particular study or an Investigator are repetitive and
        warrant action for issues of serious and continuing non-compliance.
c. HSPP Staff Responsibilities
    i. Sponsor-Imposed Suspension Unrelated to Potential Risk:
        (i.a) The HSPP staff member will process the notification from a sponsor
             of a suspension unrelated to risk for administrative acknowledgement
             requiring a letter to the PI from the Chairperson or his/her designee.
             This may occur via expedited review.
        (i.b) The HSPP staff will update the IRB database and hardcopy files
             accordingly with the current status of the research.
ii. Sponsor-Imposed Suspension for Potential Risk:
     (ii.a) The HSPP staff will process the notification from a sponsor of a
          suspension due to possible risk for full Committee review.
     (ii.b) The HSPP staff will notify the PI in writing of the IRB Committee‟s
          determinations. This letter requires a signature of the Chairperson or
          his/her designee.
     (ii.c) The HSPP staff will assist the Committee in obtaining any additional
          information needed for the Chairperson or his/her designee to
          determine if a change in the risk/benefit ratio has occurred.
     (ii.d) The HSPP staff will update the IRB database and hardcopy files
          accordingly with the current status of the research.
iii. Suspensions Due to Lapse:
     (iii.a) Prior to the study expiration date, the HSPP staff will assign the
          study for review to determine the Suspension for Lapse criteria.
          Reviews may be conducted in accordance with the level of review for
          which the study qualifies.
     (iii.b) The HSPP staff will notify the PI in writing of the IRB Committee‟s
          determinations. This letter requires a signature of the Chairperson or
          his/her designee.
     (iii.c) The HSPP staff will assist the Committee in obtaining the additional
          information required to conduct continuing review of the research.
iv. Suspensions Due to Cause:
     (iv.a) The HSPP staff will notify the PI in writing of IRB determinations.
          The letter requires a signature of the Chairperson or his/her designee.
     (iv.b) The HSPP staff will assist the Committee in obtaining information
          from the Investigator. The HSPP staff will keep each other apprised of
          all corrective actions to be taken by the Investigator and their status.
     (iv.c) The HSPP staff will complete a directed audit and/or develop an
          education plan as deemed appropriate by the IRB Committee. The IRB
          staff will also be available as a resource to the Investigator.
     (iv.d) The HSPP staff will notify the Director of the Human Subjects
          Protection Program and the IRB Chairperson, or designee immediately
          of any Suspensions for Cause.
     (iv.e) The HSPP staff will update the IRB database and hardcopy files
          accordingly with the current status of the research.
v. Terminations for Cause:
     (v.a) The IRB Chairperson will notify the PI in writing. The letter requires
          a signature of the Chairperson or his/her designee.
     (v.b) The HSPP staff will notify the Director of the HSPP and the IRB
          Chairperson, or designee immediately of any Termination for Cause.
     (v.c) The HSPP staff will update the IRB database and hardcopy files
          accordingly with the current status of the research.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.C Investigating any Non-compliance, Serious or
Continuing Noncompliance
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.C Investigating any Non-compliance, Serious or Continuing Non-Compliance
       1. Definitions:
           a. Non-compliance: Failure to comply with Federal regulations, HSPP policy, or
                the determinations or requirements of the IRB
           b. Serious Non-compliance: An action or omission knowingly taken by an
                Investigator that any other reasonable Investigator would have foreseen as
                compromising the rights or welfare of a participant.
           c. Continuing Non-compliance: A pattern of repeated actions or omissions taken
                by an Investigator that indicates a deficiency in the ability or willingness of an
                Investigator to comply with Federal regulations, IRB Policy, or determinations of
                the HSPP IRB.
           d. Research Misconduct: Any fabrication, falsification, or plagiarism in proposing,
                performing, or review research, or in reporting research results
           e. Undue influence: Occurs through an offer of an excessive, unwarranted,
                inappropriate or improper reward or other overture in order to obtain compliance
       2. Policy:
           It is the policy of Lindsey Wilson College SPC IRB to uphold its role in ensuring
           prompt reporting of any serious or continuing noncompliance with 45 CFR Part 46,
           and 21 CFR 50 and 56 or the requirements or determinations of the IRB.
           a. The IRB has the authority to suspend or terminate approval of research that is not
                being conducted in accordance with the IRB Policies, is not in compliance with
                Federal regulations, or has been associated with unexpected serious harm to
                subjects.
           b. The Director of the Human Subjects Protection Program, or designee, must
                investigate all credible reports of alleged noncompliance and inappropriate
                involvement of human subjects in research. The level of investigation will depend
                on the seriousness of the situation and the potential risk to participants. Such
                reports of noncompliance or inappropriate involvement may come from any
                source including IRB Committee members, participants and their families,
                Institutional personnel, other Institutional Committees, the media, anonymous
                sources, or the public. Goals of the IRB in investigating and managing issues of
                potential noncompliance include:
                i. Ensuring the safety of human subjects;
                ii. Developing action plans to prevent reoccurrence, and promote future
                     compliance;
                iii. Educating research staff to ensure they understand necessary federal and state
                     guidelines and regulations, and HSPP policies and procedures; and
                iv. Reporting serious or continuing noncompliance.
           c. Findings of serious or continuing noncompliance with 45 CFR Part 46, and 21
                CFR 50 and 56 or the requirements or determinations of the IRB will be reported
                to the full Committee who will make a determination(s) and/or
               recommendation(s). The Committee‟s findings will be reported to the IRB Chair,
               Director of the Human Subjects Protection Program, and the Principal
               Investigator. The Dean of the School of Professional Counseling and the Head of
               the Investigator‟s Department will be notified through the Director of the Human
               Subjects Protection Program/Research Director.
          d. When applicable, notification of serious or continuing noncompliance will also be
               forwarded to Lindsey Wilson College SPC Business Office of Research Contract
               Analysis, the Office of Sponsored Research, the Faculty Advisor, and the
               appropriate Institutional officials at external sites where Lindsey Wilson College
               SPC IRB serves as the IRB of record.
          e. The Director of the Human Subjects Protection Program, will promptly notify
               regulatory authorities, if necessary, of any determinations of serious or continuing
               noncompliance.
          f. The IRB may require whatever additional protections it deems necessary to
               safeguard the rights and welfare of participants in the Investigator‟s research.
          g. Instances meeting the definition of research misconduct will be reported to the
               Research Integrity Officer by the Director of the HSPP
          i. Attempts to unduly influence an IRB Committee Member or IRB staff are
               considered research misconduct
          ii. IRB members or staff who believe that they have been subject to undue influence
               must report this to the Director of the HSPP
          iii. The Director of the HSPP will report all attempts of undue influence of the IRB
               process to the Research Integrity Officer
References:
45 CFR 46
21 CFR 50 and 56
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.C Investigating any Non-compliance, Serious or
Continuing Noncompliance
SUB-PART: II.C.1 Procedure for Investigating and Managing Potential
Issues of Noncompliance
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.C.1 Procedure for Investigating and Managing Potential Issues of Noncompliance
       Procedure:
       This procedure outlines the process for ensuring the prompt reporting of any serious or
       continuing noncompliance with 45 CFR Part 46, 21 CFR 50 and 56 or the requirements
       or determinations of the IRB.
               a. Investigator Responsibilities:
                   i. It is the Investigator's responsibility to adhere to the IRB approved
                        protocol and not to initiate any changes or amendments to the protocol
                        prior to IRB review and approval of the change or amendment unless there
                        is apparent need to minimize risk to the participants. In this case, the
                        Investigator has 10 working days to notify the IRB of the amendment.
                   ii. The Investigator is responsible for the ethical management, accurate
                        documentation, and the protection of human participants in their research.
                   iii. Between IRB continuing reviews of a protocol and at the time of
                        continuing review of a protocol, it is the Investigator's responsibility to
                        keep the HSPP office and IRB Committees informed of any unanticipated
                        problems involving risks to subjects or others or adverse events that are
                        serious, unanticipated, and result in a change to the risk/benefit ratio, even
                        if the event occurred at a location for which Lindsey Wilson College SPC
                        IRB is not the IRB of record. The Investigator is responsible for the
                        accurate documentation, investigation and follow-up of all unanticipated
                        problems involving risks to subjects or others and possible study-related
                        adverse events. Investigators are also responsible for informing the
                        government and other sponsors of any unanticipated problems involving
                        risks to subjects or others, as appropriate.
                   iv. The Investigator complies with all requests from the IRB Committee for
                        further information or clarification regarding concerns or issues under
                        investigation.
               b. IRB Committee Responsibilities:
               i. When the IRB Committee Chair receives a report of alleged non-compliance,
                   the Chair:
                   • Reviews the information and determines whether the event is serious,
                        continuing non-compliance. If the event is not serious or does not meet the
                        definition of continuing non-compliance, the Chair will:
                             − Formulate a corrective action plan;
                             − Forward the corrective action plan to the Investigator; and
                             − Forward the information to be included in the IRB agenda as an
                             information item.
                   • Reviews the information, determines whether more information is needed,
                        and if necessary, directs an investigation by the HSPP staff (The
         Investigator is notified in writing of the need for more information or of
         the directed investigation)
     • Reviews the information, determines the information is serious or inhibits
         the rights or welfare of participants, and forwards the information to be
         included on the full IRB Committee agenda for review for consideration
         of suspension criteria or consideration of termination.
     • The IRB Committee reviews the materials provided at a convened
         meeting, to determine:
              - There is no issue of non-compliance;
              - There is non-compliance that is neither serious nor continuing;
              - There is serious or continuing noncompliance;
              - There is insufficient information to make a determination. (The IRB
              will request additional information from the Investigator and defer a
              determination to a later date.)
ii. If the allegation involves research misconduct, the IRB Chair/Director will
     report this to the Research Integrity Officer.
iii. At any time during an investigation, if the IRB suspects or identifies that
     participants are at risk, a study can be placed on suspension.
iv. The initial investigation may consist of a letter from the IRB Committee Chair
     to the Investigator, citing the alleged areas of noncompliance and the
     associated regulations. The letter should ask the Investigator to respond to the
     allegation and provide a corrective action plan within a specified timeframe.
     Additional information may be requested from the Investigator. The IRB may
     find the additional information and the Investigator‟s plan of action adequate
     or the IRB may add additional suggestions or impose additional
     restrictions/oversight in the research, based on the results of the investigation.
v. The IRB may find it necessary to request further investigation if the breadth of
     noncompliance is not known. An audit may be requested by the IRB. If an
     audit is to be conducted, the Investigator should be notified in writing of the
     purpose of the audit and what information should be provided to the IRB. The
     audit may include only information requested from and provided by the
     Investigator or may require an on-site visit where original documentation is
     reviewed and/or observed. The IRB staff member in collaboration with the
     assigned IRB Committee and the Director of the HSPP will develop and
     implement a plan for a detailed audit focusing on the areas of concern. If at
     any time during the investigation new areas of concern are discovered, they
     will be reported in writing to the assigned IRB Committee for consideration in
     determining additional actions (e.g., suspension of other studies under the
     purview of the Investigator, audit of other studies, etc.). Following any
     investigation (audit), the results will be placed on an agenda for review by the
     full Committee.
vi. The following determinations and actions may be considered at any time
     during an investigation or upon completion of an investigation of alleged non-
     compliance:
        (vi.a) The IRB may determine that the research study under review is in
            compliance with federal regulations and IRB policy, and that no further
            actions are required; or
        (vi.b) The IRB may determine that the research study under review is
            substantially in compliance with federal regulations and IRB policy, but
            may make specific recommendations to improve or enhance the study‟s
            human subjects' protections, or impose additional oversight of the research
            such as:
            • Verifying that subject selection is appropriate and observing the actual
            informed consent process by which individual consents are obtained
            • Increasing monitoring of the research activity via a data safety monitor
            or board and intervening as necessary through such steps as visits to the
            activity site and continuing evaluation by the HSPP staff
            • Requesting an off-cycle data safety monitor or board review
            • Requesting a directed audit targeting areas of concern
            • Requesting a status report after each participant receives intervention
            • Decreasing the continuing review cycle
            • Requesting additional Investigator/staff education focused on human
            subject protections from the IRB or other available resources
            • Notifying current subjects, if the information about the non-compliance
            might affect their willingness to continue participation
            • Suspending the study
            • Terminating the study
        (vi.c) Any major modifications to previously approved research taken in
            response to non-compliance set forth by the Investigator must be reviewed
            by the IRB Committee
c. HSPP Staff Responsibilities:
   i. When the HSPP staff receives a report of alleged non-compliance, the staff
        verifies whether a complete explanation from the Investigator accompanies
        the report.
        • If a complete explanation from the Investigator accompanies the report,
            the staff forwards the information to the IRB Chair for review and notifies
            the Director within 1 working day.
        • If a detailed explanation from the Investigator does not accompany the
            report the staff contacts the Investigator to request additional information
   ii. If the report contains no explanation from the Investigator or comes from a
        source other than the Investigator.
        • The staff member forwards the information to the IRB Chair for review
            and determination; and
        • The staff member notifies the Director within 1 working day.
   iii. If the report contains an explanation from the Investigator and comes from a
        source other than the Investigator the staff forwards the information to the
        IRB Chair for review and notifies the Director within 1 working day.
   iv. If the alleged non-compliance is to be reviewed by the convened IRB, the staff
        prepares the following documents to be forwarded to all members of the
        Committee for review.
   • Audit report
   • Notification of potential noncompliance, if applicable;
   • The last approval letter from the IRB
   • The last approved IRB application; and
   • The last approved consent document
   Additionally, the primary and secondary reviewers receive:
   • The last approved protocol
   • The last approved Investigator‟s Brochure, if applicable;
   • The grant, if applicable; and
   • Any pertinent information (e.g., questionnaires, reports, etc.)
v. The staff will facilitate and maintain documentation of all communication
   between the Investigator and the IRB Committee. The staff will notify the PI
   in writing of IRB determinations. (The letter requires the signature of the IRB
   Chair or his/her designee.)
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance Activities
POLICY NUMBER: II.D Reporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.D: Reporting to the Appropriate Institutional Officials, and the Department or Agency
Head(s)
       Definitions:
       1. Non-compliance: Failure to comply with Federal regulations, IRB Policy, or the
           determinations or requirements of the IRB.
       2. Serious Non-compliance: An action or omission taken by an Investigator that any
           other reasonable Investigator would have foreseen as having a negative impact on the
           rights and welfare of a participant.
       3. Continuing Non-compliance: A pattern of repeated actions or omissions taken by an
           Investigator that indicates a deficiency in the ability or willingness of an Investigator
           to comply with Federal regulations, IRB Policy, or determinations or requirements of
           the IRB.
       4. Termination for Cause: An action initiated by the IRB to stop permanently some or
           all research procedures.
       5. Suspension for Cause: An action initiated by the IRB to stop temporarily some or all
           research procedures pending future action by the IRB.
       6. Serious: An event is “serious” if it involved a serious harm to one or more persons
           (who may or may not be participants), or required intervention to prevent one or more
           persons from experiencing serious harm.
       7. Related: An event is “related” if it is “likely” to have been caused by the research
           procedures.
       8. Unexpected: An event is “unexpected” when its specificity, nature, severity or
           incidence are not accurately reflected in the information previously reviewed and
           approved by the IRB.
       9. Unanticipated: An event is “unanticipated” when it was unforeseeable at the time of
           its occurrence. The word unanticipated is not a synonym for unexpected. A research
           Investigator can monitor for an unexpected event, but cannot monitor for an
           unforeseen event. All unanticipated events are unexpected, but not vice versa.
       10. Unanticipated Problem Involving Risks to Participants or Others: Any event that
           is (1) unanticipated, (2) serious, and (3) related.

Policy:
It is the responsibility of the Lindsey Wilson College SPC IRB to assure reporting occurs
according to the Federal regulations, institutional policy and Lindsey Wilson College SPC IRB
policy.
        1. This IRB will maintain written procedures for assuring prompt reporting to the IRB,
            appropriate institutional officials, and the Department or Agency head of:
            a. Any unanticipated problems involving risk to participants or others;
            b. Any serious or continuing non-compliance with this policy or the requirements or
               determinations of the IRB; and
            c. Any suspension or termination of IRB approval.
          2. This reporting will take place within 45 days of the completion of an investigation
             and/or determination.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance Activities
POLICY NUMBER: II.D Reporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)
SUB-PART: II.D.1 Procedure for Reporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.D.1 Procedure for Reporting to the Appropriate Institutional Officials, and the
Department or Agency Head(s)
       Procedure:
       1. IRB Responsibilities.
          a. The IRB Chair will report to the HSPP Director:
             i. Any event determined by the IRB to represent unanticipated problems
                  involving risks to subjects or others;
             ii. Any non-compliance determined by the IRB to be serious or continuing non-
                  compliance; and
             iii. Any action of the IRB to suspend or terminate project approval.
       2. IRB Administration Responsibilities.
          a. The HSPP Director will prepare a letter to the Principal Investigator that outlines:
             i. The nature of the event;
             ii. The findings of the organization and IRB;
             iii. Actions taken by the organization or IRB;
             iv. Reasons for the organization‟s or IRB‟s actions; and
             v. Any plans for continued investigation or action.
          b. The letter will be sent to the following individual for review and approval:
             i. Dean of the School of Professional Counseling
             ii. The IRB chair of the Committee that made the determination.
          c. The letter is signed by the Chair of the Committee that made the determination.
          d. The HSPP Director sends a copy of the letter to:
             i. IRB Members of the applicable Committee (as an information item in the
                  agenda);
             ii. Dean of the School of Professional Counseling
             iii. Sponsored Projects; if the project is sponsored
             iv. The Department Head, Supervisor, and Faculty Advisor of the Principal
                  Investigator, if applicable;
             v. Institutional officials at external sites where LWC serves as their IRB of
                  record;
             vi. Legal Counsel, if appropriate; and/or
             vii. Risk Management, if appropriate.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.E Complaints Regarding Human Subjects Research
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007


II.E Complaints Regarding Human Subjects Research
       Policy:
       1. It is the policy of Lindsey Wilson College SPC IRB to investigate all complaints
          received regarding human subjects research conducted under its jurisdiction.
          a. The Director of the Human Subjects Protection Program, or designee must
               investigate all complaints received regarding human subjects in research under
               Lindsey Wilson College SPC IRB‟s jurisdiction. The level of investigation will
               depend on the seriousness of the situation and the potential risk to participants.
               Complaints may come from any source including IRB Committee members,
               Investigators, participants and their families, institutional personnel, other
               institutional committees, the media, anonymous sources, or the public.
          b. Complaints may come from any category of research reviewed and may include
               anyone involved or not directly involved in the research process/study.
          c. Investigations should result in finding a suitable resolution and response to the
               complainant in a timely manner.
          d. All complaints will be handled in a confidential manner. This includes any
               individual involved in notifying Lindsey Wilson College SPC IRB of an alleged
               violation of Investigator compliance.
          e. Complaints that are substantiated will be further investigated through a directed
               audit conducted by the HSPP Staff, and actions will be taken as deemed
               appropriate by the IRB Committee or Vice President of Academic Affairs.
          f. Complaints of a sensitive nature may be brought to the IRB Committee for
               discussion and recommendation.
          g. The IRB houses a suggestion box on the website to voice any suggestions,
               concerns or complaints. If any concerns are emergent in nature or are such that a
               participant may potentially be placed at risk, the suggestion box states to please
               call the HSPP directly. The suggestion box is located at the HSPP website.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.E Complaints Regarding Human Subjects Research
SUB-PART: II.E.1 Procedure for Managing Complaints Regarding Human
Subjects Research
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


II.E. 1 Procedure for Managing Complaints Regarding Human Subjects Research
        The purpose of this procedure is to outline the actions of Lindsey Wilson College SPC
        HSPP in managing a complaint received regarding human subjects research.
               a. Investigator Responsibilities:
                  i. The Investigator will follow the procedure in the application for
                       responding to questions, concerns or complaint from participants.
                  ii. The Investigator will notify the IRB of any participant or other
                       individual‟s complaints regarding the research. The complaint may be
                       reported at continuing review if it involves no risk to the participants or
                       others or does not change the risk/benefit ratio (e.g., a participant
                       complains that he/she does not like the Investigator‟s clinic hours and
                       subsequently withdraws from the research).
                  iii. It is the responsibility of the Investigator to report complaints that involve
                       potential risks to participants or to others or that result in a potential
                       change in the risk/benefit ratio as an unanticipated problem as soon as
                       possible after the Investigator first learns of the complaint but no later than
                       10 working days after the Investigator first learns of the complaint. (e.g.,
                       the College where the research is conducted complains that the research
                       assistant has not maintained her research notes in a confidential manner,
                       which may have potentially breached confidentiality)
                  vi. Investigators are to cooperate with the IRB by making documents
                       accessible, responding to written requests within the designated period,
                       and being available for questions from the IRB.
               b. IRB Committee Responsibilities:
                  i. Initial Complaint
                       (i.a) The assigned IRB Chair or his/her designee will be notified by an
                             HSPP staff member and may request that the complaint be taken to the
                             IRB Committee.
                  ii. Committee Review.
                       (ii.a) If an investigation or directed audit is warranted, the findings will be
                             taken to the IRB Committee for review.
                       (ii.b) A determination will be made by the IRB Committee of any further
                             actions that need to be taken.
               c. HSPP Staff Responsibilities:
                  i. Initial Complaint.
                       (i.a) When an HSPP staff member receives a complaint, he/she will collect
                             as much information as possible and submit a copy of the report to the
                             study file.
                       (i.b) All written complaints are to be forwarded to the IRB Chair and the
                             Director of the HSPP for investigation into the nature of the complaint.
ii. Review and Follow-up.
    (ii.a) When a complaint is substantiated, the Director of HSPP will work
         with the HSPP Staff for further investigation or arrange for a directed
         audit.
    (ii.b) HSPP Staff will notify the Investigator in writing regarding the
         nature of the complaint and ask for an action plan in order to resolve
         any outstanding issues.
    (ii.c) When the complaint involves sensitive issues, the complaint may be
         forwarded to the Vice President of Academic Affairs for discussion
         and recommendations prior to initiating any activity.
    (ii.d) The results of the investigation will be reported to the Director of the
         HSPP and the IRB Chair. If the complaint is study-related, the
         appropriate IRB Committee will also be notified of the results. If
         warranted, the results of the investigation will be forwarded to the IRB
         full Committee for further determinations and/or recommendations.
    (ii.e) Follow-up letters to the Investigator regarding Chair or IRB
         Committee determinations/actions will be placed in the study file.
    (ii.f) Copies of records of the complaint and subsequent investigation will
         also be kept in a separate file in the HSPP Office.
    (ii.g) The IRB suggestion box located at the HSPP website will be
         frequently checked and responses given if suggestions are not
         anonymous.
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.F Protocol Deviation/Violation Reporting
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


II.F Protocol Deviation/Violation Reporting
       1. Definitions:
           a. Data and Safety Monitoring: A plan to oversee the implementation of a study
                protocol for compliance monitoring.
           b. Deviation: An incident involving noncompliance with the protocol, but one that
                typically does not have a significant effect on the subject‟s rights, safety, welfare,
                and/or the integrity of the resultant data. Deviations may result from the action of
                the participant, investigator, or staff. NOTE: This definition may not match the
                Investigator’s or Sponsor’s definition.
           c. Serious Adverse Event: Any experience that suggests a significant hazard,
                contraindication, side effect, or precaution and includes any experience that
                results in a death, a life-threatening occurrence, a persistent or significant
                disability or incapacity, an inpatient hospitalization or prolongation of an existing
                hospitalization, a congenital anomaly or birth defect, and/or any other experience
                that suggests a significant hazard, contraindication, side effect or precaution that
                may require medical or surgical intervention to prevent one of the outcomes listed
                above.
           d. Unanticipated Problem Involving Risks to Subjects or Others: An undesirable
                and unintended, result of therapy or other interaction or intervention (e.g.,
                headache following spinal tap, intestinal bleeding associated with aspirin therapy,
                discovery of suicidal ideation as part of data collection, loss of confidentiality,
                protocol deviation/violation possibly affecting the risk to the subject).
           e. Violation: Changes (accidental or unintentional) to the IRB approved protocol
                procedures without prior sponsor and IRB approval. Violations generally affect
                the subject‟s rights, safety, welfare, and/or the integrity of the resultant data.
                NOTE: This definition may not match the Investigator’s or Sponsor’s definition.
       2. Policy:
           It is the policy of Lindsey Wilson College SPC IRB to be notified of any protocol
           deviations or violations that result in an increase in risk or a decrease in benefit to
           participants
       a. Deviations:
           i. It is the responsibility of the Investigator not to deviate from the protocol
                approved by
                the IRB. The Investigator must submit an amendment request to the IRB and
                receive written approval prior to implementation of any changes.
           ii. Not all deviations need to be reported to the IRB. Deviations that do not increase
                risk or decrease benefit, affect the participant‟s rights, safety, welfare, and/or
                affect
                the integrity of the resultant data does not necessarily need to be reported.
                However, some deviations while not necessarily affecting the risk/benefit to the
               participant, participant‟s rights, safety, welfare and/or affecting the integrity of the
               data may be continuous and need to be reported to the HSPP office.
          iii. When a sponsor requests that the IRB be notified of a deviation, the IRB will
               perform an expedited of the deviation submitted by the Investigator.
          iv. Repetitive deviations may be ruled by Lindsey Wilson College SPC IRB as a
               violation.
      b. Violations:
          i. Violations that increase risk or decrease benefit, affect the participant‟s rights,
               safety, welfare, and/or the integrity of the resultant data are to be reported as an
               adverse event and/or an unanticipated problem to the participant or others.
          ii. When a sponsor requests that the IRB be notified of a violation, but it does not
               increase risk or decrease benefit, affect the subject‟s rights, safety, welfare and/or
               the integrity of the resultant data, the IRB will perform an expedited review of the
               notification of violation submitted by the Investigator.
References:
21 CFR 56.108
PROGRAM: Human Subjects Protection Program
SECTION: II. IRB Compliance
POLICY NUMBER: II.F Protocol Deviation/Violation Reporting
SUB-PART: II.F.1 Procedure for Protocol Deviation/Violation
Reporting
REVIEW RESPONSIBILITY: IRB Policy and Procedure Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


II.F.1 Procedure for Protocol Deviation/Violation Reporting
        Procedure:
        This procedure provides guidance in the reporting requirements and responsibilities of
        the Investigator and Lindsey Wilson College SPC IRB regarding protocol deviations
        and/or violations.
        a. Investigator Responsibilities:
            i. The Investigator will submit any changes in the protocol prior to implementation
                 to the IRB for review and approval as required by the federal regulations by
                 submitting a letter from the Principal or Co-Principal Investigator to the IRB
                 Chair.
            ii. The Investigator will monitor research activities for adherence to the protocol and
                 determine if protocol deviations or violations have occurred.
            iii. If deviations or violations have occurred, the Investigator will evaluate the
                 deviation or violation to determine if it increased the risk, decreased the benefit,
                 affected the participant‟s or other‟s rights, safety, welfare, and/or the integrity of
                 the resultant data.
            iv. Deviations or violations that increase the risk, decrease the benefit, affect the
                 participant‟s or other‟s rights, safety, welfare, and/or the integrity of the resultant
                 data will be reported to the IRB via a letter.
            v. When the sponsor requires reporting of deviations to the IRB that do not affect the
                 risk/benefit ratio or the participant‟s or other‟s rights, safety, welfare and/or the
                 integrity of the resultant data, the Investigator should notify the IRB via a letter.
            vi. All protocol deviations/violations are to be reported to a Data and Safety Monitor
                 or Board if one exists.
            vii. All safety-monitoring reports will be submitted to the IRB as soon as possible
                 upon receipt, but no later than 10 working days after the Investigator first learns
                 of the report.
        b. IRB Committee Responsibilities:
            i. The IRB Chairperson or his/her designee will review protocol deviations and
                 violations to determine if the deviation or violation affected the risk/benefit ratio,
                 the participant‟s or other‟s rights, safety, welfare, and/or the integrity of the
                 resultant data.
            ii. If the Chairperson or his/her designee determines that the deviation or violation
                 did not negatively affect the participant‟s or other‟s rights, safety, welfare, and/or
                 the integrity of the resultant data, the IRB will acknowledge the deviation or
                 violation in writing to the Investigator.
            iii. If the Chairperson or his/her designee is unable to determine whether the
                 deviation/violation affected the participant‟s/other‟s rights, safety, welfare, and/or
                 the integrity of the resultant data, the IRB Chairperson will request additional
                 information. If the Chairperson is still unable to make a determination with the
        additional information, he/she may refer the study to full IRB Committee for
        review and determination of further actions.
   iv. If the Chairperson or his/her designee determines the violation has affected the
        risk/benefit ratio, the participant‟s or other‟s rights, safety, welfare, and/or the
        integrity of the resultant data, the Chairperson or his/her designee will request the
        violation be reported to the IRB.
   v. For deviations or violations requiring review by the full IRB Committee, one of
        the following determinations must be made:
        1. The event did not change the risk/benefit ratio and revisions to current
             documents are not needed;
        2. The event did change the risk/benefit ratio and revisions are needed to reflect
             the change;
        3. The event did change the risk/benefit ratio and additional safety measures
             (e.g., increase in review frequency, observation of informed consent process,
             appointment of an individual to monitor research activities) will be imposed
             by the IRB;
        4. The event placed participants or others at risk or harm and a Suspension is
             necessary until further investigation and/or correction actions are
             implemented.
        5. The full IRB Committee will determine if multiple deviations will be deemed
             as a violation. Additionally, the Committee may determine that repetitive
             deviations or violations may require consideration of Investigator
             noncompliance.
c. HSPP Staff Responsibilities:
   i. The staff member will pre-review the deviations submitted by the Investigator to
        determine if they qualify as a deviation per IRB definition and did not affect the
        risk/benefit ratio, the participant‟s or other‟s rights, safety, welfare and/or the
        integrity of the resultant data.
        • If the Chair determines that deviations submitted by the Investigator do not
             affect the risk/benefit ratio, the participant‟s rights, safety, welfare and/or the
             integrity of the resultant data, the staff will stamp the original document as
             received and send it to the Chair or his/her designee for an administrative
             acknowledgement.
   ii. A copy of the document will be placed in the IRB file.
   iii. If the staff determines the deviation or violation may have affected the risk/benefit
        ratio, the participant‟s or other‟s rights, safety, welfare, and/or the integrity of the
        resultant data, the staff member will request the deviation/violation be reported to
        the IRB Committee.
   v. At any time, the staff member may consult with the IRB Chairperson or his/her
        designee for guidance.
  FLOWCHART FOR PI REPORTING OF PROTOCOL DEVIATIONS*


              Did the protocol deviation significantly increase the risk to
                 the participant or significantly decrease the potential
                              benefit for the participant?


                                                      YES               NO


                                              Did the protocol deviation result in an
                                             adverse event or unanticipated problem
    This should be                           involving risks to participants or others?
  reported to the IRB
   following Lindsey
  Wilson College SPC                                  YES                NO
   SPC IRB Policy for
 reporting of adverse
        events or
     unanticipated                           Did the protocol deviation result in a
  problems involving                      change to the risk/benefit ratio or integrity
risks to participants or
                                                         of the data?
         others.


                                                      YES                NO



                                               Did the protocol deviation result in
                                             corrective actions by a Data and Safety
                                                        Monitoring Board?



         Submit DSMB                YES                 NO
         Report to the
             IRB                                                     Do not report to
                                                                     the IRB unless PI
                                                                     believes that the
                                                                     deviation affected
                                                                      the risk/benefit
   If sponsor requires IRB notification,                                    ratio
 provide a letter of deviation or protocol
           violation to the IRB.
SECTION: III. RB Review Procedures
POLICY NUMBER: III.A Institutional Review Board Committee Review
Responsibilities
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007
PROGRAM: Human Subjects Protection Program


III.A Institutional Review Board Committee Review Responsibilities
       Policy:
       It is the responsibility of Lindsey Wilson College SPC (LWC) Human Subjects
       Protection Program (HSPP) Institutional Review Board Committee Members to review
       all human subjects research activities under the College‟s jurisdiction.
       1. Committee Members.
            The mission of the LWC IRB is to protect the rights and welfare of human research
            subjects recruited to participate in research activities conducted by LWC Investigators
            through ethically responsible and scientifically valid research, continuous education
            of the research community, monitoring of research activities, and compliance with the
            federal regulations and institutional policies and procedures.
            a. Committee members have an understanding of basic ethical principles, the
                regulatory requirements, and the mechanics of serving on the IRB.
            b. Committee members conduct prospective and continuing review of proposed
                research activities according to DHHS regulations 45 CFR 46, FDA regulations
                21 CFR 50 and 56 and when applicable, VA regulations 38 CFR 16 and 17,
                Federal, State and local laws, and institutional policies and procedures including
                the IRB.
            c. Committee members evaluate the research proposal for both scientific and
                scholarly merit. This includes consideration of research design, statistical power,
                equitable subject selection process, etc.
            d. Committee members identify any conflicts of interest prior to the review of
                research activities and bring this to the attention of the staff member for
                reassignment.
            e. Committee members obtain guidance or additional information in order to
                conduct an adequate study evaluation. This may include the request of an
                additional reviewer or consultant with expertise in the area of research under
                review (e.g., a psychiatric consultant may be asked to review a study that requires
                a “wash-out” period followed by intervention with investigational or novel agents
                in a population that has a high likelihood of enrollment of subjects that are or may
                become cognitively impaired).
       2. Consultants and Ad Hoc Reviewers.
            a. Consultants and ad hoc reviewers are held to the same standards as those describe
                above.
            b. A consultant may serve as an ad hoc reviewer when expertise in a specific area is
                needed. The consultant may not be able to attend the meeting, but is expected to
                provide a written review of the research. This could be a narrative or could be
                captured on the reviewer‟s comment form.
            c. The consultant may attend the meeting to participate in the review and discussion,
                however; the consultant may not count toward quorum or vote.
          d. A Committee member or HSPP staff member may request a written review from
             an expert consultant and may also request they attend the meeting for
             participation in the discussion.
References:
45 CFR 46
21 CFR 50, 56, 312, and 600
38 CFR 16 and 17
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.A Institutional Review Board Committee Review Responsibilities
SUB-PART III.A.1 Procedure for Institutional Review Board Committee Review Responsibilities
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.A.1 Procedure for Institutional Review Board Committee Review Responsibilities
       Procedure:
       This procedure outlines the review responsibilities of Lindsey Wilson College SPC
       (LWC) Institutional Review Board (IRB).
       1. IRB Committee Member Responsibilities.
           a. Evaluation of each research study, including scientific review, will be relative to
              the complexity of the study. Outside review of the research (e.g., NIH review,
              Cooperative Group review) will be acknowledged as contributing to the review,
              but will not be considered as the only scientific/scholarly review. It is the IRB‟s
              responsibility to determine that risks are minimized through sound research
              design and reasonable in relation to anticipated benefits. The IRB will seek the
              expertise of consultants or ad hoc reviewers if the IRB Committee Members lack
              the scientific expertise to make these determinations without such consultation.
           b. Evaluation of the research will comply with DHHS and FDA regulations as
              described in the Code of Federal Regulations on Institutional Review Boards.
              Evaluation will require the completion of the reviewer‟s Comment sheet by the
              Primary and Secondary Reviewer.
           c. If a member has identified a conflict of interest, the member will excuse
              himself/herself from the discussion and vote. If during the discussion, input from
              the excused member would provide benefit to the review process, the excused
              member may be asked to return for questions, after which he/she will be excused
              for further discussion and vote.
           d. Members are expected to keep in strict confidence all information discussed
              during or after the meeting.
           e. Committee members may contact Investigators directly in order to obtain the
              necessary information for Committee review and determination, especially if
              clarification is needed.
       2. Consultants and Ad Hoc Reviewer Responsibilities.
           a. Consultants and ad hoc reviewers will evaluate the research proposal for
              scientific, scholarly merit, and other issues as requested by the IRB. This includes
              consideration of research design, statistical power, equitable subject selection
              process, risk/benefit ratio, etc.
           b. The consultant or ad hoc reviewer will not agree to review research in which
              he/she has or may be perceived as having a conflict of interest.
           c. The consultant or ad hoc reviewer will provide a written report to the IRB. They
              may be requested to attend the Committee meeting for questions and clarification
              of issues.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.B IRB Committee Determinations/Motions
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007; October, 2005


III.B IRB Committee Determinations/Motions
       Policy:
       It is the policy of Lindsey Wilson College SPC (LWC) Institutional Review Board (IRB)
       to render motions/determinations according to the Federal regulations.
       1. Approved.
            a. An approval is granted if the research activity meets the criteria for approval as
                defined in 45 CFR 46.111 and no changes to the research application are
                recommended.
       2. Approved Pending Review and Approval by the Chair or His/Her Designee.
            a. An approved pending status is granted if the research activity meets the criteria
                for approval as defined in 45 CFR 46.111 and the modifications required by the
                full Committee are such that they only require simple concurrence by the
                Investigator. The application is approved if, on review, the modifications have
                been made by the Investigator and confirmed by the Chair or his/her Designee. If
                any modifications have not been made, or additional modifications have been
                made that were not requested, the Chair or his/her designee refers the study back
                to full Committee, unless the Committee asked for factual errors.
       3. Deferred.
            a. A deferral is granted if the study does not meet the criteria for approval as defined
                in 45 CFR 46.111 or the IRB Committee recommends substantial revisions to the
                IRB Application, Sponsor‟s Protocol, informed consent document(s), or other
                pertinent documents rendering it unable to assess the risk/benefit ratio without the
                completed revisions.
       4. Revise and Resubmit.
            a. A study that lacks sufficient information to conduct an adequate review at the full
                Committee review as defined in 45 CFR 46.111 may be tabled pending receipt of
                more information. The determination may be made and lifted following further
                information from the Investigator and reviewed at for which the study qualifies.
       5. Disapproval
            a. The IRB Committee may vote to disapprove a study. A study is disapproved if it
                does meet the criteria for approval as defined in 45 CFR 46.111 and does not
                conform to the ethical principles in the Belmont. Notice of the disapproval is sent
                to the PI and includes the reasons for the disapproval and information about
                reconsideration (if any). Disapprovals may not be overridden by Organizational
                officials. The Investigator can then respond with any further rationale regarding
                the study.
       Behavioral Committee:
            • Approval as submitted
            • Approval (subject to satisfactory responses to cited critique being furnished to and
                approved by Committee; simple concurrence only)
            • Revise and resubmit (pending subsequent Committee review of substantive
                clarifications and/or modifications)
    • Disapproval (on basis of above stated Committee consideration)
6. Sponsor-Imposed Suspension.
    a. A sponsor-imposed suspension is when the IRB receives written notification that
       the sponsor has suspended the research study. This will be acknowledged by the
       IRB Committee, Chair or his/her Designee when the appropriate level of review
       determines the suspension is appropriate. The IRB Committee may impose
       additional criteria for suspension, if needed, to protect the participants from
       potential harm.
7. Suspension for Cause.
    a. A currently approved study is suspended for cause when evidence of a possible
       increase in risk to participants or non-compliance by the Investigator has been
       determined by the IRB. Suspensions for cause are made under full Committee
       review procedures. Chair or his/her Designee may suspend the research when
       immediate suspension is required to protect the safety of research participants.
8. Expiration.
    a. A currently approved study is expired when continuing review has not been
       conducted and approved prior to the study‟s expiration date. Expiration can also
       occur when the IRB has not reviewed and approved the study prior to the
       expiration date.
9. Termination for Cause.
    a. A currently approved study may be terminated if the study is not being conducted
       in accordance with the IRB policies, is not in compliance with Federal
       regulations, and/or has been associated unexpected serious harm to participants.
       Terminations for cause are made under full Committee review procedures.
PROGRAM: Human Subjects Protection Program
SECTION: III. RB Review Procedures
POLICY NUMBER: III.B IRB Committee Determinations/Motions
SUB-PART: III.B.1 Procedure for IRB Committee Determinations/Motions
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.B.1 Procedure for IRB Committee Determinations/Motions
        Procedure:
        This procedure describes the process for the rendering of the IRB Committee
        determinations/motions following the review of proposed research activities.
            a. Investigator Responsibilities.
               i. Approved: If approval is granted, the Investigator may begin the research
                    when he/she receives notification of approval from the IRB.
               ii. Approved Pending Review and Approval by the Chair or His/Her
                    Designee:
                    (ii.a) The Investigator responds to the Committee recommendations in a cover
                         letter outlining the changes (simple concurrence only). Any changes not
                         incorporated may be referred back to full Committee. The Investigator
                         includes in the response a copy of any revised documents in their entirety.
                         The changes to the documents are underlined. Clean copies of consent
                         document(s) are included for date stamping upon final approval.
                    (ii.b) Amendments receiving an approved pending status may not be
                         implemented until a satisfactory response by the Investigator has been
                         received and final approval has been granted in writing by the IRB Chair
                         or his/her designee.
                    (ii.c) Research activities may not start until all conditions have been met and
                         the IRB Chair or his/her designee has signed a final approval letter.
               iii. Deferred:
                    (iii.a) The Investigator responds to the Committee recommendations in a
                         cover letter outlining the changes and the rationale for any changes not
                         incorporated. The Investigator includes in the response a copy of any
                         revised documents in their entirety. The changes to the documents are
                         underlined. Clean copies of consent documents are included for date
                         stamping upon final approval.
                              • Deferred research must go back to the IRB Committee for re-
                                 review once a response is received.
                    (iii.b) Amendments receiving a deferred status are not implemented until an
                         adequate response has been received from the Investigator and approval
                         has been granted in writing by the IRB.
                              • Deferred amendments must go back to the IRB Committee for re-
                                 review once a response is received.
                    (iii.c) Research activities may not begin until the IRB approves the
                         study/amendment and the IRB Chair or his/her Designee has signed a final
                         approval letter.
               iv. Revise and Resubmit.
                    (iv.a) The Investigator responds to the Committee recommendations in a
                         cover letter outlining the changes and the rationale for any changes not
                 incorporated. The Investigator includes in the response a copy of any
                 revised documents in their entirety. The changes to the documents are
                 underlined. Clean copies of consent documents are included for date
                 stamping upon final approval.
                     • Studies that receive a revise and resubmit must go back to the IRB
                         Committee for re-review once a response is received.
            (iv.b) Amendments receiving a deferred status are not implemented until a
                 satisfactory response by the Investigator has been received and final
                 approval has been granted in writing by the IRB.
                     • Amendments that receive a revise and resubmit must go back to
                         the IRB Committee for re-review once a response is received.
            (iv.c) Research activities may not begin until the IRB approves the
                 study/amendment and the IRB Chair or his/her Designee has signed a final
                 approval letter.
       v. Disapproval.
            (v.a) If the IRB Committee votes to disapprove a study, notice of the
                 disapproval is sent to the PI and includes the reasons for the disapproval
                 and information about reconsideration (if any). Disapprovals may not be
                 overridden by Organizational officials. The Investigator can then respond
                 with any further rationale regarding the study.
            (v.b) Amendments that are disapproved may not be implemented until
                 response is received by the IRB.
                 • Disapproved amendments must go back to the IRB Committee for
                     further review and deliberation once a response is received.
                 • Research activities may not begin until the IRB Chair signs a final
                     approval letter.
b. IRB Committee Responsibilities. The IRB Committee Chair or his/her designee, or
   the full IRB Committee rendering decisions on reviewed research activities (e.g., new
   study/continuing review applications or amendments) may make the following
   determinations and/or motions:
       i. Approved as Submitted: Approval may be granted if the research activity
            meets the criteria for approval as defined in 45 CFR 46.111 and no changes to
            the research application are recommended.
       ii. Approved Pending Review and Approval by the Chair or His/Her
            Designee: This status is stipulated only when the requested modifications are
            clear and specific in nature and do not require clarification by the Investigator.
            Clarifications that are minor and will not change the risk to the participant
            regardless of the response can also be given this status. Changes not
            incorporated are referred back to full Committee. The recommended
            modifications are made to the IRB application, Sponsor‟s protocol, informed
            consent documents, or other pertinent documents before final IRB approval
            can be granted. The IRB Committee provides a letter to the Investigator
            stipulating the specific modifications required for approval.
            (ii.a) New study applications receiving this status are administratively
                 withdrawn if an adequate response to the Committee recommendations
          has not been received by the IRB within 6 months of the date of the
          approved (simple concurrence only) letter.
     (ii.b) Continuing review applications receiving this status are expired on the
          date of study expiration if an adequate response has not been received by
          the IRB prior to the study expiration date.
     (ii.c) Amendments receiving this status are administratively withdrawn if an
          adequate response to the Committee recommendations has not been
          received by the IRB within 6 months of the date of the approved (simple
          concurrence only) letter
iii. Deferred: A deferral is granted if the study does not meet the criteria for
     approval as defined in 45 CFR 46.111 or if the IRB Committee recommends
     substantial revisions to the IRB Application, Sponsor‟s Protocol, informed
     consent document(s), or other pertinent documents. The Investigator‟s
     response is reviewed in full Committee.
     • The IRB Committee may invite the Investigator to a Committee to allow
          the Investigator to address the concerns of the Committee.
     • New study applications receiving a deferral status are administratively
          withdrawn if adequate responses to the Committee recommendations have
          not been received by the IRB within 6 months of the date of the deferral
          letter.
     • Continuing review applications receiving a deferral status expire on the
          date of study expiration if an adequate response has not been received by
          the IRB prior to the study expiration date.
     • Amendments receiving a deferral status are administratively withdrawn if
          an adequate response to the Committee recommendations has not been
          received by the IRB within 6 months of the date of the approved (simple
          concurrence only) letter
iv. Revise and Resubmit: Revise and resubmit is granted if the study does not
     meet the criteria for approval as defined in 45 CFR 46.111 or if the IRB
     Committee recommends substantial revisions to the IRB Application, grant,
     proposal, informed consent document(s), or other pertinent documents. The
     Investigator‟s response is reviewed during a convened meeting.
     • The IRB Committee may invite the Investigator to a Committee to allow
          the Investigator to address the concerns of the Committee.
     • New study applications receiving a revise and resubmit status are
          administratively withdrawn if adequate responses to the Committee
          recommendations have not been received by the IRB within 6 months of
          the date of the deferral letter.
     • Continuing review applications receiving a revise and resubmit status
          expire on the date of study expiration if an adequate response has not been
          received by the IRB prior to the study expiration date.
     • Amendments receiving a revise and resubmit status are administratively
          withdrawn if an adequate response to the Committee recommendations
          has not been received by the IRB within 6 months of the date of the
          approved (simple concurrence only) letter
   v. Disapproval: A study is disapproved if it does meet the criteria for approval
        as defined in 45 CFR 46.111 and does not conform to the ethical principles in
        the Belmont. The Investigator can then respond with any further rationale
        regarding the study.
        • The IRB Committee may invite the Investigator to a Committee to allow
             the Investigator to address the concerns of the Committee.
   vi. Sponsor-Imposed Suspensions: A sponsor-imposed suspension notification
        is reviewed at the level of review for which the study qualifies. If there are no
        safety issues, the IRB does not change the study status and acknowledges
        receipt of the Sponsor‟s suspension requesting notification of any future
        correspondence from the sponsor. If safety issues exist and the review
        determines the suspension is appropriate, the IRB changes the study status to
        sponsor-imposed suspension and identify the criteria for the suspension. The
        IRB may impose additional criteria for suspension, if needed, to protect the
        participants from potential harm. Sponsor-imposed suspensions are lifted at
        the level of review for which the study qualifies.
   vii. Suspension for Cause: A currently approved study is suspended for cause
        when evidence of a possible increase in risk to participants or non-compliance
        by the Investigator has been determined by the IRB. Suspensions for cause are
        made under full Committee review procedures.
   viii.Expired: A currently approved study must expire if continuing review has not
        been conducted and approved prior to the study‟s expiration date. This
        determination is made at the level of review for which the study qualifies.
   ix. Termination for Cause: A currently approved study is terminated if the
        study is not being conducted in accordance with the IRB policies, is not in
        compliance with Federal regulations, and/or has been associated unexpected
        serious harm to participants. Terminations for cause are made under full
        Committee review procedures.
c. HSPP Staff Responsibilities.
   i. The HSPP staff member will capture in the minutes the determinations and
        motions as presented during the full IRB Committee meetings.
   ii. The staff prepares all Committee letters corresponding to the Committee‟s
        determinations.
   iii. The HSPP staff enters into the HSPP database expiration dates for the project
        based on the determinations.
        (iii.a) Responses from Investigators for motions of approved (simple
             concurrence only) are reviewed and changes are verified. The staff
             completes the approval letters and forward to the Chair or his/her
             Designee for review and signature. Upon completion, the approval letter is
             sent to the PI and a copy placed in the project file.
        (iii.b) Responses from Investigators for motions of deferral or revise and
             resubmit are prepared for full IRB Committee or the subcommittee for
             further review and determination.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.C Composition of IRB Committees
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


III.C Composition of IRB Committees
       Policy Instructions and Explanations:
       1. Each IRB Committee must include at least one member whose primary interests are
          in a scientific area, one member whose primary interests are in a non-scientific area,
          and one member who is not affiliated with Lindsey Wilson College SPC (i.e. not a
          family member or spouse of an employee, not a retiree).
       2. Administrative personnel, invited guests or consultants do not have voting privileges.
          a. Administrative personnel may include:
              i. Persons who are invited to attend IRB meetings by virtue of the position held
                  and;
              ii. Persons necessary to the Committee by virtue of special knowledge or
                  experience.
       3. Nomination for Membership. Nominations for faculty membership on the IRB
          Committees are made to the Chair. The Director of HSPP may call for faculty
          volunteers as needed and also seek the advice of Deans, Committee Chairs,
          Committee members, and administrative officers in making its recommendations.
          Nominations may come from Committee members, Department Heads, Deans and
          faculty nominations. The Director of HSPP in submitting nominations for
          membership to the Vice President for Research, may also recommend faculty for
          Committee Chair when positions are open.
       4. Member Selection. Invitations to membership on the IRB Committees are extended in
          writing by the VP for Research, Graduate Studies and Economic Development.
          Membership requirements and membership lists for the IRB Committees are on file in
          the Office of the Vice President for Research, Graduate Studies, and Economic
          Development and the Human Subjects Protection Office.
          a. Committee Chairs and Vice Chairs are selected as highly respected individuals
              from within or outside the institution, fully capable of managing the IRB and
              matters brought before it with fairness and impartiality.
          b. The IRB Committee Rosters are posted on the IRB website at
              http://www.lindsey.edu/.
          c. The IRB Committee requests faculty volunteers periodically and also seeks the
              advice of IRB Committee Chairs, IRB Committee Members, Division Chiefs,
              Department Chairs, and Deans in making its recommendations. Decisions for
              selecting Committee members are made to assure that the IRB Committees retain
              diversity while maintaining regulations for required individuals to serve on the
              Committee.
       5. Number of Members. The IRB Committees are required to have a minimum of five
          members each, with varying backgrounds and expertise to provide complete and
          thorough review of research activities commonly conducted by the institution. VA
          interest must be adequately represented by the inclusion of two or more VA
          employees as voting members of the IRB on each IRB that reviews VA research.
6. Alternates. Trained alternates formally listed on the IRB roster may vote in place of
   an absent voting member. Alternates are assigned according to their scientific or non-
   scientific status, i.e. PS, SS, OS, NS, as indicated on the Committee member rosters,
   and in accordance with the area of expertise required for adequate review.
   a. Meeting minutes must document when an alternate member replaces the
        appointed member.
7. Qualifications of IRB Members. The IRB Committee membership must be:
   sufficiently qualified through the diversity of the members, including consideration of
   race, gender, and cultural backgrounds and sensitivity to such issues as community
   attitudes, to promote respect for its advice and counsel Selections are made upon the
   specific needs of the committee (e.g., medical specialty, diversity, non-scientist,
   nonaffiliated, etc.) and:
   • Able to ascertain the acceptability of proposed research in terms of institutional
        commitments and regulations, applicable law, and standards of professional
        conduct and practice.
   • Composition of the membership of the IRB Committees must be adequate in light
        of the anticipated scope of Lindsey Wilson College SPC and its affiliated
        institutions‟ research activities, the types of subject populations likely to be
        involved, and the size and complexity of the institution(s).
   a. Term of Service.
        i.       Committee Members.
            • Committee members are requested to serve a minimum of three years.
            • Committee members are requested to serve as an alternate member at the
                 completion of their term.
        ii.      IRB Chairs.
            • Chairs are required to serve one year as a Committee member prior to
                 assuming the role of Chair.
            • Chairs are requested to serve a minimum of three years including a
                 minimum of one year as Chair.
            • Chairs are requested to serve an additional year as a Committee member at
                 the completion of their term to serve as a mentor for the newly selected
                 Chair to promote consistency and continuity. In addition, this will provide
                 a resource for the newly selected Chair and Committee members on
                 historical perspectives, rationale for decisions made regarding policy, and
                 meeting facilitation skills.
            • Chairs are requested to serve as an alternate member at the completion of
                 their term.
   b. Representative for Children. An IRB Committee considering a protocol involving
        children as subjects should:
        i. Assess its needs for pediatric expertise among the IRB voting membership to
            assure that it possesses the professional competence necessary to review the
            specific research activities and;
        ii. Consider inclusion of one or more individuals who are knowledgeable about
            and experienced in working with children. To fulfill this requirement, the IRB
            Committee may invite nonvoting individuals to assist in the review of issues
                   which require expertise beyond, or in addition to, that available among voting
                   IRB members.
              iii. When reviewing proposed research on handicapped children or mentally
                   disabled persons sponsored by the Department of Education, the IRB must
                   also include a member with expertise in this area as described in the
                   Department of Education‟s regulations at 34 CFR 350 and 356.
          c. Representative for Prisoners. Federal Regulations require that the IRB Committee
              membership be modified if it is to review research involving prisoners. Therefore,
              if any IRB Committee will review research involving prisoners, at least one
              member of the IRB Committee shall be a prisoner, or a prisoner representative
              with appropriate background and/or experience to serve in that capacity.
          d. Pregnant Women, Human Fetuses and Neonates. The IRB Committee considers
              all applicable Federal regulations regarding research with this population and
              review by an expert.
          e. Cognitively Impaired. The IRB Committee will include, if necessary, at least one
              member with expertise in the area of the cognitively impaired population when
              reviewing studies with this population or studies in which the participants may
              become cognitively impaired during the course of the research. Consideration
              may also be given to an additional member who is a member of the population, a
              family member of such a person, or a representative of an advocacy group for that
              population.
          f. Consultants. On a case-by-case basis, the IRB Committee may request review by
              an individual with competence in an area not represented by the Committee
              membership. The consultant does not vote with the IRB Committee.
      8. IRB Committee Member and Chair Performance Evaluations.
          a. Committee members and Chairs complete a self-evaluation annually, which
              includes the following:
              • Knowledge and application of the Federal regulations;
              • Knowledge and application of IRB policies and procedures;
              • Participation in Committee meeting discussions;
              • Interaction with Investigators and study contacts; and
              • Completion of educational requirements.
      9. Evaluation of number of IRBs. The number of IRBs must be reviewed annually to
          determine whether the reviews are accomplished in a thorough and timely manner
          and the number of IRBs is appropriate to the volume and type of research review.
          a. This review will be conducted annually with the Vice President of Academic
              Affairs and include information from the following:
              • Information obtained from the HSPP Director
              • Information obtained from the HSPP Staff
              • Information from IRB committee members and chairs
              • Information from investigators and research personnel
References:
34 CFR 350 and 356
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.C.1 Procedure for Composition of IRB Committees
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.C.1 Procedure for Composition of IRB Committees
       Procedure:
       This procedure provides guidance on the maintenance of quorum that must occur when
       the Lindsey Wilson College SPC (LWC) Institutional Review Board (IRB) Committees
       review and approve research under its jurisdiction.
       a. IRB Committee Responsibilities.
           i. Quorum.
               (i.a.) An IRB Committee meeting may convene and render a vote only under the
                    following conditions:
                    • Quorum requires a majority of the Committee voting members present
                        defined as one-half of the members plus one (e.g., 10 voting members
                        requires 6 voting members for quorum; 9 voting members requires 6
                        voting members for quorum); and
                    • Each IRB Committee must include at least one member whose primary
                        interests are in a scientific area, one member whose primary interests are
                        in a non-scientific area and one member who is not affiliated with Lindsey
                        Wilson College SPC (i.e. not a family member or spouse of an employee,
                        not a retiree).
               (i.b) Whenever possible, the IRB Committee meetings should take place with all
                    participating IRB members physically present. However, circumstances
                    sometimes warrant conducting IRB Committee meetings via a telephone
                    conference call under the following conditions:
                    • Each Committee member will receive all pertinent materials prior to the
                        meeting; and
                    • The Committee member on the telephone will actively and equally
                        participate in the discussion of all protocols (e.g., each member can hear
                        and be heard by all other participating members).
               (i.c) When reviewing research that involves children or prisoners, a Committee
                    member, an alternate member or an expert consultant who has special
                    knowledge of these vulnerable populations is required to be present during the
                    review and approval process. If the reviewer providing the expertise with
                    regard to the vulnerable population is not included on the IRB roster as a
                    voting member or alternate, he or she may not vote and may not count
                    towards quorum. Additionally, when reviewing research sponsored by the
                    Department of Education, the Committee must include one person with
                    expertise in handicapped children or mentally disabled persons when
                    reviewing research on those populations.
               (i.d) Failure of Quorum During a Convened Meeting. Should quorum fail during
                    the meeting (e.g., those with conflicts of interest being excused, early
                    departures, loss of the non-scientific member), the meeting should be
                    terminated from further vote until quorum can be restored.
           ii. Conflict of Interest.
        (ii.a) An IRB Committee member may not participate in the initial or continuing
             review of a project in which the member has an actual conflict or the
             appearance of a conflict, except to provide information requested by the IRB
             Committee.
        (ii.b) IRB Committee members should identify any potential conflicts on the
             agenda at the beginning of the meeting and absent themselves from the
             meeting room when the IRB Committee discusses and votes on the research in
             which they have a conflict of interest and such should be noted in the
             Committee minutes.
b. HSPP Staff Responsibilities.
   i. The HSPP staff member will maintain attendance in order to assure that quorum
        is maintained, despite absences and conflicts of interests, for scheduled IRB
        Committee meetings.
   ii. The HSPP staff member in attendance at the Committee meeting is responsible
        for recording accurate quorum notes and assuring that quorum is maintained
        throughout the meeting.
   iii. When the IRB Committee reviews research that involves a vulnerable population,
        the staff will assure that an individual who is knowledgeable and meets the
        requirements to review the proposed research is present, or assist in scheduling a
        consultant or ad hoc reviewer to conduct the review.
SECTION: III. IRB Review Procedure
POLICY NUMBER: III.D IRB Review of Human Subjects Research – Full Committee
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.D: IRB Review of Human Subjects Research - Full Committee
        Policy:
        It is the policy of Lindsey Wilson College SPC (LWC) Institutional Review Board (IRB)
        that all human subjects research activities under its jurisdiction be reviewed according to
        the criteria described in the Federal regulations.
        1. Full Committee Eligibility.
             a. An Investigator may request a particular type of review, but the final
                 determination is made by the IRB.
             b. A full IRB Committee must review studies not qualifying for IRB review under
                 the exempt or expedited categories.
             c. The IRB has the authority to approve, require modification in, or disapprove all
                 research activities that fall within its jurisdiction.
        2. IRB Quorum Required for Full Committee Review.
             a. The IRB Committee may only review proposed research at a convened meeting at
                 which a quorum is present. A majority of the voting members of the IRB
                 Committee are present, including at least one member whose primary interests are
                 in nonscientific areas.
             b. IRB meetings are not convened if a nonscientist is not present.
             c. No official actions take place at a meeting where a majority of the voting
                 members are not present.
             d. Should the Committee meeting lose quorum (e.g., those with conflicts being
                 excused, early departures, loss of all non-scientists), the meeting is terminated
                 from further votes until the quorum is restored.
             e. Wherever possible, IRB Committee meetings take place with all participating IRB
                 members physically present. However, circumstances sometimes warrant
                 conducting IRB meetings via telephone conference call. OHRP will recognize as
                 “convened” those IRB meetings conducted via telephone conference call,
                 provided that each participating IRB member:
                 i. Has received all pertinent material prior to the meeting to allow adequate time
                      for review and the request of additional information, if needed; and
                 ii. Can actively and equally participate in the discussion of all protocols (i.e.,
                      each member can hear and be heard by all other participating members).
                 iii. The minutes of such meetings clearly document that these two conditions
                      have been satisfied in addition to the usual regulatory requirements (e.g.,
                      attendance; initial and continued presence of a majority of members, including
                      at least one nonscientist member; actions taken by the IRB; the vote on such
                      actions; discussion and resolution of controverted issues).
             f. No IRB Committee member may participate in the IRB Committee‟s initial or
                 continuing review of a project in which the member has conflict of interest (See
                 IRB Policy VII.C). If a conflict exists, the Committee member can provide
                 information requested by the IRB Committee but cannot be present for the
                 discussion and the vote.
        3. Required Review.
a. Substantive review of standard protocols takes place at convened meetings.
   Applications undergoing review are individually presented and discussed at a
   convened meeting of the IRB Committee.
b. In conducting the full IRB Committee review, the majority of the Committee
   must agree that materials are in sufficient detail to determine the study meets
   criteria 45 CFR 46.111 and if applicable, 21 CFR 56.111 or 38 CFR 16.111 for
   approval:
   i. Risks to subjects are minimized by
        (a) using procedures which are consistent with sound research design and
            which do not unnecessarily expose subjects to risk, and
        (b) whenever appropriate, by using procedures already being performed on
            the subjects for diagnostic or treatment purposes;
   ii. Risks to subjects are reasonable in relation to anticipated benefits, if any, to
        subjects, and the importance of the knowledge that may reasonably be
        expected to result. In evaluating risks and benefits, the IRB Committee should
        consider only those risks and benefits that may result from the research (as
        distinguished from risks and benefits of therapies subjects would receive even
        if not participating in the research). The IRB Committee should not consider
        possible long-range effects of applying knowledge gained in the research
        (e.g., the possible effects of the research on public policy) as among those
        research risks that fall within the purview of its responsibility;
   iii. Selection of subjects is equitable considering the purposes of the research and
        the setting in which the research will be conducted and should be particularly
        cognizant of the special problems of research involving vulnerable
        populations and the potential need for additional protections, such as children,
        prisoners, pregnant women, mentally disabled persons, or economically or
        educationally disadvantaged persons;
   iv. Informed consent will be sought from each prospective subject or the
        subject‟s legally authorized representative, in accordance with, and to the
        extent required by Federal and State regulations and Institutional policies and
        procedures including the IRB;
   v. Informed Consent will be appropriately documented, in accordance with, and
        to the extent required by the Federal and State regulations and Institutional
        policies and procedures including the IRB;
   vi. When appropriate, the research plan makes adequate provisions for
        monitoring the data collected to ensure the safety of subjects;
   vii. When appropriate, there are adequate provisions to protect the privacy of
        subjects and to maintain the confidentiality of data, during and after the
        conclusion of the research for monitoring the data collect;
   viii.The IRB evaluates the proposed research to ensure that there are adequate
        provisions to protect the privacy of subjects and to maintain the confidentially
        of identifiable data;
   ix. There are adequate provisions to protect the rights and welfare of vulnerable
        populations from coercion or undue influence, such as children, prisoners,
        pregnant women, mentally disabled persons, or economically or educationally
        disadvantaged persons. The IRB Committee must determine if additional
                 safeguards need to be included in the study to protect the rights and welfare of
                 these subjects;
             x. When appropriate, the need for ancillary care, additional monitoring,
                 counseling, and social support are provided; and
             xi. When appropriate, the informed consent document should include the
                 additional elements of informed consent.
          c. The full IRB Committee determines a review interval for the research as
             appropriate to the degree of risk, but not greater than one year from the last date
             of IRB approval. The regulations make no provision for any grace period
             extending the conduct of research beyond the expiration date of IRB approval.
             Therefore, continuing review and reapproval of the research occurs on or before
             the date when IRB approval expires. If the research involves the following, the
             IRB will review more often than annually:
             • Previous Suspensions of the research due to compliance, record-keeping or
                 other concerns; and/or
             • Any other situations for which the IRB deems more frequent review
                 appropriate.
             • Research that involves adults unable to consent and the study is deemed
                 greater than minimal risk
             • Phase I trials
          d. Standard requirements for informed consent or its waiver or alteration apply to all
             studies meeting the criteria for approval by the full IRB Committee.
             • All research approved by the full IRB Committee is conducted in accordance
                 with all applicable Lindsey Wilson College SPC policies and procedures.
             • The decisions and requirements for modifications by the IRB Committee are
                 promptly conveyed to the Investigator. Written notification from the IRB
                 regarding a decision to disapprove a protocol is accompanied by the IRB
                 Committee‟s reasons for the decision and an invitation for reply by the
                 Investigator, either in person or in writing.
References:
45 CFR 46
21 CFR 50 and 56
38 CFR 16 and 17
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedure
POLICY NUMBER: III.D IRB Review of Human Subjects Research - Full Committee
SUB-PART: III.D.1 Initial Application Materials to be Reviewed by Full IRB Committee
REVIEW RESPONSIBILITY: RB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


         III.D.1 Procedure for IRB Review of Human Subjects Research - Full Committee
         Procedure:
         This procedure provides guidance for the review of human research activities that qualify
         for Full IRB Committee review under the Federal regulations.
         1. Investigator Responsibilities.
             a. The application is completed in its entirety and submitted to the HSPP office for
                 processing. The original application form is submitted. The application and
                 instructions for completion are located on the HSPP website:
                 http://www.lindsey.edu/.
             b. The consent form(s) may be written using the template informed consent
                 document. Instructions for writing informed consent documents are located on the
                 HSPP website under Forms Online.
             c. Studies that include vulnerable populations are submitted with supplemental
                 forms demonstrating added protections and a rationale as to why these
                 populations are to be included in the proposed research. These include:
                 • Prisoners.
                 • Pregnant women, human fetuses, neonates and fetal material.
                 • Children.
                 • Cognitively impaired.
             d. The “HIPAA Authorization Form” is completed accounting for Investigator(s)
                 and study staff who will be accessing Protection Health Information (PHI).
             e. Studies involving the use of an FDA regulated test article require the submission
                 of a copy of the FDA exemption letter.
             f. The Investigator replies to all requests for revisions and/or clarifications requested
                 by the pre-reviewers or reviewers, when applicable.
             g. Any proposed changes to IRB approved documents are submitted to the IRB
                 through the amendment process. The Investigator receives written IRB approval
                 before implementing any changes to the research study.
             h. All serious adverse events and unanticipated problems to participants or others are
                 submitted to the IRB
         2. IRB Committee Responsibilities.
             a. The Chair, in conjunction with Committee members, determines the IRB meeting
                 schedule based on availability, holidays, and LWC scheduled closures.
             b. The assigned IRB Committee member receives a copy of the review materials 5
                 days prior to the scheduled meeting to allow adequate time for review and the
                 request of additional information, if needed (e.g. supporting documentation from
                 the Investigator, literature search, etc.). Review materials are distributed to
                 Committee member offices or places of residence.
             c. IRB members and consultants with a conflict of interest state so at the beginning
                 of the meeting and should absent themselves from the meeting room during the
                 discussion and vote on the research in which they have a conflicting interest. In
      order to avoid conflicts of interest, (i) no participating IRB Committee member or
      consultant may hold a significant equity interest (e.g., partnership, stock, or profit-
      sharing) in the organization requesting IRB Committee review; (ii) no
      participating IRB Committee member or consultant may be paid more than
      reasonable compensation or receive more than reasonable benefits for IRB-related
      activities; and (iii) no IRB Committee member or consultant may receive
      compensation or benefits under arrangements that could impede or discourage
      objective decision-making on behalf of human subjects.
   d. Each study is assigned a Primary and Secondary reviewer. The reviewers assigned
      will have expertise in the area of the research adequate to the scope and
      complexity of the research. The reviewers conduct an in-depth review of all
      pertinent documentation.
      i. The Primary reviewer is to present the study in summary form to the full IRB
           Committee highlighting any research related issues and recommending
           modifications, if applicable.
      ii. The Secondary reviewer is prepared to provide any additional information not
           presented by the Primary reviewer highlighting any additional research related
           issues and recommending modifications, if applicable.
      iii. If the Committee does not have a member available with expertise adequate to
           the scope and complexity of the research, a consultant with expertise in the
           area of research will be asked to review the study and provide written
           recommendations or may be asked to attend the Committee meeting. The
           consultant may not count toward the quorum or vote.
      iv. The reviewers will assess the protocol for both scientific and scholarly merit
           in relationship to the level of risk and that in weighing risks the IRB
           Committee assess the full range of risks including physical, psychological,
           social, legal, and economic.
      v. When some or all of the subjects are likely to be vulnerable to coercion or
           undue influence, such as children, prisoners, pregnant women, mentally
           disabled persons, economically or educationally disadvantaged persons, the
           IRB Committee determines if additional safeguards need to be included in the
           study to protect the rights and welfare of these subjects.
      vi. All Committee members are given the opportunity to review, ask questions of
           the reviewers, and request modifications in the proposal.
      vii. The Committee reviews the proposed research, consents, and applicable
           documents to determine whether the study meets criteria 45 CFR 46.111, 21
           CFR 56.111 and 38 CFR 16.111 if applicable, for approval. In order to
           provide written documentation of these criteria, the Primary/Secondary
           Reviewers complete the Comment Sheet detailing how each of these criteria is
           met.
      viii. The Committee determines the review interval appropriate to the degree of
           risk, but not less than once per year.
      ix. It is typical, although not required, that the Primary reviewer makes the
           motion regarding the status of the study in accordance with applicable LWC
           IRB policies and procedures.
3. HSPP Staff Responsibilities.
a. The HSPP staff member will conduct a pre-review for studies submitted requiring
   full Committee review. If the staff member determines that the study meets
   criteria for exempt or expedited review, the Investigator will be notified. The staff
   member requests any additional documents needed for the review, as well as any
   pre-review changes.
b. E-mails requesting pre-review changes are sent by the HSPP staff member to the
   Investigator.
c. Once the pre-review changes are received from the Investigator, the HSPP staff
   member places the new study on the next available Committee agenda, assigns
   reviewers, and prepares the Primary/Secondary reviewer and other Committee
   member review materials.
d. The HSPP staff members (in consultation with the IRB Chair) assign primary and
   secondary reviewers with expertise in the area of the research adequate to the
   scope and complexity of the research. If the Committee does not have at least one
   member available with expertise adequate to the scope and complexity of the
   research, HSPP staff will assist in arranging review by a consultant with the
   required expertise. The staff member may be asked to arrange for the consultant
   to attend the Committee meeting. The consultant may not count toward the
   quorum or vote.
e. The staff member gathers the required documents for the Primary and Secondary
   reviewers as well as all other Committee members to review.
f. The staff member captures the quorum status, discussion of controverted issues,
   recommendations and determinations (including those from consultants), motions,
   and votes for each study reviewed during the Committee meeting in accordance
   with applicable LWC HSPP policies and procedures. The minutes of the IRB
   Committee meeting clearly reflect the determinations regarding risk and approval
   period (review interval). If a member has a conflict of interest, it is noted in the
   minutes that a conflict exists and that the Committee member with the conflict,
   was absent during the discussion and vote for that specific research study.
g. Letters requesting revisions from reviewers, and approval letters are drafted using
   the appropriate template and forwarded to the IRB Chair or his/her designee for
   signature.
h. Amendments, adverse events, and continuing reviews are completed per
   corresponding policies and procedures.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedure
POLICY NUMBER: III.D IRB Review of Human Subjects Research - Full Committee
SUB-PART: III.D.2 Initial Application Materials to be Reviewed by: Full IRB Committee
REVIEW RESPONSIBILITY: RB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.D.2 Initial Application Materials to be Reviewed by the Full IRB Committee
       Policy Instructions and Explanations:
       1. In conducting the initial, full Committee review of proposed research, the IRB
           Committee must obtain information in sufficient detail to make the determinations
           required under federal regulations.
       2. Materials Provided to the IRB Committee:
           a. Primary and Secondary Reviewers. The following materials should be provided to
                the primary and secondary reviewers: (Continuing Review Committee – primary
                reviewer receives all materials)
                i. Completed IRB Project Review Form/Project Approval Form with a signature
                     page;
                ii. Full investigator‟s or sponsor‟s protocol;
                iii. Informed consent documents and/or scripts, as appropriate (If DHHS, include
                     DHHS approved sample informed consent document);
                iv. Copies of surveys, questionnaires;
                v. Copies of letters of assurance or cooperation with research sites (if they exist);
                vi. Relevant grant applications;
                vii.Investigator‟s brochure (if one exists); and
                viii.Advertising intended to be seen or heard by potential subjects, including
                     email solicitations, radio/television recruitment announcements, flyers.
           b. Materials Provided to Non-Primary/Secondary Reviewers. All IRB Committee
                members (other than the primary and secondary reviewers) should receive and
                review a Project Review Form/Project Approval Form (of sufficient detail to
                make the determinations required under federal regulations), the proposed
                informed consent document(s), any advertising or recruiting material, and surveys
                and questionnaires. In addition, a copy of the complete documentation is available
                to all members for review prior to, or at the convened meeting.
       3. Grant Application.
           The primary reviewers should review the complete grant application, if any, to ensure
           that the research described in the IRB summary document is consistent with the grant
           application. The grant application does not need to be reviewed by every IRB
           Committee member. A copy of the grant application or proposal should be retained
           by the HSPP Office and made available to any IRB member who may wish to review
           it.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.E IRB Review of Human Subjects Research – Expedited Review
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.E IRB Review of Human Subjects Research - Expedited Review
       Definitions:
       1. Minimal Risk: The probability and magnitude of harm or discomfort anticipated in
          the research are not greater in and of themselves than those ordinarily encountered in
          daily life or during the performance of routine physical or psychological
          examinations or tests.
       2. Minor Amendment: A proposed change in research related activities that does not
          materially affect an assessment of the risks and benefits of the study and does not
          substantially change the specific aims or design of the study.
       Policy Instructions and Explanations:
       1. Federal regulations (45 CFR 46.110, 21 CFR 56.110 and 38 CFR 16.110) allow the
          IRB to review certain applications on an expedited basis if they meet specified
          criteria. All expedited protocols must be reviewed by the IRB at least once per year.
          Additionally, the standard requirements for informed consent (or its waiver,
          alteration, or exception) apply to all IRB approvals regardless of the type of review -
          expedited or full Committee - utilized by the IRB.
       2. An expedited review consists of a review of research involving human subjects by the
          appropriate IRB Committee Chairperson or his/her designee. In reviewing the
          research, the reviewer may exercise all of the authorities of the full Committee except
          that the reviewer, acting alone may not disapprove the research. Additionally, the
          reviewer may refer the application to the full Committee for full review as warranted.
       3. Appropriate Use of Expedited Review Procedures. Federal regulations limit the use of
          expedited review procedures to specific research categories published in the Federal
          Register. Use of expedited review by the IRB must be restricted to those applications
          that fulfill one of nine categories listed below. The categories on the list apply
          regardless of the age of subjects, except as noted.
          a. Minimal Risk. Research activities that (A) present no more than minimal risk to
              human subjects, and (B) involve only procedures listed in one or more of the
              specific nine categories, may be reviewed by the IRB using the expedited review
              procedure authorized by 45 CFR 46.110, 21 CFR 56.110.
              i. Minimal risk means that the probability and magnitude of harm or discomfort
                   anticipated in the research are not greater in and of themselves than those
                   ordinarily encountered in daily life or during the performance of routine
                   physical or psychological examinations or tests. NOTE: An example of
                   minimal risk is the risk of drawing a small amount of blood from a healthy
                   individual for research purposes or conducting a personality inventory
                   (because the risk of doing so is no greater than the risk of doing so as part of a
                   routine physical/psychological examination).
              ii. The nine categories should not be deemed to be of minimal risk simply
                   because they are included on the list.
       iii. Inclusion on the list merely means that the activity is eligible for review
            through the expedited review procedure when the specific circumstances of
            the proposed research involve no more than minimal risk to human subjects.
   b. The categories in this list apply regardless of the age of subjects, except as noted.
   c. The expedited review procedure may not be used where identification of the
       subjects and/or their responses would reasonably place them at risk of criminal or
       civil liability or be damaging to the subjects‟ financial or social standing,
       employability, insurability, reputation, or be stigmatizing, unless reasonable and
       appropriate protections will be implemented so that risks related to invasion of
       privacy and breach of confidentiality are no greater than minimal.
   d. The expedited review procedure may not be used for classified research involving
       human subjects.
   e. Additionally, the standard requirements for informed consent (or its waiver,
       alteration, or exception) apply to all IRB approvals, regardless of the type of
       review- expedited or full committee utilized by the IRB.
   f. Categories one (1) through seven (7) pertain to both initial and continuing review.
4. Categories of Research Eligible for Expedited Review. The following expeditable
   categories pertain to both initial and continuing IRB review:
   a. Clinical Studies of Drugs and Medical Devices (Category 1) only when condition
       (i) or (ii) is met.
       i. Research on drugs for which an investigational new drug application (see 21
            CFR Part 312) is not required. (Note: Research on marketed drugs that
            significantly increases the risks or decreases the acceptability of the risks
            associated with the use of the product is not eligible for expedited review.); or
       ii. Research on medical devices for which (a) an investigational device
            exemption application (see 21 CFR Part 812) is not required; or (b) the
            medical device is cleared/approved for marketing and the medical device is
            being used in accordance with its cleared/approved labeling.
   b. Collection of blood samples (Category 2) by finger stick, heel stick, ear stick, or
       venipuncture as follows:
       i. from healthy, non-pregnant adults who weigh at least 110 pounds. For these
            subjects, the amounts drawn may not exceed 550 ml in an 8 week period and
            collection may not occur more frequently than 2 times per week; or
       ii. from other adults and children, when the age, weight, and health of the
            subjects, the collection procedure, the amount of blood to be collected, and the
            frequency with which it will be collected are considered. For these subjects,
            the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-
            week period and collection may not occur more frequently than 2 times per
            week. Children are defined in the federal regulations as "persons who have not
            attained the legal age for consent to treatments or procedures involved in the
            research, under the applicable law of the jurisdiction in which the research
            will be conducted." (See 45 CFR 46.402(a)). In Kentucky, this age is 18 years
            old.
   c. Prospective collection of biological specimens for research purposes by
       noninvasive means (Category 3), for example:
       i. hair and nail clippings in a non-disfiguring manner;
     ii. deciduous teeth at time of exfoliation or if routine patient care indicates a need
          for extraction;
     iii. permanent teeth if routine patient care indicates a need for extraction;
     iv. excreta and external secretions (including sweat);
     v. uncannulated saliva collected either in an unstimulated fashion or stimulated
          by chewing gumbase or wax or by applying a dilute citric solution to the
          tongue;
     vi. placenta removed at delivery;
     vii. amniotic fluid obtained at the time of rupture of the membrane prior to or
          during labor;
     viii.supra- and sub-gingival dental plaque and calculus, provided the collection
          procedure is not more invasive than routine prophylactic scaling of the teeth
          and the process is accomplished in accordance with accepted prophylactic
          techniques;
     ix. mucosal and skin cells collected by buccal scraping or swab, skin swab, or
          mouth washings;
     x. sputum collected after saline mist nebulization.
d.   Collection of data through noninvasive procedures (Category 4) (not involving
     general anesthesia or sedation) routinely employed in clinical practice, excluding
     procedures involving X-rays or microwaves. Where medical devices are
     employed, they must be cleared/approved for marketing. (Studies intended to
     evaluate the safety and effectiveness of the medical device are not generally
     eligible for expedited review, including studies of cleared medical devices for
     new indications.) Examples:
     i. physical sensors that are applied either to the surface of the body or at a
          distance and do not involve input of significant amounts of energy into the
          subject or an invasion of the subject‟s privacy;
     ii. weighing or testing sensory acuity;
     iii. magnetic resonance imaging;
     iv. electrocardiography, electroencephalography, thermography, detection of
          naturally occurring radioactivity, electroretinography, ultrasound, diagnostic
          infrared imaging, doppler blood flow, and echocardiography;
     v. moderate exercise, muscular strength testing, body composition assessment,
          and flexibility testing where appropriate given the age, weight, and health of
          the individual.
e.   Research involving materials (data, documents, records, or specimens) that have
     been collected, or will be collected solely for non-research purposes (Category 5)
     (such as medical treatment or diagnosis). (NOTE: Some research in this category
     may be exempt from the requirement that it obtain IRB approval. This listing
     refers only to research that is not exempt).
f.   Collection of data from voice, video, digital, or image recordings made for
     research purposes (Category 6).
g.   Research on individual or group characteristics or behavior (Category 7)
     (including, but not limited to research on perception, cognition, motivation,
     identity, language, communication, cultural beliefs or practices, and social
     behavior) or research employing survey, interview, oral history, focus group,
       program evaluation, human factors evaluation, or quality assurance
       methodologies. (NOTE: Some research in this category may be exempt from the
       requirement that it obtain IRB approval. This listing refers only to research that is
       not exempt.) Appropriate Use of Expedited Review Procedures for Continuing
       Review of Research: The IRB may use an expedited procedure to conduct
       continuing review of research provided all research activities do not fall under any
       of the general restrictions, present no more than minimal risk to human subjects,
       and involve procedures listed in one or more of the following categories:
   h. Continuing review of research (Category 8) previously approved by a full IRB
       Committee as follows:
       i. WHERE:
            (i.a) the research is permanently closed to the enrollment of new subjects;
            (i.b) all subjects have completed all research-related interventions; and
            (i.c) the research remains active only for long-term follow-up of subjects; or
       ii. WHERE: no subjects have ever been enrolled (at any sites if a multi-site trial)
            and no additional risks have been identified; or;
       iii. WHERE: the remaining research activities are limited to data analysis.
   i. Continuing review of research (Category 9), not conducted under an
       investigational new drug application or investigational device exemption where
       categories 2 through 9 do not apply, but the IRB has determined and documented
       at a full Committee convened meeting that the research involves no greater than
       minimal risk and no additional risks have been identified.
   j. Appropriate Use of Expedited Review Procedures for Review of Modifications to
       Previously Approved Research: The IRB may use an expedited procedure to
       conduct review of modifications to previously approved research provided the
       changes represent a minor amendment.
5. Pre-review of expedited projects is conducted by HSPP staff in order to prepare the
   application for review by the Chair or Chair‟s designee. The following activities are
   conducted in preparation for the review to take place
   a. Project is reviewed for completeness (signatures of Principal Investigator,
       Department Head, Dean or Comparable authority, and Departmental Review
       Chair, Verification of Training Form is complete, all questions are answered on
       the Project Review Form/Project Approval Form, appendices/attachments are
       submitted.)
   b. Consent forms are reviewed for adherence to posted Guidelines and inclusion of
       material from the Project Review Form/Project Approval Form.
   c. Recruitment materials are reviewed for completeness and accuracy relative to the
       information contained in the Project Review Form/Project Approval Form.
   d. Data collection forms (i.e., questionnaires, surveys) are reviewed to check for
       completeness and content.
6. Reviewers Must Make Certain Determinations to Approve Application. In conducting
   the expedited review, the designated reviewers must review materials in sufficient
   detail to make the following determinations required under federal regulation 45 CFR
   46.111, 21 CFR 56.111 and 38 CFR 16.111, if applicable for approval.
   a. Risks to Subjects are Minimized:
       i. By using procedures which are consistent with sound research design and
           which do not unnecessarily expose subjects to risk, and;
       ii. Whenever appropriate, by using procedures already being performed on the
           subjects for diagnostic or treatment purposes.
   b. Risks to Subjects are Reasonable in relation to Anticipated Benefits, if any, to
       subjects, and the importance of the knowledge that may reasonably be expected to
       result. In evaluating risks and benefits, the reviewers should consider only those
       risks and benefits that may result from the research (as distinguished from risks
       and benefits of therapies those subjects would receive even if not participating in
       the research). The reviewers should not consider possible long-range effects of
       applying knowledge gained in the research (for example, the possible effects of
       the research on public policy) as among those research risks that fall within the
       purview of its responsibility.
   c. Selection of Subjects is Equitable. In making this assessment the reviewers should
       take into account the purposes of the research and the setting in which the
       research will be conducted and should be particularly cognizant of the special
       problems of research involving vulnerable populations, such as children,
       prisoners, pregnant women, mentally disabled persons, or economically or
       educationally disadvantaged persons.
   d. Informed Consent will be sought from each prospective subject or the subject's
       legally authorized representative, in accordance with, and to the extent required
       by federal regulation and institutional policies.
   e. Informed Consent will be appropriately documented, in accordance with, and to
       the extent required by federal regulation and institutional policies.
   f. When appropriate, the research plan makes adequate provision for monitoring the
       data collected to ensure the safety of subjects.
   g. When appropriate, there are adequate provisions to protect the privacy of subjects
       and to maintain the confidentiality of data.
   h. Vulnerable Subjects. Additionally, when some or all of the subjects are likely to
       be vulnerable to coercion or undue influence, such as children, prisoners, pregnant
       women, mentally disabled persons, or economically or educationally
       disadvantaged persons, the IRB reviewers must determine that additional
       safeguards have been included in the study to protect the rights and welfare of
       these subjects.
7. Materials to be Reviewed. The following materials should be provided to the Chair or
   the Chair‟s designee for expedited review applications:
   a. Completed IRB application with a signature page;
   b. Full Investigator‟s or Sponsor‟s protocol, (if one exists) and Relevant grant
       applications;
   c. Proposed informed consent document(s) and/or script as appropriate;
   d. Copies of surveys, questionnaires;
   e. Copies of letters of assurance or cooperation with research sites;
   f. Investigator‟s brochure (if one exists); and
   g. Advertising intended to be seen or heard by potential subjects, including email
       solicitations, radio/television recruitment announcements, flyers.
8. Determining Which Projects Require Review More Often than Annually. The
   primary reviewers and the chair reviewing the application must determine a review
   interval for the research as appropriate to the degree of risk but not more than
   annually. The regulations make no provision for any grace period extending the
   conduct of research beyond the expiration date of IRB approval. Therefore,
   continuing review and re-approval of the research occurs on or before the date when
   IRB approval expires. OHRP recognizes the logistical advantages of keeping the IRB
   approval period constant from year to year throughout the life of each project. When
   continuing review occurs annually and the IRB performs continuing review within 30
   days before the IRB approval period expires, the IRB may retain the anniversary date
   as the date by which the continuing review must occur.
9. Notification of Committee. As a means of notifying the Committee and allowing for
   comments regarding a review conducted utilizing expedited review procedures, a
   summary of the application must be documented in the agenda provided to the full
   Committee for the next possible convened meeting. This documentation includes a
   citation to the specific permissible category or categories justifying the expedited
   review. (If during a Committee meeting, a Committee member voices a concern
   regarding a project, Committee may request further information from the Principal
   Investigator or suspend the project until concerns have been addressed.)
10 Information obtained during the review of an amendment, adverse event, sponsor
   notification, or other pertinent information may possibly disqualify the study from
   being approved under an expedited status. The study is then forwarded to the full IRB
   Committee for determination.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.E IRB Review of Human Subjects Research - Expedited Review
SUB-PART: III.E.1 Procedure for IRB Review of Human Subjects Research Expedited Review
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.E.1 Procedure for IRB Review of Human Subjects Research – Expedited Review
        Procedure:
        This procedure provides guidance for the review of human subjects research activities
        that qualify for expedited review under the Federal regulations.
        a. Investigator Responsibilities.
            i. The application is completed in its entirety and submitted to the IRB Office for
                 processing. The original application form and any additional information
                 (Investigator‟s brochure, sponsor‟s protocol, dissertation, grant) are to be
                 submitted. The application and instructions for completion are located on the
                 HSPP Website at http://www.lindsey.edu/.
            ii. The consent form(s) is written using the template consent document. Instructions
                 for writing informed consent documents are located on the HSPP Website.
            iii. Studies that include vulnerable populations are submitted with supplemental
                 forms demonstrating added protections and a rationale as to why these
                 populations are to be included in the proposed research. These include:
                 • Prisoners.
                 • Pregnant women, human fetuses, neonates and fetal material.
                 • Children.
                 • Cognitively impaired.
            iv. The “HIPAA Authorization Form” is completed accounting for Investigators and
                 study staff who will be accessing Protection Health Information (PHI).
            v. The Investigator replies to all requests for revisions and/or clarifications requested
                 by the pre-reviewers or reviewers, when applicable.
            vi. Any proposed changes to IRB approved documents are submitted to the IRB as an
                 amendment. The Investigator must receive written IRB approval before
                 implementing any changes to the research study.
            vii. All unanticipated problems to participants or others are submitted to the IRB
                 Committee for review.
        b. IRB Committee Responsibilities.
            i. Expedited studies are assigned to the IRB Chair or one experienced reviewer from
                 the designated IRB Committee for review and approval. An experienced IRB
                 member means a voting member or alternate voting member who has served on
                 an IRB for at least one year, has received training relative to the expedited review
                 categories, and possesses the scientific expertise needed to review the proposed
                 research. However, the Reviewer may request a second reviewer or refer the
                 research to the full IRB Committee for further determination. If the reviewer has a
                 conflict of interest, the reviewer will contact the HSPP staff member and recuse
                 themselves from the review. The reviewer may request a second reviewer, request
                 review by an expert consultant to the IRB, or refer the study to full IRB
                 Committee for determination. However, the determination of disapproval can
                 only be made by the full Committee.
        (i.a) The reviewer reviews the application and validates or declines the
             researcher‟s claim for review under the expedited category. When declined,
             the reviewer refers the study to full Committee.
        (i.b) The reviewer assesses the protocol for both scientific and scholarly merit in
             relationship to the level of risk.
        (i.c) The reviewer reviews the proposed research, consents, and applicable
             documents to determine whether the study meets criteria 45 CFR 46.111 and
             if applicable, FDA 21 CFR 56.111 for approval. In order to provide written
             documentation of these criteria, the reviewer completes the Comment Sheet
             detailing how each of these criteria is met.
        (i.d) The reviewer determines the review interval appropriate to the degree of risk,
             but not less than once per year.
        (i.e) The reviewer may request that the study be approved, approved pending
             modifications, or referred to full Committee.
        (i.f) When revisions are requested, the modified documents are re-reviewed and,
             if acceptable, final approval granted. If they are not acceptable, the reviewer
             contacts the Investigator for a resolution. If a resolution cannot be reached, the
             modification is referred to full Committee.
        (i.g) The Chair or his/her designee verifies and signs approval letter.
        (i.h) The full Committee review the appropriate section of the IRB agenda for
             notifications of research proposals/activities that have been approved under an
             expedited review procedure.
   ii. The IRB Chair or Chair‟s designee will use the HSPP Review Sheet for IRB
        Chair or Chair‟s Designee in order to determine protocol specific findings under
        the regulations.
c. HSPP Staff Responsibilities.
   i. The staff conducts a pre-review for studies submitted requesting expedited
        review. The staff member determines whether the application includes all
        information required and requests additional information, if needed, from the
        Investigator, to assist the reviewer in making a determination.
   ii. When the study is found by the staff member not to qualify under the criteria for
        expedited review, the staff contacts the Investigator and assists with determining
        the appropriate level of review for which the study may qualify.
   iii. E-mails requesting pre-review changes are to be sent by the staff member to the
        Investigator.
   iv. The HSPP staff present the Chair with the application and additional materials for
        review of the project.
   v. When consultants to the IRB are utilized, the staff assists in obtaining a completed
        recusal agreement and assembles and distributes review materials.
   vi. Approval letters are drafted using the appropriate template, which includes a
        citation to the specific permissible category or categories justifying the expedited
        review. The letters are then forwarded to the Chair or his/her designee for
        signature.
   vii. Amendments, adverse events, and continuing reviews are processed according to
        corresponding HSPP policies and procedures.
viii. Committee notification of all research proposals/activities that received approval
     under expedited review procedures are on placed the next available agenda.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.F IRB Review of Human Subjects Research – Exempt Review
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.F IRB Review of Human Subjects Research – Exempt Review
       Definitions:
       1. Children: Persons who have not attained the legal age for consent to treatments o
            procedures involved in the research, under the applicable law of the jurisdiction in
            which the research will be conducted. According to Kentucky state law, the legal age
            for consent is 18 years of age.
       Policy Instructions/Explanations:
       It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
       Program
       (HSSP) that all human subjects research activities under its jurisdiction be reviewed to
       determine whether the research meets one or more of the exemption categories described
       in the federal regulations and complies with the ethical standards of Lindsey Wilson
       College SPC .
       1. Research activities involving human subjects that are exempt from the requirement
            that they receive IRB full or expedited review are identified in 45 CFR 46.101(b)(1-
            6). The IRB may not create new categories of this exempt research. Only the IRB
            Chair or Director of HSPP, may determine which activities qualify for an exempt
            review. Investigators do not have the authority to make an independent determination
            that research involving human subjects is exempt and must contact the HSPP office
            concerning the status of proposed research or changes in ongoing research.
       2. The Director of the Human Subjects Protection Program or Committee Chair will
            review the application and will endorse or decline the request for an exemption. The
            request for an exempt project must meet one of the six specific categories of activities
            listed in Section 4 below. The determination that a research activity is exempt from
            regulatory oversight must be provided to the Investigator in writing and should
            include the citation of the specific category justifying the exemption (e.g., 45 CFR
            46.101(b)(1-6), 45 CFR 406.301(a), 45 CFR 46.401(b) and 21 CFR 6.104(d)).
       3. If the proposed research activities do not meet the criteria for exemption, the HSPP
            office will contact the principal investigator outlining any additional information
            needed and the proper category for review.
       4. Federal regulations at 45 CFR 46.101(b) provides for six specific categories of
            activities that may qualify as exempt. NOTE: With the revision of Subpart B on
            November 13, 2001, the exemptions from IRB review listed at 45 CFR 46.101(b)
            may now be applied to research involving pregnant women, human fetuses, and
            neonates in accordance with 45 CFR 46.201(b). These categories do not apply to
            research involving prisoners and categories 1-5 do not apply to FDA regulated
            research. They are:
            a. 45 CFR 46.101(b)(1). Research conducted in established or commonly accepted
                 educational settings, involving normal educational practices, such as:
                 i. research on regular and special education instructional strategies, or
                 ii. research on the effectiveness of or the comparison among instructional
                     techniques, curricula, or classroom management methods.
b. 45 CFR 46.101(b)(2). Research involving the use of educational tests (cognitive,
   diagnostic, aptitude, achievement), survey procedures, interview procedures or
   observation of public behavior, unless:
   i. information obtained is recorded in such a manner that human subjects can be
        identified, directly or through identifiers linked to the subjects; and
   ii. any disclosure of the human subjects' responses outside the research could
        reasonably place the subjects at risk of criminal or civil liability or be
        damaging to the subjects' financial standing, employability, insurability, or
        reputation.
   iii. this exemption is not available for research involving children unless the
        research is limited to observation of public behavior when the investigators do
        not participate in the activities being observed (See 45 CFR Part 46, Subpart
        D Additional HHS, Protections for Children Involved as Subjects in
        Research).
c. 45 CFR 46.101(b)(3). Research involving the use of educational tests (cognitive,
   diagnostic, aptitude, achievement), survey procedures, interview procedures, or
   observation of public behavior that is not exempt under paragraph (b) above, if:
   i. the human subjects are elected or appointed public officials or candidates for
        public office; or
   ii. federal statute(s) require(s) without exception that the confidentiality of the
        personally identifiable information will be maintained throughout the research
        and thereafter.
d. 45 CFR 46.101(b)(4). Research involving the collection or study of existing data,
   documents, records, pathological specimens, or diagnostic specimens, if these
   sources are publicly available or if the information is recorded by the investigator
   in such a manner that subjects cannot be identified, directly or through identifiers
   linked to the subjects.
   i. To qualify for this exemption the data, documents, records, or specimens must
        be in existence before the project begins. Example: Investigator A wishes to
        screen blood samples at a rural hospital for incidence of HIV infection. She
        does not want to draw specimens specifically for this purpose; rather she
        proposes to use specimens that were drawn for some other purpose but which
        remain in the hospital laboratory. If Investigator A proposes to use specimens
        that had been drawn prior to the initiation of her research and are, for some
        reason, "on the shelf," the protocol may qualify as exempt, assuming the other
        requirements are met (i.e., the sources are either publicly available or the
        information is recorded by the investigator in such a manner that subjects
        cannot be identified, directly or through identifiers linked to the subjects). If
        she proposes to use specimens that will be drawn after the start date of her
        project for reasons unrelated to her research, the protocol is not exempt, even
        though the specimens will be drawn regardless of her use of the excess blood.
        The protocol may, however, qualify for expedited review.
   ii. Under this exemption, an investigator (with proper institutional authorization)
        may inspect private, identifiable records, but may only record information in a
        non-identifiable manner. Example: Investigator B wishes to examine court
        records of involuntary commitments to psychological institutions. If he uses
            court records that were on file before the initiation of his research, the
            protocol may qualify as exempt. If he proposes to use records filed after the
            initiation of the project, the protocol is not exempt, although it may qualify for
            expedited review.
   e. 45 CFR 46.101(b)(5). Research and demonstration projects, which are conducted
       by or subject to the approval of Federal Department or Agency heads, and which
       are designed to study, evaluate, or otherwise examine:
       i. public benefit or service programs; this exemption is for Federally supported
            projects and is most appropriately invoked with authorization or concurrence
            by the funding agency. The following criteria must be satisfied to invoke the
            exemption for research and demonstration projects examining "public benefit
            or service programs":
            (i.a) the program under study must deliver a public benefit (e.g., financial or
                 medical benefits as provided under the Social Security Act) or service
                 (e.g., social, supportive, or nutrition services as provided under the Older
                 Americans Act);
            (i.b) the research or demonstration project must be conducted pursuant to
                 specific Federal statutory authority;
            (i.c) there must be no statutory requirement that the project be reviewed by an
                 Institutional Review Board;
            (i.d) the project must not involve significant physical invasions or intrusions
                 upon the privacy of participants.
       ii. Procedures for obtaining benefits or services under those programs;
       iii. Possible changes in or alternatives to those programs or procedures; or
       iv. Possible changes in methods or levels of payment for benefits or services
            under those programs.
   f. 45 CFR 46.101(b)(6) and 21 CFR 56.104(d). Taste and food quality evaluation
       and consumer acceptance studies:
       i. if wholesome foods without additives are consumed or
       ii. if a food is consumed that contains a food ingredient at or below the level and
            for a use found to be safe, or agricultural chemical or environmental
            contaminant at or below the level found to be safe, by the Food and Drug
            Administration or approved by the Environmental Protection Agency or the
            Food Safety and Inspection Service of the U.S. Department of Agriculture.
5. Emergency use of investigational drugs, agents, or biologics will be handled in
   accordance with FDA regulations 21 CFR 56.104(c) and institutional policies and
   procedures allow for an exemption from prior review and approval by the IRB for
   emergency use, the LWC IRB requires prior notification of emergency use of
   investigational drugs, agents, or biologics.
   a. FDA regulations at 21 CFR 56.102(d), allows for one emergency use of an
       investigational drug, agent, or biologic without prospective IRB review. FDA
       regulations require that any subsequent use of the investigational product at the
       institution have prospective IRB review and approval. The only exception to this
       provision is if the IRB has not had sufficient time to convene a meeting to review
       a protocol.
        6. Exempt projects reviewed on behalf of investigators located at the VA are included in
            the IRB Committee agenda/minutes. Reviews of exempt projects for VA investigators
            are performed by an IRB Committee member designated by the IRB Chair.
        7. Amendments. Because no continuing review is required for exempt research, any
            proposed or anticipated changes in the exempt study must be submitted to the HSPP
            as an amended application. Certain changes may disqualify the research from
            receiving exempt status (i.e., addition of a vulnerable population, audio/videotaping,
            abstraction of identifiable records - either education or medical).
Reference:
45 CFR 46.101
45 CFR 46.401
21 CFR 56.104
U.S. Food and Drug Administration IRB Information Sheets: Emergency Use of Unapproved
Medical Devices, 1998 Update
U.S. Food and Drug Administration IRB Information Sheets: Emergency Use of an
Investigational Drug or Biologic, 1998 Update
OHRP Compliance Activities: Common Findings and Guidance -7/10/2002 Item #30
VHA Handbook 1200.5, Appendix A
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.F IRB Review of Human Subjects Research – Exempt Review
SUB-PART: III.F.1 Procedure for IRB Review of Human Subjects Research - Exempt
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


      III.F.1: Procedure for IRB Review of Human Subjects Research - Exempt
      Procedure:
      This procedure provides guidance in accordance with regulations to review and approve
      human subjects research in an exempt category.
      1. Investigator Responsibilities.
          a. The application is completed in its entirety and submitted to the HSPP office for
              processing. The original application and any background information are
              submitted. The application and instructions to complete the application are
              located on the IRB website: http://www.lindsey.edu.
          b. The Investigator replies to all requests for revisions and/or clarifications requested
              by the pre-reviewers or reviewers, when applicable.
          c. Any changes to the approved study within the first year are submitted to the HSPP
              as an amendment. Changes may not be implemented prior to IRB review and
              approval per Federal regulations.
          d. The Investigator is responsible for assuring that the exempt research is carried out
              in an ethical manner that includes appropriate participant protections (i.e., use of a
              disclaimer form/information sheet).
      2. IRB Committee Responsibilities.
          a. If needed, the Chair is available to assist the Director in determining if the study
              meets the exemption criteria.
      3. HSPP Administrator Responsibilities.
          a. The Director or Chair will review the proposed project to determine if the
              research qualifies for exemption.
          b. The Director or Chair will also review the proposed project to determine if the
              research meets the ethical standards of the Belmont Report and if any additional
              protections for participants are required using the Additional Considerations for
              Categories of Exemption checklist (adapted from Amdur and Bankert, 2002).
          c. The Director or Chair may:
              i. Approve the request;
              ii. Request minor revisions to the submitted documents in order to approve the
                   request, and review and approve the revisions prior to granting final approval;
                   or
              iii. Disapprove the request.
          d. If the Director or Chair disapproves the request, these individuals will determine
              the appropriate level of review, communicate this to the Investigator, and guide
              the Investigator through the submission.
          e. If the Director or Chair approves the request, the Director signs and sends a letter
              of final approval using the appropriate template.
          f. Appropriate database entries are completed, including notification of approval on
              the next available agenda for VA exempt projects only.
References:
IRB Management and Function; Amdur, R. and Bankert, E.; 2002 Jones and Bartlett
Publishers, Inc.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.G IRB Continuing Review Requirements
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.G IRB Continuing Review Requirements
       Purpose: The purpose of this policy is to outline the process for continuing review of all
       research protocols previously approved by Lindsey Wilson College SPC IRB
       Committees.
       Definitions:
       Continuing Review - Periodic review of research activity necessary to determine
       whether the risk/benefit ratio has changed, whether there are unanticipated findings
       involving risks to subjects, and whether any new information regarding the risks and
       benefits should be provided to subjects.
       Exempt Review - Studies determined by the IRB to meet regulation criteria as exempt.
       Exempt studies do not require periodic review by the IRB unless a change in the project
       is planned.
       Expedited Review - The IRB Committee Chair or designee conducts the review on
       behalf of the full Committee.
       “Not less than once per year” - Research must be reviewed, at a minimum, on or before
       the one-year anniversary date of the IRB review, not within one year of the receipt of an
       appropriate letter from the IRB.
       Full Committee Review - Studies reviewed by the full, convened IRB Committee with a
       recorded vote.
       Program/Center Application – A research project/grant that will involve several
       individual research studies to meet the goals of the overall research project. The IRB will
       conduct an in-depth review of the overall project. Each of the studies conducted as part of
       the project/grant must be submitted and approved individually.
       Policy: It is the policy of Lindsey Wilson College SPC‟s HSPP that all research protocols
       be
       periodically reviewed at intervals appropriate to the degree of risk, but not less than once
       per year.
       1. IRB Continuing Review Criteria:
           a. IRB Committee Responsibility: The criteria for continuing review are the same as
               that for initial review. Therefore, it is the responsibility of the IRB to determine
               that:
               i. Risks to subjects continue to be minimized and reasonable in relation to the
                    anticipated benefits;
               ii. Selection of subjects continues to be equitable;
               iii. Informed consent continues to be appropriately obtained and documented;
               iv. Adequate provisions for monitoring the data collected to ensure the safety of
                    the subjects is provided, when appropriate;
               v. Adequate provisions to protect the privacy of subjects and to maintain the
                    confidentiality of data, is provided, when appropriate; and
               vi. Appropriate safeguards for vulnerable populations are provided.
           b. The IRB will determine the need for verification from outside sources on a case-
               by-case basis and according to the following criteria:
      i. Randomly selected protocols;
      ii. Complex protocols involving unusual levels or types of risks to participants;
      iii. Protocols conducted by PIs who previously have failed to comply with
           Federal regulations or the requirements or determinations of the IRB; and/or
      iv. Protocols where concern about possible material changes occurring without
           IRB approval have been raised based on information provided in continuing
           review reports or from other sources.
   c. Principal Investigator Responsibility: To provide a status report to the IRB
      preferably at four (4) weeks prior to the IRB approval expiration date.
2. Types of Review:
   a. Full Committee Review:
      i. Research protocols initially reviewed by the Full Committee must be reviewed
           using full Committee review procedures, unless the study has been modified
           such that it can be reclassified as eligible for expedited review, as defined in
           the regulations.
      ii. Research activities that had previously met criteria for exempt or expedited
           review may change such that full Committee review would be required at the
           time of continuing review.
   b. Expedited Review:
      i. Research protocols that were originally reviewed using expedited review
           procedures may receive continuing review on an expedited basis, unless
           previously met criteria has changed since the previous IRB review and
           approval.
      ii. Research protocols that originally received full Committee review may
           receive expedited review if one of the following situations applies:
           (ii.a) Research is permanently closed to the enrollment of new subjects, all
                subjects have completed all research-related interventions, and research
                remains active only for long-term follow-up of subjects, OR
           (ii.b) No subjects have been enrolled and no additional risks have been
                identified since the last project review, OR
            (ii.c) The remaining research activities are limited to data analysis.
   c. Exempt Research Activities: Exempt studies do not require annual review;
      however, any changes to the research proposal must be presented to the HSPP for
      determination of whether the project still meets criteria for exemption.
   d. Expiration of IRB Approval:
      i. There is no grace period extending the conduct of the research beyond the
           expiration date of IRB approval. If continuing review materials are not
           received in the HSPP Office by the designated due date, an expiration notice
           will be issued to the Principal Investigator and/or the appropriate Advisor.
           Non-response within thirty days of the expiration notice (or due date indicated
           in the notice) will result in termination of project approval.
      ii. Enrollment of new subjects cannot occur after the expiration of IRB approval.
      iii. Continuation of study interventions/procedures for previously enrolled
           subjects, if determined by the IRB Chair or designee as being in the best
           interest of the subjects, may occur only with prior written approval.
3. IRB Approval at Continuing Review:
          a. Research may be restricted, modified or halted altogether based on continuing
             review by the IRB Committee. Re-approval status will be classified as:
             i. Re-approval as submitted.
             ii. Re-approval subject to satisfactory response to cited critique (approved by
                  Chair/designee or by Committee, depending on whether changes require only
                  simple concurrence).
                  (ii.a) For this determination, Committee may allow continuation of study
                       interventions/procedures pending final re-approval. However, enrollment
                       of new subjects will be revoked immediately or at the time current
                       approval expires, and remain revoked until final re-approval is granted.
             iii. Re-approval denied.
                  (iii.a) Re-approval will not be granted until all requested changes/concerns
                       have been addressed.
          b. Based on the IRB continuing review, previously imposed restrictions may be
             relaxed or additional restrictions may be imposed.
Reference:
45 CFR 46.109(e)
45 CFR 46.110
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.G IRB Continuing Review Requirements
SUB-PART: III.G.1 Procedure for IRB Continuing Review
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.G.1 Procedure for IRB Continuing Review
       Procedure:
       1. Notification of Continuing Review. Applications for continuing review will be mailed
           to each Principal Investigator (PI) approximately 30 days prior to the month in which
           current approval expires.
       2. Timing of Continuing Review. The HSPP office will make every effort to link as
           closely as possible:
           a. The receipt of continuing review materials by the HSPP office;
           b. The review of those materials by the IRB; and
           c. Request for revisions.
       3. IRB Committee Responsibilities.
           a. The full IRB Committee should receive and review, at a minimum:
               i. Completed Periodic Review Form; and
               ii. Periodic Review Report, which should include:
                   (ii.a) the total number of subjects enrolled at Lindsey Wilson College SPC and
                        Lindsey Wilson College SPC -affiliated sites since the study began, the
                        total number of subjects enrolled since the previous initial or continuation
                        approval, and the male/female ratio of the total number of subjects
                        enrolled to date (if multiple study arms/populations are involved, include
                        enrollment by group) (for VA research the Periodic Review Report will
                        also include minority status of participants and numbers of participants
                        from vulnerable populations);
                   (ii.b) a summary of any events that are both serious and unexpected (that
                        resulted in a change to the risk/benefit ratio since the previous review) or
                        unanticipated problems involving risks to subjects or others (serious and
                        unrelated), even if the event occurred at a location for which Lindsey
                        Wilson College SPC IRB is not the IRB of record. Individual reports
                        should have already been submitted to the IRB at the time that the PI was
                        made aware of the events;
                   (ii.c) an explanation of any subject‟s withdrawal from the research or any
                        complaints about the research since the previous review (for VA research
                        must include the cumulative number of subjects that have withdrawn and
                        an explanation for the withdrawal);
                   (ii.d) a summary of research methodology and procedures, any recent
                        literature, findings obtained thus far, amendments or modifications to the
                        research, reports on multi-center trials, DSMB reports, and any other
                        relevant information, particularly information about risks associated with
                        the research since the original approval or previous review;
                   (ii.e) any adverse events that are both serious and unexpected or unanticipated
                        problems involving risks to participants or others that occur at a location
                        for which Lindsey Wilson College SPC IRB is not the IRB of record, the
                       Lindsey Wilson College SPC is not the coordinating center, and do not
                       result in a change to the risk/benefit ratio of the study are to be
                       summarized or presented in log format (for VA research, all serious
                       adverse events and unexpected adverse events must be reported;
                  (ii.f) a copy of the all approved informed consent document (s) actually used
                       during the current review period
                  (ii.g) if enrollment continues, an unstamped copy of the informed consent
                       document to be used during the upcoming period will be stamped with the
                       new approval period.
             iii. Primary reviewers receive a copy of the current, approved protocol and any
                  modifications previously approved by the IRB.
             iv. The complete IRB file and relevant IRB minutes are available prior to and
                  during the convened IRB meeting for review by any IRB member.
          b. If the IRB determines that it needs verification from sources other than the
             Investigator, that no material changes have occurred since the previous IRB
             review, the IRB may request an independent assessment of information or data
             provided in the renewal application.
             i. The scope and extent of such an independent assessment is determined on a
                  case-by-case basis.
             ii. Sources for such outside information could include copies of FDA audits,
                  literature searches, site visits conducted by authorized personnel, reports from
                  subjects or study staff, or an audit at the direction of the IRB Committee or the
                  Director of the Human Subjects Protection Program.
          c. Determining Appropriate Interval for Continuing Review.
             i. Appropriate continuing review intervals are addressed with each review
                  conducted by the IRB.
             ii. If the research involves the following, the IRB will review more often than
                  annually:
                  • Previous suspensions of the research due to compliance, record-keeping or
                       other concerns; and/or
                  • Any other situations for which the IRB deems more frequent review
                       appropriate
                  • Research that involves adults unable to consent and the study is deemed
                       greater than minimal risk
                  • Phase I trials
References:
45 CFR 46.109(e)
45 CFR 46.110
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.G IRB Continuing Review Requirements
SUB-PART: III.G.2 Procedure for Processing the Continuing Review Application
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.G.2 Procedure for Processing the Continuing Review Application
       Procedure:
       Upon receipt of Periodic Review Form, the HSPP staff will date stamp the documents
       and check for the proper signatures and attachments. The HSPP staff forward the review
       materials to the appropriate staff member for pre-review.
       1. If the Research Study Qualifies for Full Committee Review:
           a. The staff member will pre-review the continuing review materials for
               completeness. If complete, the project will be placed on the next available agenda
               for the appropriate Committee (no more than thirty days prior to current
               expiration date). If incomplete, the designated staff member will contact the PI, or
               study appropriate study personnel, to complete the application.
           b. The staff member will compile the appropriate study documents for copying,
               prepare the reviewers‟ packets, and arrange for delivery of the packets
               approximately one week prior to the Committee meeting. Each project will be
               assigned to a Primary Reviewer who will receive copies of the current protocol
               and any subsequent amendments, in addition to the continuing review materials
               submitted by the PI.
           c. Upon Committee review of the study, the Committee may make the following
               determinations:
               i. Re-approval as submitted;
               ii. Re-approval subject to satisfactory response to cited critique (approved by
                    Chair/designee or by Committee, depending on whether changes require only
                    simple compliance);
                    (i.a) For this determination, Committee may allow continuation of study
                         interventions/procedures pending final re-approval. However, enrollment
                         of new subjects will be suspended immediately or at the time current
                         approval expires, and remain suspended until final re-approval is granted.
               iii. Re-approval denied.
           d. Following the Committee meeting, the designated staff member will prepare the
               appropriate re-approval documentation or review letter. The study file and
               documentation/letter will be forwarded to the Chair/designee for review,
               approval, and signature. The re-approval documentation or review letter and the
               approved consent form(s) [if appropriate] will be copied and mailed to the PI. A
               copy of each item will be placed in the study file. The staff member will collate
               the file and return the study file to the appropriate file area.
               i. If the study was approved subject to satisfactory response and approval by the
                    Chair/designee:
                    (i.a) The PI response will be pre-reviewed by the staff member for
                         completeness. If complete, the final approval documentation will be
                         prepared and forwarded to the Chair for review, approval and signature.
                         Appropriate documentation will then be mailed to the PI.
        ii. If the study was approved subject to satisfactory response and approval by the
             Committee OR is the re-approval was denied:
             (ii.a) The PI response will be pre-reviewed by the staff member for
                  completeness. If complete, the study will be placed on the next available
                  agenda for Committee review.
2. If the research study qualifies for Expedited Review:
   a. The staff member will pre-review the continuing review materials for
        completeness. If complete, the staff member will prepare re-approval
        documentation and forward the review materials to the Chair/designee, for
        review.
   b. Upon review of the study, the Chair or designee, may make the following
        determinations:
        i. Approved;
        ii. Requires changes;
        iii. Deferred to the full Committee; or
        iv. Terminated for lapse, or for investigation.
   c. Following Expedited review, the designated staff member will copy the re-
        approval documentation for mailing to the PI [if approval was granted] or
        compose an appropriate letter or e-mail to the PI conveying the
        changes/additional information requested by the Chair/designee. If a review letter
        was necessary, the study file and letter will be returned to the Chair for review,
        approval, and signature. The staff member will forward the original letter to the PI
        and place a copy in the study file. The staff member will collate the file and return
        the study file to the appropriate file area.
        i. If the study was approved pending changes:
             (i.a) The PI response will be pre-reviewed by the designated staff member for
                  completeness. If complete, the final approval documentation will be
                  prepared and forwarded to the Chair for review, approval and signature.
                  Appropriate documentation will then be mailed to the PI.
        ii. If the study requires full Committee review:
             (ii.a) The staff member will place the study on the next available agenda for
                  committee review and standard review procedures will be followed.
        iii. If the study was approved, the staff member will place the study on the next
             available agenda to notify the Committee of the expedited study approval.
3. If the Research Study is Conducted Under an Umbrella:
   a. The continuing review materials must be submitted by the PI with a list of sub-
        studies currently being conducted under the grant.
   b. The staff member will conduct a pre-review to verify that each sub-study is in an
        approved status. If sub-studies are not approved, the PC will contact the PI or
        study contact to resolve the issue(s). If all sub-studies are in an approved status,
        the designated staff member will prepare re-approval documentation and forward
        the study to the Chair, or designee, for review, approval, and signature.
   c. The re-approval documentation and the approved consent form(s) [if appropriate]
        will be copied and mailed to the PI. A copy of each item will be placed in the
        study file. The staff member will collate the file and return the study file to the
        appropriate file area.
   d. The staff member will place the study on the next available agenda to notify the
        Committee of the expedited study approval.
4. If the research study is Concluded (whether Full Committee, Umbrella, or
   Expedited):
   a. The PI submits a Periodic Review Form indicating closure, required report
        elements and attachments.
   b. The staff member will pre-review the study for the following:
        i. Participant enrollment since the previous continuing review;
        ii. Adverse Events reported since the previous continuing review;
        iii. Verification that study closure is appropriate.
   c. If incomplete, the staff member will contact the PI to resolve the issue(s). Once
        resolved, acknowledgment of study conclusion will be documented on the
        Periodic Review Form and the study file will be forwarded to the Chair/designee
        for review, approval and signature. The Periodic Review Form, with
        acknowledgment of study conclusion will be mailed to the PI and a copy will be
        placed in the study file.
   d. The staff member will place the study on the next available agenda to notify the
        Committee of the study closure per expedited review. A staff member will
        prepare the file for microfilming and forward the file to the microfilm area.
5. If the research study is SUSPENDED FOR CAUSE due to ethical or safety concerns
   (whether Full Committee or Expedited):
   a. The Human Subjects Officer will prepare the appropriate suspension letter as
        directed by the Chair. The PI must respond to IRB concerns and if directed,
        submit documentation that he/she has notified participants. If participants are to
        be removed from study, PI will be asked to submit plan for orderly withdrawal
        and any necessary follow-up procedures. The Human Subjects Officer will
        follow-up with PI to ensure an immediate response to IRB directives.
   b. Notification of study suspension will be forwarded to the Department Head and
        the Office of the Vice President of Academic Affairs, which will notify the
        Sponsor (if any). The Director of the Human Subjects Protection Program will
        notify appropriate Federal agencies.
   c. Any modifications made by the PI to the protocol must be reviewed and approved
        by the Chair/designee or full Committee before the research study will be
        reinstated.
6. If the Research Study is EXPIRED:
   a. If continuing review materials are not received in the HSPP office by the
        designated due date, an expiration notice will be issued to the Principal
        Investigator and/or the appropriate Advisor. Non-response within thirty days of
        the expiration notice (or due date indicated in the notice) will result in termination
        of project approval. If no response is received, HSPP staff will prepare the
        appropriate termination of study approval letter and forward it with the study file
        to the Chair for review and signature. The original letter will be mailed to the PI
        or appropriate Advisor and a copy will be placed in the study file. The file will be
        prepared for microfilming and forwarded to the microfilm area.
b. If expiration occurs, the Investigator will cease all research activities. The
   Investigator will immediately submit continuing review requirements or notify the
   IRB of study closure.
c. Notification of termination of study approval will be forwarded to the Department
   Head and the Office of the Vice President of Academic Affairs, which will notify
   the Sponsor (if any). The Director of the Human Subjects Protection Program will
   notify appropriate Federal agencies.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.H Amendments to Previously Approved Applications or Exempt Projects
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.H Amendments to Previously Approved Applications or Exempt Projects
       Definitions:
       1. Amendment: Any change to an IRB-approved study, or exempt project, regardless of
          the level of review it receives initially.
       2. Major Amendment: A proposed change in research related activities that materially
          affects an assessment of the risks and benefits of the study, substantially changes the
          specific aims, or design of the study, or includes procedures whose inclusion in a
          submission for initial review would make the study ineligible for initial review by the
          expedited procedure.
       3. Minor Amendment: A proposed change in research related activities, does not
          materially affect an assessment of the risks and benefits of the study and does not
          substantially change the specific aims or design of the study, and does not include
          procedures whose inclusion in a submission for initial review would make that study
          ineligible for initial review by the expedited procedure.
       Policy Instructions/Explanations:
       1. For previously approved applications for previously approved or exempted projects,
          all planned changes in the conduct of a study and/or changes to the consent document
          must be approved by the IRB or HSPP prior to initiation.
          a. Investigators should submit any proposed changes to the HSPP for review and
               approval. These changes may include but are not limited to the following:
               i. changes to the consent form
               ii. changes to recruitment materials
               iii. changes to assessment documents (e.g., questionnaires, surveys)
               iv. changes to protocols or procedures.
          b. Modifications to the informed consent document must take into account both
               prospective research participants and, if applicable, research participants already
               enrolled in the study. The latter may be addressed using an addendum to the
               initial informed consent document or, less preferably, by re-consenting the
               participants using the modified informed consent document.
          c. Prior to submission of an amendment, industry sponsored protocols (if applicable)
               should be updated to include proposed changes. Investigators must submit the
               exact text of an amendment or other revision to the protocol for review and
               approval. The submission should also include a summary of, and justification for,
               the changes.
          d. Pre-review of expedited and full-committee amendments are performed by the
               HSPP staff/Committee Chair or his/her designee in order to prepare the
               application for review by the Chair/Chair‟s designee or full Committee. The
               following activities are conducted in preparation for the review to take place:
               i. Amendment letters/memos are reviewed for completeness
               ii. Additional required documents (including Verification of Training Form,
                    consent form(s), recruitment materials, and data collection forms) are
                    reviewed for completeness
2. Minor Amendment Changes proposed for previously approved research (either
   through the expedited or full Committee process) may be reviewed in an expedited
   manner (review performed by the Committee Chair or Chair‟s designee.) A summary
   of the amendment must be documented in the agenda and provided to the full
   Committee for the next possible convened meeting. (If during a Committee meeting,
   a Committee member voices a concern regarding an amendment, Committee may
   request further information from the Principal Investigator or suspend the project
   until concerns have been addressed.). A minor modification is defined as a change
   that would not materially affect the assessment of the risks and benefits of the study,
   does not substantially change the specific aims or design of the study, and does not
   include procedures whose inclusion in a submission for initial review would make
   that study ineligible for initial review by the expedited procedure. Examples of minor
   modifications may include:
   a. The addition of research activities that would be considered exempt or expedited
       if considered independent from the main research protocol;
   b. An increase or decrease in proposed human research subject enrollment;
   c. Narrowing the range of inclusion criteria;
   d. Broadening the range of exclusion criteria;
   e. Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an
       administered drug, provided the dose and route of administration remain constant;
   f. Decreasing the number or volume of biological sample collections, provided that
       such a change does not affect the collection of information related to safety
       evaluations;
   g. An increase in the length of confinement or number of study visits for the purpose
       of increased safety monitoring;
   h. A decrease in the length of confinement or number of study visits, provided that
       such a decrease does not affect the collection of information related to safety
       evaluations;
   i. Alterations in human research subject payment or liberalization of the payment
       schedule with proper justification;
   j. Changes to improve the clarity of statements or to correct typographical errors,
       provided that such a change does not alter the content or intent of the statement;
   k. The addition or deletion of qualified investigators or study personnel;
   l. The addition of study sites (which may require a Federalwide Assurance (FWA)
       and appropriate IRB/IEC approval) or the deletion of study sites;
3. Major Amendment Changes. When a proposed change in a research study (including
   expedited research) is more than minor, the IRB Committee must review and approve
   changes at a convened meeting before changes can be implemented. In order to
   perform the review, Committee members receive a copy of the cover letter and any
   appropriate documents. In addition, primary and secondary reviewers will receive the
   current protocol or grant, Investigator‟s Brochure (if applicable), and any other
   pertinent information. In addition, the entire HSPP file is made available for IRB
   Committee review during the meeting. A major modification (i.e., an amendment that
   is not minor) is defined as any change which materially affects the assessment of the
   risks, benefits of the study or substantially changes the specific aims or designs of the
   study or includes procedures whose inclusion in a submission for initial review would
    make the study ineligible for initial review by the expedited procedure. Examples of
    major modifications may include:
    a. Broadening the range of inclusion criteria;
    b. Narrowing the range of exclusion criteria;
    c. Alterations in the dosage or route of administration of an administered drug;
    d. Extending substantially the duration of exposure to the test material or
        intervention;
    e. The deletion of laboratory tests, monitoring procedures, or study visits directed at
        the collection of information for safety evaluations;
    f. The addition of serious unexpected adverse events or other significant risks to the
        Informed Consent Document; or
    g. Changes, which, in the opinion of the IRB chairperson or his/her designee, do not
        meet the criteria or intent of a minor modification.
4. Exempt Research. Any proposed or anticipated changes in an exempt study must be
    approved prior to initiation of the change. The research proposal will then be
    evaluated for appropriate review. Amendments for exempt projects reviewed on
    behalf of investigators located at the VA are included in the IRB Committee
    agenda/minutes. Reviews of amendments for VA investigators are performed either
    by the IRB Chair or IRB Committee member designated by the IRB Chair.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.H Amendments to Previously Approved Applications or
Exempt Projects
SUB-PART: III.H.1 Procedure for Amendments to Previously Approved Applications or Claims for Exemption
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.H.1 Procedure for Amendments to Previously Approved Applications or Claims for
Exemption
       Procedure:
       This procedure provides guidance for submission, review and approval of amendments to
       previously approved applications or claims for exemption.
       1. Investigator Responsibilities.
       a. Any proposed or anticipated changes must be submitted to the HSPP for approval
           prior to initiation of the change.
       b. The Investigator will submit a letter summarizing the proposed amendment and a
           justification for the changes, along with the following items, as appropriate.
       • Revised protocol and/or sponsor-issued amendment;
       • Revised informed consent documents with changes highlighted in yellow;
       • Other documents associated with the requested change, including updated safety
           information.
       c. If, in the Investigator‟s opinion, the risk/benefit ratio has changed, necessitating re-
           consenting of currently enrolled participants, the Investigator will provide an
           amendment to the currently approved informed consent form. The IRB Committee
           may also request re-consenting of the participants.
       d. Based on the nature of the change, the IRB Chair or Chair‟s designee may request
           that participants be re-consented.
       e. When the Investigator makes changes to avoid an immediate hazard to the
           participant, the Investigator promptly submits information in writing to the HSPP
           office requesting the changes.
       2. IRB Committee Responsibilities.
       a. The IRB Chairperson or his/her designee may review and approve research that meets
           the definition of a minor amendment. The convened IRB Committee will receive
           notification regarding the change in the next agenda.
       b. When a proposed change in a research study represents a major amendment, the
           convened IRB Committee must review and approve changes. The IRB must review
           the change and determine whether the change is consistent with ensuring the
           participant‟s welfare. All Committee members will receive:
       • The cover letter, if applicable; and
       • All amended information or additional information including the amended protocol,
           amended IRB proposal and amended informed consent document if applicable, or the
           most current informed consent document if not amended.
       • Any additional pertinent material (e.g., questionnaires, advertisements, reports, etc.).
           Primary and secondary reviewers will receive the above materials plus:
       • The last approved protocol;
       • The last approved Investigator‟s Brochure, if applicable; and
       • The grant.
c. The IRB Committee must determine whether re-consenting of currently enrolled
   participants is necessary and whether participants who have completed research
   involvement who might be affected be re-contacted and provided with additional
   information. This determination should be based on new information regarding a
   change in the risk/benefit ratio that possibly would affect the participant‟s decision to
   continue with the research activities.
d. Review of the currently approved consent document must assure that the information
   is still accurate and complete. Any significant new findings that may relate to the
   participant‟s willingness to continue participation is provided to the participant in an
   updated consent document. Review of currently approved or proposed consent
   documents must occur during the scheduled continuing review of research by the
   IRB, but may be done more frequently if new information becomes available.
e. Exempt research.
i. Changes to exempt research may be approved by the Director or Chair or his or her
   designee (if the review status has changed).
3. HSPP Staff Responsibilities.
a. The HSPP staff member will review the requested amendment and determine if it
   reflects a major or minor change.
b. Requested changes meeting the criteria for minor amendments will be reviewed and
   approval letters signed by the IRB Chair or his/her designee.
c. Requested changes meeting the criteria for major amendments will be prepared for
   IRB Committee review by assignment of reviewers, placing the study on the next
   available Committee agenda.
d. Letters denoting the IRB Committee determinations will be drafted using the
   appropriate template and forwarded to the Chair or his/her designee for signature.
e. The HSPP staff member will assist in obtaining any additional information requested
   by the Committee Chair or reviewer.
f. At any time, the staff member may consult with the IRB Committee Chair for
   assistance in determining the type of review that is required to process the
   amendment.
g. Amendments requiring modifications in the informed consent must be date-stamped
   and processed according to IRB policies and procedures.
h. The staff member will make the appropriate database entries including Committee
   notification of approval of minor amendments on the next available agenda.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.I Reporting of Serious Adverse Events or Unanticipated Problems Involving Risks to Participants or Others
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.I Reporting of Serious Adverse Events or Unanticipated Problems Involving Risks to
Participants or Others
       1. Definitions:
            Adverse Event: An untoward or undesirable experience or any undesirable
            experience associated with the use of a medical product in a patient.
            Serious: An event is “serious” if it adversely alters the risk-potential benefit
            relationship of the research.
            Unanticipated: An event is “unanticipated” when it was unforeseeable at the time of
            its occurrence. The word unanticipated, is not a synonym for unexpected. A research
            protocol can monitor for an unexpected event, but cannot monitor for an unforeseen
            event. All unanticipated events are unexpected, but not vice versa.
            Related: An event is “related” if it is likely to have been caused by the research
            procedures.
            Risk-Potential Benefit Profile: A summary of the risks and potential benefits that
            have occurred during the course of the study.
            Unanticipated Problems Involving Risk to Participants or Others: Any event that
            was (1) unanticipated, (2) serious, and (3) related. An unanticipated problem
            involving risks to subjects or others may be a result of therapy or other intervention
            associated with an individual participating in the study.
            Serious Adverse Event: Any adverse event that results in any of the following
            outcomes: death, a life-threatening adverse event, inpatient hospitalization or
            prolongation of existing hospitalization, a persistent or significant
            disability/incapacity, or a congenital anomaly/birth defect. Important medical events
            that may not result in death, be life-threatening, or require hospitalization may be
            considered a serious adverse event when, based upon appropriate medical judgment,
            they may jeopardize the patient or subject and may require medical or surgical
            intervention to prevent one of the outcomes listed in this definition.
            Unexpected Adverse Event: Any adverse event, the specificity or severity of which
            is not consistent with the risk information described in the general investigational
            plan of elsewhere in the current application, as amended.
       Policy:
       It is the policy of the LWC HSPP to require reporting of unanticipated problems
       involving risk to participants or others to the IRB Committee.
       1. The following requires reporting to the LWC HSPP within 10 working days of the
            Investigator‟s knowledge of the problem which includes adverse events, injuries, side
            effects, deaths, or other problems occurring at the LWC or other locations in which
            the Investigator is responsible for the conduct of the research and Lindsey Wilson
            College SPC IRB serves as the IRB of Record:
            a. Any event that in the Investigator‟s opinion was unanticipated, involved risk to
                 participants or others, and was possibly related to the research procedures;
            b. Any event that requires prompt reporting to the sponsor in accordance with the
                 protocol;
   c. Any accidental or unintentional change to the IRB-approved protocol that
      increases risk or decreases benefit, affects the participant‟s rights, safety, welfare,
      or affects the integrity of the resultant data;
   d. Any accidental or unintentional change to the IRB-approved protocol that has the
      potential to recur;
   e. Any deviation from the protocol taken without prior IRB review to eliminate an
      apparent immediate hazard to a research participant;
   f. Any publication in the literature, safety monitoring report including a Data and
      Safety Monitoring Report, interim result, or other finding that indicates an
      unexpected change to the risk-potential benefit profile of the research;
   g. Any adverse event that is both a serious adverse event and an unexpected adverse
      event, which in the investigator‟s opinion is more likely than not to be related to
      the research procedures;
   h. A breech in confidentiality that may involve risk to that individual or others;
   i. Any independent safety monitoring reports or Data and Safety Monitoring Board
      reports;
   j. Any complaint of a participant that indicates an unanticipated risk or which
      cannot be resolved by the research staff; and/or
   k. Any other event that, in the opinion of the Investigator, constitutes an
      unanticipated risk.
2. Investigator Responsibilities.
   a. The research plan for safety monitoring, reporting of adverse events and/or
      unanticipated problems involving risks to subjects or others, descriptions of
      interim safety reviews and the procedures planned for transmitting the results to
      the IRB should be described in the initial IRB application. This description should
      include information regarding an independent Data and Safety Monitoring Board
      (DSMB), if one exists or an explanation why an independent data safety monitor
      is not necessary.
   b. It is the responsibility of the Investigator, to submit any independent DSMB
      report to the IRB when it becomes available.
   c. Prior to, and at the time of IRB continuing review of an approved research study,
      it is the Investigator's responsibility to keep the HSPP office informed of
      unanticipated problems involving risks to subjects or others or adverse events that
      were serious, unanticipated, and resulted in a change to the risk/benefit ratio, even
      if the event occurred at a location for which Lindsey Wilson College SPC IRB is
      not the IRB of record. An Investigator is responsible for the accurate
      documentation, investigation and follow-up of all possible study-related adverse
      events and unanticipated problems involving risks to subjects or others under
      his/her control.
   d. Investigators are responsible for informing governmental and/or other sponsors of
      any adverse event and/or unanticipated problem involving risks to subjects or
      others in accordance with their regulations and policies.
   e. The Investigator is responsible for informing the appropriate IRB of any adverse
      event and/or unanticipated problem involving risks to subjects or others in
      accordance with local policies and federal regulations.
   f. If an Investigator makes changes to avoid an immediate hazard to the participant,
       the Investigator promptly submits information in writing to the HSPP office
       requesting the changes and those changes are reviewed by the convened IRB
       Committee to determine whether they are consistent with ensuring the
       participants‟ continued welfare.
3. IRB Committee Responsibilities. The IRB is charged with the responsibility of
   reviewing reported unanticipated problems involving risks to subjects and adverse
   events in accordance with this policy. During the review, the IRB will:
   ▪ Accept the report with no changes to the risk/benefit ratio or the informed consent
       document,
   ▪ Request further information from the Investigator or Data Safety Monitor (DSM),
   ▪ Accept the report with changes to the risk/benefit ratio and the informed consent
       document. In addition, the IRB may also vote to suspend or terminate the study or
       direct the Investigator to contact subjects for re-consenting or request additional
       information regarding subject safety. The level and promptness of IRB review of
       adverse events and unanticipated problems involving risks to subjects or others
       depends upon the following criteria:
       i. The seriousness of the event;
       ii. The relationship of the event to study participation;
       iii. Whether the event has previously been described in the study procedures,
            investigator‟s brochure and/or the informed consent document;
       iv. Whether the event occurred to a subject enrolled at a location for which a
            Lindsey Wilson College SPC Investigator is involved in the conduct of the
            research or is responsible for the reporting of unanticipated problem or
            adverse event; and
       v. Whether the event changes the risk/benefit ratio.
4. For reporting purposes, Lindsey Wilson College SPC HSPP has identified three
   categories of adverse events and/or unanticipated problems involving risks to subjects
   or others: Note: Sponsors with a regulatory obligation to monitor study conduct must
   promptly notify the Investigator of any information discovered through the
   monitoring process that could affect the safety of participants, the willingness of the
   participant to continue participation, influence the conduct of the study or alter the
   IRB‟s approval to continue the study. If information exists that could directly affect
   participant‟s safety or medical care, sponsors will provide that information to Lindsey
   Wilson College SPC . The Investigator then must communicate that information to
   research participants through review and approval of the information by the IRB
   Committee. Category A Events - Lindsey Wilson College SPC as a site, Lindsey
   Wilson College SPC serves as the Coordinating Center, Lindsey Wilson College
   SPC serves as IRB of Record: For events or problems occurring to a subject enrolled
   at a Lindsey Wilson College SPC site or a site in which a Lindsey Wilson College
   SPC Investigator is involved in the conduct of the research, or is responsible for the
   reporting of adverse events and/or unanticipated problems involving risks to subjects
   or others to a regulatory agency, should be reported to the IRB as follows:
   Investigators shall promptly report to the IRB, all changes in the research activity and
   any unanticipated problems involving risk to subjects or others. All adverse events
that are both serious and unanticipated or significant problems involving risks to
subjects that may possibly be or are known to be related to the research activity:
• Method of Reporting: Events must be reported within 10 business days of
    occurrence or knowledge thereof to the HSPP office.
• Level of Review: The event can receive an expedited review, if there is no
    change in the risk/benefit ratio, the research proposal, or corresponding change in
    the consent form; otherwise, full committee review. The Chair, or designee, at the
    time of expedited review, may refer any adverse event to the full committee for
    review. All adverse events that are non-serious and unanticipated or significant
    problems involving risks to subjects that may possibly be or are known to be
    related to the research activity:
• Method of Reporting: Events must be reported within 10 business days of
    occurrence or knowledge thereof to the HSPP office.
• Level of Review: The event can receive an expedited review, if there is no
    change in the risk/benefit ratio, the research proposal, or corresponding change in
    the consent form. The chair or designee, at the time of expedited review, may
    refer any adverse event to the full committee for review.
    Category B Events - Non-Lindsey Wilson College SPC : For events occurring
    to a subject not enrolled at a Lindsey Wilson College SPC site or a site in which a
    Lindsey Wilson College SPC Investigator is not involved in the conduct of the
    research and the investigator is not responsible for the reporting of unanticipated
    problems or serious adverse events to a regulatory agency, report to the IRB as
    follows:
• All serious and unanticipated adverse events or problems involving risks to
    subjects that may possibly be or are known to be related to the research activity
    and the PI has determined that there is a change in the risk/benefit ratio of the
    research:
    Method of Reporting: The event must be reported within 10 business days of
    occurrence or knowledge thereof to the HSPP office. A separate report for each
    event, along with an amendment request and a revised Consent Form reflecting
    the change should be submitted.
    Level of Review: The event can receive an expedited review, if event meets
    criteria for expedited review; otherwise, full committee. The Chair or designee, at
    the time of expedited review, may refer any adverse event to the full committee
    for review.
• All adverse events that are both non-serious and unanticipated or significant
    problems involving risks to subjects that may possibly be or are known to be
    related to the research activity and the PI has determined that there is a change in
    the risk/benefit ratio of the research:
    Method of Reporting: The event must be reported within 10 business days of
    occurrence or knowledge thereof to the HSPP office for each event, along with an
    amendment request and a revised Consent Form reflecting the change.
    Level of Review: The event can receive an expedited review, if event meets
    criteria for expedited review, otherwise, full committee. The Chair or designee, at
    the time of expedited review, may refer any adverse event to the Full Committee
    for review.
           •  Events not resulting in changes to the risk/benefit ratio, yet of importance to the
              study or the IRB, should be included in a summary format submitted with the
              Application for Continuing Review. Individual reports of such adverse events or
              unanticipated problems involving risks to subjects or others are not required to be
              submitted to the IRB, but must be retained in the PI‟s files for reference if needed.
      5. Reporting Adverse Events and/or Unanticipated Problems Involving Risks to
          Subjects or others to the HSPP Office when a Data and Safety Monitoring Board
          (DMSB) is Designated for a Clinical Investigation. Investigators must identify the
          DSMB that will be reviewing interim results, and include a brief description of the
          monitoring plan as well as procedures for transmitting the DSMB summary reports to
          the HSPP office. The PI of multi-site trials with a DSMB is expected to promptly
          forward to the HSPP office summary reports of adverse events or unanticipated
          problems involving risks to subjects or others that reveal unanticipated, non-serious,
          and serious adverse events, protocol modifications, and other unanticipated findings
          that affect the risk/benefit ratio. Such reports should also be referenced in the
          application for Continuing Review. The IRB Committee may rely on the most recent
          report(s) from the DSMB indicating that it has reviewed study-wide adverse events,
          interim results, protocol modifications, and any recent literature that may be relevant
          to the research, in lieu of requiring individual, non-Lindsey Wilson College SPC
          adverse event reports.
      6. Authority to Terminate or Suspend for Cause The IRB has the authority to suspend or
          terminate approval of research that has been associated with unanticipated serious
          harm to participants and/or others.
Reference:
21 CFR 312.32
45 CFR 46 103(b)(5)
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.I Reporting of Serious Adverse Events or Unanticipated Problems Involving Risks to Participants or Others
SUB-PART: III.I.1 Procedure for Reporting of Serious Adverse Events or Unanticipated Problems Involving Risks to Participants or
Others
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.I.1 Procedure for Reporting of Serious Adverse Events or Unanticipated Problems
Involving Risks to Participants or Others
        Procedure:
        This procedure outlines the process for reporting unanticipated problems involving risk to
        participants or others.
        1. Investigator Responsibilities.
            a. The Investigator submits any event that requires reporting according to this policy
                and any other event that may represent an unanticipated problem involving risk to
                participants or others as follows:
                i. A letter is submitted to the IRB as soon as possible, but no later than 10
                     working days after the Investigator first learns of the event or problem. The
                     information contains the Investigator‟s assessment of causality (related or not
                     related to the study) and a description of the actual event;
                ii. Any associated materials such as medical record notations or reports with the
                     name and medical record number of the individual redacted
                iii. The Investigator submits study related events that do not occur at the LWC or
                     other locations in which the Investigator is responsible for the conduct of the
                     research and Lindsey Wilson College SPC IRB does not serve as the IRB of
                     Record in summary format at the time of continuing review. However, if the
                     Sponsor or the DSMB has determined that the study related event changes the
                     risk-potential benefit profile, the event should be reported as an amendment to
                     the IRB approved proposal.
            b. The Investigator is responsible for the accurate documentation, investigation, and
                follow-up of all unanticipated problems involving risk to participants or others
                that occur at the site in which the Investigator is responsible for the conduct of the
                research.
        2. IRB Chair/Designated Committee Member Responsibilities.
            a. All reports are provided to a Chair or a designated Committee Member for review
                within 48 hours.
            b. The reviewer is provided:
                i. A copy of the report and attachments; and
                ii. The IRB file.
            c. The Chair reviews the materials to determine whether the event represents an
                unanticipated problem involving risk to participants or others as follows:
                i. The Chair evaluates whether the event meets the following criteria:
                     • Serious (i.e., the event implies an adverse alteration in the risk-potential
                         benefit relationship of the research)
                     • Unanticipated (i.e., the event was not foreseeable)
                     • Related (i.e., likely to have been caused by the research procedures).
            d If the Chair cannot make a determination for each criterion, the event will be
                forwarded to the full IRB Committee to make these decisions.
   e. If the Chair determines that the event meets all three criteria, then the event will
      be considered an unanticipated problem involving risks to participants or others
      and the following two actions take place:
      i. The event will be referred to the IRB Committee for further action.
      ii. The event will be reported according to IRB Policy II.D.
      iii. If participants are at immediate risk of harm and there is insufficient time to
           wait for review by the convened IRB, the Chair may suspend the project.
   f. If the Chair determines that the event does not meet one or more of the three
      criteria, then the event will be considered not to represent an unanticipated
      problem involving risks to participants or others, and the report will be accepted
      and initialed by the Chair.
3. IRB Committee Responsibilities.
   a. If the Chair could not determine whether the reported event represented an
      unanticipated problem involving risks to participants or others, the IRB will
      determine whether the event meets the following criteria:
      i. Serious (i.e., the event implies an adverse alteration in the risk-potential
           benefit relationship of the research); the event is considered to not represent
           an unanticipated problem involving risks to participants or others;
      ii. Unanticipated (i.e., the event was not foreseeable); and
      iii. Related (i.e., likely to have been caused by the research procedures).
   b. The IRB may postpone a decision while awaiting additional information. In such
      cases, the IRB will consider the appropriateness of suspension on the research
      until a final determination is made.
   c. If the IRB determines that the event meets all three criteria, then the event will be
      considered an unanticipated problem involving risks to participants or others and
      the following actions take place:
      i. The IRB will consider the following actions:
           • Accept the report with no changes;
           • Accept the report with changes to the risk/benefit ratio, the protocol, the
               informed consent documents or informed consent process;
           • Request re-consenting of participants
           • Require notification to participants (including past participants) of the
               problem when such information might relate to their willingness to
               continue to take part in the research. The information to participants must
               be reviewed by the IRB prior to notification;
           • Request further information from the Investigator or Data and Safety
               Monitor/Board;
           • Increase the frequency of continuing review;
           • Impose additional monitoring by an independent monitor;
           • Place the study on “suspension” pending receipt of further information;
           • Request additional information;
           • Terminate the study for Cause.
      ii. The event will be reported.
      iii. The IRB will consider whether the event represents serious or continuing
           noncompliance.
      iv. In the case of deviations from the protocol taken without prior IRB review to
           eliminate apparent immediate hazard to a research participant, the IRB will
           consider whether the changes were consistent with the rights and welfare of
           participants.
   d. If the IRB determines that the event does not meet one or more of the three
      criteria, then the event will be considered not to represent an unanticipated
      problem involving risks to participants or others, and the report will be filed with
      no further action.
4. HSPP Staff Responsibilities.
   a. Unanticipated problems involving risk to participants or others that do not change
      the risk-potential benefit profile, study protocol or informed consent documents
      are date stamped for the IRB Chairperson or designated Committee member
      initials.
   b. Upon receipt of a report of unanticipated problems involving risk to participants
      or others,” the staff member facilitates review by the Chair or designated
      Committee Member within 48 hours.
   c. Unanticipated problems involving risk to participants or others that change the
      risk potential benefit profile, study protocol or informed consent documents are
      prepared for full IRB Committee review. The staff member places the items on
      the next Committee agenda, assigns reviewers, and prepares reviewer and
      Committee member packets. Reviewer packets for all Committee members
      include:
      i. The report of unanticipated problem involving risk to participants or others;
      ii. The DSMB or safety report, if applicable;
      iii. Any attached supplemental material submitted with the report;
      iv. An amendment request, if applicable;
      v. The current IRB approved application and informed consent document;
      vi. Any other pertinent materials such as advertisements, questionnaires, etc
      vii. The Primary and Secondary reviewer‟s packets will include all listed above
           plus:
           • The last approved protocol;
           • The last approved Investigator‟s Brochure, if applicable; and
           • The grant.
   d. The staff member will consult with the IRB Chair or designated Committee
      member for assistance in determining the appropriate level of review for
      unanticipated problems involving risks to participants and others.
   e. Letters are drafted using the appropriate template and forwarded to the IRB Chair
      or designated Committee member for signature.
   f. Appropriate database entries are completed. Unanticipated problems involving
      risk to participants or others that are acknowledged through expedited review
      procedures are included on the next available agenda for Committee notification.
   g. HSPP staff will inform the Director of the HSPP regarding any unanticipated
      problem involving risks to subjects or others. The Director will inform
      appropriate federal agencies (e.g., Office for Human Research Protections
      [OHRP], Food and Drug Administration [FDA]).
FLOWCHART FOR PI REPORTING OF SERIOUS ADVERSE EVENTS THAT OR
UNANTICIPATED PROBLEMS INVOLVING RISKS TO PARTICIPANTS OR
OTHERS

                    Did a serious adverse event OR unanticipated problem occur?



                            YES                                 NO                  Do not report
                                                                                     to the IRB.


        Is there any possibility that the event or
                                                                                    Do not report
              problem was related to study                      NO
                                                                                       to the IRB
         participation or was the event serious?
                                                                                     UNLESS the
                                                                                      PI believes
                                                                                    that there is a
                            YES                                                     change in the
                                                                                      risk/benefit
                                                                                      ratio. If so,
        Did the event/problem occur at a LINDSEY WILSON COLLEGE                         the event
        SPC site or a site in which a LINDSEY WILSON COLLEGE SPC                       should be
         Investigator is involved in the conduct of the research or is                reported to
          responsible for the reporting of serious adverse events or                     the IRB
               unanticipated problems to regulatory agencies?                          promptly.



                  YES                                        NO


             Has the PI                                    Has the PI
       determined that there                         determined that there
         is a change in the                            is a change in the
         risk/benefit ratio?                           risk/benefit ratio?


         YES             NO                            YES           NO


    Promptly              Promptly             Promptly           The PI should
    submit an             submit an           submit an           summarize the
  Adverse Event         Adverse Event      Adverse Event             event(s)/
     Report.               Report.          Report AND              problem(s)
                                                  an               and indicate
                                            amendment              no impact on
                                             to the IRB.          local subjects,
                                                                    procedures,
                                                                   consent form
                                                                      to IRB.
PROGRAM: Human Subjects Protection Program
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.J Research with Human Tissue, Blood, Genetic Material and Data
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.J Research with Human Tissue, Blood, Genetic Material and Data
       Procedure Instructions/Explanations
       This policy is intended to assist those Investigators who wish to create a repository of
       specimens/data for research purposes. The IRB is responsible for overseeing the
       collection, use, storage, and re-use of all human tissue, blood, or genetic material and all
       data that are generated within or transferred to Lindsey Wilson College SPC for research
       purposes. A Repository is considered a storage site or mechanism by which identifiable
       human tissue blood, genetic material or data are stored or archived for research by
       multiple Investigators or multiple research projects. A Repository may be established
       within or outside the Lindsey Wilson College SPC. There is no single “repository” site or
       mechanism within Lindsey Wilson College SPC. Repositories may be proposed, built,
       and maintained by individuals (i.e., Investigators, groups, programs, departments, or
       institutes. A single Investigator or a group of Investigators may wish to pool research
       specimens/data from multiple research studies into a single specimen bank or database
       that could be accessed by the group and others for future research use. Examples of
       “outside” repositories that a Lindsey Wilson College SPC PI may want to utilize include
       the private laboratories, as well as laboratories managed by colleagues at other academic
       institutions. The IRB does not oversee the storage or management of specimens/data that
       are collected and stored as part of routine clinical care or hospital procedure.
       Furthermore, the IRB does not oversee the use or management of specimens/data sent to
       a Lindsey Wilson College SPC Investigator/employee for specialized analysis as part of
       a contractual arrangement. IRB approval, however, is required prior to the use of these
       specimens/data for research purposes by a Lindsey Wilson College SPC
       Investigator/employee.
       1. The following definitions are applicable to this policy:
           a. Human Subject. A “human subject” is defined as any living individual about
                whom an investigator obtains either data (of any kind) through intervention or
                interaction with the individual; or identifiable private information (of any kind)
                even in the absence of intervention or interaction.
           b. Research. Any “systematic investigation (including research development, testing
                and evaluation) designed to develop or contribute to generalizable knowledge.”
           c. Non-Human Subjects Research. The IRB will determine which studies qualify as
                “non-human subjects research”. Typically specimens/data that are de-identified
                (stripped of all identifiers) or specimens/data utilized where all subjects are
                deceased would be considered "non-human subjects research." A cadaver is not
                considered to be a “human subject”. Therefore, research on specimens/data
                obtained from a cadaver would qualify as “non-human subjects” research.
           d. Retrospective. Research utilizing human subjects‟ specimens/data that were
                previously collected (i.e., “on the shelf”.)
           e. Prospective. Research utilizing human subject‟s specimens/data that will be
                collected in the future.
2. The use of human subjects‟ specimens and data for research can be classified into the
   following categories:
   a. Specimens/data to be collected prospectively for pre-defined research purposes
       only. This is the collection of specimens/data in relationship to a single IRB
       approved proposal. In these cases the Investigator should utilize the current IRB
       approved genetic template language (See IRB template language available on the
       IRB website http://www.lindsey.edu). In most cases, this would not be
       appropriate for a Repository.
   b. Specimens/data to be collected prospectively or retrospectively (previously
       stored), for undefined future research purposes. Collection of specimens/data that
       will be shared, used again, or stored for research purposes beyond the
       Investigator‟s original approved IRB proposal, the Investigator should bank the
       specimens or data in a “research repository” for undefined future use.
   c. Existing specimen/data collections. Investigators that wish to prospectively add to
       these collections must seek IRB approval to do so. This may be accomplished by
       setting up a “research repository”. Further, the use of these pre-existing samples
       for research purposes requires IRB approval.
SECTION: III. IRB Review Procedures
POLICY NUMBER: III.J Research with Human Tissue, Blood, Genetic Material and Data
SUB-PART: III.J.1 Procedures with Human Tissue, Blood, Genetic Material and Data
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.J.1 Procedures with Human Tissue, Blood, Genetic Material and Data
        Procedure Instructions/Explanations:
        1. The IRB oversight for the collection, use, storage, and re-use of all human tissue,
           blood, or genetic material and all data that is generated within or transferred to the
           Lindsey Wilson College SPC , for research purposes will be determined by the
           following criteria:
           a. Specimens/data to be collected prospectively for pre-defined research purposes
               only. The collection of specimens/data in relationship to a single IRB-approved
               proposal. The Investigator will submit the standard IRB application with the
               following information included in the application:
               i. the Investigator‟s plans to protect the participant‟s confidentiality;
               ii. the storage facilities;
               iii. what will happen to specimens/data when the study is completed; and
               iv. how the data will be presented and analyzed. The consent utilized will
                    incorporate the standard IRB-approved genetic template language. No
                    repository application would be submitted for this type of study.
           b. Specimens/data to be collected prospectively or retrospectively (previously
               stored), for undefined future research purposes. Collection of specimens/data that
               will be shared, used again, or stored for research purposes beyond the
               Investigator‟s original approved IRB proposal, the Investigator should bank the
               specimens or data in a “research repository”. An Investigator that wishes to
               establish a repository in connection with his/her study should include this
               information in the standard IRB application. An Investigator that wishes to
               establish a “research repository” only should complete the Repository Application
               with a corresponding standard IRB informed consent document, if applicable.
           c. Existing specimen/data collections. Investigators that wish to prospectively add to
               these existing collections must seek IRB approval to do so. This may be
               accomplished by setting up a “Research Repository” as noted above. The use of
               pre-existing samples for research purposes requires IRB approval or an IRB
               determination that this is not human subjects research.
        2. Non-Human subjects research may receive an expedited approval; however, the IRB
           must make this determination. Typically, an informed consent will not be required.
           To qualify for non-human subjects research, the Investigator must:
           a. Submit an overview of the research protocol, including the aim and hypotheses
               of the study, sample size, a description of all data to be collected, and all funding
               sources for the research activity;
           b. Explain where and how the data or specimens will/were obtained, such that
               the IRB can distinguish proper access to the data or specimens (Note: samples or
               data that are to be prospectively collected, cannot be granted exemption from IRB
               approval);
   c. Describe the samples or data in sufficient detail, such that the IRB can verify
       the absence of identifiable private information (of any kind), even in the absence
       of intervention or interaction; and
   d. Explain how or why the Principal Investigator believes the subjects are all
       deceased, without certain or reasonable knowledge that all subjects are deceased,
       the “deceased subjects” exemption category does not apply. The pathway for IRB
       approval of the collection, use, storage, and re-use of all human tissue, blood, or
       genetic material and all data is influenced by whether or not the specimens/data
       can be identified with the participant and whether specimens/data were collected
       retrospectively or will be collected prospectively.
3. Human subjects research may qualify for expedited or full Committee review. The
   IRB will make this determination in accordance with current IRB policy. The IRB
   shall consider the following criteria:
   a. the type of specimen or data to be banked;
   b. whether the specimens/data are identified/coded;
   c. what procedures are in place to “de-identify” the specimens/data;
   d. whether the collection of specimens/data require interaction with human subjects;
   e. whether the specimens/data “on the shelf” at the time the proposal is initiated;
   f. whether informed consent will be required;
   g. who will manage the repository;
   h. how and where will the specimens/data will be stored and released; and
       i. what will happen to the specimens/data should the subject withdraw consent
           or the Investigator should leave the institution. Note: The IRB will determine
           whether the specimens/data stripped of identifiers will qualify as
           “unidentified” and qualify for exempt status.
4. Examples of Human Subject Specimens for Research:
   a. Bodily human materials such as: cells, mucosal and skin; blood; urine; amniotic
       fluid; excreta and external secretions (including sweat); saliva; sputum; placental
       tissue; organs; hair; nail clippings; teeth; dental plaque and calculus; if obtained
       through “intervention or interaction with an individual” or if “identifiable”; and/or
   b. Residual diagnostic human specimens, including specimens obtained for clinical
       patient care that would have been discarded if not used for research. IRB policy
       determines that standard surgical or medical treatment consent documents may
       not be used in lie LWC specific research consent document, unless it includes all
       the elements required for standard research consent documents and has been
       approved by the IRB.
5. Examples of Human Subject Data for Research:
   a. Private information such as clinical notes and medical information that can be
       identified with individuals; whether or not the information was specifically
       collected for the study in question. This also includes private information
       provided for specific purposes by an individual, which the individual can
       reasonably expect will not be made public.
   b. Data obtained from voice, video, digital or image recordings.
   c. Data obtained from surveys, interviews, oral histories, focus groups, program
       evaluations, quality assurance methodologies, etc.
6. If a Lindsey Wilson College SPC PI plans to send any specimens/data that can be
   traced back to a participant to an outside repository for storage, Lindsey Wilson
   College SPC IRB may request the identification of the Repository as well as a copy
   of its IRB approval. The IRB may request a “written usage agreement” between the
   outside Repository and the Lindsey Wilson College SPC PI. If there is not an IRB
   overseeing an outside repository, a Certificate of Confidentiality may be requested by
   Lindsey Wilson College SPC IRB to ensure participant confidentiality. Regardless of
   where specimens/data are stored for future use, they cannot be utilized for research
   without IRB approval, as long as the specimens/data remain tied to a human subject
   (even if tied through elaborate coding). Investigator‟s wishing to research
   specimens/data that cannot possibly be tracked back to the participant, may request an
   exemption from the IRB. A Repository should not release samples to an Investigator
   without receiving documentation of IRB exemption or approval for the use of those
   samples.
PROGRAM: Human Subjects Protection Program
SECTION: III IRB Review Procedures
POLICY NUMBER: III.K Human Subject Research/Non- Human Subject Research Determination
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.K Human Subject Research/Non- Human Subject Research Determination
       Definitions:
       1. Clinical Investigation: Any experiment that involves a test article and one or more
          human subjects and that is subject to the Food and Drug Administration regulations.
       2. Test Article: Any drug (including a biological product for human use), medical
          device for human use, human food additive, color additive, electronic product, or any
          other article subject to FDA regulation.
       3. Coded Information: For the purposes of this policy, identifying information that
          would enable the investigator to readily ascertain the identity of the individual to
          whom the private information or specimens pertain has been replaced with a number,
          letter, symbol, or combination thereof and a key to decipher the code exists, enabling
          linkage of the identifying information to the private information or specimens.
       4. Human Subject (21 CFR 50.3(g)): An individual who is or becomes a participant in
          research, either as a recipient of the test article or as a control. A subject may be
          either health human or a patient.
       5. Human Subject (45 CFR 46.102(f)): A living individual about whom an
          Investigator (whether professional or student) conducting research obtains either data
          (of any kind) through intervention or interaction with the individual or identifiable
          private information (of any kind) even in the absence of intervention or interaction or
          an individual who is or becomes a participant in research, either as a recipient of the
          test article or as a control.
          a. Intervention: Includes both physical procedures by which data are gathered (e.g.,
               venipuncture) and manipulations of the subjects‟ environment that are performed
               for research purposes.
          b. Interaction: Includes communication or interpersonal contact between an
               Investigator or his/her research staff and the research participant or their private
               identifiable information.
          c. Private Information: Includes information about behavior that occurs in a setting
               in which an individual can reasonably expect that no observation or recording is
               taking place. It includes information, which has been provided for specific
               purposes by an individual, and the individual can reasonably expect will not be
               made public (e.g., a medical record). Private information must be individually
               identifiable in order to be considered information to constitute research involving
               human participants. This may include identifiable private information obtained
               from a primary participant about a third party.
       6. Research: Any systematic investigation (including research development, testing and
          evaluation) designed to develop or contribute to generalizable knowledge.
       7. Human Subject Research: Any research that involves humans and any clinical
          investigation.
       8. Non-Human Subject Research: Any activity determined by the HSPP to not
          represent “Human Subject Research.”
       Policy:
It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
Program
(HSPP) to have sole authority to determine whether an activity meets the definition of
“Human Subject Research”. When activities are conducted that might represent “Human
Subject Research,” the activities must be submitted to the IRB for a determination.
1. “Human Subject Research”/“Non-Human Subject Research” Determinations.
     a. The HSPP will assist in determining whether an activity represents “Human
         Subject Research.”
     b. An Investigator may request a determination that an activity is “Non-Human
         Subject Research.”
     c. The HSPP will make a determination whether an activity is “Human Subject
         Research” by considering whether the activity either:
         i. Meets the regulatory definitions of “research” that involves “humans
              subjects,” or
         ii. Meets the regulatory definition of “clinical investigation.”
2. Non-Research.
     a. Activities are not research if they do not involve a systematic approach involving
         a predetermined method for studying a specific topic, answering a specific
         question, testing a specific hypothesis, or developing theory.
         i. Examples of systematic investigations include, but are not limited to:
              • Observational studies;
              • Interviews (including those that are open-ended) or survey studies;
              • Group comparison studies;
              • Test development; or
              • Program evaluation.
         ii. Examples of activities that would not normally be considered systematic
              investigations include, but are not limited to:
              • Training activities (e.g., human subjects being trained to perform a certain
                  technique or therapy such as art therapy, psychoanalysis, oral history
                  techniques); and
              • Classroom exercises involving human participants or human participant
                  data where the objective of the activity is to teach proficiency in
                  performing certain tasks or using specific tools or methods.
     b. Activities are not research if they do not contribute to generalizable knowledge or
         if the results (or conclusions) of an activity are not intended to be extended
         beyond a single individual or an internal program (e.g., publications or
         presentations).
         i. Examples of activities that are typically not generalizable include:
              • Biographies and service or course evaluations, unless they can be
                  generalized to other individuals;
              • Services, courses, or concepts where it is not the intention to share them
                  beyond Lindsey Wilson College SPC community;
              • Classroom exercises solely to fulfill course requirements or to train
                  students in the use of particular methods or devices; and
           •    Quality Assurance activities designed to continuously improve the quality
                or performance of a department or program where it is not the intention to
                share them beyond Lindsey Wilson College SPC community.
   c. Thesis or dissertation projects conducted to meet the requirements of a graduate
      degree are usually considered generalizable and therefore, require HSPP review
      and approval.
3. Non-Human Subject.
   a. Activities do not involve humans as participants if they do not involve the process
      of obtaining specimens or data through intervention or interaction with individual
      participants or identifiable private information.
   b. Information is considered “not identifiable” if it includes none of the following:
      i. Name;
      ii. Any geographic subdivisions smaller than a state, including street address,
           city, country, precinct, ZIP code, and their equivalent geocodes, except for the
           initial three digits of a ZIP code;
      iii. All elements of dates (except year) directly related to an individual (e.g., date
           of birth, admission);
      iv. Telephone numbers;
      v. Fax numbers;
      vi. Electronic mail addresses;
      vii. Social security numbers;
      viii. Medical record numbers;
      ix. Health plan beneficiary numbers;
      x. Account numbers;
      xi. Certificate/license numbers;
      xii. Vehicle identifiers and serial numbers, including license plate numbers;
      xiii. Device identifiers and serial numbers;
      xiv. Web Universal Resource Locators (URLs);
      xv. Internet Protocol (IP) address numbers;
      xvi. Biometric identifiers, including finger and voiceprints;
      xvii. Full-face photographic images and any comparable images; and
      xviii. Any other unique identifying number, characteristic, or code.
   c. Specimens/data that are received by the Investigator as de-identified stripped that
      are stripped of all HIPAA identifiers as noted above.
   d. When the Investigator receives:
      i. Private information or specimens with no code or link that would allow an
           Investigator to establish identity, this would not involve human subjects. For
           example, a publicly available, unidentifiable, non-linked cell line qualifies as
           not involving human subjects.
   e. The Investigator may receive coded private information or specimens and qualify
      for non-human subject if the following conditions are met:
      i. The code is not derived or related to the HIPAA identifiers that must be
           stripped from the PHI (e.g., patient MR# + last 4 digits of individuals Social
           Security Number);
             ii. The private information or specimens were not collected specifically for the
                  currently proposed research project through an interaction or intervention with
                  living individuals; and
             iii. The Investigator cannot readily ascertain the identity of the individuals to
                  whom the coded private information or specimens pertain, because:
                  • The key to decipher the code is destroyed before the research begins;
                  • The Investigator and the holder of the key enter into an agreement
                      prohibiting the release of the key to the Investigator under any
                      circumstances, until the individuals are deceased;
                  • The private information is received from an IRB-approved repository or
                      data management center that includes written operating procedures that
                      prohibit the release of the key to the Investigator under any circumstances,
                      until the individuals are deceased; or
                  • There are other legal requirements prohibiting the release of the key to the
                      Investigator until the individuals are deceased.
          f. A cadaver is not considered to be a human subject. However, research involving
             cadavers must be submitted to the LWC HSPP and the HSPP will determine
             which studies qualify as a “non human subject.”
      3. All “Non-Human Subject Research” is subject to all applicable institutional and
          HSPP policies and procedures as described in 3 a - f above.
References:
45 CFR 46
21 CFR 50 and 56
PROGRAM: Human Subjects Protection Program
SECTION: III IRB Review Procedures
POLICY NUMBER: III.K Human Subject Research/Non- Human Subject Research Determination
SUB-PART: III.K.1 Procedure for Human Subject Research/Non-Human Subject Research Determination
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


III.K.1 Procedure for Human Subject Research/Non-Human Subject Research
       Determination
       Procedure:
       This procedure provides guidance for the determination of non-human subject or non-
       research projects.
       1. Investigator Responsibilities.
           a. Investigators may request a determination of non-human subject research.
       2. IRB Committee Responsibilities. If needed, the Chairperson or his/her Designee will
           be available to assist the HSPP staff in determining whether an activity meets the
           definition of “human subject research.”
       3. HSPP Staff Member Responsibilities.
           a. The HSPP staff member will discuss the proposed project with the investigator
               using a checklist to determine if the research qualifies as non-human subject
               research.
           b. The staff member may:
               • Request an application be submitted if it appears that the project involves
                   human subject research.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.A Legally Effective and Prospectively Obtained Informed Consent
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.A Legally Effective and Prospectively Obtained Informed Consent
      Definitions:
      1. Assent: An individual‟s affirmative agreement to participate in research obtained in
         conjunction with permission from the individual‟s parent(s) or guardian. Mere failure
         to object should not, absent affirmative agreement, be construed as assent.
      2. Informed Consent: An individual‟s voluntary agreement, based upon adequate
         knowledge and understanding of relevant information, to participate in research or to
         undergo a diagnostic, therapeutic, or preventive procedure.
      3. Children: Persons who have not attained the legal age for consent for treatments or
         procedures involved in the research under the applicable law of the jurisdiction in
         which the research will be conducted.
      4. Guardian: An individual "who is authorized under applicable State or local law to
         consent on behalf of a child to general medical care." 45 CFR 46.402(e).
      5. Minor: A minor is a person under 18 years of age. In Kentucky, a minor becomes an
         adult by operation of law at age 18, at which time the person becomes fully liable for
         his or her own acts, contracts, and the like.
      6. Emancipated Minor: A minor who is married, enlisted in the service, or
         emancipated by court order. A homeless minor may be emancipated. Investigators
         should contact the General Counsel‟s office to determine whether a homeless minor is
         emancipated.
      7. Legally Authorized Representative: means an individual or judicial or other body
         authorized under Kentucky law to consent on behalf of a prospective subject to
         participate in the procedure(s) involved in the research.
      8. Health Care Agent: The health care agent is the individual named in a Durable
         Power of Attorney for Health Care (DPAHC) executed by the subject while the
         subject had decision-making capacity. The health care agent acts on the subject‟s
         behalf to make health care decisions, including enrolling the subject in a research
         study, when the subject is unable to provide consent.
      9. Legal Guardian or Conservator: A legal guardian or conservator is a person
         appointed by a court to make decisions for an individual who has been judicially
         determined to be incompetent.
      Policy:
      1. Generally, the IRB must ensure that provisions are made to obtain legally effective
         informed consent prospectively from each research subject or the subject‟s legally
         authorized representative. However, consent does not solely include a written
         document, but an ongoing discussion that is culturally and linguistically appropriate
         to each research population. Documentation of informed consent must be obtained
         unless alternate procedures are approved by the IRB. The IRB must review all
         informed consent documents and assure the adequacy of the information contained in
         the consent document and the Federal regulations regarding the required elements of
         informed consent.
2. Each subject or the subject‟s legally authorized representative must sign and date a
   copy of the current IRB-approved consent form prior to enrollment or participation in
   any phase of the study, unless the requirement is waived by the IRB.
3. Definition of a Child:
   a. Child: In the state of Kentucky children under the above federal regulatory
      definition above are those individuals under the age of 18 years, with the
      exception of:
      i. Emancipated minors.
      ii. Individuals involved in research whose procedures are limited to treatment for
           venereal disease, sexual assault, or donating blood.
4. Definition of Guardian:
   a. Guardian. Under Kentucky law, a person appointed through the court system as a
      child‟s legal guardian may consent to inclusion of the child in research. To enroll
      the child, guardianship papers should be presented.
   b. Grandparents and other relatives or caregivers may not consent unless they have
      been granted formal custody of the child by a court. In such cases, the Principal
      Investigator (PI) must obtain a copy of the court‟s order as evidence of that
      person‟s authority to consent on the child‟s behalf or in accordance with
      Kentucky State law.
   c. Foster Children. Before enrolling foster children or other children who are wards
      of the state investigators should contact General Counsel‟s Office to be certain
      that the individuals providing permission are the legal guardians of the child.
5. Definition of Legally Authorized Representative:
   a. Children. For children, their parents or legal guardians are the legally authorized
      representatives who may consent to their participation in research. To enroll the
      child, guardianship papers should be presented.
   b. Cognitively Impaired Adult Subjects outside of the VAMC. For an adult subject
      who lacks the capacity to consent, in the state of Kentucky the legally authorized
      representative is any of the following individuals when the research involves
      health care procedures:
       The participant‟s health care agent
       The participant‟s legal guardian or conservator
       Any of the individuals listed below in order of preference (as allowed by
           Kentucky State law) For an adult subject who lacks the capacity to consent,
           in the state of Kentucky the legally authorized representative is any of the
           following individuals when the research does not involve health care
           procedures:
           i. The participant‟s legal guardian or conservator
           ii. Any individual approved by the General Counsel‟s Office on a case-by –
               case basis.
       Spouse (unless legally separated) (if the spouse declines to provide consent,
           then the next individual cannot be asked to give consent)
       Adult child (if more than one child, consent from a majority of the children
           who are reasonably available)
       Parent
       Domestic partner
               Sibling
               Close friend
          c. Cognitively Impaired Veteran Subjects. For cognitively impaired veteran subjects
              who would be enrolled in research studies at a Department of Veterans Affairs
              facility, informed consent may be obtained from those individuals authorized by
              38 CFR Parts 16 and 17 and applicable VHA Handbook policies.
      4. Studies involving subjects who are decisionally-impaired may take place over
          extended periods. The IRB should consider whether periodic re-consenting of
          individuals should be required to ensure that a subject‟s continued involvement is
          voluntary. The IRB may require that Investigators re-consent subjects after taking
          into account the study‟s anticipated length and the condition of the individuals to be
          included (e.g., subjects with progressive neurological disorders). Additionally, the
          IRB should consider whether and when to require a reassessment of decision-making
          capacity.
References:
45 CFR 46.116
38 CFR 16 and 17
45 CFR 46.116(c) and (d)
45 CFR 46.402(e)
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.A Legally Effective and Prospectively Obtained Informed Consent
SUB-PART: IV.A.1 Procedure for Obtaining Legally Effective and Prospectively Informed Consent
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.A.1 Procedure for Obtaining Legally Effective and Prospectively Informed Consent
       Procedure:
       This procedure outlines the responsibilities of Lindsey Wilson College SPC (LWC)
       Human Subjects Protection Program (HSPP) and the Investigator in obtaining legally
       effective and prospective informed consent from research participants.
       1. Investigator Responsibilities.
           a. The Investigator provides a detailed description of the intended method for
               obtaining informed consent in the initial application.
           b. All informed consent documents (full written documents, oral scripts, short forms,
               and assent forms) are submitted for review and approval by the LWC IRB prior to
               use.
           c. Any changes in the informed consent documents are submitted as an amendment
               to the IRB for review and approval prior to use.
           d. Informed consent must:
               i. Be solicited in circumstances that minimize the possibility of coercion and
                    undue influence;
               ii. Allow sufficient time and the opportunity for the participant to consider
                    participation (including the opportunity for exchange of information and the
                    ability of the participant to ask questions);
               iii. Utilize language understandable to the participant;
               iv. Not waive or appear to waive participants‟ rights; and
               v. Include each of the required elements and applicable additional elements of
                    informed consent describing the research and the nature of research
                    participation as required by Federal regulations.
           e. Unless specifically waived by the IRB, informed consent is documented in
               writing through the use of a current IRB-approved informed consent document
               signed and dated by the participant or by the participant‟s legally authorized
               representative prior to enrollment or participation in any phase of the research
               study.
           f. The Investigator assures the informed consent process in research is an ongoing
               exchange of information between the research team and the study participants
               throughout the course of a research study. Informed consent is a continuous
               process of communication and acknowledgement over time, not just a signed
               document.
       2. IRB Committee Responsibilities.
           a. The IRB Committee, the Chair or his/her designee reviews the planned research
               activities whether submitted for initial review, continuing review or as an
               amendment, and assures that the informed consent document is congruent with
               the IRB application, Investigator‟s brochure, Sponsor‟s or Investigator‟s protocol,
               grant and/or contract, and contains the necessary elements of informed consent as
               required by the Federal regulations.
   b. The IRB Committee, the Chair or his/her designee must consider whether the
      consent process satisfies the following: (IRB members may use the HSPP Policies
      and Procedures or the Consent Checklist for assistance in making these
      determinations
      i. Whether legally effective informed consent is sought from each prospective
           participant or the participant‟s legally authorized representative;
      ii. There is sufficient information about who will conduct the consent interview;
      iii. There is sufficient information regarding the timing of informed consent
           (including any waiting period between information provided to the participant
           and obtaining the consent);
      iv. Whether informed consent is solicited in circumstances that minimize the
           possibility of coercion and undue influence;
      v. Whether there is sufficient time and opportunity for the participant to consider
           participation (including the opportunity for exchange of information and the
           ability of the participant to ask questions);
      vi. Whether the language is understandable to the participant; and
      vii. That the informed consent document does not waive or appear to waive
           participants‟ rights.
   c. When reviewing the informed consent document, the reviewers may request
      necessary revisions to the content, language, punctuation, and/or grammar in
      order for the intended target population in order that the those individuals may
      clearly understand the proposed research activities and make an informed decision
      on whether to participate in the research.
   d. Unless specifically waived by the IRB, the IRB Committee, the Chair or his/her
      designee determines whether the plan for informed consent includes the use of an
      IRB-approved informed consent document signed and dated by the participant or
      by the participant‟s legally authorized representative prior to enrollment or
      participation in any phase of the research study.
   e. The IRB Committee, the Chair or his/her designee approves the informed consent
      process and method of documentation, indicating whether the proposed consent
      process is appropriate for the proposed research activities and the target
      population as a part of the overall IRB approval of the study.
   f. The IRB Committee may add consent auditors/monitors to the consent process
      when the level of risk is high or when vulnerable subjects are involved in more
      than minimal risk research; especially when there is no expected benefit to
      subjects.
3. HSPP Staff Responsibilities.
   a. The HSPP staff member conducts a pre-review of the informed consent
      documents submitted with a new study application to determine that the correct
      forms have been utilized for the targeted population, assesses the readability of
      the document, and assures that all the necessary elements as required by the
      Federal regulations are present for adequate informed consent. If additional
      information regarding the informed consent process or documentation is needed,
      the HSPP staff member contacts the Investigator and requests the additional
      information.
          b. The HSPP staff member will prepare written correspondence to be reviewed by
             the Chair or his/her designee that includes whether a consent auditor/monitor is
             required as a method to increase protections to participants.
References:
45 CFR 46.111
45 CFR 46.116 and 46.117
21 CFR 50.24 and 50.25
38 CFR 16 and 17
OHRP Guidance Document: Informed Consent Tips, March 1993
OHRP Guidance Document: Informed Consent, Legally Effective and Prospectively Obtained
(OPRR REPORTS 95-03)
IRB Management and Function; Amdur, R. and Bankert, E.; 2002 Jones and Bartlett Publishers,
Inc.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.A Legally Effective and Prospectively Obtained Informed Consent
SUB-PART: IV.A.2 Procedure for Incorporating the Elements of Informed Consent
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.A.2 Procedure for Incorporating the Elements of Informed Consent
       Procedure:
       This procedure outlines the responsibilities of Lindsey Wilson College SPC (LWC)
       Institutional Review Board (IRB) and the Investigator in incorporating the required
       elements into the informed consent document as required by the Federal regulations.
       a. Investigator Responsibilities. Federal Regulations require that specific elements be
           contained in all informed consent documents unless waived by the IRB. The required
           elements of informed consent as stated in the Code of Federal Regulation 21 CFR and
           45 CFR 46.116 may not be omitted (unless waived by the IRB) and there may not be
           discrepancies between the IRB application and the informed consent documents
           regarding the purpose, subject selection, procedures, confidentiality, risks, and
           benefits of the research. The HSPP encourages investigators to use the HSPP
           informed consent document template when developing consent documents.
           i. Required Elements. The basic elements of consent to be included in every
                informed consent document are:
                (i.a) A clear statement that the study involves “research”;
                (i.b) An explanation of the purposes of the research;
                (i.c) The expected duration of the subject‟s participation;
                (i.d) A complete description of the procedures to be followed, and identification
                     of any procedures, which are performed solely for the purpose of research and
                     are experimental;
                (i.e) An adequate description of the reasonably foreseeable risks and discomforts;
                (i.f) An adequate description of any benefits to the participant or others that may
                     reasonably be expected from the research;
                (i.g) A description of appropriate alternative procedures or courses of treatment
                     that might be advantageous to the subject;
                (i.h) A description of the extent to which confidentiality of records identifying the
                     participant and privacy will be maintained;
                (i.i) For research that is greater than minimal risk, an explanation as to whether
                     any medical treatments are available if injury occurs and, if so, what they
                     consist of, or where further information may be obtained.
                 (i.j) An explanation of whom to contact for answers to questions about research
                     and to voice comments or concerns (e.g., Investigator or the HSPP office)
                     subject‟s rights (e.g., the HSPP office), and whom to contact in the event of a
                     research-related injury to the participant;
                (i.k) A statement that participation is voluntary, refusal to participate will involve
                     no penalty or loss of benefits to which the subject is otherwise entitled, and
                     the subject may discontinue participation at any time without penalty or loss
                     of benefits to which the subject is otherwise entitled.
           ii. Additional Elements. The informed consent documents should, when appropriate,
                include the following additional elements:
     (ii.a) For women of child bearing potential, a statement that the particular
          treatment or procedure may involve risks to the participant (or the embryo or
          fetus, if the participant is or may become pregnant) which are currently
          unforeseeable;
     (ii.b) Anticipated circumstances under which the subject‟s participation may be
          terminated by the Investigator without regard to the participant‟s consent;
     (ii.c) If there is the potential that costs of research procedures will not be paid by
          the sponsor or the participant‟s insurance, a description of any additional costs
          to the participant that may result from participation in the research should be
          described in the consent document;
     (ii.d) The consequences of a participant‟s decision to withdraw from the research
          and procedures for orderly termination of participation by the subject;
     (ii.e) A statement that significant new findings developed during the course of the
          research which may relate to the participant‟s willingness to continue
          participation will be provided to the participant;
     (ii.f) The approximate number of participants involved in the study;
     (ii.g) Study treatment(s) and the probability of random assignment to placebo or
          to each treatment; and
     (ii.h) The IRB may require that information, in addition to that required in Federal
          regulations, be given to research participants when in its judgment the
          information would meaningfully add the protection of the rights and welfare
          of participants.
iii. Second Person. The language of the consent document should be in the second
     person style (i.e., “you”), which may help convey that there is a choice to be made
     by the subject rather than presumption of the subject‟s consent with the use of the
     first person style.
iv. No Unproved Claims of Effectiveness. No unproved claims of effectiveness or
     certainty of benefit, either implicit or explicit, may be included in the informed
     consent document.
v. Informed Consent Document Language May Not Be Too Complex. The
     information provided in the informed consent documents must be in language
     understandable to the subject. The informed consent document should not include
     complex language that would not be understandable to all subjects eligible for the
     study. Technical and scientific terms should be adequately explained using
     common or lay terminology. Non-English consent form should be translated and
     it is encouraged that it then back-translated to English to be certain of the
     accuracy of the translation and the information conveyed.
vi. Exculpatory Language in Informed Consent Documents. Informed consent
     documents may not contain any exculpatory language through which the subject
     is made to waive or appear to waive any of the subject's legal rights, or releases or
     appears to release the investigator, the sponsor, the College, or its agents from
     liability for negligence.
vii. No Exculpatory Language. The informed consent documents may not contain any
     exculpatory language through which the participant is made to waive or appear to
     waive any of the participant‟s legal rights, or releases or appears to release the
        investigator, the sponsor, the College, or its agents from liability for negligence.
        Examples of Acceptable Language:
        • Data or knowledge obtained from you in this research may be used to
             establish a commercial product that could be patented and licensed. There are
             no plans to provide financial compensation to you should this occur.
        • By consenting to participate, you authorize the use of your data for the
             research described above. Examples of Unacceptable Exculpatory Language:
        • By agreeing to this use, you should understand that you would give up all
             claims to personal benefit from commercial or other use of these substances.
        • You voluntarily and freely donate any and all blood, urine, and tissue samples
             to the U.S. Government and hereby relinquish all right, title, and interest to
             said items.
        • By consenting to participate in this research, you give up any property rights
             you may have if a commercial product is created in the course of the research.
        • You waive any possibility of compensation for injuries that you may receive
             as a result of participation in this research.
b. IRB Committee Responsibilities.
   i. The IRB Committee, the Chair or his/her designee will review the informed
        consent documents to assure the documents contain all the required elements of
        consent as defined by the Federal Regulations and determine when the additional
        elements that are appropriate and should be incorporated into the documents. IRB
        Committee members will use a checklist to assure that all documents contain the
        required elements and when the additional elements are appropriate.
   ii. There are two circumstances under which the regulations give the IRB the
        authority to waive the required consent.
   iii. The IRB Committee, the Chair or his/her designee will review the informed
        consent documents to assure:
        (iii.a) There are no discrepancies within the informed consent documents, the IRB
             application, the Sponsor‟s or Investigator‟s Protocol, the Investigator‟s
             Brochure, the grant and/or the contract regarding the purpose, risks, and
             benefits of the research;
        (iii.b) The language of the consent document is in the second person style (i.e.,
             “you”);
        (iii.c) The documents do not contain unproven claims of effectiveness or certainty
             of benefit, either implicit or explicit;
        (iii.d) The information provided in the informed consent documents are in a
             language understandable to the participant population and does not include
             complex language that would not be understandable to all participants;
        (iii.e) Informed consent documents do not contain any exculpatory language
             through which the participant is made to waive or appear to waive any of the
             participant's legal rights, or releases or appears to release the investigator, the
             sponsor, the College, or its agents from liability for negligence; and
c. HSPP Staff Member Responsibilities.
   i. The staff member will conduct a pre-review of the informed consent documents
        submitted with a new study application to determine that the correct forms have
        been submitted for the targeted population, assess the readability of the document,
    and that all required elements are present for adequate informed consent,
    including if any additional elements are appropriate.
ii. If additional information regarding the informed consent process or
    documentation is needed, the staff member will contact the Investigator and
    request the additional information.
                         Elements of Informed Consent Checklist

A clear statement that the study involves research.
An explanation of the purposes of the research.
The expected duration of the subject's participation.
A complete description of the procedures to be followed.
Identification of any procedures, which are experimental, and those that are standard of care.
A description of any reasonably foreseeable risks or discomforts to the participant.
A description of any benefits to the participant or to others, which may reasonably be expected from the
research.
A disclosure of appropriate alternative procedures or courses of treatment if any that might be advantageous
to the participant.
A description of the extent to which confidentiality of records identifying the participant and privacy will be
maintained.
For research involving more than minimal risk, an explanation as to whether any compensation, and an
explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist
of, or where further information may be obtained.
An explanation of whom to contact for answers to pertinent questions about the research (e.g., Investigator)
and research participants' rights (e.g., IRB office), and whom to contact in the event of a research-related
injury to the participant.
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
which the participant is otherwise entitled, and the participant may discontinue participation at any time
without penalty or loss of benefits, to which the participant is otherwise entitled.

  Lindsey Wilson College SPC IRB requires the following additional elements, if applicable.

For women or childbearing potential, a statement that the particular treatment or procedure may involve
risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are
currently unforeseeable.
Anticipated circumstances under which the subject's participation may be terminated by the Investigator
without regard to the subject's consent.
If there is the potential that costs of research procedures will not be paid by the sponsor or the participant‟s
insurance, a description of any additional costs to the participant that may result from participation in the
research should be described in the consent.
The consequences of a participant's decision to withdraw from the research and procedures for orderly
termination of participation by the participant.
A statement that significant new findings developed during the course of the research, which may relate to
the participant's willingness to continue participation, will be provided to the participant.
The approximate number of participants involved in the study.
Study treatment(s) and the probability of random assignment to placebo or to each treatment.
NOTE: The IRB may require that information, in addition to that required in the Federal regulations, be
given to research participants when in its judgment the information would meaningfully add to the
protection of the rights and welfare of participants.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.B Documentation of Informed Consent for Human Subjects Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.B Documentation of Informed Consent for Human Subjects Research
      Policy:
      1. Three Options for Documentation of Informed Consent. The IRB may approve
         procedures for documentation of informed consent that involve either:
         a. A written consent form signed by the subject;
         b. A short form written consent form with oral presentation; or
         c. In limited circumstances, a waiver of the signed written consent form may be
              granted. Each of these three options is described in detail below. It is the
              responsibility of the IRB Committee to determine which of the procedures
              described below is appropriate for documenting informed consent in protocols
              that it reviews.
      2. Option One: Written Consent Form Signed by Subject or Legally Authorized
         Representative. The IRB should require that informed consent be documented by the
         use of a written consent form approved by the IRB and signed and dated by the
         subject or the subject's legally authorized representative. This consent form must
         embody the elements of informed consent required by Federal regulations. This form
         may be read to the subject or the subject‟s legally authorized representative.
         However, the investigator should allow the subject or the legally authorized
         representative adequate opportunity to read the consent document before it is signed.
         A copy of the document must be given to the person signing the form.
         a. The written informed consent document should embody, in language
              understandable to the subject, all the elements necessary for legally effective
              informed consent.
         b. Subjects who do not speak English should be presented with an informed consent
              document written in a language understandable to them.
      3. Option Two: Oral Presentation Using a Short Form. As an alternative to standard
         written informed consent documents, oral presentation of informed consent
         information may be used.
         a. In such cases, the subject must be provided with both:
              i. A short form written informed consent document stating that the elements of
                  consent have been presented orally to the subject or the subject‟s legally
                  authorized representative; and
              ii. A written summary of the information that is presented orally.
         b. Witness Required. A witness to the oral presentation is required. The witness
              must sign both the short form written informed consent document and a copy of
              the written summary.
         c. The subject or the legally authorized representative must sign and date the short
              form written consent document.
         d. The person obtaining consent (e.g., the Presenter or Principal Investigator) must
              sign and date a copy of the written summary of the information that is presented
              orally. The person obtaining consent may not be the witness to the consent. A
              witness must be a person un-involved in the research.
   e. Participants Who Do Not Speak English. Where informed consent is documented
      using this short form procedure for non-English speaking subjects, the written
      informed consent document should embody, in language understandable to the
      subject, all the elements necessary for legally effective informed consent. When
      this procedure is used with subjects who do not speak English,
      i. The oral presentation and the short form written informed consent document
           should be in a language understandable to the subject;
      ii. The IRB-approved English language informed consent document may serve
           as the summary; and;
      iii. The witness should be fluent in both English and the language of the subject.
      iv. The IRB Committee must receive all foreign language versions of the short
           form document as a condition of approval.
      v. Expedited review of these versions is acceptable if the protocol, the full
           English language informed consent document, and the English version of the
           short form document have already been approved by the convened IRB
           Committee.
4. Option Three: Waiver of Documentation of Signed Informed Consent.
   a. The IRB may waive the requirement for the investigator to obtain a signed
      consent form for some or all subjects if the IRB finds either:
           i. That the only record linking the subject and the research would be the
               consent document and the principal risk would be potential harm resulting
               from a breach of confidentiality such as the subject‟s participation in an
               illegal or dangerous activity; or;
               Note: When the IRB waives the requirement for documentation under this
               condition, each subject must be asked whether the subject wants
               documentation linking the subject with the research, and the subject's
               wishes will govern. NOTE: Waiver of documentation of signed
               informed consent where research has FDA oversight is not permitted
               using the above criteria
           ii. That the research presents no more than minimal risk of harm to subjects
               and involves no procedures for which written consent is normally required
               outside of the research context.
               Note: Minimal risk means that the probability and magnitude of harm or
               discomfort anticipated in the research are not greater in and of themselves
               than those ordinarily encountered in daily life or during the performance
               of routine physical or psychological examinations or tests. An example of
               minimal risk is the risk of drawing a small amount of blood from a healthy
               individual for research purposes (because the risk of doing so is no greater
               than the risk of doing so as part of a routine physical examination).
               NOTE: Waiver of documentation of signed informed consent where
               research has FDA oversight is permitted using the above criteria [21
               CFR 56.109(c)(1)]
   b. In cases in which the signed documentation requirement is waived, the IRB in
      most cases, will require the Principal Investigator to provide subjects with a
      written statement regarding the research, sometimes referred to as a Disclaimer
      Form.
5. Use of Facsimile or Mail to Document Informed Consent. The IRB may approve a
   process that allows the informed consent document to be delivered by mail or
   facsimile to the potential subject or the potential subject‟s legally authorized
   representative and to conduct the consent interview by telephone when the subject or
   the legally authorized representative can read the consent document as it is discussed.
   All other applicable conditions for documentation of informed consent must also be
   met when using this procedure.
6. No Verbal Consent. Verbal agreement to participant in a research is not permitted
   unless the documentation or process of informed consent is waived by the IRB
   Committee, or the Chair or his of her designee
7. Documentation of Waiver. – When the IRB waives the requirement for signed
   consent, this will be noted in the letter to the Investigator and in the Abstract of the
   project published in the Minutes of the IRB Meeting.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.B Documentation of Informed Consent for Human Subjects Research
SUB-PART: IV.B.1 Procedure for Documentation of Informed Consent for Human Subjects Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.B.1 Procedure for Documentation of Informed Consent for Human Subjects Research
       Procedure:
       The purpose of this procedure is to provide guidance on documentation of prospective,
       legally effective informed consent from research participants or their legally authorized
       representative.
       1. Investigator Responsibilities.
           a. All informed consent documents (full written documents, oral scripts, short forms,
               and assent forms) will be submitted to the IRB with the new study submission.
               i. Use of the HSPP templates for informed consent is encouraged for drafting all
                    written informed consent documents. Appropriate templates, template
                    language, and instructions are located on the HSPP website at
                    http://www.lindsey.edu/ and select “Forms On-line” from the left column.
               ii. Informed consent documents will be written in language that is at the
                    appropriate reading and comprehension level for the targeted population.
                    Generally, a 6th to 8th grade reading level is recommended for adult consent
                    documents.
               iii. The IRB recommends that the informed consent documents apply to the
                    following division of target populations:
                    • Age 18 or older utilizing the adult informed consent document;
                    • Ages 15 to 17 utilizing an assent form, which may be in the same
                        language as the adult informed consent document and countersigned by a
                        parent/guardian;
                    • Ages 10 to 14 utilize a written assent form and indicate their assent in
                        writing;
                    • Ages 6 to 9 utilizing an assent form written simply and at a
                        comprehension level appropriate for a 6 year old and attested to by a
                        witness;
                    • Less than 6 years of age utilizing an oral script in very simple language
                        appropriate for children of this age group.
           b. Obtaining Informed Consent.
               i. The Investigator will provide a copy of the currently approved and IRB date-
                    stamped informed consent documents to the participant or his or her legally
                    authorized representative.
               ii. A legally authorized representative which includes a guardian or conservator,
                    or someone appointed as an agent for the participant, may grant permission
                    for the individual to participate in research.
               iii. The Investigator will provide the participant or his or her guardian or
                    conservator, agent, or legally authorized representative adequate time to read
                    the consent, ask questions, and consider the risks and/or benefits to
                    participation in the research study prior to obtaining their signature.
   iv. Assent and dissent and documentation of such are to be obtained as directed
        by the determination of the IRB Committee.
   v. Participants or the participant‟s legally authorized representative will provide
        a signature and the date of signature on all informed consent documents,
        unless a waiver of documentation has been requested by the Investigator and
        approved by the IRB.
c. Oral Presentation Using Short Form.
   i. When consent is obtained orally, the Investigator will use a short form written
        informed consent document stating that the elements of consent have been
        presented orally to the participant or the participant‟s legally authorized
        representative, as well as written summary of the information that is presented
        orally.
   ii. A witness to the oral presentation is required. The witness must sign and date
        both the short form written consent document and a copy of the written
        summary.
   iii. The participant or the guardian, or conservator, agent, or legally authorized
        representative must sign and date the short form written consent document.
   iv. The person obtaining consent (e.g., the Principal Investigator or Study
        Coordinator) must sign and date a copy of the written summary of the
        information that is presented orally. The person obtaining consent may not be
        the witness to the consent.
d. Non-English Speaking Participants.
   i. Translation of English Language Informed Consent Document. Participants
        who do not speak English should be presented with an informed consent
        document written in a language understandable to them. The IRB strongly
        encourages the use of a full translation of the entire informed consent.
   ii. Translations and back translations for targeted populations that are non-
        English speaking must be submitted for review and approval. The Investigator
        may wish to delay translation until IRB approval is granted for the English
        version informed consent documents or the short form documents to avoid
        extra translation costs.
   iii. If a translation service was used, the Investigator is encouraged to provide the
        qualifications of the individual or the service that was used to translate the
        informed consent documents or short form documents. If a service was not
        used, the Investigator is encouraged to include any credentials, certifications,
        education, native language fluency, etc.
e. Use of Short Form Consent Document. When informed consent is documented
   using the short form consent procedure for non-English speaking participants, the
   following is applicable:
   • The oral presentation and the short form consent documents will be provided
        in a language understandable to the participant;
   • The IRB-approved English language informed consent document may serve
        as the summary; and
   • A witness who is fluent in both English and the language of the participant
        should be present. Required signatures for short form consent procedures
        include:
       •   The short form document should be signed and dated by the participant or the
           participant‟s legally authorized representative;
      • The summary (i.e., the English language informed consent document) should
           be signed and dated by the person obtaining consent as authorized under the
           protocol; and
      • The short form document and the summary should be signed and dated by the
           witness. When the person obtaining consent is assisted by a translator, the
           translator may serve as the witness.
      NOTE: the FDA discourages the use of the short form consent document in
      research for which the FDA has oversight.
   f. Waiver of Documentation of Informed Consent.
      i. The Investigator will assess the proposed research to determine if it meets
           regulatory requirements for a waiver of documentation of informed consent.
      ii. The Investigator will submit for review a request for a waiver.
      iii. When the IRB waives the requirement for documentation of informed
           consent, each participant must be asked whether he or she wants
           documentation linking him or her with the research, and the participant‟s
           wishes will govern.
   g. The person obtaining consent should document the consent process in the
      participant‟s medical record or the participant‟s research record. This may
      include:
      i. How consent was obtained;
      ii. The participant‟s level of comprehension (did they appear to understand, did
           they ask questions, were they able to reiterate the main purpose of the study,
           procedures, risks, etc.);
      iii. The participant‟s decision-making capacity at the time of consent (were they
           alert and oriented);
      iv. The time given for the participant to consider the research and whether others
           were involved in the decision-making;
      v. Who was present during the consenting process;
      vi. For VA research, the IRB Committee, the Chair or his/her designee
           determines if the patient‟s medical record (electronic or paper) must be
           flagged to protect the subject‟s safety by indicating the subject‟s participation
           in the study (date pt. entered and date pt. terminated study participation) and
           the source of more information about the study. A waiver may occur if either
           requirement is met:
           (vi.a) The subject‟s participation in the study involves only one encounter,
               involves only the use of a questionnaire or the use or the use of previously
               collected biological specimens, or
           (vi.b) The identification of the patient as a subject in a particular study (if the
               study is not greater than minimal risk) would place the subject at greater
               than minimal risk.
   h. Any revisions to the informed consent process or documents will be submitted to
      the IRB for review and approval prior to use.
2. IRB Committee Responsibilities.
         a. The Investigator‟s plan to obtain informed consent should be assessed by the IRB
            Committee, the Chairperson, or his or her designee to assure the appropriate
            conditions are met.
         b. The IRB should consider the nature of the proposed subject population, the type
            of information to be conveyed, and the circumstances under which the consent
            process will take place (e.g., manner, timing, place, personnel involved);
         c. All elements of consent as required by the Federal regulating, as well as any
            appropriate additional elements are incorporated into the documents using the
            Elements of Informed Consent Checklist made available at IRB Committee
            meeting;
         d. Provisions have been made if the study is to include non-English speaking
            participants and the translated documents have been verified to be in a language
            understandable to the participant;
         e. The reviewers are to verify that the informed consent documents are congruent
            with the study protocol and IRB application. If not, the reviewer or Committee
            will request revisions prior to granting final approval;
         f. The reviewers will assure that the written language is in lay terms with correct
            grammar, spelling, and punctuation for readability and understanding.
         g. The IRB Committee must review all amendments to the informed consent process
            or documentation if the requested amendments change the risk/benefit ratio. The
            Committee will consider whether re-consenting participants is required.
         h. When the research includes children, the IRB must determine whether assent is
            required, for what ages assent is required, and how assent is to be documented.
            i. Decisions to waive documentation of informed consent must be clearly
                documented in the reviewer‟s Comment Sheet regarding the assessment of the
                proposed research to determine if it meets regulatory requirements for a
                waiver of documentation of informed consent. When the IRB waives the
                requirement for documentation of informed consent under 45 CFR
                46,117(c)(1), each participant must be asked whether he or she wants
                documentation linking him or her with the research, and the participant‟s
                wishes will govern.
      3. HSPP Staff Responsibilities.
         a. The HSPP staff will conduct a pre-review of all informed consent documents
            submitted for IRB review.
         b. E-mails requesting pre-review changes to the informed consent documents are to
            be sent to the Investigator by the staff member.
         c. Once the pre-review revisions are received from the Investigator, the staff will
            place the new study with the revised informed consent documents on the next
            available IRB Committee agenda, assign reviewers, and prepare the reviewer and
            Committee packets.
         d. Once final approval is granted by the IRB, the informed consent documents will
            be stamped with approval and expiration dates.
         e. Changes to the informed consent process and/or documents are to be completed
            according to the IRB amendment policy and procedure.

References:
45 CFR 46.111
45 CFR 46.116 and 46.117
21 CFR 50 and 56
OHRP Guidance Document, “Informed Consent, Non-English Speakers” dated November 1995.
OHRP IRB Guidebook, “PROTECTING HUMAN RESEARCH SUBJECTS: Institutional
Review Board Guidebook"
Food and Drug Administration, Information Sheets: “Guidance for Institutional Review Boards
and Clinical Investigators”, 1998 Update.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.C Waiver of Informed Consent for Human Subject Research or Exception of Informed Consent for Emergency
Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.C Waiver of Informed Consent for Human Subject Research or Exception of Informed
Consent for Emergency Research
      Definition:
      1. Emergency Research: Research conducted in participants who are in a life-
          threatening or emergent situation, where available treatments are unproven or
          unsatisfactory, and the collection of valid scientific evidence, which may include
          evidence obtained through randomized placebo-controlled investigations, is necessary
          to determine the safety and effectiveness of particular interventions.
      2. Minimal Risk: The probability and magnitude of harm or discomfort anticipated in
          the research are not greater in and of themselves than those ordinarily encountered in
          daily life or during the performance of routine physical or psychological
          examinations or tests.
      Policy Instructions/Explanations:
      1. It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
          Program (HSPP) to grant a waiver from informed consent for research or an
          exception from informed consent for qualifying emergency research in congruence
          with the Federal regulations and IRB policies and procedures.
      2. Option One: Waiver for Research Activities Designed to Study Certain Aspects of
          Public Benefit or Service Programs. The IRB may approve a consent procedure,
          which does not include, or which alters, some or all of the elements of informed
          consent, or waive the requirement to obtain informed consent entirely provided the
          research is not subject to the FDA regulations and the IRB finds and documents
          that:
          a. The research or demonstration project is to be conducted by or subject to the
              approval of state or local government officials and is designed to study, evaluate,
              or otherwise examine:
              i. Public benefit or service programs;
              ii. Procedures for obtaining benefits or services under those programs;
              iii. Possible changes in or alternatives to those programs or procedures; or
              iv. Possible changes in methods or levels of payment for benefits or services
                   under those programs; and
          b. The research could not practicably be carried out without the waiver or alteration.
      3. Option Two: Waiver for Minimal Risk Studies. Additionally, the IRB may approve a
          consent procedure, which does not include, or which alters, some or all of the
          required elements of informed consent, or waives the requirements to obtain informed
          consent entirely provided the research is not subject to the FDA regulations and the
          IRB finds and documents that:
          a. The research involves no more than minimal risk to the subjects; and
          b. The waiver or alteration will not adversely affect the rights and welfare of the
              subjects; and
    c. The research could not practicably be carried out without the waiver or alteration;
        and
    d. Whenever appropriate, the subjects will be provided with additional pertinent
        information after participation.
4. Option Three: Exception from Informed Consent Requirements for Emergency
    Research Subject to FDA Regulations. A third strictly limited exemption from the
    informed consent requirements exists for a class of research activities that may be
    carried out in human subjects who are in need of emergency therapy and for whom,
    because of the subjects' medical condition and the unavailability of legally authorized
    representatives, no legally effective informed consent can be obtained.
    a. This waiver does not apply to research involving (i) fetuses, (ii) pregnant women,
        (iii) human in vitro fertilization , or (iv) research involving prisoners.
    b. The IRB may review and approve a clinical investigation without requiring
        informed consent of all research subjects be obtained if the IRB (with the
        concurrence of a licensed physician who is a member of or consultant to the IRB
        and who is not otherwise participating in the clinical investigation) finds and
        documents each of the following:
        i. The target population for the research is in a life-threatening situation,
             available treatments are unproven or unsatisfactory, and the collection of valid
             scientific evidence, which may include evidence obtained through randomized
             placebo-controlled investigations, is necessary to determine the safety and
             effectiveness of particular interventions.
        ii. Obtaining informed consent is not feasible because:
             (ii.a) The subjects will not be able to give their informed consent as a result of
                  their medical condition;
             (ii.b) The intervention under investigation must be administered before
                  consent from the subjects‟ legally authorized representatives is feasible;
                  and
             (ii.c) There is no reasonable way to identify prospectively the individuals
                  likely to become eligible for participation in the clinical investigation.
        iii. Participation in the research holds out the prospect of direct benefit to the
             subjects because:
             (iii.a) The subjects are facing a life-threatening situation that necessitates
                  intervention;
             (iii.b) Appropriate animal and other preclinical studies have been conducted,
                  and the
             information derived from those studies and related evidence support the
             potential for the intervention to provide a direct benefit to the individual
             subjects; and
             (iii.c) The risks associated with the investigation are reasonable in relation to
                  what is known about the medical condition of the potential class of
                  subjects, the risks and benefits of the proposed intervention or activity.
        iv. The clinical investigation could not practicably be carried out without the
             waiver.
        v. The proposed investigational plan defines the length of the potential
             therapeutic window based on scientific evidence, and the Investigator has
     committed to attempting to contact a legally authorized representative for each
     subject within that window of time and, if feasible, to asking the legally
     authorized representative contacted for consent within that window rather than
     proceeding without consent. The Investigator must agree to summarize efforts
     made to contact legally authorized representatives and make this information
     available to the IRB at the time of continuing review.
vi. The IRB has reviewed and approved informed consent procedures and an
     informed consent document consistent with Federal regulations and IRB
     policies and procedures. The informed consent procedures and the informed
     consent document are to be used with subjects or their legally authorized
     representatives in situations where use of such procedures and documents is
     feasible.
vii. Additional protections of the rights and welfare of the subjects will be
     provided, including, at least:
     (vii.a) Consultation (including, where appropriate, consultation carried out by
         the IRB) with representatives of the communities in which the clinical
         investigation will be conducted and from which the subjects will be
         drawn;
     (vii.c) Prior to the initiation of the clinical investigation, public disclosure to
         the communities in which the clinical investigation will be conducted and
         from which the subjects will be drawn of plans for the investigation and its
         risks and expected benefits;
     (vii.d) At the completion of the clinical investigation there are plans for public
         disclosure of sufficient information to apprise the community and
         researchers of the study. The information must include the demographic
         characteristics of the research population and results of the clinical
         investigation.
     (vii.e) Establishment of an independent data and safety monitoring committee
         to exercise oversight of the clinical investigation; and
     (v.ii.f) If obtaining informed consent is not feasible and a legally authorized
         representative is not reasonably available, the Investigator must commit to
         attempting to contact within the therapeutic window, the subject‟s family
         member who is not a legally authorized representative, and asking whether
         he/she objects to the subject‟s participation in the clinical investigation.
         The Investigator will summarize efforts made to contact family members
         and make this information available to the IRB at the time of continuing
         review.
viii. Procedures must be in place to inform, at the earliest feasible opportunity,
     each subject, or if the subject remains incapacitated, a legally authorized
     representative of the subject, or if such a representative is not reasonably
     available, a family member, of the subject‟s inclusion in the clinical
     investigation, the details of the investigation and other information contained
     in the informed consent document, specifically that the he/she may
     discontinue the subject‟s participation at any time without penalty or loss of
     benefits of which the subject is otherwise entitled.
        ix. If a legally authorized representative or family member is told about the
             clinical investigation and the subject‟s condition improves, the subject is also
             to be informed as soon as feasible.
        x. If a subject is entered into a clinical investigation with waived consent and the
             subject dies before a legally authorized representative or family member can
             be contacted, information about the clinical investigation is to be provided to
             the subject‟s legally authorized representative or family member, if feasible.
        xi. All clinical investigation records, including regulatory files, must be
             maintained for at least 3 years after the completion of the clinical investigation
             and will be accessible for inspection and copying by the regulatory authorities,
             as applicable.
        xiii. If the IRB determines it cannot approve a request for exception from
        informed consent requirements in emergency research because the clinical
        investigation does not meet the criteria according to Federal regulations, IRB
        policies and procedures, or other relevant ethical concerns, the IRB must
        document its findings and provide these findings promptly in writing to the
        clinical investigator who will forward to the sponsor of the clinical investigation.
5. Option Four: Research Not-Subject to FDA Regulations. The IRB finds:
    a. The research does not meet FDA regulations in 21 CFR 50; and
    b. Items i-vii as stated in Option Three above are met.
6. “Deferred Consent” or “Ratification” Not Allowed. Informed consent procedures that
    provide for other than legally effective and prospective obtained consent fail to
    constitute informed consent under the Federal Regulations for the protection of
    human subjects. Therefore, waiving informed consent using a method other than
    those described above and specified in the Federal Regulations is a violation of this
    policy.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.C Waiver of Informed Consent for Human Subject Research or Exception of Informed Consent for Emergency
Research
SUB-PART: IV.C.1 Procedure for Waiver of Informed Consent for Human Subject Research or Exception of Informed Consent for
Emergency Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.C.1 Procedure for Waiver of Informed Consent for Human Subject Research or
Exception of Informed Consent for Emergency Research
       Purpose:
       This procedure provides guidance on obtaining a waiver of informed consent; and
       requesting approval for exception from informed consent in emergency research from
       Lindsey Wilson College SPC (LWC) Human Subjects Protection Program (HSPP).
       1. Investigator Responsibilities.
          a. Waiver of informed consent in public benefit or service programs or for minimal
              risk research.
              (i.a). The Investigator will assess the proposed research to determine if it meets
                   regulatory requirements for a waiver of informed consent.
                   • The Investigator must still provide an information sheet or disclaimer form
                       to all study participants
          b. Exception from informed consent requirements for emergency research. The
              Investigator is responsible for providing all study documents and any additional
              materials requested by the IRB to prepare and conduct community consultation
              and public disclosure of the proposed research.
              (ii.a) The Investigator will prepare and submit to the IRB materials in preparation
                   for public disclosure following completion of the research.
              (ii.b) The Investigator will establish an independent data and safety monitoring
                   committee to exercise oversight of the clinical investigation.
              (ii.c) When the Investigator is unable to locate a legally authorized representative,
                   the Investigator will attempt to contact, within the therapeutic window, the
                   participant‟s family member who is not a legally authorized representative, to
                   ask whether he or she objects to the individual‟s participation. A summary of
                   efforts to contact the legally authorized representative and family members is
                   made available to the IRB at the time of continuing review.
       2. IRB Committee Responsibilities.
          a. The IRB reviewers will consider the request for a waiver of informed consent and
              the Investigator‟s justification verifying and documenting that regulatory
              conditions are applicable to the proposed research activity.
          b. If the IRB reviewers agree with the Investigator‟s justification and documentation
              for waiver or alternation of the consent process, they will document on the
              reviewer‟s Comment Sheet that they agreed with the Investigator‟s justifications.
          c. If the IRB reviewers do not agree with the Investigator‟s justification, but agree
              for other reasons that waiver or alteration of the consent process is allowable and
              appropriate, they must document on the reviewer‟s Comment Sheet, their own
              protocol specific findings that justify the waiver or alteration of consent.
          d. If the IRB reviewers do not agree that waiver or alteration of the consent process
             is allowable and appropriate, they will document such on the reviewer‟s Comment
             Sheet.
          f. When amendments are made to a currently approved research study, the waiver of
             informed consent is reassessed by the IRB Committee, Chair or his or her
             designee, and a determination made as to whether the conditions for the waiver
             have been altered, necessitating the rescinding of the waiver. If this occurs, the
             IRB also determines whether currently enrolled participants must be re-consented
             by the Investigator.
      3. HSPP Staff Responsibilities.
          a. The HSPP staff member will conduct a pre-review of the request for waiver of
             consent to verify that the study meets the criteria for a waiver of informed
             consent. If the staff member determines that the study does not meet the criteria
             for a waiver, the Investigator is contacted for further clarification or guidance on
             drafting an informed consent document.
          b. E-mails requesting pre-review changes are sent to the Investigator by the staff
             member.
          c. Once the pre-review revisions are received from the Investigator, the staff
             member will forward the study and informed consent documents for review by the
             appropriate process (expedited or IRB Committee review).
          d. Staff member will ensure that the minutes document the determinations required
             by the regulations and protocol-specific findings justifying the recommendations
             made by the IRB Committee.
References:
21 CFR 56.109(c)(1)
21 CFR 56.109(d)
21 CFR 50.24
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.D Assent/Dissent by Children or Cognitively Impaired Adults Who Lack Decision-Making Capacity
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007
REVISED: October 2007


IV.D Assent/Dissent by Children or Cognitively Impaired Adults Who Lack Decision-
Making Capacity
      Definitions:
      Assent: An individual‟s affirmative agreement to participate in research obtained in
           conjunction with permission from the individual‟s parents or guardian. Mere failure
           to object should not, absent affirmative agreement, be construed as assent.
      Children: According to Federal regulations, children are “persons who have not attained
           the legal age for consent to treatments or procedures involved in the research, under
           the applicable law of the jurisdiction in which the research will be conducted.
      Cognitive Impairment: Having a psychiatric disorder (e.g., psychosis, neurosis,
           personality or behavior disorder), an organic impairment (e.g., dementia) or a
           developmental disorder (e.g., mental retardation) that affects cognitive or emotional
           functions to the extent that capacity for judgment and reasoning is significantly
           diminished. Others, including individuals under the influence of or dependent on
           drugs or alcohol, those suffering from degenerative diseases affecting the brain,
           terminally ill patients, and individuals with severely disabling physical handicaps,
           may also be compromised in their ability to make decisions in their best interest.
      Dissent: An individual‟s negative expressions, verbal and/or non-verbal, that they object
           to participation in the research or research activities.
      Guardian: An individual who is authorized under applicable State or local law to
           consent on behalf of a child to general medical care.
      Legally Authorized Representative: An individual, judicial, or other body authorized
           under applicable law to grant permission on behalf of a prospective participant for
           participation in research activities.
      Parent: A child's biological or adoptive parent.
      Permission: The agreement of parents or legal guardians to the participation of their
           child or ward in research.
   Policy:
      1. In instances where the subject is not legally capable of giving informed consent (e.g.,
           child) or where the subject is cognitively impaired, the IRB must find that adequate
           provisions are made for soliciting the assent of the subject when in the judgment of
           the IRB, the subject is capable of providing assent as prescribed for the IRB in 45
           CFR 46, Subpart A.
      2. "Assent" means a subject‟s affirmative agreement to participate in research. Mere
           failure to object should not, absent affirmative agreement, be construed as assent.
      3. In determining whether subjects are capable of assenting, the IRB shall take into
           account the age, maturity, language used, and psychological state of the subject
           involved based on information provided by the Principal Investigator. This judgment
           may be made for all subjects to be involved in research under a particular protocol, or
           for each subject, as the IRB deems appropriate. If the IRB determines that the
           capability of some or all of the subjects is so limited that they cannot reasonably be
   consulted or that the intervention or procedure involved in the research holds out a
   prospect of direct benefit that is important to the health or well-being of the subject
   and is available only in the context of the research, the assent of the subject is not a
   necessary condition for proceeding with the research. Even where the IRB determines
   that the subjects are capable of assenting, the IRB may still waive the assent
   requirement.
4. When the IRB determines that assent is required, it shall also determine whether and
   how assent must be documented.
5. Investigators must complete a Project Review Form or Project Approval Form to
   request inclusion of children as research subjects. If the IRB, using the required
   criteria, determines that approval for the inclusion of children in the research activity
   can be granted, one of the following italicized statements must be added to the
   minutes at the end of the summary of the protocol and the list of stipulations for
   approval:
   a. 46.404. Research not involving greater than minimal risk – The research involves
       children and was therefore, examined against provisions of Subpart D of 45 CFR
       46.404 (Research not involving greater than minimal risk) and 46.408
       (Requirements for permission by parents or guardians and for assent by children),
       as well as the current guidelines for inclusion of children in research. The IRB
       found the research to be of minimal risk to the child, and after considering the
       age, maturity, and psychological state of the children to be enrolled in this study,
       determined that adequate provisions are made for soliciting the assent of the child
       and permission of a parent or legally authorized guardian who has been granted
       authority to consent for medical care, including research. As a general rule of
       thumb, depending on the complexity of the project, the IRB requires that children
       age 6-9 be asked to verbalize their assent/dissent to participate which will be
       attested to by a witness, children age 10-14 must indicate their assent in writing,
       and children 15 to 17 may sign an assent form that is countersigned by a
       parent/guardian. Children under the age of six may be verbally assented as
       appropriate for their age and ability.
   b. 46.405. Research involving more than minimal risk but presenting the prospect of
       direct benefit to the individual subjects – The research involves children and was
       therefore examined against provisions of Subpart D of 45 CFR 46, particularly
       46,405 and 46.408, as well as the current guidelines for inclusion of children in
       research. The IRB found the research involves more than minimal risk to the child
       but presents reasonable prospect for direct benefit to the child. The IRB also
       found the research risks to be justified by the anticipated benefits of the child, and
       the risk of benefit analysis to be at least as favorable as that presented by available
       alternative approaches. Also, after considering the age, maturity, and
       psychological state of the children to be enrolled in this study, the IRB determined
       that adequate provisions are made for soliciting the assent of the child and
       permission of a parent or legal guardian who has been granted authority to
       consent for medical care, including research. As a general rule of thumb,
       depending on the complexity of the project, the IRB requires that children age 6-9
       be asked to verbalize their assent/dissent to participate which will be attested to
       by a witness, children age 6-14 must indicate their assent in writing using an
   assent form, and children 15 to 17 may sign an assent form that is countersigned
   by a parent/guardian. Children under the age of six may be verbally assented as
   appropriate for their age and ability.
c. 46.406. Research involving greater than minimal risk and no prospect of direct
   benefit to individual subjects, but likely to yield generalizable knowledge about
   the subject’s disorder or condition. - The research involves children and was
   therefore examined against provisions of Subpart D of 45 CFR 46, particularly
   46,405 and 46.408, as well as the current guidelines for inclusion of children in
   research. The IRB found the research involves more than minimal risk to the child
   and presents no reasonable prospect for direct benefit to the child, but is likely to
   yield generalizable knowledge about the child‟s disorder or condition. The IRB
   found the risks represented a minor increase over the minimal risk, the research
   procedures reasonably commensurate with experiences inherent in their actual or
   expected medical, dental, psychological, social, or educational situations, the
   research is likely to yield generalizable knowledge of vital importance for the
   understanding or treatment of the child‟s disorder or condition. Also, after
   considering the age, maturity, and psychological state of the children to be
   enrolled in this study, the IRB determined that adequate provisions are made for
   soliciting the assent of the child and permission of both parents, if available, or
   legally authorized guardian(s)who has been granted authority to consent for
   medical care, including research. As a general rule of thumb, depending on the
   complexity of the project, the IRB requires that children age 6-9 be asked to
   verbalize their assent/dissent to participate which will be attested to by a witness,
   children age 10-14 must indicate their assent in writing, and children 15 to 17
   may sign an assent form that is countersigned by a parent/guardian. Children
   under the age of six may be verbally assented as appropriate for their age and
   ability.
d. 46.407. Research not otherwise approvable which presents an opportunity to
   understand, prevent, or alleviate a serious problem affecting the health and
   welfare of children. - The research involves children and was therefore examined
   against provisions of Subpart D of 45 CFR 46, particularly 46,405 and 46.408, as
   well as the current guidelines for inclusion of children in research. The IRB found
   the research to otherwise not be approvable but presents with an opportunity to
   understand, prevent, or alleviate a serious problem affecting the health or welfare
   of children. The IRB must advise the investigator that it cannot approve the
   inclusion of children in the research, and that to do so, a request to consider
   approval of the research must be made to the Secretary of Health and Human
   Services, through the IRB. If requested, the Secretary will convene a panel of
   experts to review the research for inclusion of children.
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.D Assent/Dissent by Children or Cognitively Impaired Adults Who Lack Decision-Making Capacity
SUB-PART: IV.D1 Procedure for Assent/Dissent by Children or Cognitively Impaired Adults who Lack Decision-Making Capacity
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007


IV.D.1 Procedure for Assent/Dissent by Children or Cognitively Impaired Adults who
Lack Decision-Making Capacity
       Procedure:
       The purpose of this procedure is to outline the process for obtaining assent in children
       and cognitively impaired adults who lack the capacity for decision-making for
       participation in research activities.
           1. Investigator Responsibilities.
               a. The Investigator will provide a description of the targeted study population in
                   the application. When the targeted population includes children or cognitively
                   impaired adults who lack decision-making capacity, the Investigator will also
                   provide a detailed description on how assent and dissent will be obtained and
                   documented, or request consideration of a waiver of assent and dissent.
               b. The Investigator will draft the assent documents and may utilize the assent
                   template located on the HSPP website at http://www.lindsey.edu and select
                   “Forms On-line” from the left column.
               c. The Investigator will provide plans for assessment and documentation of
                   examples of behaviors demonstrating assent and dissent in the targeted
                   populations.
               d. The Investigator will obtain permission from the child‟s parents or legal
                   guardians in conjunction with assent requirements. Documentation of
                   permission from the child‟s parents or legal guardians is provided by their
                   signature and date on the informed consent document.
               e. Permission must also be obtained for research participants who are cognitively
                   impaired and/or lack decision-making capacity from the individual‟s legally
                   authorized representative, unless a waiver of informed consent has been
                   granted by the IRB. Permission will be documented by the legally authorized
                   representative‟s signature and date on the informed consent document.
           2. IRB Committee Responsibilities.
               a. The IRB Committee will review research-involving children and cognitively
                   impaired adults who lack decision-making capacity to determine whether
                   assent and dissent is:
                   i. Required of all participants in the proposed research; or
                   ii. Required on a case-by-case basis, when in the Investigator‟s opinion, the
                       individual is able to comprehend the proposed research purpose and
                       associated activities and procedures.
               b. The IRB Committee will also consider granting a waiver of assent in
                   circumstances in which the targeted population does not have the ability to
                   comprehend the proposed research purpose and/or associated procedures.
               c. The IRB Committee will consider granting a waiver of assent in
                   circumstances in which the research holds out the prospect of direct benefit
                that is important to the health or well-being of the participant and is available
                only in the context of the research.
             d. The IRB shall take into account the age, maturity, and psychological state of
                the participants involved to determine if and when assent is required and the
                method of documenting assent.
             e. The IRB will review the Investigator‟s plan for assessment of the research
                participant‟s ability to provide assent and dissent and determine if the plan is
                appropriate. The IRB will make recommendations for additional requirements,
                when necessary.
          3. HSPP Staff Responsibilities.
             a. The staff member will complete a pre-review of the initial study submission
                involving children or cognitively impaired adults who lack decision-making
                capacity for the inclusion of assent and dissent plans, or a request for a waiver
                of assent and dissent in these targeted populations.
             b. If the plan for assent and dissent is not included in the initial submission, the
                staff member will request additional information from the Investigator.
             c. The staff member will pre-review the assent documents assuring that each has
                been presented in an age appropriate language for children and in simple lay
                language for the cognitively impaired adults who lack decision-making
                capacity. The staff member will forward recommendations for revisions to the
                Investigator.
             d. The staff member will assign the study to the reviewers who have the
                expertise in the area of the proposed research and the population targeted. If a
                member with those qualifications is not a regular Committee member, an
                expert consultant will be sought.
References:
The Belmont Report
45 CFR 46, Subpart D
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.E Approval and Expiration Dates on Informed Consent Documents
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007
REVISED: May, 2005; July. 2005


IV.E Approval and Expiration Dates on Informed Consent Documents
      Policy Instructions/Explanations:
         1. The IRB Office must affix the approval and expiration dates to all approved
             informed consent documents. Copies of the current, dated documents are the only
             versions that may be used by investigators in obtaining consent. This procedure
             helps ensure that only the current, IRB-approved informed consent documents are
             presented to subjects and serves as a reminder to the investigators of the need for
             continuing review.
             a. Clinical projects conducted by researchers at a Veterans Administration
                 Hospital must have an IRB stamp on each page of the consent form, per VHA
                 Handbook 1200.5, Appendix C, 3 Documentation of Informed Consent (b)(1)
                 dated July 15, 2003.
         2. Approval Date. The approval date should be the date that the protocol and
             informed consent documents were granted approval by the IRB, unless one of the
             following apply:
             a. If the Application has received a continuing review approval of the protocol
                 and informed consent document(s), the date of the most recent continuing
                 review approval should be used.
             b. If IRB has approved a modification to the informed consent document, the
                 date of the IRB‟s approval of the modification should be used as the approval
                 date.
             c. The approval date, which appears on the consent document, is the date of
                 approval of the most recent version of the consent document. The consent
                 document with the most current approval date is the one that should be used
                 until it is superseded by a more current consent document.
         3. Expiration Date. The expiration date should correspond to the end of the current
             IRB approval period (expiration date reflects that approval has expired as of
             midnight 11:59 pm on the previous day).
PROGRAM: Human Subjects Protection Program
SECTION: IV IRB Informed Consent Process
POLICY NUMBER: IV.E Approval and Expiration Dates on Informed Consent Documents
SUB-PART: IV.E.1 Stamping IRB Approval and Expiration Dates on Informed Consent Documents
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
EFFECTIVE DATE: October 2007
REVISED: October 2007


IV.E.1 Stamping IRB Approval and Expiration Dates on Informed Consent Documents
       Policy Instructions/Explanations
       The Office for Human Research Protections (OHRP) recommends that Institutional
       Review Boards (IRBs) require approval and expiration dates on all approved informed
       consent documents (ICD) and that only those documents bearing approval and expiration
       dates be used when obtaining informed consent from human subjects. Lindsey Wilson
       College SPC IRB will date stamp ICDs for new IRB applications, continuing review
       applications. Date stamping of amended ICDs will be required as they occur. In the event
       the ICD is formatted correctly for date stamping, the IRB will date stamp the ICD in the
       upper right hand corner.
       1. Date of IRB Approval on ICDs. (synonymous with previously used final approval
           date):
           a. If the IRB application is approved by the convened IRB, the date of the convened
               IRB committee meeting will be the date of IRB approval stamped on the ICD.
           b. If the IRB application is approved with changes to the ICD pending review and
               approval by the Chair, the date the changes are verified by the Chairperson (or
               designee) will be the date of IRB approval stamped on the ICD.
           c. If the IRB application approved by the Chair using the expedited review process,
               the date of the approval letter signed by the Chairperson (or designee) will be the
               date of IRB approval stamped on the ICD.
           d. The date of IRB approval stamped on an amended ICD is the date the convened
               IRB or Chairperson (or designee) granted approval for the amendment.
       2. Calculating the Date of IRB Expiration on the ICD:
           a. Example – Approval at a convened IRB Committee meeting:
                   02/01/2001 Committee meeting date
                   02/01/2002 Expiration date (project expiration occurs midnight 11:59 pm
                   01/31/02)
           b. Example – Approval pending simple concurrence by the Investigator:
                   02/01/2001 Committee approves study with minor changes
                   03/01/2001 Response received and reviewed by the Chair
                   02/01/2002 Date of IRB expiration for a 12-month period (project expiration
                   occurs midnight 11:59 pm 01/31/02)
                   08/01/2001 Date of IRB expiration for a 6-month period (project expiration
                   occurs on midnight 11:59 pm 07/31/01)
           c. Expedited Review:
               Since there is no convened meeting for an expedited review, the expiration date
               will be calculated based on the approval period recommended by the IRB
               Chairperson (or designee) using the date that the initial IRB application or
               continuing review application was approved by the Chair.
           d. Amendments:
       The approval date of an amendment that affects the ICD does not affect the
       calculation of the expiration date unless the committee changes the review period.
3. How to Date Stamp an ICD:
   Once approval is granted, the HSPP staff member will stamp the date of IRB
   approval in the top right corner of the first page of the consenting document (see
   sample below). The date of IRB approval will match the date in the final approval
   letter and the date of IRB expiration will be calculated as previously described in
   Section 2. (NOTE: Date stamps for non-medical consenting documents will use the
   term “PARTICIPANT”.)

       Sample:
       APPROVED BY THE LINDSEY WILSON COLLEGE SPC IRB
       THIS STAMP MUST APPEAR ON ALL
       DOCUMENTS USED TO CONSENT SUBJECTS.
       DATE:___________ EXPIRATION:__________
4. Distribution and Storage of Stamped ICDs:
   The HSPP staff member will copy the date stamped ICD and the final approval letter
   and verify the copies are reproducible and forward a copy of the original final
   approval letter and the stamped ICD (do not staple) to the principal investigator. The
   original ICD should be kept in the IRB files. The investigator will be notified in the
   final approval letter that only ICDs stamped with the date of IRB approval and
   expiration are to be copied and used for obtaining informed consent from subjects.
5. ICDs Required with Committee Letters, Amendments and Continuing Review Forms:
   Investigators will be required to submit an unstamped copy of the most recent ICD
   with all committee letter responses, amendments, and continuing review applications.
   This updated ICD will be date stamped by the HSPP Staff when approved. If the ICD
   is not approved, it will not be date stamped and will be filed with the other documents
   submitted for approval. Only approved ICDs will be date stamped. The following
   template language should be inserted in the letter to the Investigator to request
   updated consent documents:
   “Approval is granted with the understanding that no further changes or additions will be
   made either to the procedures followed or to the consent form(s) used (copies of which we
   have on file) without the knowledge and approval of the Human Subjects Committee and
   your College or Departmental Review Committee. Any research related physical or
   psychological harm to any subject must also be reported to each committee. A College policy
   requires that all signed subject consent forms be kept in a permanent file in an area
   designated for that purpose by the Department Head or comparable authority. This will assure
   their accessibility in the event that College officials require the information and the principal
   investigator is unavailable for some reason.”
6. Continuing Review of Studies with no Intent to Enroll Additional Subjects:
   If there is no intent to enroll additional subjects in the upcoming approval period, it is
   not necessary to date stamp the ICD. However, the study cannot be re-opened to
   enrollment without an amendment including a current ICD. If subjects were enrolled
   during the previous approval period, the investigator is required to submit a copy of
   the most recently approved and date stamped ICD.
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.A IRB Office Records
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


V.A IRB Office Records
      Policy Instructions/Explanations:
      1. The IRB office files (term used interchangeably with HSPP files) must be maintained
          in a manner that contains a complete history of all IRB actions related to the formal
          review and approval of a protocol, including continuing reviews, amendments and
          adverse event reports. As part of oversight responsibilities, the VA R&D Committee
          must have access to all IRB records and must review all minutes of the IRB(s)
          reviewing protocols of that VA facility
      2. Document Retention. The HSPP office must retain all records regarding a submitted
          application for at least three (3) years (including cancelled studies without participant
          enrollment) after the project is completed or terminated. If the project is never
          approved or is withdrawn by the investigator or returned to the investigator by the
          IRB, a letter to file is generated and the title page of the project is maintained along
          with this letter for three (3) years.
      3. Access to Documents. The HSPP office must make all records accessible for
          inspection and copying by authorized representatives of the sponsoring Department or
          sponsoring Regulatory Agency at reasonable times and in a reasonable manner.
      4. The HSPP office must prepare and/or maintain the following documents in a secure
          and confidential manner:
          a. Applications. Copies of all research applications reviewed, approved sample
              consent forms, data safety monitoring board reports, progress reports submitted
              by investigators, reports of injuries to subjects and other required documents (see
              policy V.A.3).
          b. Minutes. The minutes of all IRB Committee meetings.
          c. Continuing Review. Records of continuing review activities.
          d. Correspondence with Investigators. Copies of all written correspondence, emails,
              and pertinent phone logs between the IRB and the investigators that are applicable
              to the project once it is approved. Email correspondence leading up to the
              approval of Expedited projects will be destroyed by once the project is approved
              by the IRB.
          e. List of IRB Committee Members. A list of IRB Committee members identified
              by:
              i. Name and status of member (e.g., Chair);
              ii. Earned degrees;
              iii. Scientific status;
              iv. Representative capacity;
              v. Indications of experience such as board certifications, licenses, etc., sufficient
                   to describe each member's chief anticipated contributions to IRB
                   deliberations;
              vi. Any employment or other relationship between each member and the
                   institution (for example: full-time employee, part-time employee, member of
            governing panel or board, stockholder, paid or unpaid consultant). Changes in
            IRB Committee membership must be reported to OHRP, if necessary, by the
            HSPP office promptly;
       vii. Affiliation status; and
       viii. Alternates for
   f. IRB Committee Member CV/Résumé
5. Policies and Procedures.
   a. Written procedures, which the HSPP office and the IRB Committees will follow:
       i. For conducting its initial and continuing review of research and for reporting
            its findings and actions to the investigator and the institution;
       ii. For determining which projects require review more often than annually and
            which projects need verification from sources other than the investigators that
            no material changes have occurred since previous IRB review;
       iii. For ensuring prompt reporting to the IRB of proposed changes in a research
            activity, and for ensuring that such changes in approved research, during the
            period for which IRB approval has already been given, may not be initiated
            without IRB review and approval except when necessary to eliminate apparent
            immediate hazards to the subject;
       iv. Ensuring prompt reporting to the IRB, appropriate institutional officials, and
            the Government Agency for:
            (iv.a) Any unanticipated problems involving risks to subjects or others
            (iv.b) Any serious or continuing noncompliance with this policy or the
                 requirements or determinations of the IRB; and
            (iv.c) Any suspension or termination of IRB approval.
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.A IRB Office Records
SUB-PART: V.A.1 Procedure for Documentation of IRB Committee Meeting Minutes
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


V.A.1 Procedure for Documentation of IRB Committee Meeting Minutes
       Policy Instructions/Explanations:
       1. HSPP Staff Member Responsibilities. The HSPP staff member attending the
          convened IRB Committee meeting will draft notes in detail to document the IRB
          Committee discussions and determinations. The minutes of all IRB Committee
          meetings must be in sufficient detail to demonstrate:
          a. Attendance at the meetings, to include:
              i. Whether or not an alternate is voting;
              ii. When a member leaves the room;
              iii. When a member absents him/herself during the vote due to a conflict of
                   interest;
              iv. Initial and continued presence of a majority of members, (quorum) including
                   at least one nonscientist member;
              v. If the meeting was terminated early due to loss of quorum
          b. For each protocol discussed the minutes should reflect:
              i. The assigned reviewers and their scientific or non-scientific status as indicated
                   on the IRB Committee rosters [e.g. NS (non-scientist, OS (other scientist), PS
                   (physician scientist), SS (social scientist), including the use of any expert
                   consultants and their scientific or nonscientific status and specialty;
              ii. If a Committee member is excused from the meeting due to a conflict of
                   interest during the discussion and vote of the study;
              iii. Actions taken by the IRB Committee;
              iv. Discussion of any controverted issues and resolutions;
              v. Justification of any deletion or substantive modification of information
                   concerning risks or alternative procedures contained in a DHHS-approved
                   sample informed consent document;
              vi. The suspension or notification of expiration, and any issues that arise where
                   treatment may be continued for safety purposes;
              vii. The vote on these actions including the number of voting “for,” “against,” or
                   “abstaining”
                   (vi.a) In order to document the continued existence of a quorum, votes should
                        be recorded in the minutes using the following format: Total Votes = 15,
                        For: 14, Against: 0, and Abstained: 1 (last name of abstaining member).
              viii. The criteria for approval found in regulations 45 CFR 46.111 and if
                   applicable, 21 CFR 56.111 have been discussed and the rationale documented
              viii. The level of risk (e.g., minimal or greater than minimal) and the approval
                   period (review interval) appropriate to the level of risk should be determined.
              ix. When a protocol is reviewed the following are discussed at the convened
                   meeting:
                   (ix.a) That the risks to subjects are minimized and reasonable in relation to the
                        anticipated benefits;
            (ixb) That the selection of subjects are reasonable in relation to anticipated
                benefits;
            (ix.c) That informed consent is appropriately documented
            (ix.d) That there are:
                • Provisions for monitoring of subject safety are in place appropriate to
                    the study,
                • Protections to ensure the privacy of subjects and confidentiality of
                    data, and;
                • Appropriate safeguards for vulnerable populations, (e.g fetus, pregnant
                    women, children and prisoners)
                • When protocol revisions are requested or if a proposal is disapproved,
                    the basis for doing so as well as a written summary of the discussion of
                    controverted issues and their resolution;
                • Continuing review determinations (as described below).
       x. Detailed information provided by consultants.
       xi. Evaluation of VA specific criteria for projects with vulnerable populations.
2. Continuing Review. The minutes of IRB meetings should clearly reflect the IRB
   Committee‟s determination regarding which protocols require continuing review
   more often than annually, as appropriate to the degree of risk, and the approval period
   (review interval).
   a. The minutes should reflect that the IRB Committee determined:
       i. The criteria for approval found in regulations 45 CFR 46.111 and if
            applicable, 21 CFR 56.111 have been discussed and the rationale documented
       ii. The risks to subjects (e.g., minimal or greater than minimal ad the approval
            period, appropriate to the level of risk);
       iii. The selection of subjects continues to be reasonable in relation to anticipated
            benefits;
       iv. Informed consent continues to be appropriately documented;
       v. DHHS-Supported Multi-center Clinical Trials. When the IRB Committee
            reviews DHHS-approved informed consent documents for DHHS-supported
            multi-center clinical trials, the minutes should reflect any instance in which
            the IRB Committee requested or approved the Investigator‟s deletions or
            substantive modifications of information concerning risks or alternative
            procedures contained in the DHHS-approved sample informed consent
            document.
3. Specific Findings. When specific findings on the part of the IRB Committee are
   required these findings should be fully documented in the IRB Committee minutes
   and should include protocol-specific information justifying each IRB finding. For
   example:
   a. Alteration or Waiver of Informed Consent. When approving a procedure, which
       alters or waives the requirements for informed consent, the minutes must
       document that the Committee made the required findings.
   b. Waiver of Documentation of Informed Consent. When approving a procedure,
       which waives the requirement for obtaining a signed consent form, the minutes
       must document that the Committee made the required findings.
   c. Research Involving Prisoners. When approving research involving prisoners, the
       minutes must document that the Committee made the seven additional findings
       and the specific category, which authorizes the research.
       i. Additionally, the minutes must reference that at least one member of the IRB
           Committee is a prisoner, or a prisoner representative with appropriate
           background and experience to serve in that capacity, except when a particular
           research project is reviewed by more than one IRB, only one IRB need satisfy
           this requirement.
       ii. If a prisoner representative is selected to serve on the IRB Committee, the
           person must have a close working knowledge of prison conditions and the life
           of a prisoner. Suitable individuals could include present or former prisoners;
           prison chaplains; prison psychologists, prison social workers, or other prison
           service providers; persons who have conducted advocacy for the rights of
           prisoners; or any individuals who are qualified to represent the rights and
           welfare of prisoners by virtue of appropriate background and experience.
   d. Research Involving Children. When approving research involving children, the
       minutes must document that the Committee made the required findings with
       regard to the categories of risk:
       • Research not involving greater than minimal risk
       • Research involving greater than minimal risk but presenting the prospect of
           direct benefit to the individual subjects
       • Research involving greater than minimal risk and no prospect of direct benefit
           to individual subject‟s disorder or condition
       • Research not otherwise approvable which presents an opportunity to
           understand, prevent, or alleviate a serious problem affecting the health or
           welfare of children
           i. Wards of the State or Other Agency. When reviewing research involving
                children who are wards of the state or any other agency, institution, or
                entity, the IRB must find and document in the minutes that such research
                is:
                (i.a) related to their status as wards of the State; or
                (i.b) conducted in schools, camps, hospitals, institutions, or similar
                     settings in which the majority of children involved as subjects are not
                     wards.
   e. Research Involving Fetuses, Pregnant Women, Neonates or Research on
       Transplantation of Fetal Tissue. When approving research involving a fetus,
       pregnant women, neonates, or the transplantation of fetal tissue, the minutes must
       document that the Committee made the findings in accordance with IRB policy.
   f. Research Involving Cognitively Impaired. When reviewing research involving
       individuals who are cognitively impaired and/or lack decision-making capacity,
       the IRB must find and document in the minutes whether the participant was
       incompetent or had an impaired decision-making capacity (in accordance with
       VA regulations) as appropriate and that the informed consent form was reviewed
       and approved for such use.
4. Alternates. Meeting minutes must document when an alternate Committee member
   replaces the appointed Committee member.
     5. Telephonic Participation. At a meeting in which Committee members participate via
        telephone, each participating IRB Committee member must receive all pertinent
        material prior to the meeting, and be able to actively and equally participate in the
        discussion of all protocols relevant to that persons‟ review.
     6. Emergency Situations. When reviewing protocols that anticipate an emergency
        situation, the IRB Committee meeting minutes must specifically record the licensed
        physician member‟s affirmative vote.
     7. The Primary Reviewer. is responsible for providing justification for approval under
        criteria 45 CFR 46.111 and if applicable, 21 CFR 56.111 and for providing
        documentation of the justification on the “Reviewer‟s Comment Form.” Once
        revisions are finalized, the minutes will be forwarded and the final approval vote for
        acceptance of the minutes will take place at the next convened meeting.
     8. Distribution of Minutes. Copies of each IRB Committee‟s minutes (complete, non-
        redacted) should be distributed to the IRB Committee Members, and the office of the
        Vice President for Research.

Reference:
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.A IRB Office Records
SUB-PART: V.A.2 Procedure for IRB Committee Meeting Agendas
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: May, 2005; July 2005


V.A.2 Procedure for IRB Committee Meeting Agendas
       Policy Instructions/Explanations:
       1. New IRB Proposals Submitted for Review. At a convened meeting, the IRB shall
          review all newly proposed human subjects research. This excludes those projects that
          either meet one or more of the exemption categories as authorized in 45 CFR
          46.101(b) and 21 CFR 56. 104(d) or one or more of the expedited categories as
          authorized in 45 CFR 46.110.
       2. Continuing Review Applications. At a convened meeting, the IRB shall review all
          continuing human subjects research at intervals appropriate to the degree of risk, but
          not less than once per year. This excludes those projects that either meet one or more
          of the exemption categories as authorized by 45 CFR 46.101(b) or one or more of the
          expedited categories as authorized in 45 CFR 46.101(b)(8) or (9).
       3. Major Amendments. At a convened meeting, the IRB shall review any and all
          proposed changes to approved human subjects research. This excludes those projects
          that either meet one or more of the exemption categories as authorized in 45 CFR
          46.101(b) or one or more of the expedited categories as authorized in 45 CFR 46.110.
       4. Serious, and Unexpected Adverse Events to be Presented. At a convened meeting, the
          IRB shall review serious and unexpected adverse events based on the following
          factors:
          a. The seriousness of the event;
          b. Whether the event is described in the study protocol and informed consent
              document;
          c. Whether the event occurred at a location for which the IRB is the IRB of record;
              and
          d. The PI‟s recommendations as to whether the adverse event was a direct result of a
              subject‟s participation in the research study.
       5. Expedited Review Determinations. When a determination regarding a review
          conducted utilizing expedited review procedures has been made, this must be
          documented in the agenda provided to the full Committee for the next possible
          convened meeting as authorized in 45 CFR 46.110(c).
          a. This documentation must include a citation to the specific permissible category or
              categories justifying the expedited review.
          b. This documentation advises all committee members of research proposals that
              have been approved under the expedited review procedure. Acceptance of the
              minutes will constitute full Committee endorsement.
       6. Notification of Approvals by Chair. The agenda will also include approvals by the
          Chair, such as approvals of new and continuing projects, minor amendments, studies
          for which “conditions have been met” and study closures. Acceptance of the minutes
          will constitute full Committee endorsement of such approvals.
       7. Noncompliance. The HSPP Office staff will initially report promptly to the IRB
          Chairperson any serious or continuing noncompliance with the regulations or
          requirements of the IRB. This will be followed by including an item on the next
          official IRB Committee meeting agenda.
      8. Audits and Monitoring. The results of any significant auditing or monitoring process
          by the HSPP will be reported to the Full IRB Committee on the agenda of the next
          regularly scheduled meeting. However, if information gained during the auditing or
          monitoring process indicates that human subjects of a research project are exposed to
          unexpected serious harm, the IRB may suspend or terminate the research project prior
          to the next regularly scheduled IRB meeting.
      9. Education for IRB Members. As needed at a convened IRB meeting via memo,
          newsletter, or a list-serve, a member of the IRB or HSPP will update the IRB
          members in regards to:
          a. Current federal regulations;
          b. Local policies and procedures;
          c. Any changes in federal regulations;
          d. Any changes in local policies and procedures; or
          e. Other items as requested by the HSPP office or IRB Committee.
      10. Agendas and review materials will be distributed to Committee members 5 days prior
          to scheduled review when possible.
      11. Addendums and review materials will be distributed to Committee members in five
          working days to allow ample time for adequate review of the addendum item.
          Consideration of the complexity and the scope of the research will be given in
          determining the appropriate time required for adequate review. The Committee
          member will notify the HSPP staff member if additional time will be required, to
          allow for prioritization and reassignment of the addendum item.
References:
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.A IRB Office Records
SUB-PART: V.A.3 Procedure for Anatomy of the IRB File
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007; October, 2005


V.A.3 Procedure for Anatomy of the IRB File
       1. Policy Instructions/Explanations:
       This procedure identifies and directs the anatomy of Biomedical and Behavioral Sciences
       IRB files, in order to ensure compliance with the record keeping requirements for IRB
       records as defined in Title 45 CFR Part 46.115 and Title 21 CFR Part 50.115.
           a. Behavioral IRB File. Should include the following:
               i. Information about all submissions, correspondence, and other communication
                    regarding the study, and should be filed in reverse chronological order. This
                    information should include, but is not limited to the following:
               ii. Original IRB application;
               iii. Committee action letters;
               iv. Determinations required by the regulations/protocol-specific findings for
                    research that receives an expedite procedure;
               v. Scientific evaluations;
               vi. Revised IRB application;
               vii. Final approval letters;
               viii. Current date stamped informed consent documents (DHHS-approved sample
                    consent documents, if any);
               ix. Amendments;
               x. Applications for continuing review;
               xi. Audit reports;
               xii. Legal opinions;
               xiii. Written letters of correspondence;
               xii. For the VA Health Care System the file must include all correspondence
                    between the IRB Committee and the VA R & D Committee;
               xiv. Electronic mail correspondence directly affecting a protocol review/change;
               xv. Letters of cooperation from performance sites;
               xvi. Copies of IRB approvals from collaborating institutions or performance sites;
               xvii. Copies of assurance documents from collaborating institutions;
               xviii. Copies of memorandums of understanding (MOU);
               xix. Serious unexpected or unanticipated Adverse Event Reports;
               xx. Documentation of protocol violations;
               xxi. Outside safety reports;
               xxii. Grant applications;
               xxiii. Dissertation or thesis proposals;
               xxiv. Investigator brochures;
               xxv. Sponsor‟s protocols;
               xxvi. Other supporting documents (journal articles, publications, etc.).
References:
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.B IRB Fee Policy for Industry-Sponsored Applications
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


V.B IRB Fee Policy for Industry- Sponsored Applications
      Policy Instructions/Explanations:
      1. As part of the IRB application form the Investigator (PI) will be asked if the
         submission is for an industry-sponsored proposal.
      2. All industry-sponsored applications submitted to the IRB are assessed a fee for new
         applications and continuing review applications requiring full committee review.
      3. An IRB Database has been created for Human Subjects Protection Program (HSPP)
         office to track these applications.
      4. If an application is received and is not designated as industry-sponsored by the
         Investigator, but is later determined by the IRB to be industry-sponsored, the HSPP
         office will generate an invoice, or Interdepartmental billing (IDB) form, which will be
         sent to the Principal Investigator. The invoice will clearly show a description of the
         charge and the amount being assessed.
      5. If payment has not been received within 180 days of submission to the IRB a second
         IDB invoice will be sent to the PI.
      6. IRB applications that are dependent on State, Federal, Investigator initiated (with
         industry sponsorship), non-profit foundation or internal funds will be excluded from
         this charge.
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.B IRB Fee Policy for Industry-Sponsored
SUB-PART: V.B.1 Procedure for Processing Industry-Sponsored
IRB Applications
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


V.B.1 Procedure for Processing Industry-Sponsored IRB Applications
       Procedure:
          a. Upon receipt of a new application or an application for continuing review, the
             HSPP staff member will check the Sponsor section to determine if the Principal
             Investigator has specified the proposal as industry-sponsored.
          b. If the proposal is industry-sponsored, the HSPP staff member will enter the data
             from the IRB Application into the HSPP IRB Fees Database and continue
             processing of the IRB application per normal procedures.
          c. Upon receipt of a new application or continuing review, the staff member as part
             of their routine checklist, will review the submission to determine if the industry-
             sponsored selection is valid. Industry-sponsored identifiers include: determining if
             the application is for a non-federal multi-center trial, a company‟s or sponsor‟s
             protocol number in numerical sequence appears on the front page of the sponsor‟s
             protocol, or if a company‟s or sponsor‟s logo appears on the front page of the
             sponsor‟s protocol. The staff member will also verify who will pay the IRB fee
             and will notify the HSPP staff member if there is a discrepancy.
          d. Waiver of IRB Fees: There may be extenuating circumstances where charging
             IRB processing fees would be unwarranted. Principal Investigators may send a
             formal letter (not email) requesting waiver of IRB processing fees to the Vice
             President for Research, who has complete discretion in waiving fees. If a request
             has been granted, the Director of HSPP, or their designee will document approval
             of fee waiver in the IRB Fees Database.
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.C Development, Approval, and Maintenance of
IRB Policies and
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


V.C Development, Approval, and Maintenance of IRB Policies and Procedures
      Policy:
      It is the policy of Lindsey Wilson College SPC Institutional Review Board (IRB) that all
      policies and procedures for conducting research activities under its jurisdiction be written
      and maintained in congruence with Federal regulations, State and local laws, LWC
      policies and procedures, and standards of regulatory, accrediting, and funding agencies.
      1. Lindsey Wilson College SPC IRB policies and procedures are to be reviewed every
           three years or when changes in regulations, laws, personnel and institutional policies
           and key personnel (eg., Signatory Officials) necessitate revision.
      2. Lindsey Wilson College SPC IRB policies and procedures are developed and
           maintained by the IRB Policy and Procedure Committee under the direction of the
           Director of the Human Subjects Protection Program.
      3. Lindsey Wilson College SPC IRB is charged with the implementation and enforcement
           of its policies and procedures.
References:
45 CFR 46.103(b)(4) and (5)
OHRP Compliance Activities: Common Findings and Guidance, July 10, 2002
PROGRAM: Human Subjects Protection Program
SECTION: V. Records, Documentation and Fees
POLICY NUMBER: V.C Development, Approval, and Maintenance of IRB Policies and Procedures
SUB-PART: V.C.1 Procedure Development, Approval, and Maintenance of Policies and Procedures
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


V.C.1 Procedure Development, Approval, and Maintenance of Policies and Procedures
       Procedure:
       This procedure outlines the process for the development, approval and maintenance of
       Lindsey Wilson College SPC Institutional Review Board (IRB) policies and procedures.
       1. Investigator Responsibilities:
          a. The Investigator should review all Lindsey Wilson College SPC IRB policies and
              procedures as part of the required initial training for conducting human subjects
              research at Lindsey Wilson College SPC . Current policies and procedures are
              located on the IRB website at http://www.lindsey.edu.
          b. It is the responsibility of the Investigator to routinely view the IRB website for
              new or revised IRB policies and procedures.
          c. The Investigator should contact an HSPP staff member or the Director of the
              HSPP for clarification of policies and procedures, when needed.
       2. IRB Administration Responsibilities:
          a. The Director of the HSPP, IRB members, and HSPP staff will routinely view the
              OHRP and FDA websites for issuance of guidance documents, changes in
              regulations, and determination letters for use in upgrading the IRB policy and
              procedures.
          b. The IRB, Director of the HSPP and/or the Office of General Council for Lindsey
              Wilson College SPC will meet as needed to discuss changes and assist with
              interpretation of Federal, State and local regulations affecting IRB polices and
              procedures.
          c. The Director of the HSPP, or designee will provide educational sessions to the
              IRB Committee members and HSPP staff member regarding IRB policies and
              procedures, as well as updates or revisions in a timely manner.
          d. The IRB Policy and Procedure Sub-Committee is responsible for the development
              and maintenance of IRB policies and procedures as directed by the Director of the
              HSPP.
       3. HSPP Staff Responsibilities:
          a. The HSPP staff member will use the IRB policies and procedures posted on the
              IRB website when processing research activities.
          b. The HSPP staff member may consult with the Director of HSPP and/or IRB
              Chairs for guidance in applying the IRB policies and procedures to processing
              research activities.
          c. If the HSPP staff member notices that a policy or procedure is inaccurate or out of
              date, the staff member should bring it to the attention of the Director of the HSPP
              who will communicate to the Chair of the IRB Policy and Procedure sub-
              Committee, or they can communicate it directly to the Chair of the IRB Policy
              and Procedure Sub-Committee. It is the responsibility of all IRB and HSPP staff
              members to keep the IRB policies and procedures current and applicable to the
              daily processes.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.A Investigator Qualifications
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.A Investigator Qualifications
       Definitions:
       Assurance: A contract or agreement that establishes standards for human research as
          approved by the Office for Human Research Protections (OHRP).
       Institutional Review Board (IRB): A specifically constituted review body established
          or designated by an entity to protect the rights and welfare of human subjects
          recruited to participate in biomedical or behavioral/social science research.
          Policy:
          It is the policy of Lindsey Wilson College SPC Institutional Review Board (IRB) that
          all Investigators meet the following requirements to conduct human subjects research
          under the jurisdiction of the LWC IRB.
          1. All human subjects research that is conducted by or under the direction of any
               employee, faculty, staff, student, or agent of the LWC in connection with his or
               her institutional responsibilities must be reviewed by the LWC HSPP.
          2. All LWC employees, faculty, staff, students or agents of Lindsey Wilson College
               SPC will have reviewed the ethical principles of The Belmont Report, Federal
               and State laws and regulations, institutional policies and procedures, LWC HSPP
               policies and procedures, and if applicable, Good Clinical Practice standards when
               conducting human subjects research. Additionally, they will have completed the
               required training (initial and continuing education) for the ethical conduct of
               human subjects research.
          3. Student Conducted Research. All activities that meet the definition of research
               with human subjects and that are conducted by students must be reviewed by the
               IRB.
               a. Activities that must be reviewed and approved by the IRB include:
                   i. All master‟s theses and doctoral dissertations that involve human research
                       participants; and
                   ii. All class or other projects that involve human research participants and
                       for which findings may be published or otherwise disseminated and
                       contribute to generalizable knowledge.
               b. Oversight by Faculty Advisor. All students and fellows applying for IRB
                   review must obtain a faculty advisor prior to submitting the application to the
                   HSPP. The faculty advisor must have completed the required training for the
                   ethical conduct of human subjects research and accepts responsibility for the
                   oversight of the student-conducted research.
          4. Conflict of Interest. The protection of human research participants requires
               objectivity in communicating risks, selecting subjects, promoting informed
               consent, and gathering, analyzing and reporting data. Therefore, the IRB should
               consider conflict of interest issues in its deliberations of applications.
5. All individuals conducting human subjects research must be adequately qualified
   and licensed relevant to the scope and complexity of the research conducted.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.A General Responsibilities
SUB-PART: VI.A.1 Procedure for Assuring Investigator Qualifications
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.A.1 Procedure for Assuring Investigator Qualifications
       Procedure:
       This procedure outlines the necessary qualifications for Investigators to conduct human
       subjects research under the jurisdiction of Lindsey Wilson College SPC (LWC) Human
       Subjects Protection Program (HSPP).
       1. Investigator Responsibilities.
          a. Prior to submitting research applications for the review and approval of the LWC
               IRB the Investigator will:
            i. Complete the required IRB training on human research protections (initial and
                 continuing);
            ii. Disclose any conflicts of interest of the Investigator or study personnel;
            iii. Assure that other Investigators and study personnel have completed the required
                 IRB training (initial and continuing) and are familiar with the proposed
                 research;
            iv. Assure other Investigators and study personnel are competent and licensed, if
                 applicable, relevant to the scope and complexity of the research conducted.
            v. Conduct research in accordance with the ethical principles of The Belmont
                 Report, Federal and State regulations, Institutional policies and procedures,
                 LWC HSPP policies and procedures, and if applicable, Good Clinical Practice
                 (GCP) standards.
          b. All students and fellows conducting human subjects research under the
               jurisdiction of the LWC will enlist a faculty advisor to provide oversight to his or
               her project.
       2. IRB Committee Responsibilities.
          a. The IRB reviewer will assure that Investigator is competent and licensed, if
               applicable, relevant to the scope and complexity of the research conducted.
          b. The IRB reviewer may request additional information, qualification
               documentation, or licensure to assure competence in performing proposed
               research activities.
       3. HSPP Staff Responsibility.
          a. The staff member will verify all Investigators and study personnel have
               completed the required HSPP human research protections training.
          b. The staff member will provide information to Investigators and study personnel
               regarding the completion of required HSPP training, if not already completed.
          c. If needed, the staff member will assist Investigators and study personnel in the
               appropriate reporting of conflicts of interest.
       4. HSPP Staff Member Responsibilities.
          a. HSPP staff member will verify all Investigators and study personnel have
               completed the required IRB training upon receipt of a new IRB application.
          b. The HSPP staff member will not process IRB applications until all Investigators
               and study personnel have completed the required IRB training.
c. The HSPP staff member will contact the Principal Investigator (PI) or study
   contact when required training of all Investigators and study personnel is
   incomplete and inform the PI that the study cannot be processed by the IRB until
   required training is complete.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.B General Responsibilities of Investigators
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.B General Responsibilities of Investigators
      Policy:
      The LWC policies and procedures are designed to protect the rights and safety of human
      research participants based on the ethical principles of the Belmont Report
      1. Human Subject Protections. The Principal Investigator (PI) is the ultimate protector
          of the subject‟s rights and safety. Each PI is obligated to be personally certain that
          each subject is adequately informed and freely consents to participate in the PI‟s
          research. The PI must personally assure that every reasonable precaution is taken to
          reduce to a minimum any risk to the subject. The PI also assumes responsibility for
          compliance with all federal, state and institutional rules and regulations related to
          research involving human subjects, human subject-derived information and materials
          and, if applicable, to the Good Clinical Practice Guidelines as adopted by the Food
          and Drug Administration (FDA) available at http://www.fda.gov/oc/gcp/default.htm.
          For example, the PI may not initiate any research involving human subjects without
          IRB review and approval. The Investigator is the ultimate protector of the
          participant‟s rights and safety. Each Investigator is obligated to be personally certain
          that each participant is adequately informed and freely consents to participate in the
          research. The Investigator must personally assure that every reasonable precaution is
          taken to reduce risks to the participants.
      2. Additional College Committee Approvals. Prior to IRB review of any research that
          requires additional review and approval from other College committee(s) and/or
          institution(s), it is the responsibility of the PI to obtain the necessary approval from
          that committee.
      3. Supervision and Auditing of Research Process. It is the responsibility of the PI to
          assure that all procedures in a study are performed, with the appropriate level of
          supervision, only by individuals who are licensed or otherwise qualified to perform
          them under Federal Laws relative to the conduct of human research and the laws of
          Kentucky and the policies of Lindsey Wilson College SPC . Furthermore, it is the
          responsibility of the PI to regularly review their research process and address any
          deficiencies identified.
      4. Investigator Training. It is the responsibility of the PI to complete initial training and
          to remain up-to-date with changes in federal regulations, state and local laws, Lindsey
          Wilson College SPC policies and procedures, and compliance expectations. Further,
          it is the responsibility of the PI to ensure that key personnel who are responsible for
          the design and conduct of the study are adequately trained with regards to the use of
          human subjects in research.
      5. Investigator and Key Study Personnel Conflicts of Interest. It is the Investigator‟s
          responsibility to disclose all actual or perceived conflicts of interest as defined by
          institutional policy to the LWC IRB for review. It is the Investigator‟s responsibility
          to assure all actual or perceived conflicts of interest as defined by institutional policy
          are reviewed and a determination rendered by the Institutional Review Committee.
6. Congruence with Funding Proposals. It is the responsibility of the PI to ensure that
    the protocol/project reviewed by the IRB is consistent with the proposal for funding
    for extramural or intramural support. Further, the PI is the liaison between the IRB
    and the sponsor.
7. Amendments/Requests for Change in IRB Application. It is the responsibility of the
    PI to not deviate in any way from the IRB-approved protocol until the Principal
    Investigator has received written approval from the IRB regarding the changes, unless
    the safety of the subject mandates immediate implementation of a change.
8. Researchers‟ Records. At a minimum, the PI must maintain research records for at
    least three (3) years from the date of completion of the research. All records must be
    accessible for inspection and copying by authorized representatives of the IRB, HSPP
    staff, or contracted auditors and the department or agency supporting the research.
    Beyond three (3) years, requirements for record retention vary with the type of
    research conducted. All Health Insurance Portability and Accountability Act
    (HIPAA) related documentation must be maintained for at least six (6) years from the
    date of the last use or disclosure of the Protected Health Information (PHI). In the
    event the Investigator moves to another location and leaves the LWC, the HSPP
    office must be notified. The Investigator may either have another LWC Investigator
    assume Principal Investigator responsibilities, close each of his or her research studies
    with the IRB, or take the research studies to the new location. The Investigator must
    also notify in writing to the IRB Committee the plan for the data.
9. Confidentiality. The conditions for maintaining confidentiality of the subjects and the
    research records are required for the life of the data. These rules apply equally to any
    and all research conducted or assisted by students, staff, and faculty. In addition,
    protocols conducted with FDA regulated articles must be kept in accordance with
    current FDA regulations. The Investigator must have a clear guidelines as to what
    information will be revealed to whom and under what circumstances, and
    communicate these conditions to participants in clear language in the informed
    consent document.
10. Protected Health Information (PHI). Research activities which include individually
    identifiable health information of participants will be handled in accordance with the
    Health Insurance Portability and Accountability Act of 1996 (HIPAA). It is the
    responsibility of the Investigator to ensure the privacy and security of health
    information in oral, written or electronic formats in order to prevent inappropriate or
    unauthorized disclosure. It is the responsibility of the IRB Committee to verify that
    the applicable requirements of the HIPAA Privacy Rule have been met 45 CFR 164
    and 164.502 and other laws regarding protection and use of veterans‟ information ,
    including the Privacy Act of 1974, 5 U.S.C. 552a; VA Claims Confidentiality Statute,
    38 U.S.C. 5701; Confidentiality of Drug Abuse, Alcoholism and Alcohol Abuse,
    Infection with Human Immunodeficiency Virus (HIV), and Sickle Cell Anemia
    Medical Records, 38 U.S.C. 7332; and Confidentiality of Healthcare Quality
    Assurance Review Records, 38 U.S.C. 5705.
11. Adverse Events. The PI must report to the IRB, Data and Safety Monitoring Boards
    (DMSB) if applicable, sponsors, and federal agencies any adverse events and all
    unanticipated problems involving risks to human subjects or others that occur in the
    course of the research in accordance with 21 CFR 312 and 21 CFR 812, and with
    Lindsey Wilson College SPC IRB Policy for Reporting Adverse Events and
    Unanticipated Risks to Subjects. An adverse event is anything that the subject
    experiences during the course of the research activity from the time they are
    consented until the time of study completion, whether or not it is considered related to
    the research. Generally only serious and unexpected adverse events are reported to
    the IRB. An example of an unanticipated risk could be the loss of a researcher‟s
    notebook or computer that contains sensitive, identifiable data on research subjects.
12. Additional Requirements For Activities Involving Vulnerable Populations. The IRB
    must review and approve the use of a vulnerable population in research activities.
    Special considerations are provided in the Federal regulations and the LWC HSPP
    policies and procedures.
    a. Pregnant women, Human Fetuses, and Transplantation of Fetal Tissue. The PI
        must ensure that all requirements are satisfied and adequate provision has been
        made for monitoring the actual informed consent process. For example, the IRB
        or PI may, when appropriate, require participation of subject advocates in (a)
        overseeing the actual process by which individual consents are secured, or (b)
        monitoring the progress of the consenting activity and intervening as necessary.
    b. Prisoner Research. If a participant becomes a prisoner after enrollment in
        research, the PI is responsible for reporting in writing this situation to the IRB
        immediately upon learning of the situation. The Investigator must cease all
        interactions or interventions with the prisoner-participant until approval has been
        received from the LWC IRB Committee (and OHRP if applicable). Projects in
        which there is a likelihood of prisoner enrollment, the PI must provide regular
        assessment of subjects activities related to their detainment.
    c. Children. For research activities involving children, the Investigator must assure
        that all requirements are satisfied. The Investigator is responsible for assuring
        parental permission, as well as child assent/dissent, in accordance with the
        determinations of the LWC IRB.
    d. Cognitively Impaired. Research activities involving individuals that are or who
        may become decisionally impaired may have diminished autonomy that may limit
        their capacity to provide consent. Therefore, the Investigator is responsible for
        assuring that informed consent is conducted in accordance with the
        determinations of the LWC IRB.
13. Continuing Review. All approved research proposals, with the exception of those
    which qualify for exemption in accordance with 45 CFR 46.101(b) and 21 CFR
    56.104(d), must receive continuing review at intervals appropriate to the degree of
    risk as determined by the IRB. Continuing review must be conducted not less than
    once per year. Continuing review Continuing review must be substantive and
    meaningful. Therefore the Investigator must submit a comprehensive summary of the
    research activities and progress since the last continuing review, which would include
    a summary of adverse events, amendments, results of literature searches, publications,
    etc. The Investigator is responsible for being aware of the current literature in his/her
    field of study to assure participants are no longer placed at risk if additional risks
    have been identified or no benefit has been proven.
15. Federalwide Assurances (FWA), Memos of Understanding (MOU), and Other IRB
    Approvals.
a. It is the Investigator‟s responsibility to assure that the proper approvals and
   agreements are in place prior to the commencement of research. This includes
   research at performance sites, “engaged” or “not engaged,” that are not a legal
   entity of Lindsey Wilson College SPC .
b. The Investigator is responsible for submitting copies of all IRB approvals or
   letters of cooperation, whichever is applicable, for all performance sites indicated
   in the IRB application that are not a legal entity of Lindsey Wilson College SPC .
c. The Investigator must assure that each performance site indicated in the IRB
   Application as “engaged” in research, has a current FWA and IRB approval, not
   just initially but throughout the conduct of the research.
d. If the LWC IRB has agreed to serve as the IRB of Record for a performance site
   “engaged” in research as evidenced by an executed MOU/Institutional
   Agreement, it is the Investigator‟s responsibility to uphold the terms and
   conditions defined within the MOU/Institutional Agreement.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.B Investigator Qualifications
SUB-PART: VI.B.1 Procedure for General Responsibilities of Investigators
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.B.1: Procedure for General Responsibilities of Investigators
       Procedure:
       This procedure outlines the general responsibilities of Investigators conducting research
       involving humans.
       1. Investigator Responsibilities.
          a. The Investigator will obtain knowledge regarding Federal, State, and local laws
              and regulations, institutional policies, IRB policies and procedures, the ethical
              principles of The Belmont Report, and Good Clinical Practice (GCP) Guidelines,
              if applicable, prior to conducting research involving humans.
          b. The Investigator will assure protection of the participant‟s rights and safety by
              adequate design and conduct of research, as well as oversight of all research
              processes and procedures and other research personnel involved in research
              activities.
          c. The Investigator will assure protection adequate arrangements for protecting the
              participant‟s privacy regarding physical, behavioral or psychological intrusion
              during and after the research.
          d. The Investigator will assure protection adequate arrangements for protecting the
              confidentiality of the participant‟s identifiable data during and after the research.
          e. The Investigator will apply for IRB review and approval according to HSPP
              policies and procedures prior to conducting human subjects research.
          f. The Investigator will complete the required HSPP. Instructions and access to
              training is available on the HSPP Website at http://www.lindsey.edu. The
              Investigator will assure that all key study personnel have completed the required
              IRB training prior to IRB submission of research applications.
          g. The Investigator will respond to all IRB requests for additional information in
              regards to verifying knowledge, training, and resources adequate to perform
              research involving human participants.
              i. The Investigator will assure that required approvals from other College
                  committees or institutions are granted prior to beginning research activities.
              ii. The Investigator will assure the proper handling, storage, and dispensing of all
                  investigational agents and when not using the services of the inpatient
                  pharmacy
       2. IRB Committee Responsibilities.
          a. The IRB Primary and Secondary reviewer will assure the Investigators and key
              study personnel have adequate knowledge, processes, personnel, and facilities to
              conduct human subjects research according to Federal, State, local laws and
              regulations, ethical principles of The Belmont Report, and GCP guidelines.
              b. The IRB may request from the Principal Investigator (PI) additional
              documentation to assure the Investigators and key study personnel have adequate
              knowledge, processes, personnel, and facilities to conduct human subject research
              under the jurisdiction of the LWC HSPP.
3. IRB staff responsibilities.
   c. The staff will offer guidance on Federal, State, and local laws and regulations
      governing human subjects research to Investigators and key study personnel as
      needed.
   d. The staff will stay abreast of current Federal, State, and local laws and regulations
      governing human subjects research and act as a resource to the IRB Committee in
      its review and determinations of human subjects research.
   e. The HSPP staff will provide educational opportunities in human research
      protections for Investigators and key study personnel.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.C Investigator and Study Personnel Disclosure of Conflict of Interest or a Conflict of Commitment
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.C Investigator and Study Personnel Disclosure of Conflict of Interest
       Definitions:
       1. Research Personnel: The Principal Investigator (Clinical Investigator) and all
            individuals responsible for the design or conduct, or reporting of research.
       2. Relative: As defined by UA policy relatives include: parents, parents-in-law, brother,
            sister, spouse, son, daughter, brother-in-law, sister-in-law, son-in-law, daughter-in-
            law, grandparents, great-grandparents, grandchildren, great-grandchildren, aunt,
            uncle, niece and nephew.
       Policy:
       It is the policy of Lindsey Wilson College SPC ‟s HSPP that when any of the following
       exist, that they may influence, or appear to influence the employee‟s objectivity in
       carrying out his/her responsibilities to the college and the protection of human subjects:
       • The investigators or research personnel (or relatives) serve as a speaker or consultant
            to the sponsor, the manufacturer, or the owner of the product or program being
            evaluated.
       • The investigators or research personnel (or their relatives) have a proprietary interest,
            derive a direct or indirect benefit, hold equity or receive income annually from the
            sponsor, manufacturer, or owner of the product or program being evaluated.
       • The investigators or research personnel (or relatives) serve in an administrative or
            advisory capacity to the sponsor (e.g., Board of Directors with or without
            compensation) If the Principal Investigator answers “yes” to ANY of the above
            statement, The Principal Investigator must attach copy of LWC Conflict of Interest
            and Commitment Disclosure Form to the HSPP application and submit the Conflict of
            Interest and Commitment Disclosure Form with the application to the HSPP office.
            1. Disclosure of Financial Interests:
                a. All PIs, their staff (or their relatives) must disclose in advance other equity
                     interests, income, proprietary interests, employment, or fiduciary relationships
                     described above.
                      (a.i) A disclosure shall be sufficiently detailed and timely as to allow careful
                          and objective evaluation by the Institutional Review Committee (conflict
                          of interest committee). The information must be accurate and not false,
                          erroneous, misleading, or incomplete.
                     (a.ii) A disclosure must be made of any compensation by the Investigator or
                          research personnel including the Investigator‟s/research personnel‟s
                          “relatives” whose value could be affected by the study or by the study
                          outcome
                b. Final review of research by the convened IRB is held until the IRB has
                     completed its review of the financial interest.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.C Investigator and Study Personnel Disclosure of Conflict of Interest
SUB-PART: VI.C.1 Procedure for Investigator and Study Personnel Disclosure of Conflicts of Interest
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.C.1 Procedure for Investigator and Study Personnel Disclosure of Conflicts of Interest
       Procedure:
       This procedure outlines the process for disclosing and reporting conflicts of interest in
       human subjects research.
       Procedure:
       a. Investigator Responsibilities.
          i. Investigators, research personnel (and relatives) must disclose to the Institutional
               Review Committee (IRC) (via the HSPP) all financial interest in association with
               the human subjects research project under review by completing and submitting
               Lindsey Wilson College SPC Conflict of Interest and Commitment Disclosure
               form.
          ii. Disclosures must be performed:
               (ii.a) With the initial HSPP application using the Conflict of Interest and
                    Disclosure form;
               (ii.b) At each continuing review of the project; and
               (ii.c) Within 10 days of becoming aware of any previously undisclosed financial
                    interest. The Investigator must comply with all recommendations of the
                    College Institutional Review Committee (IRC) to minimize the conflict.
       b. IRB Committee Responsibilities.
          i. The IRB requires review of the IRC prior to review by the IRB.
          ii. Following the recommendations of the IRC, a recommendation is returned to the
               IRB for review and approval. If the IRC determines that a significant financial
               interest was not present, the research will be reviewed by the IRB Committee with
               consideration given to any recommendations made by the IRC. If the IRC
               determines that a significant financial interest was present, the recommendations
               of the IRC are reviewed by the convened IRB in order to consider the effect of the
               conflict of interest on the participant and the management plan recommended by
               the IRC.
          iii. The IRB may choose to accept or not accept the recommendations of the IRC. If
               the IRB does not accept the recommendations of the IRC it will include in its
               decision the reasons for non-acceptance in a letter to the Investigator.
       c. HSPP Staff Responsibilities.
          i. The staff member will request that the PI forward the Conflict of Interest and
               Commitment Disclosure form to the HSPP office
                    (i.a) The HSPP staff will forward the Conflict of Interest and Commitment
                         Disclosure form to the HSPP Director for submission to the IRC.
          ii. The staff member drafts all letters for signature of the Chair or the Chair‟s
               designee, assuring that final approval letters for all studies that involve a conflict
               of interest include a statement regarding the review recommendations from
               Lindsey Wilson College SPC‟s Institutional Review Committee.
       d. Institutional Responsibilities.
i. The IRC reviews all conflicts of interest in accordance with Institutional policies
     and Federal regulations.
ii. The IRC makes recommendations to the IRB according to College policies.
iii. The IRB Committee members are informed in writing of the outcome of the
     review from the Institutional Review Committee.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.D Certificate of Confidentiality
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.D Certificate of Confidentiality
      Policy Instructions/Explanations:
      1. Data collection about sensitive issues (such as illegal behavior, alcohol or drug use, or
          sexual practices or preferences) requires the protection of confidentiality beyond
          preventing accidental disclosures. Under federal law, researchers can obtain an
          advance grant of confidentiality, known as a Certificate of Confidentiality that will
          provide protection against compulsory disclosure, such as by subpoena, for research
          data. The investigator should describe in the IRB application any conditions under
          which confidential information might be disclosed and create an informed consent
          document that accurately reflects those conditions, including any voluntary disclosure
          by the researcher. The IRB is required to determine whether the risks to subjects are
          minimized, informed consent is appropriate, and privacy and confidentiality
          protections are adequate.
      2. A Certificate of Confidentiality provides protection for the researcher and the subjects
          against compelled disclosure of identifying information about subjects of biomedical,
          behavioral, clinical, and other research (Public Health Service Act '301(d), 42 U.S.C.
          '241(d)). Under this Act, the Secretary of HHS may authorize persons engaged in
          research to protect the privacy of subjects by withholding from all persons not
          connected with the conduct of the research the names or other identifying
          characteristics of the subjects. This means that researchers may not be compelled in
          any Federal, State or local civil, criminal, administrative, legislative, or other
          proceedings to identify their subjects.
          a. The protection is available only when the research is of a sensitive nature where
              the protection is judged necessary to achieve the research objectives.
          b. Research can be considered sensitive if it involves the collection of information in
              the following categories:
              i. Information relating to sexual attitudes, preferences, or practices;
              ii. Information relating to the use of alcohol, drugs or other addictive products;
              iii. Information pertaining to illegal conduct;
              iv. Information that if released could reasonably be damaging to an individual‟s
                   financial standing, employability, insurability, or reputation within the
                   community;
              v. Information that would normally be recorded in a patient's medical record,
                   and the
              disclosure of which could reasonably lead to social stigmatization or
                   discrimination;

               vi. Information pertaining to an individual's psychological well-being or mental
                    health;
               vii. Genetic information.
        3. The Confidentiality Certificate does not govern the voluntary disclosure of identifying
            characteristics of research subjects, but only protects subjects from compelled
disclosure of identifying characteristics by the researcher. Researchers, therefore, are
not prevented from the voluntary disclosure of matters such as child abuse or a
subject's threatened violence to self or others. However, if a researcher intends to
make such voluntary disclosures, the consent form should clearly indicate this.
a. Application Process To apply for a Certificate of Confidentiality, under the
   authority of Section 301(d) of the Public Health Service Act (42 U.S.C. Section
   241(d)) in order to protect against involuntary disclosure of the identities of
   research subjects, the PI will direct a letter containing the following information
   using the numbering scheme shown.
   i. Title of the project.
   ii. Source and number of the supporting grant (if applicable, e.g., National
       Institute of Neurological Disorders and Stroke NS12345, otherwise type
       "None").
   iii. Name and location of sponsoring/host institution.
   iv. Documentation of Institutional Review Board (IRB) approval (letter or form
       signed by authorized IRB representative).
   v. Copy of informed consent/assent forms to be used in study with language
      describing the Confidentiality Certificate protections and the circumstances in
      which a voluntary disclosure might be made.
   vi. Name, title or position at sponsoring institution, mailing address,
       telephone/fax numbers, email address, and summary of the relevant training of
       the Principal Investigator.
   vii. Beginning date and expected end date of the project.
   viii. Concise description (e.g., 1-2 paragraphs) of the project aims and research
        methodology (omit "Background"). Include number, source and description of
        the human subjects.
   ix. Reasons for requiring confidentiality.
   x. Means used to protect subjects' identities (e.g., coded by number, kept in
      locked files, identifiers destroyed when study completed).
   xi. Assurances: (a) that personnel involved in the conduct of the research will
       comply with all the requirements of 45 CFR Part 45 "Protection of Human
       Subjects" (Non-DHHS-supported projects must comply with 45 CFR 46.103
       (c) and document legally informed consent in a manner consistent with the
       principles stated in 45 CFR 46.111); (b) that the Certificate of Confidentiality
       will not be represented as an endorsement of the project by the DHHS
       Secretary or used to coerce individuals to participate in the research project;
       (c) that the recipient of the Confidentiality Certificate will use the vested
       authority to protect the identity of research subjects; (d) that all subjects will
       be informed that a certificate has been issued and that subjects will be
       provided with a description of the protection covered by the certificate; and
       (e) that subjects who enter the project after termination of the certificate will
       be informed of the termination. (Please type the assurances verbatim.)
       xii. The application must be signed by the individual primarily responsible for the
            conduct of the research, or a senior official.
Example Language Used in Consent Forms
To help us further protect your privacy, the investigators have obtained a consent form
from the Department of Health and Human Services (DHHS). With this Certificate, the
investigators cannot be forced (for example by court subpoena) to disclose research
information that may identify you in any Federal, State, or local civil, criminal,
administrative, legislative, or other proceedings. Disclosure will be necessary, however,
upon request of DHHS for audit or program evaluation purposes. You should understand
that a Confidentiality Certificate does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in this research.
Note however, that if an insurer or employer learns about your participation, and obtains
your consent to receive research information, then the investigator may not use the
Certificate of Confidentiality to withhold this information. This means that you and your
family must also actively protect your own privacy. Finally, you should understand that
the investigator is not prevented from taking steps, including reporting to authorities, to
prevent serious harm to yourself or others.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.D Certificate of Confidentiality
SUB-PART: VI.D.1 Procedure for Certificate of Confidentiality
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.D.1 Procedure for Certificate of Confidentiality
       Procedure:
       This procedure describes the responsibility of the Investigator and Lindsey Wilson
       College SPC (LWC) Institutional Review Board (IRB) when a Certificate of
       Confidentiality is obtained for a research project.
       1. Investigator Responsibilities.
          a. The Investigator will consider applying for a Certificate of Confidentiality when
              the results of research participation would yield information in one or more of the
              following categories:
              i. HIV status, AIDS related complications, or other sexually transmitted diseases
                   (STDs);
              ii. Information relating to sexual attitudes, preferences, or practices;
              iii. Information relating to the use of alcohol, drugs or other addictive products;
              iv. Information pertaining to illegal conduct;
              v. Information that if released could reasonably be damaging to an individual‟s
                   financial standing, employability, or reputation within the community;
              vi. Information that would normally be recorded in a patient‟s medical record,
                   and the disclosure of which could reasonably lead to social stigmatization or
                   discrimination;
              vii. Information pertaining to an individual‟s psychological well-being or mental
                   health;
              viii. Information collected that may be considered sensitive in connection with
                   behavioral interventions and epidemiologic studies; and
              ix. Genetic information.
          b. How to apply for the Certificate of Confidentiality.
              i. Assistance is located at http://grants.nih.gov/grants/policy/coc/.
              ii. It must be noted that the issuance of this certificate is up to the discretion of
                   the NIH. If granted, the Certificate provides indefinite protection from
                   compulsory disclosure, such as subpoena for research data.
              iii. Applications for a Certificate of Confidentiality should be submitted to the
                   NIH at least three (3) months prior to the date on which enrollment is
                   expected to begin.
          c. The Investigator should notify the IRB that a Certificate of Confidentiality has
              been requested in the initial IRB submission.
              i. The Investigator must include language describing the Certificate of
                   Confidentiality, as well as any voluntary disclosures, in the “Confidentiality”
                   section of the informed consent document template.
              ii. A copy of the IRB approval letter will be forwarded by the Investigator to the
                   agency, in which the certificate was applied, for final review and
                   determination.
       2. IRB Committee Responsibilities.
   a. The IRB Reviewer will assure that the proposed research meets regulatory
      requirements for approval under 45 CFR 46.111, which includes provisions to
      protect the privacy of participants and confidentiality of data. This IRB
      determination will include the recommendation of a Certificate of Confidentiality
      when the proposed research includes sensitive information that may cause harm to
      the participant as a result of compelling disclosure.
   b. The IRB primary and secondary reviewer will review the informed consent
      documents to assure that a description of the Certificate of Confidentiality and
      any voluntarily, disclosure plans by the Investigator are appropriately described.
      The reviewers will verify the appropriate template language from is included in
      the consent form.
   c. If the Investigator has not already applied for a Certificate of Confidentiality,
      upon its review of the research, the IRB may recommend that an Investigator
      apply for a Certificate of Confidentiality.
3. HSPP Staff Responsibilities.
   a. The staff member will conduct pre-review of the proposed research and consider
      the potential collection of sensitive information as defined and verify that a
      request for a Certificate of Confidentiality has been initiated.
   b. The staff member will consult with the IRB Chair if the study contains sensitive
      information for guidance on whether the Investigator should be contacted and
      advised to initiate the request for a certificate, if he or she has not initiated such a
      request.
   c. The staff member will pre-review the informed consent documents to verify that a
      description of the Certificate of Confidentially is included, as well as any planned
      voluntary disclosures by the Investigator.
   d. The staff member will proceed with procedures for review and approval at the
      review level in which the study qualifies.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.E Data and Safety Monitoring Plans
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.E Data and Safety Monitoring Plans
      Definitions:
      1. Data and Safety Monitor (DSM): An individual assigned to conduct interim
           monitoring of accumulating data from research activities to assure the continuing
           safety of research participants, relevance of the study question, appropriateness of the
           study, and integrity of the accumulating data. The individual should have expertise in
           relevant medical, ethical, safety and scientific issues.
      2. Data and Safety Monitoring Board (DSMB): A formally appointed independent
           group consisting of at least three (3) members assigned to conduct interim monitoring
           of accumulating data from research activities to assure the continuing safety of
           research participants, relevance of the study question, appropriateness of the study,
           and integrity of the accumulating data. Membership should include expertise in the
           relevant field of study, statistics, and research study design.
      3. Data and Safety Monitoring Committee (DSMC): Another term for a DSMB
      4. Data and Safety Monitoring Plan (DSMP): A DSMP describes how the
           Investigator plans to oversee the research participant‟s safety and welfare and how
           adverse events will be characterized and reported. The intensity and frequency of
           monitoring should be tailored to fit the complexity and size of the particular study.
      Policy:
      It is the policy of Lindsey Wilson College SPC Human Subjects Protection Program
      (IRB) that biomedical and behavioral research submitted to the IRB for review that are
      greater than minimal risk include a plan to assure the safety and welfare of participants.
      This requirement excludes “exempt” research.
      1. The Principal Investigator should appoint a DSM, or DSMC/DSMB for his or her
           study as appropriate for the size and complexity involved in the research. The
           Principal Investigator may manage the plan to assure the safety and welfare of
           participants.
      2. Research activities where a DSMC/DSMB would be considered:
           a. The study is intended to provide definitive information about the effectiveness
               and/or
               safety of a medical intervention;
           b. Prior data suggests that the intervention under study has the potential to induce
               potentially unacceptable toxicity;
           c. Prior data suggest that manipulation of the study participants may induce
               potentially unacceptable psychological outcome;
           d. Vulnerable populations who are in a weakened position, stigmatized,
               institutionalized, unable to speak for themselves, lack autonomy, or whose illegal
               activities may become known to law enforcement;
           e. The study is evaluating mortality or another major endpoint, such that inferiority
               of one treatment arm has safety as well as effectiveness implications; or
   f. It would be ethically important for the study to stop early if the primary question
      addressed has been definitively answered, even if secondary questions or
      complete safety information were not yet fully addressed.
3. DSMC/DSMB Composition.
   a. The DSMC/DSMB should have multidisciplinary representation, including
      physicians from relevant medical specialties and biostatisticians. This may
      include other experts such as bioethicists, epidemiologists and basic scientists.
   b. The DSMC/DSMB should have membership limited to individuals free of
      apparent significant conflicts of interest, whether they are financial, intellectual,
      professional, or regulatory in nature.
   c. The appropriate size depends on the type of study and types of expertise needed.
4. DSMC/DSMB Responsibilities.
   a. The primary responsibility of the DSMC/DSMB is to safeguard the interests of
      study participants. Therefore, the DSMC/DSMB will approve the safety measures
      in the protocol:
      i. To preserve the study integrity and credibility; and
      ii. To facilitate the availability of timely as well as reliable findings to the
           broader clinical community.
   b. The DSMC/DSMB should provide written documentation confirming that they
      have read the protocol and agree with the study design and the data safety
      monitoring plan (DSMP).
   c. The DSMC/DSMB will review the progress of the study carefully and diligently.
   d. The DSMC or DSMB will assure that all significant adverse events are reported
      to the IRB Committee according to policies and procedures.
   e. The DSMC/DSMB will be available to the Investigator for consultation
      concerning any untoward study events or any questions regarding consent issues.
   f. The DSMC/DSMB will provide a letter of predefined frequency to the IRB,
      through the Investigator, summarizing the oversight activities of the DSMC or
      DSMB during the monitoring period which should include:
      i. Results of any chart reviews;
      ii. Summary of consultations with the Investigator; and
      iii. Concerns, if any, regarding subject safety or study drug tolerability.
5. DSMC/DSMB Charter.
   a. The DSMC/DSMB Charter should include the following:
      i. A detailed presentation of the membership composition, including
           qualifications and experience;
      ii. Roles and responsibilities of the DSMC or DSMB and if relevant, of Steering
           Committee members;
      iii. The authority of the DSMC/DSMB (e.g. advisory to the Sponsor, PI).
      iv. The timing and purpose of meetings;
      v. The procedures for maintaining confidentiality;
      vi. The format, content and frequency of DSMC/DSMB reports;
      vii. Statistical procedures including monitoring guidelines, which will be used to
           monitor the identified primary, secondary, and safety outcome variables; and
      viii. Plans for changing frequency of interim analysis as well as procedures for
           recommending protocol changes.
          b. A copy of this Charter should be maintained with the research study files.
      6. DSMC/DSMB Tasks. Tasks may include, but not be limited to, the following:
          a. Conduct initial review of the proposed research to assure quality study conduct;
          b. Review procedures to assure quality of study conduct including data management
              and quality control procedures;
          c. Evaluate the quality of ongoing study conduct by evaluating the study accrual,
              compliance with eligibility, participant adherence to study requirements, and
              accuracy and completeness of data;
          d. Consider factors external to the study when relevant information becomes
              available, such as scientific or therapeutic developments that may have an impact
              on the safety of the participants or the ethics of the study;
          e. Recommend early termination based on efficacy results;
          f. Recommend termination due to unfavorable benefit-to-risk or inability to answer
              study questions;
          g. Recommend continuation of ongoing studies;
          h. Consideration of overall picture; primary and secondary analysis;
          i. Modify sample sizes based on ongoing assessment of event rates; and
          j. Review final results.
      7. Data Safety Monitoring Plan. Some studies do not require a DSMC/DSMB. In these
          cases, an individual may serve as the Data Safety Monitor. However, a plan is
          required for all greater than minimal risk biomedical and behavioral research that is
          not “Exempt” under Federal regulations. The following contains information that
          should be included in the plan:
          a. A description of a plan to monitor progress and safety;
              i. This may include a plan for safety review by the Monitor, or DSMC/DSMB at
                   predetermined intervals relevant to the complexity and size of the research;
              ii. Depending on the complexity and size of the research, the plan may include
                   assessments of data quality, timeliness, participant recruitment, accrual, and
                   retention.
          b. A description of the plan to assure compliance with reporting of adverse events
              and/or unanticipated problems involving risk to participants or others. This may
              include:
              i. A description of the process for detecting and reporting serious and
                   unexpected adverse events and/or unanticipated problems involving risk to
                   participants or others;
              ii. A description of who will be monitoring and collecting the adverse events
                   (e.g., PI, Research Nurse, etc.);
              iii. Specification of who will be notified of an adverse event (e.g., IRB, NIH,
                   FDA, PI, etc.)
              iv. A description indicating the timing of reports;
              v. A plan for annual reporting of adverse events if the study is longer than one
                   year;
              vi. A description of a plan to assure suspensions of funded trials are reported to
                   the Sponsored Projects director; and
              vii. A description of a plan to assure data accuracy and protocol compliance.
References:
IRB Management and Function; Amdur, R. and Bankert, E.; 2002 Jones and Bartlett Publishers,
Inc.
PROGRAM: Human Subjects Protection Program
SECTION: VI Investigator Responsibilities
POLICY NUMBER: VI.E Data and Safety Monitoring Plans
SUB-PART: VI.E.1 Procedure for Data and Safety Monitoring Plans
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VI.E.1 Procedure for Data and Safety Monitoring Plans
       Procedure:
       This procedure outlines the use of data and safety plans to assure extra protections and
       safety in research involving humans that are greater than minimal risk.
       1. Investigator Responsibilities.
           a. It is the responsibility of the Investigator to identify the Data Safety Monitor
               (DSM) or the Data Safety Monitoring Committee (DSMC) or Board (DSMB) in
               the initial IRB application.
           b. The Investigator will provide a detailed description of the data safety monitoring
               plan (DSMP) in the initial application as well as the study protocol for all greater
               than minimal risk research.
           c. All DSMC/DSMB reports are to be submitted to the IRB within 10 days of receipt
               by the Investigator.
       2. IRB Committee Responsibilities.
           a. The IRB Committee will review the initial IRB application to assure the adequacy
               of the Data Safety Monitoring Plan (DSMP) in relationship to the size,
               complexity, and level of risk of the proposed research and the provisions for
               monitoring data collected to provide for the welfare of participants.
           b. The IRB Committee will review the qualifications and experience of the DSM or
               the composition of the DSMC/DSMB including the qualifications and experience
               of the individual members. The IRB Committee may make recommendations
               regarding expertise, frequency of meetings, etc., to the Investigator for the
               enhancement of human participant protections.
           c. The IRB Committee may request additional information or clarification regarding
               the DSMP, DSM, or DSMC/DSMB.
       3. HSPP Staff Responsibilities.
           a. The staff member will conduct a pre-review of the IRB application and verify the
               inclusion of a plan to assure the safety and welfare of participants for all
               biomedical/behavioral research that is greater than minimal risk (excluding
               “exempt” research).
           b. The staff member will correspond with the Investigator or the study contact if the
               protocol submitted lacks adequate plans for assuring proper data collection and
               participant safety.
           c. The staff member will assist the Investigator or study contact in meeting the IRB
               requirements for a DSMP.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.A Policy for Payment of Voting Community Committee Members
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.A Policy for Payment of Voting Community Committee Members
      Policy Instructions/Explanations:
      1. Voting community committee members of each of the IRBs may be paid a stipend for
          each meeting attended as compensation for the time and effort involved in reviewing
          proposals and attending meetings. This stipend must be approved by the Office of
          Academic Affairs
      2. Meeting Cancellation. If a meeting must be cancelled once convened due to lack of
          quorum, the community committee members will not receive compensation.
      3. Alternates. Community member alternates who are asked to attend and/or are sitting
          in for an absent voting community member will be compensated in place of the
          regular voting community member. Community member alternates attending on their
          own initiative and are not attending in the place of a voting community member will
          also receive compensation as they add to the discussion that occurs in the meeting.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.A Policy for Payment of Voting Community Committee Members
SUB-PART: VII.A.1 Procedure for Payment of Voting Committee Community Members
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORGINAL CREATION DATE: October 2007


VII.A.1 Procedure for Payment of Voting Community Committee Members
       Procedure:
       1. The minutes from each board meeting will be assessed for attendance in January and
          July for the previous 6 months.
       2. Payment of community committee members employed as independent contractors by
          Lindsey Wilson College SPC will be processed using Lindsey Wilson College SPC
          Check Request Form for payment made directly to community committee members.
          The following information will be kept on file for bi-annual processing:
          a. Name
          b. Address
          c. Department Code Number
          d. Account Number
          e. Description of Service
          f. Social Security Number
          g. Signature
       3. The HSPP will provide bi-annual payment forms to the Office of the Vice President
          of Academic Affairs including the amount of compensation and actual dates of
          service signed by the HSPP Director. The Office of the Vice President of Academic
          Affairs will forward the appropriate information to the Finance Department for check
          processing.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.B Committee Member Compensation and Recognition
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.B Committee Member Compensation and Recognition
      Policy:
      It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
      Program (HSPP) to provide compensation for voting IRB Behavioral Committee
      members.
      1. IRB Committee Member Payment.
           a. Chair may also be paid a stipend for the additional time and effort involved in
               performing the duties of a Chair.
           b. This stipend is also paid for attendance at an Ad Hoc or Emergency IRB
               Committee Meeting but must be approved by the Director of HSPP.
      2. Meeting Cancellation.
           a. If a meeting must be cancelled once convened due to a lack of quorum, the
               Committee members present will still receive compensation.
      3. Written Comments.
           a. Reviewers who submit comments but do not attend the Committee meeting will
               not be compensated, as achieving quorum is the primary reason for providing
               compensation.
      4. Alternates.
           a. Alternates who are asked to attend a Committee meeting and are sitting in for an
               absent voting member will be compensated in place of the regular voting member.
               Alternates attending a Committee meeting on their own initiative, not in the place
               of a voting member, will not receive compensation.
      5. Ex-officio Members, Administrative and Pharmacy Representatives. Ex-officio
           members, administrative, and pharmacy representatives will not be compensated for
           Committee meetings attended as their participation is considered an expectation of
           their job and institutional responsibilities.
      6. Recognition Outside of Payment.
           a. It is recommended by the IRB that the efforts of IRB Committee Members and
               IRB Chairpersons are recognized by their respective departments or divisions as a
               consideration of promotion for their service and contribution to the Institution‟s
               overall mission of the highest commitment to research, education and patient care.
           b. IRB Committee members and Chairpersons receive human research protections
               training above the minimum required for Investigators and study personnel. They
               also have a wide variety of resources available to assist with their IRB duties, e.g.
               Committee Member Handbook, IRB Reference Manual, etc.
           c. Representatives of each IRB Committee (including IRB Committee Members and
               Chairpersons) are requested to attend national conferences each year on various
               human research protections topics.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.B Committee Member Compensation and Recognition
SUBPART: VII.B.1 Procedure for Committee Member Compensation and Recognition
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.B.1 Procedure for Committee Member Compensation and Recognition
       Procedure:
       This procedure outlines the process for providing payment to voting members of Lindsey
          Wilson College SPC (LWC) Institutional Review Board (IRB) Committees.
       1. IRB Committee Member Responsibilities.
          a. During Committee Member orientation, the Committee members will complete
              paperwork that will designate how the compensation is to be allocated. It is the
              Committee Member‟s responsibility to update the IRB Administration of any
              required changes to this allocation. This includes any revisions to Committee
              Members department address or home address for payments that are mailed to the
              Member.
          2. IRB Administration Responsibilities.
          a. Payment of IRB Committee members employed by LWC will be processed
              directly to the Committee members or by electronic transfer.
              i. The following payment options are available:
                   (i.a) Direct payment to the Committee member;
              ii. The following information will be kept on file for monthly processing of
                   payment for LWC faculty and staff:
                   (ii.a) Employee ID;
                   (ii.b) Name;
                   (ii.c) Home department ID;
                   (ii.d) Pay group;
                   (ii.e) VMG participant status;
                   (ii.f) Earning type;
                   (ii.g) Department center number;
                   (ii.h) Job code;
                   (ii.i) Account Number (optional);
                   (ii.j) Research Fund Center Number (optional);
                   (ii.k) Social Security Number; and
                   (ii.l) Signature.
              iii. The Director of HSPP will maintain and sign a monthly spreadsheet and
                   forward it to the Department of Finance for processing. The following
                   information is included on the spreadsheet:
                   (iii.a) The information noted in II.A.2;
                   (iii.b) Dates of service;
                   (iii.c) Amount to be paid;
                   (iii.d) Start date of the payment cycle;
                   (iii.e) End date of the payment cycle; and
                   (iii.f) A description of the service (reason).
          b. Payment of Committee members not employed by LWC will be processed using
              the LWC “Contract and Payment Form for External Consultants.”
   i. The following information will be kept on file for monthly processing for non-
       Lindsey Wilson College SPC faculty and staff:
       (i.a) Name;
       (i.b) Mailing address;
       (i.c) Social Security Number;
       (i.d) Description of Service; and
       (i.e) Signature.
   ii. These individual forms must be processed and submitted monthly to the
       Department of Finance with the signatures of the contractee and the Director
       of HSPP.
c. The Director of HSPP is responsible for verifying the amounts posted on the
   monthly ledger sheets.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.C IRB Committee Member Conflict of Interest
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.C IRB Committee Member Conflict of Interest
       Definitions:
       1. Conflicting Interest: IRB Committee Members, consultants and HSPP staff are
          considered to have a conflicting interest if they have any:
          a. Significant financial interest as defined below;
          b. Role in the conduct of the research; or
          c. Other individual conflict of interest.
       2. Individual Conflict of Interest: An “Individual Conflict of Interest” exists when
          any significant actual or potential financial interest (defined below as a “Substantial
          Interest”) of an Employee or an Employee‟s Relative may influence, or appear to
          influence that Employee‟s objectivity in carrying out his/her responsibilities to the
          College, in connection with the Employee‟s conduct or reporting of Research or any
          College Business Transaction or Research Transaction , in ways that could lead to
          any manner or form of personal gain for the Employee or for his/her Relative.
       3. IRB Committee Member: An individual serving as an IRB Committee Member
          including Chairs, alternates or expert consultants regardless of voting privileges.
       4. Relative: Relative means a person whose relationship with an Employee satisfies
          either of the following criteria:
          a. The Employee‟s spouse, child, child‟s child, parent, grandparent, brother or sister
              of the whole or half blood and their spouses and the parent, brother, sister or child
              of a spouse. or
          b. A person related to an Employee within the third degree by either marriage,
              adoption, or blood. Relationships to the third degree include: parents, parents-in-
              law, brother, sister, spouse, son, daughter, brother-in-law, sister-in-law, son-in-
              law, daughter-in-law, grandparents, great-grandparents, grandchildren, great-
              grandchildren, aunt, uncle, niece, and nephew.
       5. Remote Interest: means any of the following
          a. Any interest or income less than a monetary value of $10,000 annually;
          b. That of a non-salaried officer of a nonprofit corporation;
          c. That of a landlord or tenant of a contracting party;
          d. That of an attorney of a contracting party
          e. That of a member of a nonprofit cooperative marketing association;
          f. The ownership of less than 3 percent of the shares of a for-profit corporation from
              which the total annual dividend income to the Employee (Employee‟s Relative
              does not exceed five percent of the Employee‟s (or Employee‟s Relative‟s) total
              annual income, and other payments from the corporation to the Employee (or
              Employee‟s Relative) do not exceed 5 percent of the Employee‟s (or Employee‟s
              Relative‟s) annual income;
          g. That of an Employee (or Employee‟s Relative being reimbursed for actual and
              necessary expenses incurred in the performance of official duties;
     h. That of a recipient of public services generally provided by the College, on the
         same terms and conditions as if he/she were not a College Employee or such
         Employee‟s Relative
     i. That of a public school board member when the Relative involved is not a
         dependant or a spouse.
     j. That of an Employee, or that of a Relative of the Employee, unless the contract or
         decision involved would confer a direct economic benefit or detriment upon an
         officer or employee of any of the following: (i) another political subdivision; (ii) a
         public agency of another political subdivision; or (iii) a public agency other than
         the same governmental entity, or upon the Relative of such officer or Employee.
     k. That of a member of a trade, business, occupation, or professional association or
         class of persons consisting of at least 10 members which is no greater than the
         interest of the other members of that trade, business, occupation, profession, or
         class of persons.
     l. Gifts to an Employee or his/her Relative, in cash or in kind, of nominal value, and
         totaling no more than $400.00, in any year in the aggregate, from any entity doing
         business with the College.
     m. In connection with any Clinical Study, the receipt of any other benefit that is not a
         Significant Payment of Other Sorts (as defined below).
6. Significant Payment of Other Sorts: Payments made by the sponsor any Clinical
     Study to the Investigator or to the College to support activities of the Investigator
     (e.g., grant to fund ongoing research activities, compensation in the form of
     equipment, retainers for ongoing consultation or honoraria, that have a monetary
     value of $25,000 (or more, exclusive of the costs of conducting the Clinical Study,
     during the time the Investigator is carrying out the applicable Clinical Study and for a
     period of one year following its completion.
7. Substantial Interest: Any pecuniary or proprietary interest,, either direct or indirect,
     other than a Remote Interest (as defined above), including but not limited to: salary or
     other payments for services (e.g. consulting fees or honoraria); equity interests (e.g.
     stocks, stock options) or other ownership interests; intellectual property rights (e.g.
     patents, copyrights and royalties from such rights); and in connection with clinical
     studies, any significant payment of other sorts (as defined above).
Policy:
It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
Program (HSPP) that all conflicting interests of an IRB Committee Member, consultants,
and HSPP staff be declared before review of any research under IRB jurisdiction. IRB
Committee Members, consultants, and HSPP staff with a conflicting interest may not
participate in any portion of the review of research activities except to provide
information requested by the IRB and must absent themselves from the meeting during
the IRB‟s deliberative discussion and vote on the affected research.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.C IRB Committee Member Conflict of Interest
SECTION: VII.C.1 Procedure for IRB Committee Member Conflict of Interest Disclosure
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.C.1 Procedure for IRB Committee Member Conflict of Interest Disclosure
       Procedure:
       This procedure outlines the IRB Committee member, consultant, and HSPP staff member
       responsibilities regarding required disclosure of conflicts of interest when reviewing
       human subjects research.
       1. Individual with Conflict Responsibilities.
           a. Each Committee Member must review this Procedure and corresponding Policy
              and sign a “Recusal Agreement” initially at IRB Committee Member training and
              annually thereafter.
           b. Each consultant must read this Procedure and corresponding Policy and sign a
              “Recusal Agreement” before reviewing a research protocol and disclose any
              conflicting interest.
           c. Each HSPP staff member must review this Procedure and corresponding Policy
              and sign a “Recusal Agreement” initially and annually.
           d. At the initiation of the IRB Committee meeting, the Chairperson or a designated
              Committee Member will call upon IRB members, consultants, or others in
              attendance of the meeting to declare any conflicting interests with items on the
              agenda.
           e. IRB Committee Members, consultants, HSPP staff member with a conflicting
              interest may not participate in any portion of the review of research activities
              except to provide information requested by the IRB and must absent themselves
              from the meeting during the IRB‟s deliberative discussion and vote on the
              affected research.
           f. IRB Committee Members, consultants, and HSPP staff member may absent
              themselves from the discussion and vote for any reason, if they feel it is necessary
              to avoid any appearance of a conflicting interest.
           g. IRB Committee Members, consultants, and HSPP staff member may absent
              themselves from the discussion and vote for any reason, if they feel any member
              of the research team or others has exerted undue influence.
       2. HSPP Staff Responsibilities.
           a. The HSPP staff member will assist with identification and disclosure of any
              conflicting interest during Committee meetings.
           b. The HSPP staff member records in the minutes and database each time a member
              is excused from the Committee discussion and vote due to a conflict of interest.
PROGRAM: Human Subjects Protection Program
SECTION: VII IRB Membership
POLICY NUMBER: VII.D 4 Procedure for Requesting Legal Counsel Opinion
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL DATE: October 2007


VII.D Procedure for Requesting Legal Counsel Opinion
      Procedure:
      This procedure defines the process for Lindsey Wilson College SPC (LWC) Human
      Subjects Protection Program (HSPP) to obtain an opinion from the Office of General
      Counsel for issues pertaining to human research.
      1. All requests for opinions from the Office of General Counsel must be made by the
         HSPP Director.
      2. Issues such as acceptable language for the informed consent documents,
         determinations regarding exculpatory language, local and State laws, and privacy
         issues are among the items in which an opinion from legal counsel may be requested.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.A Investigator and Study Personnel Training
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VIII.A Investigator and Study Personnel Training
       Policy Instructions/Explanations:
       1. The Human Subjects Protection Program (HSPP) staff and website
          (www.lindsey.edu) provide information to individuals who conduct or review human
          subjects research. Lindsey Wilson College SPC Federal-wide Multi-Project
          Assurance, The Belmont Report; the Federal Regulations at 45 CFR Part 46,
          guidelines/policies of Federal Regulations or agencies related to human subject
          research, for providing information to the IRB can be found on the website to assure
          compliance. These documents are available in downloadable formats.
       2. The HSPP office provides information to individuals who conduct or review human
          subjects research where they may review or obtain the HSPP Policies and Procedures
          for Investigators conducting human research in printed and downloadable formats
          from the HSPP website. The policies and procedures include detailed information
          concerning:
          a. Federal and Institutional requirements for the protection of human research
              subjects;
          b. The IRB's roles and responsibilities;
          c. The requirements and procedures for initial and continuing IRB Committee
              review and approval of research;
          d. The rationale and procedures for proposing that the research may meet the criteria
              for expedited review;
          e. The requirements and procedures for verifying that research is exempt from IRB
              Committee review;
          f. The responsibilities of investigators during the review and conduct of research;
          g. Requirements and procedures for notifying the IRB office of unanticipated
              problems or events involving risks to subjects, as well as any other serious
              adverse events;
          h. An explanation of the distinction between FDA requirements for emergency use
              of test articles versus DHHS regulations for the conduct of human subjects
              research.
       3. All Lindsey Wilson College SPC study Investigators and research personnel are
          required to participate in training to ensure the protection and rights of human
          subjects. The HSPP will accept evidence of Investigator training via two methods for
          the convenience of the Investigators:
          a. Protecting Study Volunteers in Research; by Cynthia McGuire Dunn, Gary
                                st        nd
                 Chadwick (1 and 2 edition, also referred to as the Rochester book). There are
                 two types of examinations using this resource: Med-I, is the on-line test, that
                 allows the test-taker to take the test on-line and immediately obtain the results (a
                 LWC ID number is required) or Med-II which is a paper and pencil test found at
                                     nd
                 the back of the 2 edition. Once this test is completed it is then submitted to the
                 HSPP for grading.
   b. Planning Ethically Responsible Research by Joan Sieber. This text and the
       associated examination are intended for investigators conducting behavioral
       sciences research. This test and instructions can be downloaded from the IRB
       website and taken as a paper and pencil test. Examinations will be graded by an
       HSPP staff member, and investigators must achieve a score of 80% or higher for
       certification on the Sieber exam. For non-Lindsey Wilson College SPC
       researchers, evidence of successfully passing some other acceptable form of
       human subjects protection training, such as the NIH examination is acceptable.
       Principal Investigators are responsible for ensuring that their research support
       staff associated with human subjects research are adequately trained using the
       above noted training tools on the protection of the rights and safety of human
       subjects and evidence of that training is to be provided in the Project Review
       Form/Project Approval Form.
4. Upon request by Investigators, Training Seminars will be provided on specific topics
   relating to the IRB process and Federal guidelines. Such topics may include, but are
   not limited to:
   a. An Introduction to the IRB Process – A Workshop on Writing and Submitting an
       Application to the IRB (presented monthly as needed);
   b. Informed Consent Process/Capacity to Give Consent;
   c. How to write a Consent Form that Subjects will understand;
   d. Sponsored Research, Grants and Contracts;
   e. Bio-safety/Radiation Safety Issues and how they relate to the IRB;
   f. Investigational New Drugs/Investigational Device Exemptions;
   g. How to prepare for an audit…am I compliant?
   h. Final Approval – then what? (an update on Amendments),
   i. Adverse Events, and the Continuing Review Process;
   j. An update on the IRB, and
   k. Research with Native Americans
5. The HSPP office houses information on assorted topics related to issues and
   regulations on human subjects research. These tools are available for reference or
   temporary loan upon request. 6. The IRB website provides a “Frequently Asked
   Questions” page, with the added feature of visitors being able to submit questions
   and/or ask for regulation clarification via email to HSPP staff.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.A Investigator and Study Personnel Training
SUB-PART: VIII.A.1 Procedure for Investigator and Study Personnel Training
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VIII.A.1 Procedure for Investigator and Study Personnel Training
       Procedure:
       This procedure defines the process of meeting the educational requirements for
       Investigators and study personnel conducting research involving humans under the
       jurisdiction of Lindsey Wilson College SPC (LWC) Human Subjects Protection Program
       (HSPP).
       1. Investigator and Study Personnel Responsibilities.
           a. Initial Training. All Investigators and study personnel, must have completed
               Lindsey Wilson College SPC Human Subjects Protection Program Training,
               which includes one of the following:
               i. Protecting Study Volunteers in Research; by Cynthia McGuire Dunn, Gary
                                         st       nd
                        Chadwick (1 and 2 edition, also referred to as the Rochester book). This
                        training is required for investigators performing biomedical research. There
                        are two types of examinations using this resource: Med-I, is the on-line test,
                        that allows the test-taker to take the test on-line and immediately obtain the
                        results (a LWC ID number is required) or Med-II which is a paper and pencil
                                                               nd
                      test found at the back of the 2 edition. Once this test is completed it is then
                      submitted to the HSPP for grading.
                 ii. Planning Ethically Responsible Research by Joan Sieber. This text and the
                      associated examination are intended for investigators conducting behavioral
                      sciences research. This test and instructions can be downloaded from the IRB
                      website and taken as a paper and pencil test. Examinations will be graded by
                      an HSPP staff member, and investigators must achieve a score of 80% or
                      higher for certification on the Sieber exam. For non-Lindsey Wilson College
                      SPC researchers, evidence of successfully passing some other acceptable
                      form of human subjects protection training, such as the NIH examination is
                      acceptable. Principal Investigators are responsible for ensuring that their
                      research support staff associated with human subjects research are adequately
                      trained using the above noted training tools on the protection of the rights and
                      safety of human subjects and evidence of that training is to be provided in the
                      Project Review Form/Project Approval Form.
              b. The Investigator and study personnel will keep abreast of current events and
                 review the IRB website http://www.lindsey.edu/ for current IRB policies and
                 procedures and the Federal regulations, especially those applicable to their area of
                 research. The website includes the following:
                 i. LWC‟s Federalwide Assurance;
                 ii. The IRB Committee Rosters;
                 iii. An IRB Contact List;
                 iv. The HSPP calendar of events;
                 v. The IRB Organizational Chart;
                 vi. IRB Policies and Procedures;;
       vii. Template Language for Informed Consent Documents;
   c. Investigators and key study personnel are encouraged to attend additional
       educational opportunities sponsored by the LWC throughout the year.
       i. HSPP workshops are conducted every month, alternating between
            Behavioral/Social Science and Health Science, to provide education on
            important issues.
       ii. The HSPP provides individualized education to research Investigators and/or
            their staff, requests from colleges/departments for training in specific areas or
            through deficiencies identified by the Committee.
       iii. “HIPAA and Research.” This brochure is a quick reference guide for LWC
            Investigators and study personnel, and includes the following information:
            (iii.a) A description of HIPAA;
            (iii.b) A list of direct identifiers;
            (iii.c) HIPAA rules in regards to research involving humans;
            (iii.d) Tracking of disclosures; and
            (iii.d)Website addresses for additional information.
   d. The Investigator may subscribe to the HSPP listserve in order to facilitate the
       receipt of all mass e-mail notifications alerting them of pertinent IRB issues or
       decisions that may impact their research.
2. HSPP Administration Responsibilities.
   a. The HSPP will maintain a record system of the completion of research personnel
       training.
   b. The HSPP will conduct educational sessions throughout the year for all LWC
      faculty and staff.
3. HSPP Staff Responsibilities.
   a. The HSPP staff member will check the Verification of Training Form and verify,
       if necessary, in the HSPP database the completion of the Investigator and key
       study personnel training requirements as stated above.
   b. The staff member will notify the Investigator and key study personnel that the
       HSPP training requirements must be met prior to the initiation of research
       involving humans under the jurisdiction of the LWC HSPP.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.B IRB Committee Member Training
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007
REVISED: October 2007


VIII.B IRB Committee Member Training
       Policy Instructions/Explanations:
       1. New IRB Committee members are required to attend an introductory training session
          prior to participating (voting) at an IRB committee meeting. Additionally, new
          members are encouraged to attend and observe committee meetings prior to
          beginning their term. Training sessions are designed to provide education on the
          following topics:
          a. Responsibilities and obligations of IRB committee members;
          b. Consent;
          c. Risk/benefit;
          d. Subject selection;
          e. Effective meeting skills;
          f. Terms and regulations (FDA, OPRR, NIH, Lindsey Wilson College SPC , etc.);
          g. Meeting basics (quorum, voting procedures, acceptable templates, etc.);
          h. Obligations of committee members regarding the protection of human subjects;
          i. Vulnerable populations; and
          j. Conflict of Interest
       2. Reference materials provided to new IRB Committee Members include, but are not
          limited to:
          a. The Belmont Report;
          b. 45 CFR 46;
          c. 21 CFR 50, 56;
          d. Glossary of Terms from the OPRR Member Guidebook;
          e. Current Lindsey Wilson College SPC Federal-wide Assurance;
          f. Listing of IRB Committee Members and HSPP Office Staff;
          g. HSPP Policies and Procedures; and
          h. Internet access to IRB forms, templates and General Instructions.
       3. Regular training/updates will be provided to experienced Committee Members either
          individually or incorporated into scheduled IRB committee meetings, or as memos,
          emails, or newsletters, and may include such topics as:
          a. Changes in Federal regulations and guidance documents.
          b. Changes in Lindsey Wilson College SPC HSPP processes or forms; and
          c. Review of the responsibilities and obligations of committee members with regards
              to the protection of human subjects.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.B IRB Committee Member Training
SUB-PART: VIII.B.1 Procedure for IRB Committee Member Training
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VIII.B.1 Procedure for IRB Committee Member Training
       1. Procedure:
       This procedure outlines the process for completing the human research protections
       educational requirements for Lindsey Wilson College SPC (LWC) Human Subjects
       Protection Program (HSPP) Committee Member.
           a. IRB Committee Member Responsibilities. All new Committee members are
               required to complete an initial orientation before being allowed to serve on the
               IRB Committee. This orientation includes the following:
               i. An educational session:
                   • LWC HSPP Policies and Procedures;
                   • DHHS Regulations 45 CFR 46;
                   • FDA Regulations 20 CFR 50 and 56;
                   • Applicable State and Federal Laws;
                   • Committee Member Responsibilities;
                   • Types of Review including Exempt, Expedited, Full Committee;
                   • Primary and Secondary Reviewer Assignments and Responsibilities;
                   • Distribution of IRB Materials for Review;
                   • Pre-review by HSPP staff;
                   • Assessment of Risks;
                   • Informed Consent Process, Documentation, Required Elements, Waivers;
                   • Confidentiality and HIPAA;
                   • Vulnerable Populations and Supplemental Reviewer‟s Comment Sheets;
                   • Data Safety Monitoring Plan;
                   • Identification of External Sites and Requirements;
                   • Documentation and Discussion of Review Criteria;
                   • Voting;
                   • Conflict of Interest;
                   • Determination of Review Intervals; and
                   • Attendance, Notification of Absence, and Payment.
           b. Committee Meeting Attendance and Observations. New IRB Committee members
               must attend and observe at least one IRB committee meeting prior to functioning
               as a voting member.
           c. Each new IRB Committee member will receive the book entitled “Institutional
               Review Board Member Handbook” by Robert Amdur, which is composed of the
               following:
               • IRB Administrative Information;
               • Committee Rosters;
               • HHS Regulations - 45 CFR 46;
               • FDA Regulations – 21 CFR PART 50, 56;
               • Significant Differences in the FDA and the DHHS Regulations;
               • Expedited Categories;
      • OHRP Decision Charts (9/98);
      • Glossary of Terms.
   d. IRB Committee Member Continuing Education.
      i. All IRB Committee members are required to complete a self-evaluation tool
           assessing their knowledge, and identifying educational needs for the coming
           year.
      ii. IRB Committee members are encouraged to participate in at least one
           additional continuing education opportunity each year. The following are
           available:
           (ii.a) Presentations by HSPP staff;
           (ii.c) Any other local, regional or national educational opportunities on human
                research protections.
      iii. Monthly education is provided at the IRB Committee meetings.
           (iii.a) The IRB reference library is available for all IRB Committee members
                to obtain additional information regarding the history and conduct of
                research activities.
           (iii.b) The IRB Committee member will review materials presented at IRB
                Committee meetings and request additional educational resources as
                required.
2. HSPP Staff Responsibilities.
   a. The HSPP staff member will assure the Committee member has completed all
      initial education requirements.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education, Training and Evaluation
POLICY NUMBER: VIII.C HSPP Staff Member Education, Training and Evaluation
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VIII.C HSPP Staff Member Education, Training and Evaluation
       Policy:
       It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
       Program (HSPP) that the HSPP will hire staff members according to LWC Human
       Resources policies and procedures and guidelines and that HSPP job descriptions will be
       updated regularly in order to select staff with the background and training required by the
       HSPP. Staff members will receive high quality, comprehensive education and training
       regarding human research protections, current events, Federal regulations and HSPP
       policies and procedures.
       1. An orientation checklist will be initiated by the HSPP Director for all new staff and
            will be completed within three months of the staff member‟s hire date.
       2. Initial Training and Orientation. Lindsey Wilson College SPC Human Subjects
            Protection Program requires all newly hired employees complete specific training
            programs.
            a. All new HSPP staff members will complete the following training during
                orientation:
                i. Collaborative IRB Training Initiative (CITI);
                ii. Committee Meeting Observations;
                iii. OHRP IRB 101 Course.
            b. New IRB staff members receive a copy of the HSPP Policies and Procedures to
                use as a tool for assistance in learning and applying Federal regulations and
                guidance, HSPP policies and procedures and additional references.
            c. All new staff members will be assigned a preceptor. The preceptor will provide
                guidance and support during the orientation period and beyond.
            d. The HSPP Director will evaluate the progress of each new staff member at six
                months from his or her hire date. The evaluation will consist of an assessment of
                the key functions of the position. Input will be obtained from the staff member‟s
                preceptor, IRB Chairperson, and other staff members, as applicable. A copy of the
                written evaluation is provided to the new staff member.
       3. HSPP Staff Continuing Education. All IRB staff members are expected to complete
            the HSPP requirements and HSPP training annually. In addition, HSPP staff are
            required to attend a minimum of four educational sessions each year. HSPP staff are
            also encouraged to attend one local, regional or national conference per year in
            human research protections. HSPP staff are expected to attend all scheduled weekly
            staff meetings.
       4. Staff members and IRB certification. Staff members are encouraged to obtain IRB
            certification. This is dependent on experience, length of time in department, and
            certification eligibility requirements.
            a. Additional educational opportunities include:
                i. Team building workshops;
                ii. Continuous Quality Improvement training as all staff members are responsible
                     for CQI activities in their individual, team and committee work processes; and
              iii. The IRB reference library is available for additional information regarding the
                   history and conduct of research activities.
       5. Staff Evaluations. All staff members will receive an annual performance evaluation
          per institutional policy. This is a collaborative process to facilitate the employee‟s
          personal and professional growth. Clear and specific goals will be developed to help
          achieve the employee‟s potential and the department‟s objectives.
          a. The staff member‟s supervisor will conduct the annual performance evaluation
              based on the employee‟s input and focused on identifying strengths and
              developing an action plan for any areas of weakness.
          b. New staff members will be evaluated at 6 months, based on performance as
              required by Human Resources. The supervisor will discuss the new staff
              member‟s progress and together develop an action plan for any areas of
              deficiency as well as departmental and personal goals.
          c. All staff members complete a self-evaluation at the time of annual evaluation.
References:
Lindsey Wilson College SPC Human Subjects Protection Program Website: http://www.lindsey.edu/
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education, Training and Evaluation
POLICY NUMBER: VIII.C HSPP Staff Training
SUB-PART: VIII.C.1 Procedure for HSPP Staff Education and Training
and Evaluation
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


VIII.C.1 Procedure for HSPP Staff Education, Training and Evaluation
       Procedure:
       This procedure outlines the process for completing the human research protections
       educational requirements for Lindsey Wilson College SPC (LWC) Human Subjects
       Protection Program (HSPP) staff member.
       1. HSPP Staff Member Responsibilities.
          a. New IRB staff members will complete the Collaborative IRB Training Initiative
               (CITI) training modules. This internet-based course in human research protections
               and bioethics is designed specifically for all personnel that have a significant
               involvement in the planning, conduct, and analysis of any scientific activity that
               employs human research participants. The course consists of training modules
               that are divided into two tracks: Biomedical Research and Social/Behavioral
               Research. The new staff member will complete all of the modules in the track that
               is the focus of the team in which they are a member. The HSPP Staff member will
               log onto http://www.citiprogram.org and complete set of modules most applicable
               to the type of research to be reviewed.
               i.       Biomedical Research Modules:
                    a. Module 1- History and Ethics;
                    b. Module 2- Defining Research;
                    c. Modulr 3- Regulatory Overview; and
                    d. Module 3- Informed Consent.
               ii.      Social/Behavioral Modules:
                    a. Module 1- History and Ethics;
                    b. Module 2– Defining Research;
                    c. Module 3- Regulatory Overview; and
                    d. Module 5- Informed Consent.
               iii. A minimum score of 80% must be obtained. IRB Staff members not reaching
                    a passing score will need to review the content of the modules and re-take the
                    exam until a score of ≥80% is obtained.
          b. The new HSPP staff member will attend and observe either one Biomedical
               Committee or Behavioral Science Committee meeting as well as observe the post-
               Committee work with the HSPP preceptor staff member.
          c. The new HSPP staff member will complete the OHRP IRB 101 Course. This
               course consists of discussion of human participant research; a description of the
               ethical principles underlying the conduct of human research; and an overview of
               the Federal regulations governing IRB operations and human research.
          d. New IRB Staff members receive a copy of the HSPP Policies and Procedures as
               well as the following materials:
               i. 45 CFR 46 & Expedited Categories;
               ii. 21 CFR 50 & 21 CFR 56 – FDA Regulations;
               iii. FDA Fact Sheets;
     iv. OHRP Flow Charts;
     v. OPRR (OHRP) Common Findings & Guidance (11/98);
     vi. Ethical Guidelines:
          (vi.a)Nuremberg Code;
          (vi.b)Declaration of Helsinki; and
          (vi.c)The Belmont Report;
     vii. LWC‟s FWA;
     viii. Family Education Rights and Privacy Act (FERPA) information;
          (viii.a) Vulnerable Populations :
          (viii.b) Vulnerable Population Checklists;
     ix. Various OHRP Guidance Documents (e.g., Certificates of Confidentiality; and
          Continuing Review)
     x. HIPAA Guidance Book
e.   The HSPP reference material includes information on assorted topics related to
     issues and regulations on human research protections. The materials are available
     for checkout upon request.
f.   All HSPP staff members are encouraged to attend a minimum of one local,
     regional or national conference in human research protections the following
     during each year (12 months) of employment:
g.   All HSPP staff members are required to attend four of the following during each
     year (12 months) of employment:
     i. This may include but is not limited to:
          (i.a) HSPP workshops
          (i.b) Continuous Quality Improvement Conferences; and
          (i.c) Other research or human protections related education offerings
               sponsored by departments at the LWC, or external offerings.
h.   All staff will sign a HSPP “Recusal Agreement” document.
     i. Staff members are encouraged to obtain IRB certification. This is dependent
          on experience, length of time in department, and certification eligibility
          requirements. Initial certification and recertification costs are paid for by the
          IRB. Staff members are encouraged to use the IRB library for study materials
          to prepare for the exams.
     ii. The applicable job description for the HSPP staff designates a specific time
          frame for the possible completion of one of the following certifications:
          a. Certified IRB Professional (CIP). The Council for Certification of IRB
               Professionals (CCIP) is a program that has established certification
               standards and mechanisms with the input from a group of experts
               representing a broad diversity of practice and experience in the field of
               human research protections. The certification examination evaluates an
               individual's knowledge of ethical principles, historical events, regulatory
               requirements, and operational and functional issues relating to IRBs and
               human research protections programs.
          b. Certification in IRB Management (CIM). The National Association of IRB
               Managers supports this certification with a primary purpose of measuring
               competency beyond the program where one is presently employed. This
               certification examination also evaluates an individual's knowledge of
                ethical principles, historical events, regulatory requirements, and
                operational and functional issues relating to IRBs and human research
                protections programs through the use of a timed and monitored
                competency exam.
2. Other certifications are supported by the HSPP and include:
   a. Association of Clinical Research Professionals (ACRP): Certified Clinical
      Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA);
   b. Society of Clinical Research Associates (SoCRA): Certified Clinical Research
      Professional (CCRP); and
   c. Regulatory Affairs Professional Society (RAPS): Regulatory Affairs Certified
      (RAC).
   d. The HSPP Director will evaluate each new employee at 6 months and annually.
      i. The 6 month evaluation will include:
           (i.a) Agendas and minutes composed by the new staff member will be
                reviewed and evaluated.
      ii. A plan of action is developed at the six-month evaluation period in the areas
           identified as needing additional education, training, and development.
      iii. It is expected that the new staff member would be satisfactorily performing all
           key functions of the job at the six-month evaluation point.
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.D Community Outreach
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007; October, 2005


VIII.D: Community Outreach
      Policy:
      It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
      Program (HSPP) to provide information to the community regarding the rights of a
      research participant as a volunteer.
      1. The HSPP will provide a local telephone number, toll-free number, and email address
           to each participant consented to participate in research in which the LWC HSPP has
           jurisdiction. This information should appear on every informed consent document
           following a statement for participants to call the HSPP office or email the HSPP
           office if they have questions regarding their rights as a research volunteer, if they
           want to talk to someone other than the research team (or can‟t reach the research
           team), answer general questions, address concerns or complaints or want to give input
           about the research.
      2. The HSPP will maintain a suggestion box that contains a telephone number so that
           participants can communicate with HSPP office staff and ask questions, and voice
           concerns or complaints.
      3. The HSPP will maintain a mechanism to receive complaints from participants or
           others in a confidential manner.
      4. A participant brochure is available entitled, “Are You Thinking About Participating
           in a Research Study?” and includes the following:
           a. A lay definition of research and research personnel;
           b. A description of an IRB and its role;
           c. What information should be made available in an informed consent;
           d. Protection of research participants; and
           e. Who to contact for more information.
      5. The HSPP will make available on the HSPP website links to community outreach
           resources such as:
           a. National Institutes of Health sponsored web site, called Clinical Trials; and
           b. ECRI (formerly the Emergency Care Research Institute) a nonprofit health
               services research agency website on participating in clinical trials
PROGRAM: Human Subjects Protection Program
SECTION: VIII HSPP Education and Training
POLICY NUMBER: VIII.D Community Outreach
SUB-PART: VIII.D.1 Procedure for Community Outreach
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007; October, 2005


VIII.D.1 Procedure for Community Outreach
       Procedure:
       The purpose of this procedure is to outline the process for maintaining community
       outreach activities offered by Lindsey Wilson College SPC (LWC) Human Subjects
       Protection Program (HSPP).
           a. Investigator Responsibilities.
               i. The Investigator is responsible for assuring the informed consent document
                    contains the HSPP local telephone number, toll-free phone number, and web
                    address for participants to call if they have questions regarding their rights as
                    a volunteer for research, if they want to talk to someone other than the
                    research team (or can‟t reach the research team), ask general questions,
                    address concerns or complaints, or give input about the research.
               ii. If the IRB has waived the documentation of informed consent, it is the
                    Investigator‟s responsibility to provide the IRB toll-free phone number to the
                    participant by other means.
               iii. The Investigator may request copies of the community outreach brochures for
                    distribution to participants.
       b. IRB Committee Responsibilities.
           i. The IRB Committee, Chair, or designated Committee Member will review each
               informed consent document to assure that the HSPP local telephone number, toll-
               free phone number and web address is included with a statement regarding who
               the participant may call if they have any questions regarding their rights as a
               research participant, if they want to talk to someone other than the research team
               (or can‟t reach the research team), ask general questions, address concerns or
               complaints, or give input about the research.
           ii. The IRB Committee, Chair, or designated Committee Member will review each
               request for waiver of informed consent to determine if the Investigator should
               provide another mechanism for distributing the IRB toll-free phone number to
               research participants.
       c. HSPP Staff Responsibilities.
           i. During the pre-review of proposed research the HSPP staff member will assure
               that each informed consent document contains the HSPP local telephone number,
               toll-free phone number, and web address for participants to call the HSPP office
               or email the HSPP office if they have questions regarding their rights as a
               research volunteer, if they want to talk to someone other than the research team
               (or can‟t reach the research team), ask general questions, address concerns or
               complaints, or give input about the research. If the Investigator is requesting a
               waiver of documentation of informed consent, the staff will request information
               from the Investigator regarding the method of informing the participants of the
               IRB toll-free number for questions.
ii. The HSPP staff member will assist in the distribution of an informational
     brochure to Lindsey Wilson College SPC research community regarding
     participant‟s rights as a volunteer in research including the IRB toll-free phone
     number.
iii. The HSPP staff member will assist the HSPP in the maintenance of links to
     various LWC community outreach resources available on the IRB website.
iv. The HSPP staff will maintain contact information on the website for the
     participant to contact the HSPP office if research staff cannot be reached or in the
     event the participant wishes to contact someone other than the research staff.
v. The HSPP Director will evaluate, make changes, and implement changes to the
     outreach program as needed.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.A Special Categories of Research: Children in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


IX.A Special Categories of Research: Children in Research
      Definitions:
      Parent means a child‟s biological or adoptive parent.
      Guardian means an individual who is authorized under applicable State or local law to
          consent on behalf of a child to general medical care. In accordance with 21 CFR
          50.3(s), guardian also means an individual who is authorized to consent on behalf of a
          child to participate in research.
      Ward In accordance with 21 CFR 50.3(q), ward means a child who is placed in the legal
          custody of the State or other agency, institution or entity, consistent with applicable
          Federal, State or local law.
      Policy Instructions/Explanations:
      1. The special vulnerability of children makes consideration of involving them as
          research subjects particularly important. To safeguard their interests and to protect
          them from harm, special ethical and regulatory considerations apply for reviewing
          research involving children. The IRB may approve research involving children only if
          special provisions are met. The IRB must classify research involving children into
          one of four categories and document their discussions of the risks and benefits of the
          research study. The four categories of research involving children that may be
          approved by the IRB Committees are based on degree of risk and benefit to individual
          subjects.
                                                                                                   th
            a. Under this policy, children include all those who have not yet reached their 18
               birthday (e.g., 0 through 17 years old) according to age of majority as cited in the
               Kentucky State laws.
         2. Four Categories of Human Research Include:
            a. Research Involving Minimal Risk When the IRB finds that no greater than
               minimal risk to children is present, the IRB may approve the proposal only if the
               IRB finds that adequate provisions are made for soliciting the assent of the
               children and the permission of their parents or guardians. Such research projects
               may be reviewed and approved under the Expedited regulations.
            b. Research Involving Greater than Minimal Risk but Presenting the Prospect of
               Direct Benefit to the Individual Subjects If the IRB finds that more than minimal
               risk to children is presented by an intervention or procedure but that the
               intervention or procedure holds out the prospect of direct benefit for the
               individual subject, or by a monitoring procedure that is likely to contribute to the
               subject's well-being, the IRB may approve the research only if the IRB finds that:
               i. the risk is justified by the anticipated benefit to the subjects;
               ii. the anticipated benefit to the risk is at least as favorable to the subjects as that
                    presented by available alternative approaches; and
               iii. adequate provisions are made for soliciting the assent of the children and
                    permission of their parents or guardians, as set forth below.
            c. Research Involving Greater than Minimal Risk and No Prospect of Direct Benefit
               to Individual Subjects, but Likely to Yield Generalizable Knowledge about the
      Subject's Disorder or Condition. If the IRB finds that more than minimal risk to
      children is presented by an intervention or procedure that does not hold out the
      prospect of direct benefit for the individual subject, or by a monitoring procedure
      which is not likely to contribute to the well-being of the subject, the IRB may
      approve the research only if the IRB finds that:
      • the risk represents a minor increase over minimal risk;
      • the intervention or procedure presents experiences to subjects that are
          reasonably commensurate with those inherent in their actual or expected
          medical, dental, psychological, social, or educational situations;
      • the intervention or procedure is likely to yield generalizable knowledge about
          the subjects' disorder or condition which is of vital importance for the
          understanding or amelioration of the subjects' disorder or condition; and
      • adequate provisions are made for soliciting assent of the children and
          permission of their parents or guardians, as set forth below.
   d. Research Not Otherwise Approvable Which Presents an Opportunity to
      Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or
      Welfare of Children. If the IRB does not believe the research proposal meets any
      of the requirements set forth above, it may still approve the protocol but only if:
      • the IRB finds that the research presents a responsible opportunity to further
          the understanding, prevention, or alleviation of a serious problem affecting the
          health or welfare of children; and
      • the Secretary of the Department of Health and Human Services, after
          consultation with a panel of experts in pertinent disciplines (for example:
          science, medicine, education, ethics, law) and following opportunity for
          public review and comment, has determined either:
          i. that the research in fact satisfies one of the conditions set forth above, or
              the following:
              (i.a) the research presents a reasonable opportunity to further the
                   understanding, prevention, or alleviation of a serious problem affecting
                   the health or welfare of children;
              (i.b) the research will be conducted in accordance with sound ethical
                   principles; and
              (i.c) adequate provisions are made for soliciting the assent of children and
                   the permission of their parents or guardians, as set forth below.
3. Requirements for Permission by Parents or Guardians and for Assent by Children
   a. Adequate Provisions for Child‟s Assent. The IRB must find that adequate
      provisions are made for soliciting the assent of child subjects when in the
      judgment of the IRB the children are capable of providing assent. For purposes of
      this policy, "Assent" means a child's affirmative agreement to participate in
      research. Mere failure to object should not, absent affirmative agreement, be
      construed as assent.
      i. In determining whether children are capable of assenting, the IRB shall take
          into account the ages, maturity, language, and psychological state of the
          children involved. This judgment may be made for all children to be involved
          in research under a particular protocol, or for each child, or age range as the
          IRB deems appropriate. The child should be given an explanation of the
        proposed research procedures in a language that is appropriate to the child's
        age, experience, maturity, comprehension, and condition.
   ii. Waiver of Assent. If the IRB determines either of the following to be true,
        then the assent of the children is not a necessary condition for proceeding with
        the research:
        (ii.a) The capability of some or all of the children is so limited that they
             cannot reasonably be consulted; or
        (ii.b) The intervention or procedure involved in the research holds out a
             prospect of direct benefit that is important to the health or well-being of
             the children and is available only in the context of the research. Therefore,
             when the research offers the child the possibility of a direct benefit that is
             important to the health or well-being of the child and is available only in
             the context of the research, the IRB may determine that the assent of the
             child is not necessary. Additionally, in such circumstances a child's
             dissent, which should normally be respected, may be overruled by the
             child's parents, at the IRB's discretion. When research involves the
             provision of experimental therapies for life-threatening diseases such as
             cancer, however, the IRB should be sensitive to the fact that parents may
             wish to try anything, even when the likelihood of success is marginal and
             the probability of extreme discomfort is high. Should the child not wish to
             undertake such experimental therapy, difficult decisions may have to be
             made. In general, if the child is a mature adolescent and death is imminent,
             the child's wishes should be respected. Finally, even where the IRB
             determines that the child subjects are capable of assenting, the IRB may
             still waive the assent requirement under circumstances in which consent
             may be waived for adults in accordance with the waiver or alteration of
             informed consent procedures.
b. Adequate Provisions for Parents‟ or Guardian‟s Permission. The IRB must find
   that adequate provisions are made for soliciting the permission of each child's
   parents or legally authorized representative.
   i. Research involving minimal risk. Where parental permission is to be obtained,
        the IRB may find that the permission of one parent is sufficient for research
        not involving minimal risk. Note: Minimal risk means that the probability and
        magnitude of harm or discomfort anticipated in the research are not greater in
        and of themselves than those ordinarily encountered in daily life or during the
        performance of routine physical of psychological examinations or tests. An
        example of minimal risk is the risk of drawing a small amount of blood from a
        healthy individual for research purposes (because the risk of doing so is no
        greater than the risk of doing so as part of a routine physical examination).
   ii. Research involving greater than minimal risk but presenting the prospect of
        direct benefit to the individual subjects. Where parental permission is to be
        obtained, the IRB may find that the permission of one parent is sufficient for
        research involving greater than minimal risk but presenting the prospect of
        direct benefit to the individual subjects.
   iii. Research involving greater than minimal risk and no prospect of direct benefit
        to individual subjects, but likely to yield generalizable knowledge about the
          subject's disorder or condition. When the research is approved and permission
          is to be obtained from parents, both parents must give their permission unless
          one parent is deceased, unknown, incompetent, or not reasonably available, or
          when only one parent has legal responsibility for the care and custody of the
          child. This should be documented.
     iv. Research not otherwise approvable which presents an opportunity to
          understand, prevent, or alleviate a serious problem affecting the health or
          welfare of children. When the research is approved and permission is to be
          obtained from parents, both parents must give their permission unless one
          parent is deceased, unknown, incompetent, or not reasonably available, or
          when only one parent has legal responsibility for the care and custody of the
          child.
c.   Waiver of Parental or Guardian Permission. If the IRB determines that a research
     protocol is designed for conditions or for a subject population for which parental
     or the legally authorized representative permission is not a reasonable requirement
     to protect the subjects (for example, neglected or abused children), it may waive
     the consent requirements described above as stated in 45 CFR 46.408, provided:
     i. an appropriate mechanism for protecting the children who will participate as
          subjects in the research is substituted, and
     ii. the waiver is consistent with Federal, State, or local law. The choice of an
          appropriate mechanism would depend upon the nature and purpose of the
          activities described in the protocol, the risk and anticipated benefit to the
          research subjects, and their age, maturity, status, and condition.
     iii. protocol specific waiver of parental or guardian permission must be
          documented in the IRB Committee minutes
     iv. the research is not subject to the FDA regulations
d.   Documentation.
     i. Permission by parents or guardians shall be documented in the same manner
          as required for adult subjects.
     ii. When the IRB determines that assent of a child is required, it shall also
          determine whether and how assent must be documented.
e.   Wards of the State or Other Agency. Children who are wards of the state or any
     other agency, institution, or entity can be included in research only if the IRB
     finds and documents that such research is:
     i. related to their status as wards; or
     ii. conducted in schools, camps, hospitals, institutions, or similar settings in
          which the majority of children involved as subjects are not wards.
f.   The IRB must require appointment of an advocate for each child who is a ward, in
     addition to any other individual acting on behalf of the child as guardian or in
     loco parentis. One individual may serve as advocate for more than one child. The
     advocate shall be an individual who has the background and experience to act in,
     and agrees to act in, the best interests of the child for the duration of the child's
     participation in the research and who is not associated in any way (except in the
     role as advocate or member of the IRB) with the research, the investigator(s), or
     the guardian organization.
4. Pediatric Expertise on IRB Committee. An IRB Committee considering a protocol
   involving children as subjects should:
   a. assess its needs for pediatric expertise among the IRB voting membership to
      assure that it possesses the professional competence necessary to review the
      specific research activities and;
   b. consider inclusion of one or more individuals who are knowledgeable about and
      experienced in working with children. To fulfill this requirement, the IRB
      Committee may invite nonvoting individuals to assist in the review of issues
      which require expertise beyond, or in addition to, that available among voting
      IRB members.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.A Special Categories of Research: Children in Research
SUB-PART: IX.A.1 Procedure for Special Categories of Research: Children in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


IX.A.1 Procedure for Special Categories of Research: Children in Research
       1. Procedure:
       This procedure provides guidance on the special ethical and regulatory considerations of
       children involved in human subjects research under the jurisdiction of Lindsey Wilson
       College SPC (LWC) Human Subjects Protection Program (HSPP).
           a. Investigator Responsibilities.
              i. The Investigator will submit information in the application indicating whether
                   children will be a target population for research activities.
              ii. Plans should be described regarding if and how assent and dissent will be
                   obtained and documented for IRB review and approval.
                   (ii.a) An Investigator must take into account the ages, maturity, and
                        psychological state of the children involved when planning methods to
                        obtain and document assent. The LWC IRB recommends the following:
                        • Age 18 or older utilizing the adult informed consent document;
                        • Ages 15 to 17 utilizing an assent form, which may be in the same
                            language as the adult informed consent document and countersigned
                            by a parent/guardian;
                        • Ages 10 to 14 utilize a written assent form and indicate their assent in
                            writing;
                        • Ages 6 to 9 utilizing an assent form written simply and at a
                            comprehension level appropriate for a 6 year old and attested to by a
                            witness;
                        • Less than 6 years of age utilizing an oral script in very simple
                            language appropriate for children of this age group.
                   (ii.b) An Investigator should not solicit a child‟s assent without intending to
                        take his or her wishes seriously. In situations where the potential benefits
                        of the study are such that the physicians and parents will enroll the child
                        regardless of the child‟s wishes, the child should simply be told what is
                        planned and should not be deceived. In such cases, the Investigator should
                        request a waiver for assent from the IRB.
                   (ii.c) Once a waiver of assent has been approved, the Investigator will obtain
                        parental permission unless waiver from parental permission has been
                        granted.
                   (ii.d) The Investigator may not approach the child to assent to the research
                        study until the parents or legal guardians have given written permission.
       b. IRB Committee Responsibilities.
           i. The IRB Committee must review the proposed research taking into consideration
              all applicable LWC policies, as well as the degree of risk and discomfort involved
              in the research in relation to the direct benefits it offers to the child before it can
              determine whether or not the IRB has authority to approve the study.
ii. When determining whether children are capable of assenting, the IRB shall take
     into account the age, maturity, and psychological state of the children targeted for
     the study population. This determination may apply to all children involved in the
     study, or on a case-by-case basis, as deemed necessary by the IRB.
iii. The IRB must determine the appropriate ages for assent and the method of
     documentation of assent.
iv. The IRB must assure that special protections afforded to children found in 45
     CFR 46, Subpart D have been met for this population.
v. The IRB Committee may not review or make a determination regarding studies
     involving children, as a target population, unless it has sufficient expertise in
     pediatric ethical, clinical, and psychosocial issues. Therefore, a Committee
     member or an ad hoc member must be in attendance at the convened meeting or
     experts who have this knowledge must be consulted by the IRB. When the IRB
     Committee renders its determination, it will include:
     (v.a) The children‟s category and corresponding rationale under which the
         proposed research qualifies (e.g., 45 CFR 46.404-407); and
     (v.b) Adequate provisions for obtaining assent and dissent from the children and
         how such assent and dissent will be documented. If assent and dissent is
         waived by the Committee, the rationale for such determination must be
         provided and information documented in the Committee meeting minutes.
     (v.c) Federally-funded studies determined by the IRB Committee to meet 45 CFR
         46.407 for children, will be given a approval (simple concurrence) status until
         a determination by the Secretary of the Department of Health and Human
         Services (DHHS) is received. The Director of the Human Subjects Protection
         Program will be promptly notified when the IRB determines a study is
         determined to meet 45 CFR 46.407. Documentation sent to the Secretary shall
         include:
     (v.d) IRB minutes from the convened meeting documenting the IRB findings;
         • The complete IRB application and informed consent documents;
         • The relevant protocol and/or grant application; and
         • Any supporting material including the Investigator‟s Brochure, if
              applicable.
     (v.e) If OHRP grants approval under Category 46.407, then the IRB may grant
         final approval.
     (v.f) If OHRP requires changes in the process of approval, or any other changes
         are made after the IRB “approved pending” modifications, an amendment
         must be submitted for review and approved by the IRB Chairperson or his or
         her designee, unless the IRB Chairperson determines the changes submitted
         are major, which require IRB Committee review.
     (v.g) At any time the Chairperson may refer the study to the IRB Committee for
         further review.
vi. Non-Federally funded studies determined by the IRB Committee to meet 45 CFR
     46.407 for children, and meet all criteria for approval under 45 CFR 46.111, will
     be given a “pending approval” status until the research proposal is reviewed by
     both an expert panel and a community panel, for recommendations.
          vii. When children as wards of the State are involved in research under 45 CFR
               46.407, the required additional individual acting on behalf of the child as guardian
               or in loco parentis may serve as advocate for more than one child. The advocate
               shall be an individual who has the background and experience to act in, and
               agrees to act in, the best interest of the child for the duration of the child‟s
               participation in the research and who is not associated in any way with the
               Investigators, or the guardian organization.
      c. HSPP Staff Responsibilities.
          i. The staff member will verify that the application is completed as part of the initial
               study documents.
          ii. The staff member will conduct a pre-review and take into consideration the type
               of research and verify the appropriate category of research under Subpart D.
          iii. The staff member takes into consideration the age, maturity, and psychological
               state of the children targeted in the proposed research when pre-reviewing the
               assent and informed consent documents.
          iv. E-mails requesting pre-review changes to the informed consent documents are to
               be sent to the Investigator by the staff member.
          v. Once the pre-review revisions are received from the Investigator, the staff
               member will place the new study with the revised informed consent documents on
               the next available Committee agenda, assign reviewers with appropriate expertise
               in children, and prepare the reviewer and Committee packets.
References:
45 CFR 46.116
45 CFR 46 Subpart D
OHRP Report 98-03, NIH Policy Guidance on the Inclusion of Children in Research
IRB Guidebook, Chapter 6, Section C, Children and Minors
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.A Special Categories of Research: Children in Research
SUB-PART: IX.A.2 Review of Non-Federally Funded Research Meeting 45 CFR 46.407
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


IX.A.2 Review of Non-Federally Funded Research Meeting 45 CFR 46.407
       Procedure:
       This procedure outlines the process for reviewing non-federally funded research that
       meets 45 CFR 46.407 for the protection of children as a vulnerable population.
       1. Investigator Responsibilities.
        a. The Investigator is responsible for providing a written rationale for use of this
           vulnerable population, including supporting documentation (e.g., literature search) of
           study design, safety monitoring, and risk/benefit ratio justification.
        b. The Investigator will provide additional documentation or materials as requested by
           the IRB in order to support the justification for research under category 45 CFR
           46.407.
        c. The Investigator will, as requested, assist the IRB as necessary by providing any
           additional materials and documentation required for adequate review.
       2. IRB Committee Responsibilities.
        a. The IRB Committee will review the proposed research and determine that the
           research involving children does not meet the requirements for approval under 45
           CFR 46.404 (research not involving greater than minimal risk), 46.405 (research
           involving greater than minimal risk but presenting the prospect of direct benefit to
           individual subjects), or 46.406 (research involving greater than minimal risk and no
           prospect of direct benefit to the individual subjects but likely to yield generalizable
           knowledge about the subject's disorder or condition), but that the research, not
           otherwise approvable, presents a reasonable opportunity to further the
           understanding, prevention or alleviation of a serious problem affecting the health or
           welfare of children.
           i. The IRB Committee will provide the rationale and documentation that the
                research does not meet 45 CFR 46.404, 46.405, or 46.406 for the protection of
                this vulnerable population.
           ii. The IRB Committee will provide rationale and documentation that the research
                would be approvable under 45 CFR 46.407.
           iii. The IRB will consult with experts at DHHS, experts in relevant disciplines, and
                representatives of the community in which the research will be conducted to
                provide the opportunity for review and comment, before determining whether the
                proposed research may be conducted under 45 CFR 46.407.
           iv. The IRB Committee will recommend any additional compliance guidelines (e.g.,
                increased review frequency, observation of consent and assent process,
                additional DSMB protections, etc.).
       3. HSPP Staff Responsibilities.
        a. The staff member will prepare guidance to assist the IRB Committee in making a
           determination that a proposed research meets 45 CFR 46.407 for the IRB
           Committee.
       b. The staff member will notify the HSPP Director of the 45 CFR 46.407 determination
           by the Committee.
       c. Following the determination that a non-federally funded research proposal meets 45
           CFR 46.407, the staff member team will seek guidance from administration and/or
           OHRP in the continuation of review under this category.
      4. IRB Administration Responsibilities.
       a. IRB Administration will assist with oversight of proceedings and processes.
References:
45 CFR 46, Subpart D
21 CFR 50, Subpart D
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.B Special Categories of Research: Prisoners in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


IX.B Special Categories of Research: Prisoners in Research
      1. Policy Instructions/Explanations:
          The special vulnerability of prisoners makes consideration of involving them as
          research subjects particularly important. Prisoners may be under constraints because
          of their incarceration, which could affect their ability to make a truly voluntary and
          un-coerced decision whether or not to participate as subjects in research. To
          safeguard their interests and to protect them from harm, special ethical and regulatory
          considerations apply for reviewing research involving prisoners Therefore, if a
          protocol involves the use of prisoners as subjects, both the general IRB Policies apply
          and the special ones outlined in this Policy apply. The IRB may only approve
          research involving prisoners if these special provisions are met.
          a. Unique Definition of Minimal Risk. For research involving prisoners, the
              definition of minimal risk differs from the definition of minimal risk as stated in
              the Common Rule. Unique to this policy, "Minimal risk" is defined as the
              probability and magnitude of physical or psychological harm that is normally
              encountered in the daily lives, or in the routine medical, dental, or psychological
              examination of healthy persons.
      2. Applicability of Policy Providing Special Protections for Prisoners.
          a. This policy applies to all research involving prisoners as subjects when one or
              more of the following apply:
              i. The research is sponsored by Lindsey Wilson College SPC; or
              ii. The research is conducted by or under the direction of any employee or agent
                   of Lindsey Wilson College SPC in connection with his or her institutional
                   responsibilities; or
              iii. The research is conducted by or under the direction of any employee, student,
                   or agent of Lindsey Wilson College SPC using any property or facility of
                   Lindsey Wilson College SPC .
          b. The requirements of this Policy are in addition to those imposed under the other
              Lindsey Wilson College SPC policies and state and federal law and regulations to
              human subjects‟ research.
          c. Definition of Prisoner. As used in this policy "Prisoner" means any individual
              involuntarily confined or detained in a penal institution. The term is intended to
              encompass individuals sentenced to such an institution under a criminal or civil
              statute, individuals detained in other facilities by virtue of statutes or commitment
              procedures which provide alternatives to criminal prosecution or incarceration in
              a penal institution, and individuals detained pending arraignment, trial, or
              sentencing.
          d. When Subjects Become Prisoners During a Research Protocol. This Policy
              applies whenever any human subject in a research protocol becomes a prisoner at
              any time during the protocol, e.g., after the research has commenced. This is
              necessary because it is unlikely that review of the research and the consent
       document contemplated the constraints imposed by the possible future
       incarceration of the subject.

      i. If a subject becomes a prisoner after enrollment in research, the Principal
           Investigator is responsible for reporting in writing this situation to the IRB
           immediately
      ii. At the earliest opportunity after receiving the Principal Investigator‟s notice or
           otherwise becoming aware of the prisoner status of a subject the IRB should
           review the protocol again with a representative as a member of the IRB
           Committee who is knowledgeable about prisons and/or prison life. The
           Committee should take special consideration of the conditions of being a
           prisoner. Additionally, the IRB Committee should confirm that, when
           appropriate, the informed consent process includes information regarding
           when subsequent incarceration may result in termination of the subject‟s
           participation by the investigator without regard to the subject‟s consent.
      iii. Upon this review, the IRB can either (a) approve the involvement of the
           prisoner-subject in the research in accordance with this policy or (b)
           determine that this subject must be withdrawn from the research.
3. Composition of IRB When Prisoners Are Involved.
   a. If an IRB regularly reviews research that involves prisoners, consideration shall
      be given to the inclusion of one or more individuals who are knowledgeable about
      and experienced in working with these subjects.
   b. To review a protocol involving prisoners as subjects:
      i. A majority of the IRB Committee (exclusive of prisoner members) shall have
           no association with the prison(s) involved, apart from their membership on the
           IRB; and
      ii. At least one member of the IRB Committee shall be a prisoner, or a prisoner
           representative with appropriate background and experience to serve in that
           capacity. If more than one IRB is reviewing the research, only one IRB need
           satisfy this requirement.
           (ii.a.) If a prisoner representative is selected to serve on the IRB Committee,
                the person must have a close working knowledge of prison conditions and
                the life of a prisoner. Suitable individuals could include present or former
                prisoners; prison chaplains; prison psychologists, prison social workers, or
                other prison service providers; persons who have conducted advocacy for
                the rights of prisoners; or any individuals who are qualified to represent
                the rights and welfare of prisoners by virtue of appropriate background
                and experience.
           (ii.b) The prisoner representative is a voting member of the IRB Committee.
   c. The overall composition of the IRB Committee might need to change if a number
      of individuals are associated with the prison or if a prisoner or prison
      representative is added.
   d. The IRB must meet the special composition requirements for all types of review
      of the protocol: initial review, continuing review, protocol amendments, and
      reports of unanticipated problems involving risks to subjects or others.
   e. In addition, the IRB must notify Office of Human Research Protection (OHRP) of
       any change in the IRB roster occasioned by the addition of a prisoner or a
       prisoner representative. Specifically, the IRB Office should (1) notify OHRP of
       the name and qualifications of the prisoner representative, if the approved IRB
       roster does not currently reflect this information; (2) maintain the CV of the
       prisoner representative serving on the IRB.
4. Additional Duties of the IRB where prisoners are involved; 45 CFR 46.305.
   a. In addition to all other responsibilities prescribed for IRBs under this part, the
       IRB shall review research covered by this subpart and approve such research only
       if it finds that:
       i. The research under review represents one of the categories of research
            permissible under 45 CFR 46.306(a)(2).
       ii. Any possible advantages accruing to the prisoner through his or her
            participation in the research, when compared to the general living conditions,
            medical care, quality of food, amenities, and opportunity for earnings in the
            prison, are not of such a magnitude that his or her ability to weigh the risks of
            the research against the value of such advantages in the limited choice
            environment of the prison is impaired;
       iii. The risks involved in the research are commensurate with risks that would be
            accepted by non-prisoner volunteers;
       iv. Procedures for the selection of subjects within the prison are fair to all
            prisoners and immune from arbitrary intervention by prison authorities or
            prisoners. Unless the principal investigator provides to the IRB justification in
            writing for following some other procedures, control subjects must be selected
            randomly from the group of available prisoners who meet the characteristics
            for that particular research project;
       v. The information is presented in language which is understandable to the
            subject population;
       vi. Adequate assurance exists that parole boards will not take into account a
            prisoner‟s participation in research in making decisions regarding parole, and
            each prisoner is clearly informed in advance that participation in the research
            will have no effect on his or her parole; and
       viii. Where the IRB finds there may be need for follow-up examination or care of
            participants after the end of their participation, adequate provisions have been
            made for such examination or care, taking into account the varying lengths of
            individual prisoners‟ sentences, and for informing participants of this fact.
   b. The IRB shall carry out such other duties as may be assigned by the Secretary of
       DHSS.
   c. The institution shall certify to the Secretary of DHSS, in such form and manner as
       the Secretary may require, that the duties of the IRB under this section have been
       fulfilled.
5. Specific Findings of IRB Required to Approve Research. When the IRB is
   reviewing a protocol in which a prisoner is a subject, the IRB Committee, in
   accordance with 45 CFR 46.306, must make the following additional findings:
   a. The research under review represents one of the following categories of research:
     i. A study of the possible causes, effects, and processes of incarceration, and of
          criminal behavior, provided that the study presents no more than minimal risk
          and no more than inconvenience to the subjects;
     ii. A study of prisons as institutional structures or of prisoners as incarcerated
          persons, provided that the study presents no more than minimal risk and no
          more than inconvenience to the subjects;
     iii. Research on conditions particularly affecting prisoners as a class (for
          example, vaccine trials and other research on hepatitis which is much more
          prevalent in prisons than elsewhere; and research on social and psychological
          problems such as alcoholism, drug addiction, and sexual assaults); or
     iv. Research on practices, both innovative and accepted, which have the intent
          and reasonable probability of improving the health or well-being of the
          subject;
     v. Research that involves epidemiologic studies that meet the criteria of
          45CFR46 Waiver of Applicability of Certain Provisions of Department of
          Health and Human Services regulations for Protection of Human Research
          Subjects for Department of Health and Human Services Conducted or
          Supported Epidemiologic Research Involving Prisoners as Subjects.
     vi. The sole purpose of the research are one of the following:
     • To describe the prevalence or incidence of disease by identifying all cases;
     • To study potential risk factor associations for disease;
     vii. The institution responsible for the conduct of the research certifies to the
          Office of Human Research Protections, DHHS, acting on behalf of the
          Secretary that the IRB approved the research and fulfilled it duties under
          45CFR 46.305(a)(2)-(7) and determined and documented that:
     • The Research presents no more than minimal risk and no more than
          inconvenience to the prisoner-participants
     • Prisoners are not a particular focus or the research
b.   Any possible advantages accruing to the prisoner through his or her participation
     in the research, when compared to the general living conditions, medical care,
     quality of food, amenities and opportunity for earnings in the prison, are not of
     such a magnitude that his or her ability to weigh the risks of the research against
     the value of such advantages in the limited choice environment of the prison is
     impaired;
c.   The risks involved in the research are commensurate with risks that would be
     accepted by non-prisoner volunteers;
d.   Procedures for the selection of subjects within the prison are fair to all prisoners
     and immune from arbitrary intervention by prison authorities or prisoners. Unless
     the principal investigator provides to the Board justification in writing for
     following some other procedures, control subjects must be selected randomly
     from the group of available prisoners who meet the characteristics needed for that
     particular research project;
e.   The information is presented in language, which is understandable to the subject
     population;
f.   Adequate assurance exists that parole boards will not take into account a
     prisoner's participation in the research in making decisions regarding parole, and
        each prisoner is clearly informed in advance that participation in the research will
        have no effect on his or her parole; and
    g. Where the IRB finds there may be a need for follow-up examination or care of
        participants after the end of their participation, adequate provision has been made
        for such examination or care, taking into account the varying lengths of individual
        prisoners' sentences, and for informing participants of this fact.
6. Permitted Research Involving Prisoners. For research conducted or supported by
    Department of Health and Human Services (DHHS) to involve prisoners, two actions
    must occur: (1) the IRB must certify to OHRP that it has reviewed and approved the
    research under the federal regulations (see subsection c below); and (2) OHRP must
    determine that the proposed research falls within one of the categories of permissible
    research described above.
    a. If an investigator wishes to engage in non-DHHS-supported research, certification
        is not required.
    b. The IRB certification to OHRP should consist of a certification letter stating that
        i. the IRB has been constituted properly according to federal regulation;
        ii. the IRB considered and made the required seven findings set forth in 45 CFR
             46.305; and
        iii. the “IRB finds that category [Identify which category applies] of 45 CFR
             46.306 permits this research to go forward with prisoners as human subjects.”
             The certification letter should also provide a brief description of the research
             sufficient to allow OHRP to determine whether or not to concur with the IRB;
             and, whether OHRP needs to consult with appropriate experts and publish a
             Federal Register Notice. The IRB Office should retain a copy of this letter.
7. Prisoners Who Are Minors. When a prisoner is also a minor (e.g., an adolescent
    detained in a juvenile detention facility is a prisoner), Policy regarding Children in
    Research will also apply.
8. Expedited Review of Research Involving Prisoners is Not Allowed. The full IRB
    Committee must review research involving prisoners as human subjects.
9. Exemption from Review of Research Involving Prisoners is Not Allowed.
    Research that would otherwise be exempt from the requirement that it receive IRB
    approval is not exempt when the research involves prisoners.
10. Documentation. When approving a protocol involving prisoners the minutes must
    document that the Committee made the findings required above. The IRB must
    classify research involving prisoners into one of the seven categories described in
    Paragraph 4(a) above and document in the minutes their discussions of the risks and
    benefits of the research study.
11. Federal Bureau of Prisons. The Federal Bureau of Prisons places special restrictions
    on research that takes place within the Bureau of Prisons. The IRB should review the
    regulations at 28 CFR Part 512 when considering such research.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.B Special Categories of Research: Prisoners in Research
SUB-PART IX.B.1 Procedure for Special Categories of Research: Prisoners in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


IX.B.1 Procedure for Special Categories of Research: Prisoners in Research
       Procedure:
       This procedure outlines the responsibilities as mandated by the Federal regulations when
       prisoners are involved as participants in research.
       1. Investigator Responsibilities.
           a. The Investigator will submit the application indicating whether prisoners will be a
              target population for research activities. If the participant population has an
              increased potential to become prisoners, and the Investigator will be interacting,
              intervening, or collecting identifiable private information during the incarceration,
              the Investigator may choose to have the proposal reviewed initially by the IRB for
              prisoner participation.
           b. The Investigator must report in writing to the IRB immediately when a participant
              becomes a prisoner after enrollment in research activities. If the research was not
              reviewed and approved by the IRB in accordance with 45 CFR 46 Subpart C, the
              Investigator must notify the IRB in writing of the event. All research interactions
              and interventions with, and obtaining identifiable private information about, the
              now incarcerated prisoner-participant must cease until the requirements of
              Subpart C have been satisfied with respect to the relevant research activities.
              NOTE: The IRB Chairperson may determine that the subject may continue to
              participate in the research until the requirements of Subpart C are satisfied in
              special circumstances in which the Investigator asserts that it is in the best
              interests of the subject to remain in the research study while incarcerated.
           c. Investigators are responsible for obtaining and providing documentation of
              approval from the detention or correctional facility involved (i.e., prisons, jails,
              workhouses, etc.) to the IRB.
           d. The Investigator will provide any additional documents or materials required for
              certification to the Secretary (through OHRP) for Federally funded research
              involving prisoners.
           e. The Investigator may not screen, recruit, or enroll any individual involuntarily
              confined or detained in a penal institution without written IRB approval. If the
              biomedical or behavioral research is conducted or supported by HHS, it also
              requires review and written approval by the Secretary (through OHRP) before any
              research activities may begin, including screening and enrollment.
       2. IRB Committee Responsibilities.
           a. The IRB Committee must review the proposed research taking into consideration
              all applicable LWC policies and procedures, as well as the additional
              requirements for prisoners to participate in research as described in 45 CFR 46,
              Subpart C.
           b. The Committee may not review or make determinations regarding studies
              involving prisoners as a target population unless the Committee has a member
              who is a prisoner or a prisoner representative with a close working knowledge,
   understanding and appreciation of prison conditions from the perspective of the
   prisoner. Documentation of expertise is provided by the curriculum vitae of the
   prisoner or prisoner representative serving on the IRB.
c. The IRB Committee will review the proposed research, consents, and applicable
   documents to determine whether the study meets criteria 45 CFR 46.111 and 21
   CFR 56.111 for approval. In order to provide written documentation of these
   criteria, the Primary reviewer must complete the Comment Sheet detailing how
   each of these criteria is met. In addition, the IRB will discuss the additional
   protections necessary for this. The Primary reviewer will be responsible for
   documenting these additional protections. All seven criteria for approval must be
   met and documented individually.
d. When a research participant becomes a prisoner, and the IRB has not previously
   reviewed the proposal for prisoner populations, the IRB will conduct a review of
   the research proposal in accordance with Subpart C and make one of the
   following determinations:
   i. IRB review and approval is not required if the research interactions and
        interventions or obtaining of identifiable private information will not occur
        during the incarceration period; or
   ii. Approve withdrawal of the participant(s) from the study if withdrawal will not
        place the participant at undue harm or risk; or
   iii. Approve research participation for non-prisoner participants but approve
        pending for prisoner-participants if the seven required findings in 45 CFR
        46.305(a) have been met but the IRB is still waiting on the receipt of the
        Secretary‟s determination (through OHRP if research is DHHS support
        research) that the proposed research falls within the categories of research
        permissible under 45 CFR 46.306(a)(2). All interactions and interventions
        with, and obtaining identifiable private information must cease for these
        prisoner-participants until the requirements of Subpart C have been satisfied
        with respect to the relevant protocol. NOTE: The Office for Human Research
        Protection (OHRP) has allowed one important exception. In special
        circumstances in which the Principal Investigator asserts that it is in the best
        interests of the participant to remain in the research study while incarcerated,
        the IRB Chairperson may determine that the subject may continue to
        participate in the research until the requirements of Subpart C are satisfied.
        (iii.a) Approve research participation for non-prisoner participants but defer
             for prisoner-participants if the seven required findings in 45 CFR
             46.305(a) have not been met to the satisfaction of the IRB. All interactions
             and interventions with, and obtaining identifiable private information must
             cease for these prisoner-participants until the requirements of Subpart C
             have been satisfied with respect to the relevant protocol. NOTE: OHRP
             has allowed one important exception. In special circumstances in which
             the Principal Investigator asserts that it is in the best interests of the
             participant to remain in the research study while incarcerated, the IRB
             Chairperson may determine that the subject may continue to participate in
             the research until the requirements of subpart C are satisfied.
e. For DHHS supported research, the institution must certify to the Secretary
   (through OHRP) that the IRB designated under its assurance of compliance has
   made the seven findings required under 45 CFR 46.305(a) and a statement
   indicating that the IRB chose one of the four permissible categories of research in
   45 CFR 46.306(a)(2).
   i. It is sufficient to include a statement that indicates that the IRB made the
        required findings under 45 CFR 46.305(a). OHRP does not require that the
        prisoner letter include a specific listing or rationale behind the IRB findings.
        The institution may wish to include a brief, protocol-specific explanation of
        the IRB‟s rationale for each finding.
   ii. The institution must indicate in the certification letter which of the four
        categories of permissible research involving prisoners in 45 CFR 46.306(a)(2)
        is applicable to the proposed research. Research involving prisoners can
        proceed only if the research fits under a category of permitted research under
        45 CFR 46.306(a)(2). OHRP will make its own determination, based on the
        information in the prisoner certification letter, the protocol materials and the
        grant application as to whether any of the four categories apply to the
        proposed research. OHRP may or may not concur with the IRB‟s choice of
        category.
   iii. The institution may wish to include a statement that indicates that the IRB was
        constituted as per the requirements in 45 CFR 46.304. OHRP does not require
        that the prisoner certification letter include information about the manner in
        which the IRB fulfills the requirements of 45 CFR 46.304. The institution may
        wish to provide the name of the prisoner representative.
   iv. In addition to the prisoner certification letter, the following information must
        also be sent to OHRP:
        (iv.a) The protocol application (which includes the protocol and any IRB
            submission materials including the informed consent forms); and
        (iv.b) The grant application (including any grant award updates).
   v. OHRP encourages the inclusion of the following information with the prisoner
        certification letter:
        (v.a) OHRP Assurance #;
        (v.b) IRB # for designated IRB;
        (v.c.) Site(s) where research involving prisoners will be conducted;
        (v.d) If prisoner research site is “engaged in research”, provide OHRP
            Assurance # for that site;
        (v.e) DHHS Grant Award #;
        (v.f) DHHS Funding Agency Name;
        (v.g) Funding Agency Grants/Program Officer Name and Telephone #;
        (v.h) Title of DHHS Grant;
        (v.i) Title of Protocol (if the same as the title of the grant, indicate as such);
        (v.ij) Version date of the informed consent form to be used with prisoners;
   vi. Date(s) of IRB Meeting(s) in which the protocol was considered and provide a
        chronology of:
        (vi.a) Date of initial IRB review; and/or
        (vi.b) Date of Subpart C reviews including:
         (a) Type of IRB review (initial, amendment, addendum, continuing
              review); and
         (b) Special IRB review for prisoner issues.
vii. Principal Investigator; and
viii. Reason for IRB review (choose the applicable reasons):
     (viii.a) Non-prison study (not previously reviewed and certified under Subpart
         C) in which participant has become incarcerated (or otherwise fits the
         definition of prisoner in 45 CFR 46.303(c)) and the PI wishes to continue
         the individual‟s participation in the study;
     (viii.b)Non-prison study with at-risk population (i.e., probationers, substance
         abusers);
     (viii.c)Non-prison study, majority of study population are non- prisoners but
         PI seeks to enroll some prisoners (as defined in 45 CFR 46.303(c));
     (viii.d)Minimal risk DHHS conducted or supported epidemiologic research,
         majority of study population are non-prisoners but PI seeks to enroll some
         prisoners (prisoners are not the focus of the study) and the sole purpose of
         the study is either:
         • To describe the prevalence or incidence of a disease by identifying all
              cases; or
         • To study potential risk factor associations for a disease.
     (viii.e)Initial Subpart C review of study designed to be conducted in a prison
         or using prisoners as defined in 45 CFR 46.303(c), the PI seeks to enroll
         already incarcerated subjects.
ix. The following will be included in the prisoner certification letter:
     (ix.a) Justification for the use of prisoners in the study. If applicable, delineate
         the protocol to be conducted in the prison from the overall project
         described in the grant application;
     (ix.b) Study objectives or study aims;
     (ix.c) Brief summary of study procedures;
     (ix.d) Customary treatment or services at the prison (or alternative to
         incarceration) research site(s) for the condition being studied;
     (ix.e) Description of how risks specific to a prison (or alternative to
         incarceration) setting are minimized;
     (ix.f) Whether the prison site(s) are “engaged in research” and whether they
         have obtained an assurance with OHRP;
     (ix.g) Whether a Certificate of Confidentiality was obtained by the PI for the
         study;
     (ix.h) Describe recruitment procedures in the specific prison (or alternative to
         incarceration) setting; and/or
     (ix.i) Describe how the consent form was altered for use with a prison
         population or specific prisoner and whether the subsequently incarcerated
         participant will be reconsented.
vii. All prisoner research certification letters should be mailed to: OHRP Prisoner
     Research Coordinator Office for Human Research Protections (OHRP)
     Department of Health and Human Services The Tower Building 1101
     Wootton Parkway, Suite 200 Rockville, MD 20852
            viii. The IRB Committee may approve the research for non-prisoner populations
                 until all the criteria in Subpart C are satisfied.
            ix. The IRB must inform the Investigator in writing that no prisoner-subjects can
                 be enrolled or involved until the IRB/institution receives a letter from OHRP
                 that acknowledges receipt of the prisoner certification and indicates the
                 Secretary‟s (through OHRP) determination that the proposed research falls
                 within the categories of research permissible under 45 CFR 46.306(a)(2).
      3. HSPP Staff Responsibilities.
         a. The staff member will verify that application (indicating use of a prison
            population) is completed by the Investigator as part of the initial study documents.
         b. The staff member will conduct a pre-review and take into consideration the
            requirements under 45 CFR 46, Subpart C, under which prisoners may participate
            in human subjects research.
         c. The staff member will e-mail the Investigator with any questions or needed
            clarification in regards to the prisoner population.
         d. The staff member will verify that the Committee reviewing the research involving
            a prisoner has at least one member who is a prisoner or prisoner representative in
            attendance.
         e. To adequately document the IRB review of the research:
            i. The curriculum vitae of the prisoner or prisoner representative serving on the
                 IRB will be on file in the IRB;
            ii. The discussion and determinations of the IRB regarding the seven additional
                 findings required under HHS regulations at 45 CFR 46.305(a) will be
                 documented in the minutes.
         f. The staff member will assist in preparing documents for the certification letter and
            prepare a draft certification letter to the Secretary (through OHRP) which will be
            signed by the appropriate institutional official listed on UA‟s FWA.

Reference:
45 CFR 46 Subpart C
28 CFR 512
OHRP Guidance Document: “OHRP Guidance on Involvement of Prisoners in Research”, May
23, 2003.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.C Special Categories of Research: The Fetus, Pregnant
Women, and Human Neonates and Transplantation of
Fetal Tissue
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGIAL CREATION DATE: October 2007
REVISED: October 2007


IX.C Special Categories of Research: The Fetus, Pregnant Women, and Human Neonates and
Transplantation of Fetal Tissue
      Definitions:
      1. Dead Fetus: A fetus that exhibits neither heartbeat, spontaneous respiratory activity,
           spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord (if
           still attached).
      2. Delivery: Complete separation of the fetus from the woman by expulsion or
           extraction or any other means.
      3. Fetus: The product of conception from implantation until delivery.
      4. Human Fetal Tissue: Tissue or cells obtained from a dead human embryo or fetus
           after a spontaneous or induced abortion, or after a stillbirth.
      5. Neonate: A newborn.
      6. Nonviable Neonate: A neonate after delivery that, although living, is not viable.
      7. Pregnancy: Encompasses the period of time from implantation until delivery. A
           woman shall be assumed to be pregnant if she exhibits any of the presumptive signs
           of pregnancy, such as a missed menses, until the results of a pregnancy test are
           negative or until delivery.
      8. Viable: As it pertains to the neonate, means being able, after delivery, to survive
           (given the benefit of available medical therapy) to the point of independently
           maintaining heartbeat and respiration.
      Policy:
      It is the policy of Lindsey Wilson College SPC Institutional Review Board (IRB) to
      review and approve all research involving pregnant women, human fetuses, and neonates
      of uncertain viability or nonviable neonates based on the Federal regulations at 45 CFR
      46 Subpart B and in addition to those imposed under other IRB policies, procedures, and
      other applicable Federal, State, and local laws.
      1. Research involving women who are or may become pregnant should receive special
           attention from the IRB because of women's additional health concerns during
           pregnancy and because of the need to avoid unnecessary risk to the fetus. Further, in
           the case of a pregnant woman, the IRB must determine when informed consent of the
           father is required for the research. Special attention is justified because of the
           involvement of a third party (the fetus) who may be affected but cannot give consent
           and because of the need to prevent harm or injury to future members of society.
           Procedural protections beyond the basic requirements for protecting human
           participants are prescribed in the Federal regulations for research involving pregnant
           women. Relevant discussions and decisions will be documented in the meeting
           minutes.
      2. §46.204: Research Involving Pregnant Women or Fetuses. Pregnant women or fetuses
           may be involved in research if all of the following conditions are met:
   a. Where scientifically appropriate, preclinical studies, including studies on pregnant
      animals, and clinical studies, including studies on non-pregnant women, have
      been conducted and provide data for assessing potential risks to pregnant women
      and fetuses; and
   b. The risk to the fetus is caused solely by interventions or procedures that hold out
      the prospect of direct benefit for the woman or the fetus; or if there is no such
      prospect of benefit, the risk to the fetus is not greater than minimal and the
      purpose of the research is the development of important biomedical knowledge
      which cannot be obtained by any other means; and
   c. Any risk is the least possible for achieving the objectives of the research; and
   d. If the research holds out the prospect of direct benefit to the pregnant woman, the
      prospect of a direct benefit both to the pregnant woman and the fetus, or no
      prospect of benefit for the woman nor the fetus when risk to the fetus is not
      greater than minimal and the purpose of the research is the development of
      important biomedical knowledge that cannot be obtained by any other means, her
      consent is obtained in accord with the informed consent provisions of 45 CFR 46
      Subpart A; and
   e. If the research holds out the prospect of direct benefit solely to the fetus then the
      consent of the pregnant woman and the father is obtained in accord with the
      informed consent provisions of 45 CFR 46 Subpart A, except that the father‟s
      consent need not be obtained if he is unable to consent because of unavailability,
      incompetence, or temporary incapacity or the pregnancy resulted from rape or
      incest; and
   f. Each individual providing consent under (D) or (E) above, is fully informed
      regarding the reasonably foreseeable impact of the research on the fetus or
      neonate; and
   g. For children as defined in 45 CFR 46.402(a) who are pregnant, assent and
      permission are obtained in accord with the provisions of 45 CFR 46 Subpart D;
      and
   h. No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
      and
   i. Individuals engaged in the research will have no part in any decisions as to the
      timing, method, or procedures used to terminate a pregnancy; and
   j. Individuals engaged in the research will have no part in determining the viability
      of a neonate.
   k. Research in which the subject is a fetus, in-utero or ex-utero (including human
      fetal tissue) must not be conducted at VA facilities, or at approved off-site
      facilities
3. §46.205: Research Involving Neonates.
   a. Neonates of uncertain viability. Until it has been ascertained whether or not a
      neonate is viable, a neonate may not be involved in research covered by this
      policy unless the following additional conditions have been met:
      i. The IRB must determine that:
           (i.a) The research holds out the prospect of enhancing the probability of
                survival of the neonate to the point of viability, and any risk is the least
                possible for achieving that objective; or
           (ii.b) The purpose of the research is the development of important biomedical
                knowledge which cannot be obtained by other means and there will be no
                added risk to the neonate resulting from the research; and
           (ii.c) The legally effective informed consent of either parent of the neonate, or
                if neither parent is able to consent because of unavailability,
                incompetence, or temporary incapacity, the legally effective informed
                consent of either parent‟s legally authorized representative is obtained in
                accord with 45 CFR 46 Subpart A, except that the consent of the father or
                his legally authorized representative need not be obtained if the pregnancy
                resulted from rape or incest.
   b. Nonviable neonates. After delivery a nonviable neonate may not be involved in
      research covered by this policy unless all of the following additional conditions
      are met:
      i. Vital functions of the neonate will not be artificially maintained; and
      ii. The research will not terminate the heartbeat or respiration of the neonate; and
      iii. There will be no added risk to the neonate resulting from the research; and
      iv. The purpose of the research is the development of important biomedical
           knowledge that cannot be obtained by other means; and
      v. The legally effective informed consent of both parents of the neonate is
           obtained in accord with 45 CFR 46 Subpart A, except that the waiver
           alteration provisions of §46.116(c) and (d) do not apply. However, if either
           parent is unable to consent because of unavailability, incompetence, or
           temporary incapacity, the informed consent of one parent of a nonviable
           neonate will suffice to meet the requirements of this paragraph, except that the
           consent of the father need not be obtained if the pregnancy resulted from rape
           or incest. The consent of a legally authorized representative of either or both
           of the parents of a nonviable neonate will not suffice to meet the requirements
           of this paragraph.
   c. Viable neonates. If a neonate is judged viable (i.e. likely to survive to the point of
      sustaining life independently, given the benefit of available medical therapy), it is
      then called an infant and should be treated as a child for purpose of research
      participation. A neonate, after delivery, that has been determined to be viable may
      be included in research only to the extent permitted by and in accord with the
      requirements of 45 CFR 46 Subparts A and D.
4. §46.206: Research Involving, After Delivery, the Placenta, the Dead Fetus, or Fetal
   Material.
   a. Research involving, after delivery, the placenta; the dead fetus; macerated fetal
      material; or cells, tissue, or organs excised from a dead fetus, shall be conducted
      only in accord with any applicable Federal, State, or local laws and regulations
      regarding such activities.
      i. For example, Kentucky Code makes it unlawful for any person or entity to
           engage in the following activities on a fetus or embryo resulting from an
           induced abortion (36-2302):
      ii. medical experimentation, or
      iii. scientific or medical investigation.
   b. If information associated with material described in paragraph A of this section is
       recorded for research purposes in a manner that living individuals can be
       identified, directly or through identifiers linked to those individuals, those
       individuals are research subjects and all pertinent subparts of the regulations are
       applicable.
5. §46.207: Research Not Otherwise Approvable Which Presents an Opportunity to
   Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare
   of Pregnant Women, Fetuses, or Neonates. The Secretary of the Department of Health
   and Human Services (DHHS) will conduct or fund research that the IRB does not
   believe meets the requirements of 45 CFR 46.204 or 45 CFR 46.205 only if:
   a. The IRB finds that the research presents a reasonable opportunity to further the
       understanding, prevention, or alleviation of a serious problem affecting the health
       or welfare of pregnant women, fetuses, or neonates; and
   b. The Secretary, after consultation with a panel of experts in pertinent disciplines
       (for example: science, medicine, ethics, law) and following opportunity for public
       review and comment, including a public meeting announced in the Federal
       Register, has determined either:
       i. That the research, in fact, satisfies the conditions of §46.204, as applicable; or
       ii. The following:
           (ii.a) The research presents a reasonable opportunity to further the
                understanding, prevention, or alleviation of a serious problem affecting the
                health or welfare of pregnant women, fetuses, or neonates; and
           (ii.b) The research will be conducted in accord with sound ethical principles;
                and
           (ii.c) informed consent will be obtained in accord with the informed consent
                provisions of 45 CFR 46 Subpart A and other applicable subparts of 45
                CFR 46.
6. Modification or Waiver of Specific Requirements. Upon the request of the
   Investigator (with the approval of the IRB), the Secretary of the Department of Health
   and Human Services may modify or waive any of the above requirements of this
   policy.
7. Studies in Which Pregnancy is Coincidental to Subject Selection.
   a. Any study in which women of childbearing potential are possible subjects may
       inadvertently include pregnant women. Federal regulations require that, when
       appropriate, subjects be provided a statement that the particular treatment or
       procedure may involve risks to the subject (or to the embryo or fetus, if the
       subject is or may become pregnant) which are currently unforeseeable as part of
       the informed consent process.
   b. The IRB must judge whether the mother's participation would pose any risk to the
       fetus or nursing infant. In some studies, the IRB may need to assure that non-
       pregnant subjects are advised to avoid pregnancy or nursing for a time during or
       following the research. Furthermore, where appropriate, subjects should be
       advised to notify the Investigator immediately should they become pregnant. In
       some instances, there may be potential risk sufficient to justify requiring that
       pregnant women either be specifically excluded from the research or studied
       separately.
8. Exemption from Review. Note that with the revision of Subpart B on November 13,
   2001, the exemptions from IRB review listed at 45 CFR 46.101(b) may now be
   applied to research involving pregnant women, human fetuses, and neonates in
   accordance with 45 CFR 46.201(b).
9. Research on Transplantation of Fetal Tissue. The IRB must assure that the following
   provisions have been met before approving such research activities:
   a. Research involving the transplantation of human fetal tissue for therapeutic
      purposes may be conducted only if the woman providing the tissue makes a
      statement, in writing and signed by the woman, declaring that:
      i. The woman donates the fetal tissue for research; and
      ii. The donation is made without any restriction regarding the identity of
           individuals who may be the recipients of transplantations of the tissue; and
      iii. The woman has not been informed of the identity of any such individuals.
   b. Research involving the transplantation of human fetal tissue for therapeutic
      purposes may be conducted only if the attending physician with respect to
      obtaining the tissue from the woman involved makes a statement, in writing and
      signed by the attending physician, declaring that:
      i. In the case of tissue obtained pursuant to an induced abortion:
           (i.a) The consent of the woman for the abortion was obtained prior to
                requesting or obtaining consent for a donation of the tissue for use in such
                research; and
           (i.b) No alteration of the timing, method, or procedures used to terminate the
                pregnancy was made solely for the purposes of obtaining the tissue; and
           (i.c) The abortion was performed in accordance with applicable State law; and
      ii. The tissue has been donated by the woman in accordance with (paragraph 9.
           a) of this Section; and
      iii. Full disclosure has been provided to the woman with regard to:
           (iii.a) Such physician‟s interest, if any, in the research to be conducted with
                the tissue; and
           (iii.b) any known medical risks to the woman or risks to her privacy that
                might be associated with the donation of the tissue and that are in addition
                to risks of such type that are associated with the woman‟s medical care.
   c. Research involving transplantation of human fetal tissue for therapeutic purposes
      may be conducted only if the Principal Investigator (PI) makes a statement in
      writing and signed by the PI, declaring that the PI:
      i. Is aware that:
           (i.a) The tissue is human fetal tissue; and
           (i.b) The tissue may have been obtained pursuant to a spontaneous or induced
                abortion or pursuant to a stillbirth; and
           (i.c) The tissue was donated for research purposes; and
      ii. The PI has provided such information to other individuals with responsibilities
           regarding the research; and
      iii. The PI will require, prior to obtaining the consent of an individual to be a
           recipient of a transplantation of the tissue, written acknowledgment of receipt
           of such information by such recipient; and
             iv. The PI has had no part in any decisions as to the timing, method, or procedures
                 used to terminate the pregnancy made solely for the purpose of the research.
          d. Research involving transplantation of human fetal tissue for therapeutic purposes
             may be conducted only if the head of the agency or other entity conducting the
             research involved certifies to the Secretary of the Department of Human Services
             (DHHS) that the statements required under paragraphs B and C of this section
             will be available for audit by the Secretary.
             i. Research involving transplantation of human fetal tissue for therapeutic
                 purposes may be conducted only if it is conducted in accordance with
                 applicable Federal, State and local laws and institutional policies and
                 procedures.
References:
45 CFR 46 Subpart B
OHRP Guidance Document: “Fetal Tissue Transplantation”, February 2003.
42 USC 289g and Sections 498 and 498A
OHRP Guidance Document, “Fetal Tissue Transplantation,” February 7, 2003.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.C Special Categories of Research: The Fetus, Pregnant Women, and Human Neonates and Transplantation of Fetal
Tissue
SUB-PART: IX.C.1 Procedure for Special Categories of Research: The Fetus, Pregnant Women, and Human Neonates and
Transplantation of Fetal Tissue
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGIAL CREATION DATE: October 2007


IX.C.1 Procedure for Special Categories of Research: The Fetus, Pregnant Women, and Human
Neonates and Transplantation of Fetal Tissue
       Procedure:
       The purpose of this procedure is to provide guidance on the requirements for review and
       approval for pregnant women, human fetuses, neonates, and transplantation of fetal tissue
       activities in human subjects research under Lindsey Wilson College SPC (LWC) Human
       Subjects Protection Program (HSPP) jurisdiction.
       1. Investigator Responsibilities.
           a. The Investigator will submit the application indicating that the target population
                for research includes pregnant women, fetuses, neonates, or research on
                transplantation of fetal tissue.
           b. Once the full IRB Committee approves the study, the Investigator will obtain
                informed consent from the mother and father.
           c. It is the Investigator‟s responsibility to provide the extra declarations in the
                consent document when conducting research on transplanted fetal tissue.
       2. IRB Committee Responsibilities.
           a. The IRB Committee will review and approve research in accordance with the
                Federal regulations at 45 CFR 46 Subpart A.
           b. The IRB Committee must review the proposed research taking into consideration
                all applicable IRB polices and the requirements for involvement of pregnant
                women, fetuses, neonates, and fetal tissue transplantation activities in research.
           c. The IRB will discuss the additional protections necessary for this population. The
                Primary reviewer will be responsible for documenting these added protections.
           d. When the research involves fetal tissue for transplantation, the IRB must obtain
                and review the required written and signed statements by the research participant,
                the Investigator and the attending physician obtaining the tissue from the woman.
       3. HSPP Staff Responsibilities.
           a. The staff member will verify that the application is completed as part of the initial
                study documents.
           b. The staff member will conduct a pre-review and will take into consideration the
                additional requirements under Subpart B for research activities involving pregnant
                women, fetuses, neonates, or research involving transplantation of fetal tissue.
           c. E-mails requesting pre-review changes to the informed consent documents are to
                be sent to the Investigator by the staff member.
           d. Once the pre-review revisions are received from the Investigator, the staff
                member will place the new study with the revised informed consent documents on
                the next available Committee agenda, assign reviewers with the appropriate
                expertise, and prepare the reviewer and Committee packets.
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.D Special Categories of Research: Cognitively Impaired
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGIAL CREATION DATE: October 2007


IX.D Special Categories of Research: Cognitively Impaired
      Definitions:
      1. Assent: An individual‟s affirmative agreement to participate in research obtained in
           conjunction with permission from the individual‟s legally authorized representative.
           Mere failure to object should not, absent affirmative agreement, be construed as
           assent.
      2. Cognitively Impaired: Having a psychiatric disorder (e.g., psychosis, neurosis,
           personality or behavior disorder), an organic impairment (e.g., dementia) or a
           developmental disorder (e.g., mental retardation) that affects cognitive or emotional
           functions to the extent that capacity for judgment and reasoning is significantly
           diminished. Others, including persons under the influence of or dependent on drugs or
           alcohol, those suffering from degenerative diseases affecting the brain, terminally ill
           patients, and persons with severely disabling physical handicaps, may also be
           compromised in their ability to make decisions in their own best interest.
      3. Dissent: An individual‟s negative expressions, verbal and/or non-verbal that they
           object to participation in the research or research activities.
      Policy:
      It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
      Program (HSPP) to review, approve, and provide guidance on the special ethical
      considerations when cognitively impaired participants are involved in human subjects
      research.
      1. IRB Review and Approval of Research Involving Cognitively Impaired Participants.
           Because cognitively impaired individuals may have diminished autonomy that may
           limit their capacity to provide consent or their ability to withdraw, research involving
           cognitively impaired participants should be reviewed and approved through
           consideration of the LWC HSPP policies and the special considerations as determined
           by the Belmont Report, Federal and State regulations, and guidance documents.
           a. The LWC IRB must review all research in which cognitively impaired individuals
               will be considered as participants to assure that the Investigator has provided
               additional safeguards to protect the rights and welfare of this vulnerable
               population.
           b. The IRB must consider the degree of cognitive impairment of the participant, the
               level of risk and the prospect of benefit to the individual participant.
           c. For research with cognitively impaired participants or those with impaired
               decision-making, the IRB committee must document (in writing) the
               determination regarding each of the required criteria listed in IX.D.1 for all
               research. If these criteria are met, the IRB Committee may approve the inclusion
               of incompetent subjects or subjects with impaired decision-making capacity in
               research projects on the basis of informed consent from authorized
               representatives. Both investigators and committee members must be aware that
               for some subjects their decision-making capacity may fluctuate. For subjects with
               fluctuating decision-making capacity or with decreasing capacity to give consent,
       a re-consenting process may be necessary. Although incompetent to provide
       informed consent, some persons may resist participating in a research protocol
       approved by their representative. Under no circumstances may subjects be forced
       or coerced to participate.
2. Requirements for Evaluating Decision-Making Capacity for Cognitively Impaired
   Participants.
   a. The IRB must find that appropriate provisions are made for determining the
       participant‟s ability to provide consent or their ability to withdraw, through
       evidence of one or more of the following pertaining to the individual:
       i. The ability to make a choice;
       ii. The ability to understand relevant information;
       iii. The ability to appreciate the situation and its likely consequences; and
       iv. The ability to manipulate information rationally.
   b. The determination of capacity to consent or ability to withdraw may be made
       through a standardized measure or consultation with another qualified
       professional. The IRB Committee must approve the process for making such a
       determination.
   c. Because the capacity to consent or the ability to withdraw may fluctuate, the IRB
       must evaluate the process for continued verification of understanding and
       willingness to participate.
       i. The consent procedures should describe a plan for protecting individuals who
            may lose their capacity to provide consent or their ability to withdraw while
            participating in research activities (e.g., use of an research participant
            advocate).
       ii. The IRB may require that an outside witness observe and confirm the
            consenting process.
   d. For participants who lack decision-making capacity, the permission of the
       individual‟s legally authorized representative is required and assent should be
       obtained from the participant.
       i. In research situations where there is the potential for direct benefit to the
            participant, the IRB may waive the requirement to obtain assent. However,
            permission from the legally authorized representative must be obtained.
       ii. Even where the IRB determines that the individuals are capable of consenting
            or withdrawing, the IRB may still waive the consent requirements under the
            circumstances described in the LWC IRB informed consent policy.
            NOTE: Waiver does not apply to research subject to FDA regulations
   e. The IRB must also review and approve the appropriate consent documents with
       the required elements of consent written in a language understandable to the
       participant.
3. Appropriate Provisions for Legally Authorized Representative Consent.
   a. When it is determined by the Investigator that the participant lacks decision-
       making capacity, the IRB must find that appropriate provisions are made for
       soliciting the permission of each individual‟s legally authorized representative
       unless the criteria are met to approve a waiver of informed consent.
4. Institutionalized Individuals.
           a. The IRB must consider the rationale and justification for involvement of
              institutionalized participants, including an explanation as to why non-
              institutionalized individuals could not be used.
       5. Composition of IRB when Cognitively Impaired Participants are Involved in
           Research.
           a. When reviewing research involving cognitively impaired participants, individuals
              considered incompetent or individuals who have an impaired decision-making
              capacity, the IRB Committee will include into its composition one or more
              individuals who are knowledgeable about and experienced in working with these
              individuals.
           b. When the study requires review by the full IRB Committee, it must meet the
              special composition requirements when conducting reviews for initial review,
              continuing review, protocol amendments, and reports of adverse events or
              unanticipated problems when the research involves cognitively impaired
              individuals.
References:
The Belmont Report
The Office of Human Subjects Research (OHSR), National Institutes of Health, Information
Sheet #7, “Research Involving Cognitively Impaired Subjects: A Review of Some Ethical
Considerations”
VHA Handbook 1200.5
PROGRAM: Human Subjects Protection Program
SECTION: IX Vulnerable Populations
POLICY NUMBER: IX.D Special Categories of Research: Cognitively Impaired
SUB-PART: IX.D.1 Procedure for Special Categories of Research: Cognitively Impaired
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGIAL CREATION DATE: October 2007


IX.D.1 Procedure for Special Categories of Research: Cognitively Impaired
       Procedure:
       This procedure provides guidance on the special ethical and regulatory considerations of
       cognitively impaired individuals involved in human subjects research under the
       jurisdiction of Lindsey Wilson College SPC (LWC) Human Subjects Protection Program
       (HSPP).
       1. Investigator Responsibilities.
           a. The Investigator will submit the application indicating whether cognitively
               impaired participants will be a target population for research activities.
           b. The research plan should address the following considerations:
               • A rationale as to why is it necessary to include this population;
               • A description of potential benefits to this population;
               • A justification for the use of institutionalized individuals, if applicable;
               • A description as to why non-institutionalized individuals could not be used;
               • A description of the research as it pertains to the institutionalization, if
                   applicable;
               • A justification of any plan to hospitalize participants or extend their
                   hospitalization for research purposes;
               • A description of the procedure for determining capacity for decision-making
                   of the individuals;
               • A description as to how individuals will be protected in the event they lose
                   their capacity to consent and their capacity to withdraw;
               • A description of the methods for assuring adequate protections for the privacy
                   of the participants and the confidentiality of the information gathered;
               • A description as to how permission will be obtained and documented from the
                   legally authorized representative, if applicable;
               • A process for consulting with the participant‟s health care provider, when
                   applicable; and
               • A description of any research procedures that may likely interfere in the
                   participant‟s ongoing therapy or regimes.
           c. An Investigator should not solicit consent of a participant who lacks decision-
               making capacity without intending to take his/her wishes seriously. In situations
               where the potential benefits of the study are such that the physicians and legally
               authorized representative would enroll the participant regardless, and the
               participant‟s capacity is so diminished that he/she could not understand the
               ramifications of not participating, the participant should simply be told what is
               planned and should not be deceived.
               i. A request of wavier for consent should be submitted to the IRB for
                   determination.
               ii. Should a situation exist in which the target population lacks decision-making
                   capacity either through trauma, life-threatening condition, or coma, the
           Investigator may submit a request for consent from a legally authorized
           representative.
   d. The Investigator must present an informed consent document to the IRB for
      review containing the appropriate amount of information for the participant to
      make an informed decision. If, in the opinion of the Investigator, a complete
      informed consent document is not appropriate, a waiver or alteration of informed
      consent should be requested including a rationale for the alteration.
      i. Once approved, the Investigator may proceed with consent of the participant
           and/or legally authorized representative as outlined in IRB Policy IV.A, unless
           a waiver has been granted.
   e. Investigators must be aware that for some subjects, their decision-making
      capacity may fluctuate. For subjects with fluctuating decision-making capacity or
      those with a decreasing capacity to give consent, a re-consenting process with
      surrogate (legally authorized representative) consent may be necessary (Although
      incompetent to provide informed consent, some persons may resist participating
      in a research protocol approved by their representatives. Under no circumstances
      may subjects be forced or coerced to participate.
2. IRB Committee Responsibilities.
   a. The IRB Committee must review the proposed research taking into consideration
      all applicable HSPP policies and procedures, as well as the degree of risk and
      discomfort involved in the research in relation to the direct benefits it offers to the
      participant. In addition, the IRB must be sure that additional safeguards are in
      place to protect the rights and welfare of these participants.
   b. The Committee will consider the necessity of involving subjects who are unable
      to provide consent or other vulnerable populations not covered by other specific
      policies and procedures (e.g., institutionalized individuals) as potential
      participants in research studies. Incapable participants (those who do not have
      sufficient capacity to consent) should not be involved in research that could be
      conducted with capable participants. However, the Committee may permit
      incapable participants or other vulnerable populations not covered by other
      specific policies and procedures (e.g., institutionalized individuals) to participate
      in research when access is provided to benefits that may be derived through
      participation and not otherwise available.
   c. The effects of separation from supportive family or friends, of disruption in
      schooling or employment, and the question of responsibility for bearing any
      additional costs should be carefully considered by the IRB.
   d. When determining whether the participants are capable of providing consent, the
      IRB shall take into account the decision-making capacity of the study population.
      This determination may apply to all participants to be involved in the study, or on
      a case-by-case basis, as deemed necessary by the IRB. For research with this
      population including VA research, the IRB Committee must determine that the
      following conditions apply:
      • Only incompetent persons or persons with impaired decision-making capacity
           are suitable as research participants;
      • Competent persons are not suitable for the proposed research;
   •   The investigator must demonstrate to IRB a compelling reason to include
       incompetent individuals or persons with impaired decision-making capacity as
       participants;
   • Incompetent persons or persons with impaired decision-making capacity must
       not be proposed as subjects simply because they are readily available;
   • The proposed research entails no significant risk, tangible or intangible, or if
       the research presents some probability of harm, there must be at least a greater
       probability of direct benefit to the participant;
   • Incompetent people or persons with impaired decision-making capacity are
       not to be subjects of research that imposes a risk of injury, unless that research
       is intended to benefit that participant and the probability of benefit is greater
       than the probability of harm;
   • Procedures have been devised to ensure the participants‟ representatives are
       well informed regarding their roles and obligations to protect incompetent
       participants or persons with impaired decision-making capabilities;
   • Legally authorized representatives will be told that their obligation is to try to
       determine what the subject would do if competent, or if the subject‟s wishes
       cannot be determined, what they think is in the incompetent person‟s best
       interest.
e. The Committee will make the determination in writing of each of the above-listed
   criteria for all research, including VA research. If these criteria are met, the IRB
   may approve the inclusion of incompetent subjects or subjects with impaired
   decision-making capacity in research projects on the basis of informed consent
   from authorized representatives
f. IRB members must be aware that for some subjects, their decision-making
   capacity may fluctuate. For subjects with fluctuating decision-making capacity or
   those with a decreasing capacity to give consent, a re-consenting process with
   surrogate (legally authorized representative) consent may be necessary. Although
   incompetent to provide informed consent, some persons may resist participating
   in a research protocol approved by their representatives. Under no circumstances
   may subjects be forced or coerced to participate
g. For research involving adults unable to consent, the IRB must consider the
   following:
   i. Consent may be requested and accepted from a legally authorized
       representatives in situations where the prospective participants are
       incompetent or have impaired decision-making capacity, as determined and
       documented in the person‟s medical record in a signed and dated progress
       note.
   ii. Determination that a participant is incompetent or has an impaired decision-
       making capacity must be made in accordance with the following requirements
       or as established by a legal determination:
       (ii.a) A practitioner, in consultation with the chief of service, after appropriate
            medical evaluation, may determine that the prospective participant lacks
            decision-making capacity and is unlikely to regain it within a reasonable
            period of time.
           (ii.b) If the determination that the prospective participant lacks decision-
                making capacity is based on a diagnosis of mental illness, consultation
                with a psychiatrist or licensed psychologist must be obtained.
           (ii.c) Whenever feasible, the practitioner must explain the proposed research
                to the prospective participant even when the surrogate (legally authorized
                representative) gives consent.
      iii. Forced or coerced to participation in a research study is prohibited. The
           Committee must consider possible coercion in its deliberations for
           consideration of inclusion of those individuals with impaired decision-making
           capacity or incompetent subjects.
   e. The methods in which the full IRB Committee approves a new study submission
      will be followed. In addition to determining whether the study meets criteria 45
      CFR 46.111 for approval, the Primary reviewer must also complete the Comment
      Sheet to assure that adequate provisions and documentation of such provisions
      have been made for this population.
   f. The Committee may not review or make a determination regarding studies
      involving the cognitively impaired, as a target population, unless it has sufficient
      expertise in the ethical, clinical, and psychosocial issues impacting this
      population. Therefore, a Committee member who is knowledgeable about and
      experienced in working with these subjects must be in attendance at the convened
      meeting or an expert consultant who has this knowledge must be consulted by the
      IRB. When the IRB Committee renders its determination it will include:
      i. Requirements for determining the decision-making capacity of the target
           population or on a case-by-case bases, or a rationale why this requirement will
           be waived; and
      ii. Appropriate methods for assuring the amount of information contained in the
           consent documents is appropriate for the target population and the legally
           authorized representative, when necessary.
   g. When institutionalized individuals are involved in research, the IRB must verify
      that the institution has granted approval for the research to take place at that site.
      Depending on whether the performance site is “engaged in research”, a letter of
      site approval or a letter of cooperation signed by an official of the institution is
      required.
3. HSPP Staff Responsibilities.
   a. The staff member will verify that application is completed as part of the initial
      study documents.
   b. The staff member will conduct a pre-review and take into consideration the
      capacity of the participants in the proposed research when pre-reviewing the
      informed consent documents.
   c. E-mails requesting pre-review changes to the informed consent documents are to
      be sent to the Investigator by the staff member.
   d. Once the pre-review revisions are received from the Investigator, the staff
      member will place the new study with the revised informed consent documents on
      the next available Committee agenda, assign reviewers with the appropriate
      expertise, and prepare the reviewer and Committee packets.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.A HIPAA Policy
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.A Health Insurance Portability and Accountability Act (HIPAA) Policy
      Purpose:
      This policy defines the circumstances under which Protected Health Information (PHI)
      may and may not be used internally or disclosed externally in connection with research
      activities. This Policy covers all PHI, which is or may be created, used or disclosed by,
      through or during research activities, and applies to all faculty, staff and students who
      conduct research, assist in the performance of research, or otherwise use or disclose PHI
      in connection with research activities at Lindsey Wilson College SPC.
      Definitions:
      Anonymous Data: Information that was previously recorded or collected without any of
          the 18 identifiers defined by HIPAA regulation and no code is assigned which would
          allow data to be traced to an individual
      Authorization is defined as a customized document, usually prepared as a stand alone
          document, used in conjunction with the informed consent document, that gives the
          covered entity permission to use specified PHI for a specific purpose, or to disclose
          PHI to a third party specified by the subject in the authorization. Lindsey Wilson
          College SPC IRB requires the authorization to be a stand alone document.
      Business Associate A person or entity that performs certain functions or activities that
          involve the use or disclosure of protected health information, on behalf of or provides
          services to, a covered entity
      Covered Component (CC) Department or division of the covered entity that engage in
          „covered functions‟ and any component that engages in activities that would make
          such component a „business associate‟ of a component that performs covered
          functions if the two components were separate legal entities.
      Covered Entity (CE): Under HIPAA regulations, this is a health plan, a health care
          clearinghouse, or a health care provider who transmits any health information in
          electronic form in connection with a HIPAA transaction.
      Data Use Agreement is defined as an agreement between the Covered Entity and the
          recipient of the PHI. This agreement establishes who is permitted to use or receive the
          limited data set; and provides that the limited data set recipient will:
          a. Not use or further disclose the information other than as permitted by the data use
               agreement or as otherwise required by law;
          b. Use appropriate safeguards to prevent use or disclosure of the information other
               than as provided for by the data use agreement;
          c. Report to the covered entity any use or disclosure of the information not provided
               for by its data use agreement of which it becomes aware;
          d. Ensure that any agents, including a subcontractor, to whom it provides the limited
               data set agrees to the same restrictions and conditions that apply to the limited
               data set recipient with respect to such information; and
          e. Not identify the information or contact the individuals.
Individually Identifiable Health Information: Any information collected from an
   individual (including demographics) that is created or received by a health care
   provider, health plan, employer, and/or health care clearinghouse that relates to the
   past, present or future physical or mental health or condition of an individual, or the
   provision of health care to an individual or the past, present or future payment for the
   provision of health care to an individual and identifies the individual and/or to which
   there is reasonable basis to believe that the information can be used to identify the
   individual (45 CFR 160.103).
Limited Data Set is defined as PHI that excludes the following direct identifiers of the
   individual or of relatives, employers, or household members of the individual:
   a. Names;
   b. Postal address information, other than town or city, state, and zip code;
   c. Telephone numbers;
   d. Fax numbers;
   e. Electronic mail addresses;
   f. Social Security numbers;
   g. Medical Record numbers;
   h. Health plan beneficiary numbers;
   i. Account numbers;
   j. Certificate/license numbers;
   k. Vehicle identifiers and serial numbers, including license plate numbers;
   l. Device identifiers and serial numbers;
   m. Web Universal Resource Locators (URLs);
   n. Internet Protocol (IP) address numbers;
   o. Biometric identifiers, including finger and voiceprints; and
   p. Full face photographic images and any comparable images.
   q. Admission or procedure dates
   r. Date of birth
Minimum Necessary Standard : Covered Entities must take reasonable steps to limit
   the use or disclosure of PHI to the minimum necessary to accomplish the intended
   purpose.
Privacy Breach: Disclosure in oral, paper, or electronic format of Protected Health
   Information (PHI) that is not permitted under the HIPAA Privacy Rule.
Protected Health Information (PHI): Individually identifiable health information that
   is or has been collected or maintained by a covered entity or covered component,
   such as the College Medical Center UMC) or Speech and Hearing Sciences, including
   information that is collected for research purposes only, and can be linked back to the
   individual participant.
Use of PHI : Querying, viewing, and/or extracting any protected health information for
   research purposes within the covered entity.
Disclosure of PHI: Providing PHI to another entity or person. This entity may be an
   internal component, another covered entity or a business associate with whom the CE
   has signed a Business Associate Agreement.
Preparatory to Research: Any action taken in assessing the research
   question/hypothesis such as accessing medical records, querying of databases for any
   type of individually expiration date or event, or a statement such as “end of research
    study” or “identifiable health information, or any activity where PHI is accessed to
    prepare a research protocol.
Policy: It is the policy of Lindsey Wilson College SPC‟s HSPP that confidentiality of
research data be used/stored/disclosed according to current HIPAA regulations as
follows:
1. Research Use or Disclosure of PHI With Authorization.
    a. The researcher must obtain an authorization from all participants in research prior
        to the use or disclosure of PHI for any research related purpose that is not
        otherwise permitted or required under this Policy.
    b. The researcher must submit the HIPAA Authorization Form as part of the IRB
        Application for review and approval. The template addresses the following
        elements:
        i. A specific and meaningful description of the information to be used or
             disclosed;
        ii. The name or identification of the persons or class of persons authorized to
             make or receive disclosures of PHI and to use the PHI for research-related
             purposes;
        iii. An expiration date or event, or a statement such as “none” when appropriate
             (e.g., for a research database);
        iv. A statement that the individual may revoke the authorization if requested in
             writing to the Principal Investigator. However, the researcher may continue to
             use and disclose, for research integrity and reporting purposes, any PHI
             collected from the individual, pursuant to such authorization before it was
             revoked;
        v. A statement that an individual‟s clinical treatment may not be conditioned
             upon whether the individual signs the research authorization;
        vi. A statement that Personal Health Information ( PHI) disclosed to another
             party, who does not meet the definition of a Covered Entity, could potentially
             be re-disclosed by the recipient and would no longer be protected under
             HIPAA.
        vii. The individual‟s signature (or that of his/her authorized representative) and
             date.
2. Waiver of Authorization.
    a. In some circumstances, research authorizations otherwise required under this
        Policy may be waived or altered by the IRB, provided the following criteria are
        satisfied and documented:
        i. The use or disclosure of PHI involves no more than a minimal risk to the
             privacy of individuals based on the presence of all following elements:
             (i.a) An adequate plan to protect the identifiers from improper use and
                  disclosure;
             (i.b) An adequate plan to destroy the identifiers at the earliest opportunity
                  consistent with the conduct of the research, unless there is a health or
                  research justification for retaining the identifiers as required by law.
             (i.c) Adequate written assurances that the protected health information will
                  not be reused or disclosed to any other person or entity, except as required
                  by law, for authorized oversight of the research project, or for other
               research for which the use or disclosure of PHI would be permitted by this
               Policy.
      ii. The research could not practicably be conducted without the waiver.
      iii. The research could not practicably be conducted without access to and use of
           the PHI.
   b. A request for Waiver of Authorization must be completed by the researcher and
      submitted to the IRB for prior review and approval; and
   c. Uses or Disclosures of PHI made pursuant to a Waiver are subject to the
      Minimum Necessary Standard.
   d. Documentation of Waiver of Authorization for PHI
      The following language should be included in the letter of approval to the
      Principal Investigator:
      We received your request for waiver of Authorization Form for the above
      referenced project. Elimination of use of this form pose(s) no more than minimal
      risk to participating subjects. Regulations issued by the U.S. Department of
      Health and Human Services [45 CFR 46.110(b)(2)] authorize approval for this
      type of request through the expedited review procedures. Regulations issued by
      the U.S. Department of Health and Human Services [45 CFR 46.512(i)(2)]
      authorize the use of disclosure of Protected Health Information (PHI) without the
      written authorization of the individual or the opportunity for the individual to
      agree or object based upon the determination that risk to the privacy of
      individuals is minimal, that the investigator will protect the identifiers from
      improper use or disclosure, by destruction of the identifiers at the earliest
      opportunity consistent with the research, with the condition that the PHI will not
      be reused or disclosed outside this study except as detailed in the request of
      waiver of authorization and that the research could not be practicably conducted
      without this waiver or without the PHI. PHI that may be used or disclosed for this
      protocol is limited to (state disclosed elements). A brief summary of this request
      will be documented in the IRB Committee Minutes. This waiver is approved
      effective Day/Month/Year.
3. Use and Disclosure of PHI Without Authorization When It Is Preparatory to
   Research.
   a. Researchers may use or disclose PHI without IRB review for the development of
      a research protocol, provided that all of the following criteria are satisfied:
      i. The use or disclosure of PHI is solely to prepare a research protocol, or to
           identify prospective research participants for purposes of seeking an
           authorization;
      ii. The researcher shall not record or remove the PHI from the Covered Entity;
      iii. The PHI sought is necessary for the purposes of the research.
4. Use and Disclosure of Decedent’s PHI Without Authorization.
   a. Researchers may use and disclose a decedent‟s PHI for research purposes without
      IRB review provided that all of the following criteria are satisfied:
      i The use will be solely for research on the PHI of a decedent;
      ii. The PHI sought is necessary for the purposes of the research; and
      iii. The researcher has documentation of the death of the individual about whom
           information is being sought.
5. Use or Disclosure of “De-Identified” Protected Health Information.
   a. De-identified health information is exempt from HIPAA regulations and may be
      used or disclosed for research purposes without an authorization or IRB waiver of
      authorization.
   b. Researchers must provide documentation to the IRB that the health information
      has been de-identified by one of the following two methods:
      i. Statistical Method: The IRB may determine that health information is de-
           identified for purposes of this Policy, if an independent, qualified statistician:
           (i.a) Determines that the risk of re-identification of the data, alone or in
                combination with other data, is very small; and
           (i.b) Documents the methods and results by which the health information is
                de-identified, and the expert makes his/her determination of risk. Note: the
                expert may not be the researcher or anyone directly involved in the
                research study.
      ii. Removal of All Identifiers: Health Information is considered de-identified if
           the 18 HIPAA specific identifying elements relating to the individual,
           relatives, or employer has been removed. In addition, there is no other
           available information that could be used alone or in combination to identify an
           individual. Identifiers that must be removed are: 1. Names 2. Geographic
           subdivisions smaller than a State, including street address, city, county,
           precinct, and the initial three digits of the zip code if the geographic unit is
           greater than 20,000 people 3. All elements of dates (except year) related to an
           individual - including dates of admission, discharge, birth, death - and for
           persons >89 y.o., the year of birth cannot be used. 4. Telephone numbers 5.
           FAX numbers 6. Electronic mail addresses 7. Social Security Numbers 8.
           Medical Record numbers 9. Health plan beneficiary numbers 10. Account
           numbers 11. Certificate/license numbers 12. Vehicle identifiers and serial
           numbers including license plates 13. Device identifiers and serial numbers 14.
           Web URLs 15. Internet protocol addresses 16. Biometric identifiers, including
           finger and voice prints 17. Full face photos and comparable images 18. Any
           unique identifying number, characteristic or code
      iii. The de-identified information may be assigned a re-identification code that
           can be affixed to the research record that will permit the information to be re-
           identified if necessary, provided that, the key to such a code is not accessible
           to the researcher requesting to use or disclose the de-identified health
           information.
6. Limited Data Set.
   a. A researcher may use or disclose a Limited Data Set for any research purpose
      without an authorization or Waiver of Authorization.
   b. A Limited Data Set must exclude all of the following direct identifiers of the
      individual or of the individual‟s relatives, employers, or household members of
      the individual: names; postal address information other than town or city, state,
      and zip code; telephone numbers; fax numbers; electronic mail addresses; social
      security numbers; medical record numbers; health plan beneficiary identifiers;
      account numbers; certificate/license numbers; vehicle identifiers and serial
      numbers, including license plate numbers; device identifiers and serial numbers;
              web universal resource locators (URL); internet protocol (IP) address numbers;
              biometric identifiers, including finger and voice prints; full face photographic
              images and any comparable images; and any other number, characteristic or code
              that could be used to identify the individual.
           c. A Limited Data Set may be used or disclosed only if there is a Data Use
              Agreement between the Covered Entity and the recipient of the limited data set
              (available on the IRB website at http://www.lindsey.edu).
       7. Individual’s Access to Research Information.
           a. Individuals who participate in research have a right to access their own PHI that is
              maintained in a Designated Record Set. However, individuals participating in
              research protocols that include treatment may be denied access to their PHI
              obtained in connection with that research protocol, provided that:
              i. The PHI was obtained in the course of the research;
              ii. The individual agreed to the denial of access in the research authorization;
              iii. The research remains in process; and
              iv. The individual‟s rights to access such PHI are re-instated once the research
                   study has ended and the research authorization has expired.
       8. Individual’s Revocation of Research Authorization.
           a. An individual may revoke his/her authorization, in writing to the Principal
              Investigator, at any time. However, the researcher may continue to use and
              disclose, for research integrity and reporting purposes, any PHI collected about
              the individual pursuant to a valid authorization before it was revoked.
       9. Transition Provisions.
           a. Researchers may continue to use and disclose PHI created or received before and
              after April 14, 2003, if the researcher has obtained any one of the following prior
              to such date:
              i. The individual‟s informed consent to participate in the research; and
              ii. An IRB waiver of the informed consent process for the research.
           b. Researchers who have indicated their studies will continue to accrue subjects after
              April 14, 2003, must incorporate the template authorization language into the
              protocol‟s currently approved informed consent document.
References:
45 CFR Parts 160 and 164
45CFR 164.502(e) Uses and disclosures of protected health information: disclosures to business
associates
Reference: 45CFR 154.514 (b)
45 CFR 160.103 General Administrative Requirements: Definitions
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.A HIPAA Policy
SUB-PART X.A.1 Procedure for Addressing HIPAA Policy
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.A.1 Procedure for Addressing Health Insurance Portability and Accountability Act
(HIPAA) Policy
       1. Procedure:
          This procedure provides guidance to assure that all studies conducted at Lindsey
          Wilson College SPC (LWC) are in compliance with the HIPAA regulations.
          a. Investigator Responsibilities.
             i. For studies approved prior to April 14, 2003, the implementation deadline for
                  the HIPAA privacy rule, Investigators must include the "Authorization to
                  Use/Disclose PHI (Protected Health Information)”.
                  (i.a) The Investigator must complete all study specific information to assure
                       that all required elements of authorization are presented to the participant.
             ii. For new studies submitted after April 14, 2003, Investigators wishing to
                  create, use, or disclose PHI as part of the research activities, the authorization
                  should be included in the consent document.
                  (ii.a) The Investigator must complete all study specific information, to assure
                       that all required elements of authorization are presented to the participant.
                       When the research involves standard of care treatments that will be billed
                       to the participant‟s insurance, this should be clearly stated so that the
                       participant is informed as to the exact information to be disclosed and for
                       what purpose.
                  (ii.b) The Investigator must submit the Authorization Form to the IRB for
                       review and approval prior to use with study participants.
             iii. For studies requesting a waiver of authorization to use or disclose PHI, the
                  Investigator must make a written request and submit the request to the IRB for
                  review and approval. When a waiver of authorization is granted by the IRB,
                  the Investigator is required to track all disclosures of the PHI.
             iv. When a study meets the criteria for exemption under 45 CFR 46.101(b)(4),
                  Investigators may access PHI for the purpose of creating a limited data set as
                  preparatory to research.
             v. Investigators wishing to disclose the limited data set outside of the LWC must
                  submit a Data Use Agreement executed between the LWC and the recipient.
                  An example of a "Data Use Agreement” is available for external use. The
                  “Data Use Agreement” must be submitted to the (contract office) HSPP for
                  review and approval, prior to release of the limited data set.
          b. IRB Committee Responsibilities.
             i. The IRB will review all IRB applications and human subject research
                  proposals for adequate privacy measures to maintain the confidentiality of the
                  research participants and their data.
             ii. For studies reviewed and approved prior to April 14, 2003 requiring a HIPAA
                  Authorization Form, the IRB must review the study specific language for
                  congruency with the approved IRB template language.
   iii. For new study and continuing review applications submitted after April 14,
        2003 requiring HIPAA authorization language, the IRB is to compare the
        informed Authorization Form.
   iv. The IRB may review and approve requests for a waiver of authorization under
        standard or expedited procedures.
   v. The IRB may review and approve the use and disclosure of a limited data set
        through expedited procedures.
c. HSPP Staff Responsibilities.
   i. The staff member will pre-review all new submissions for appropriate privacy
        and confidentiality as agreed upon by the LWC HSPP.
   ii. The staff member will contact the Investigator or study contact to request
        revision to the Authorization Form that does not contain the appropriate
        template language.
   iii. The staff member will review all continuing review submissions to verify that
        appropriate privacy and confidentiality template language has been written
        into the Authorization Form.
   iv. The staff member may prepare the study for IRB review and approval prior to
        receiving the appropriate template language. However, the reviewers must be
        made aware that the necessary revisions have been requested and the status of
        the approval must be pending receipt of these changes.
d. HSPP Director or staff member will notify Lindsey Wilson College SPC Privacy
   Officer of any perceived privacy breaches involving study participants under the
   HIPAA Privacy Rule.
   i. The Privacy officer will investigate the incident and report the findings to the
        appropriate IRB Chair and the HSPP Director.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.B Modifications to HIPAA Authorization Language
For Lindsey Wilson College SPC Covered Entity Participants
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.B. Modifications to HIPAA Authorization Language for Lindsey Wilson College SPC
Covered Entity Participants

        Purpose: The purpose of this policy is to clarify modifications to Lindsey Wilson
        College SPC Covered Entity authorization language for use and disclosure of PHI.
        Definition:
        Protected Health Information (PHI) is defined as individually identifiable health
             information that is or has been collected or maintained by a covered entity or covered
             component, such as Speech & Hearing Sciences or the Campus Health including
             information that is collected for research purposes only, and that can be linked back
             to the individual participant.
        Covered Entity (CE): Under HIPAA regulations, this is a health plan, a health care
             clearinghouse, or a health care provider who transmits any health information in
             electronic form in connection with a HIPAA transaction. (Reference: 45 CFR
             160.103.)
        Policy:
        It is the policy of the IRB to review modifications to the HIPAA authorization template
        language through expedited review. This language should incorporate the approved
        template language available on the IRB website at http://www.lindsey.edu.
        1. Principal Investigator initiated modifications to the HIPAA template language.
             a. The PI must update the wording within the enclosed brackets to provide study-
                 specific information. The PI is instructed to modify the template language as
                 necessary in order to properly inform the research participant of the possible study
                 related use and disclosure of their protected health information.
        2. Sponsor or Funding Agency initiated modifications to the HIPAA template language.
             a. The IRB will not accept sponsor or funding agency initiated modifications to
                 Lindsey Wilson College SPC authorization language. A sponsor or funding
                 agency may include pertinent information regarding their use and disclosure of
                 individually identifiable health information in either the “procedure” or “risk”
                 section of the informed consent document. Requested modifications to the
                 informed consent document will be reviewed in the same manner as an
                 amendment and may be submitted to the full Committee, if needed.
             b. IRB disapproval of sponsor or funding agency initiated modifications to the
                 HIPAA authorization template language does not affect the status of the currently
                 approved research study.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.B Modifications to HIPAA Authorization Language for Lindsey Wilson College SPC Covered Entity
Participants
SUB-PART: X.B.1 Procedure for Modifications to HIPAA Authorization Language for Lindsey Wilson College SPC Covered Entity
Participants
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.B.1 Procedure for Modifications to HIPAA Authorization Language for Lindsey Wilson
College SPC Covered Entity Participants
       Procedure:
       This procedure provides guidance on requested modifications to the HIPAA
       Authorization template language for research participants under the jurisdiction of
       Lindsey Wilson College SPC (LWC) Human Subjects Protection Program (HSPP).
       1. Investigator Responsibilities.
          a. The Investigator will create the proposed wording for the HIPAA Authorization
              Form to provide study-specific information. The Investigator will modify the
              template language as necessary in order to properly inform research participants
              of the possible study related use and disclosure of their protected health
              information (PHI). This modification will be submitted with new study
              submissions, or as an amendment to the IRB for review and approval.
          b. When the sponsor or funding agency requests inclusion of pertinent information
              regarding the use and disclosure of individually identifiable health information, it
              must be incorporated into the HIPAA Authorization Form for review by the IRB
              Committee, Chair or Chair‟s designee
       2. IRB Committee Responsibilities.
          a. Requests for modifications to the HIPAA template language by an Investigator
              will be reviewed as a part of the application for IRB review and approval.
          b. Request for modifications to the HIPPA template language for a current study will
              be reviewed following the IRB amendment policies and procedures.
          c. Sponsor-requested modifications to the HIPAA template language must be in
              accordance with current IRB policies and procedures.
       3. HSPP Staff Responsibilities.
          a. The HSPP staff member will review all continuing review submissions to verify
              that the appropriate privacy and confidentially template language has been
              inserted into the informed consent documents and request any necessary
              revisions.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.C Compensation or Medical Treatment if Injury Occurs During Participation in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.C. Compensation or Medical Treatment if Injury Occurs During Participation in
Research
      Policy Instructions/Explanations:
      1. For Biomedical projects, unless waived, all subjects must be provided an explanation
         as to whether any compensation will be provided to them in the event of injury and an
         explanation as to whether any medical treatments are available if injury occurs and, if
         so, what they consist of, or where further information may be obtained by the subject.
         On rare occasions this requirement may also apply to Behavioral projects.
      2. For all applications approved prior to adoption of this Policy and for all studies with
         no benefit to human subjects (normal volunteers) and some studies funded by
         Departments, NIH, or other Agencies for which no adverse event treatment funds are
         available from the sponsors, the following, or similar language must be included in
         the consent document, unless specifically waived by the IRB: “Immediate and
         necessary care for adverse events will be provided without charge if you are injured
         because of participation in this research project. The Lindsey Wilson College SPC
         will neither provide for the costs of further treatment beyond immediate necessary
         care nor provide monetary compensation for such injury.”
      3. For Commercially Sponsored Studies, the Informed Consent document must include
         one of the following three choices and the above paragraph (given the provisions of
         the agreement with the sponsor), unless specifically waived by the IRB:
         a. Any costs for the treatment of research related adverse events will be paid for or
             reimbursed by the sponsor. **(This is the preferred language.)
         b. Any costs for the treatment of research related adverse events will be charged to
             you or your insurance carrier. However, if for any reason these costs are not
             covered by insurance, they will be paid for or reimbursed by the sponsor. **(Use
             of this option requires that it match the agreement to be approved by The Office
             of Academic Affairs.)
         c. Any Costs for the treatment of research related adverse events will be charged to
             you or your insurance carrier. However, if for any reason these costs are not
             covered by insurance, they will be your responsibility. **(Use of this option
             requires that it matches the agreement approved by The Office of Academic
             Affairs.)
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.C Compensation or Medical Treatment if Injury Occurs During Participation in Research
SUB-PART: X.C.1 Procedure for Compensation for Medical Treatment if Injury Occurs During Participation in Research
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.C.1 Procedure for Compensation for Medical Treatment if Injury Occurs During
Participation in Research

         Procedure:
         This procedure provides guidance for compensation or medical treatment if injury occurs
         while participating in research conducted at Lindsey Wilson College SPC (LWC) or by
         LWC investigators as part of their institutional responsibilities.
            a. Investigator Responsibilities.
            i. The Investigator will utilize LWC template language of the informed consent
                document template which provides guidelines for immediate necessary care for
                adverse events or injury. The informed consent template language is located on
                the IRB website at http://www.lindsey.edu/ in the left column under “Forms On-
                line”.
            ii. The Investigator will also incorporate the appropriate template language for
                compensation of the costs associated with immediate necessary care as follows:
                (ii.a) For all applications approved prior to adoption of this policy and for all
                     studies with no benefit to human participants (normal volunteers) and some
                     studies funded by Federal departments, NIH, or other Federal agencies for
                     which no adverse event treatment funds are available from the sponsors, the
                     following language should be included in the consent document, unless
                     specifically waived by the IRB: “Immediate necessary care will be provided
                     by Lindsey Wilson College SPC without charge if you are injured because of
                     participation in this research project. However, Lindsey Wilson College SPC
                     makes no commitment to provide for the costs of further treatment beyond
                     immediate necessary care nor to provide monetary compensation for such
                     injury.”
                (ii.b) For commercially sponsored studies, compensation or payment of
                     immediate necessary care for injury related to participation in research
                     activities shall be provided according to the contractual agreement between
                     the sponsor and Lindsey Wilson College SPC. This determination is made
                     through the Business Office. Three types of provisions are acceptable to use
                     as template language in the informed consent document.
                     • “Any costs for the treatment of research related injuries beyond immediate
                         necessary care would be paid for or reimbursed by the sponsor.”
                     • “Any costs for the treatment of research related injuries will be charged to
                         your insurance carrier. If for any reason these costs are not covered by the
                         insurance, they will be charged to the sponsor.”
                     • “Any costs for the treatment of research related injuries will be charged to
                         your insurance carrier. If for any reason these costs are not covered by
                         insurance, they will be your responsibility.”
            ii. In addition to one of the previous template language paragraphs, the following
                paragraph is required: “Regardless of who is responsible for the costs, immediate
        necessary care will be provided by Lindsey Wilson College SPC if you are
        injured because of participation in this research project. However, Lindsey Wilson
        College SPC makes no commitment to provide for the costs of further treatment
        beyond immediate necessary care nor to provide monetary compensation for such
        injury.”
   iii. For research sponsored by the Department of Defense, the following
        compensation language is required: “If you are hurt or get sick because of this
        study, you can receive medical care at an Army hospital or clinic free of charge.
        You will only be treated for injuries that are directly caused by the research study.
        The Army will not pay for your transportation to and from the hospital or clinic. If
        you have questions about this medical care, talk to the Principal Investigator for
        this study, (insert name and phone number here). If you pay out-of-pocket for
        medical care elsewhere for injuries caused by this research study, contact the
        Principal Investigator. If the issue cannot be resolved, contact the U.S. Army
        Medical Research and Material Command (USAMRMC) Office of the Staff
        Judge Advocate (legal office) at (301) 619-7663/2221.”
   iv. Research conducted at a VA Hospital with participants who are veterans must
        include the following injury language: “As a veteran subject you will not be
        required to pay for any treatment received as a research subject which is being
        done solely for the purpose of this research study. However, your insurance
        carrier will be billed for all routine care and clinical procedures, if applicable. If
        you are in the “discretionary work load” category you are subject to making a co-
        payment as indicated by a means test. Your doctor should be able to provide you
        with this information or refer you to the appropriate individual for any questions
        you may have. As a veteran, you will receive medical care and treatment for
        injuries suffered as a result of participating in a VA research program in
        accordance with Federal law. You will incur no additional charges for additional
        medical care that may result from injury or complications that are a direct result
        of your participation in this study.”
b. IRB Committee Responsibilities.
   i. The IRB will review and approve the proposed compensation and injury language
        as a part of the new study submission.
   ii. The IRB will render its determination for approval of compensation or medical
        treatment for medical injury as follows:
   (ii.a) The IRB will verify that the template language for injury is contained in the
        appropriate section of the informed consent document.
   (ii.b) The IRB will review the injury language to assure readability and
        understandability in relation to the proposed target study population.
c. HSPP Staff Responsibilities.
   i. The staff member will review the informed consent documents verifying that the
        LWC template language for immediate necessary care is detailed in the
        “Liability” section of the informed consent document.
   ii. The staff member will verify that a copy of the sponsor‟s agreement regarding
        compensation for injury while participating in a specific research activity has
        been submitted as part of the initial submission packet for review and approval by
     the IRB. If the copy is not included, the staff member will e-mail the Investigator
     and obtain the necessary copy.
iii. The new study may be scheduled for IRB review without the contract language.
     However, the study cannot receive final approval until the contract is received by
     the IRB and the injury language in the consent document is verified to be
     congruent with the sponsor‟s contract language.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.D Screening for Diseases Reportable to the
State Health Department and/or Public Health Services
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.D. Screening for Diseases Reportable to the State Health Department and/or
Public Health Services
       Policy Instructions/Explanations:
       1. Investigators at Lindsey Wilson College SPC and all its affiliates must comply fully
          with all applicable Federal, state and local policies and guidelines, including those
          concerning notification of seropositivity, counseling, and safeguarding confidentiality
          where research activities directly or indirectly involve the study of human
          immunodeficiency virus (HIV). The State of Kentucky Department of Health requires
          the reporting of seropositive cases within 5 working days.
       2. During its review of an application, the IRB should consider and the investigator‟s
          protocol must address issues of obtaining informed consent, confidentiality, the
          notification process, the timeliness of informing individuals, and counseling of the
          individuals and others designated by the individual (e.g., sexual partners).
       3. General Policy: Where HIV, Hepatitis B, and Hepatitis C, sexually transmitted
          diseases, and tuberculosis screening testing is conducted for both research and health
          services activities, domestic and foreign, individuals whose test results are associated
          with personal identifiers must be informed of their own test results and provided the
          opportunity to receive appropriate counseling unless the situation calls for an
          exception. Positive test results may be reported to State or Federal Public Health
          Authorities, who may contact and counsel the subject. This procedure must be
          described in the informed consent document.
       4. Exceptions to General Policy:
          a. Pertaining to an Individual. Where there are compelling and immediate reasons
              that justify not informing a particular individual that he or she is seropositive
              (e.g., indicating that an individual would attempt suicide), the particular
              individual need not be informed of their test results. When this exception is
              utilized, the details of the exception must be documented by the investigator or
              another responsible individual at the testing facility. The Principal Investigator
              must promptly report the exception to the IRB Office without identifying the
              individual. It will be presented to the next scheduled IRB Committee meeting for
              review and approval of the exception or deviation.
          b. Pertaining to Protocol Design. Because circumstances may exist in which
              extremely valuable knowledge might be gained from research involving subjects
              who might be expected to refuse to learn their test results, an exception included
              in the protocol design may be proposed to the IRB Committee reviewing the
              research proposal. The IRB Committee shall consider the particular circumstances
              of the research study, the characteristics of the target research subjects, and other
              factors, and may approve a testing procedure that would allow research subjects
              to participate without being informed of their individual results. In proposing such
              an exception, the investigator can demonstrate why not to the satisfaction of the
              IRB that:
   i. research subjects will be informed of their risk of infection.
   ii. there is good reason to believe that a requirement for test result notification
         would significantly impair collection of study information that could not be
         obtained by other means;
   iiii. research subjects will receive risk reduction counseling require test
         notification counseling whether or not they receive their test results;
   iv. research subjects will be informed of their risk of infection, whether or not
         they have it;
   v. the risk/benefit ratio to individuals, their partners, and society will be
         periodically reevaluated by the IRB Committee so that the study might be
         revised or terminated if it is determined that it is no longer justifiable to allow
         subjects to continue to participate without receiving their HIV test results.
c. Pertaining to Foreign Sites. Activities conducted at foreign sites should be
   carefully evaluated to account for cultural norms, the health resource capabilities
   and official health policies of the host country. The IRB Committee must consider
   if any modification to the policy is significantly justified by the risk/benefit
   evaluation of the research. The IRB Committee should consider seeking expert
   advice, e.g., local public health experts, in evaluation of these projects.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.D Screening for Diseases Reportable to the State Health Department and/or Public Health Services
SUB-PART: X.D.1 Procedure for Screening for Diseases Reportable to the State Health Department and/or Public Health Services
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.D.1 Procedure for Screening for Diseases Reportable to the State Health Department
and/or Public Health Services
       Procedure:
       This procedure outlines the processes to assure that human immunodeficiency virus
       (HIV) testing, Tuberculosis, Hepatitis C, and other sexually transmitted diseases and
       associated with human research participants under the jurisdiction of Lindsey Wilson
       College SPC (LWC) Human Subjects Protection Program (HSPP) is congruent with
       Federal, State and local regulations.
       a. Investigator Responsibilities.
           i. The Investigator will detail the method for obtaining informed consent for HIV
                (and other sexually transmitted diseases) testing in research as a part of the initial
                study submission to the IRB or provide a description of the process for de-
                identifying blood samples taken from participants.
           ii. Exceptions Pertaining to an Individual. When there are compelling and immediate
                reasons that justify not informing an individual participant of his or her
                seropositive results, the Investigator must promptly report this exception to the
                IRB without disclosing the participant‟s identity to the IRB.
           iii. The Investigator must notify the Agency Head of Public Health Service (PHS)
                supported research when an exception of notification has been granted by the
                IRB.
           iv. In order to obtain legally effective informed consent from a research participant
                when the research involves HIV testing, the Investigator will provide the
                following additional explanations:
                • In general terms, the type of test to be performed should be described,
                    including an explanation that the test is for HIV infection and not for AIDS,
                    the need for medical follow-up and/or counseling and social support if the test
                    is positive, and the possibility of false negative and false positive test results;
                • Any alternatives to performing the test must be stated. If not having the HIV
                    test would mean that a potential participant cannot enter the study, this must
                    be explained;
                • The risks of a positive test should be described to include significant anxiety,
                    adverse effect on insurability, discrimination in housing, employment, or
                    public accommodations, and changes in interpersonal relationship with loved
                    ones; and
                • The Investigator must ask the participant if a more detailed explanation is
                    desired or if he or she has any particular questions prior to obtaining consent
                    for testing.
           v. The Investigator must consider that research records are subject to subpoena by
                law enforcement agencies and therefore for added protection of participants, the
                Investigator may apply for a “Certificate of Confidentiality”. The participant will
                be notified of this in the informed consent document.
           vi. The Investigator will include in the informed consent document, that sponsors of
               funded studies (e.g., NIH, drug companies), and/or regulatory agencies (e.g.,
               OHRP, FDA, PHS) will have access to research records that may contain
               confirmation of HIV and test results from other sexually transmitted diseases and
               may be subject to mandatory infectious disease reporting to appropriate agencies.
       b. IRB Committee Responsibilities.
           i. During its review of an application, the IRB should consider issues of obtaining
               informed consent, confidentiality, the notification process, the timeliness of
               informing individuals, and counseling of the individuals and others designated by
               the individual (e.g., sexual partners).
           ii. When reviewing research that includes HIV testing of participants, the IRB must
               render a determination that:
               • The HIV testing is integral to the design of the proposed research and no
                   alternative testing that yields comparable information is available;
               • The Investigator has provided informed consent detailing the risks of
                   performing HIV testing, which addresses confidentiality issues; and
               • The Investigator is trained and capable of informing participants of positive
                   findings and that he or she is qualified to impart sensitive information, inform
                   the participant of privacy and confidentiality issues, and is prepared to impart
                   participants with a reference for additional counseling and follow-up, when
                   needed.
       c. HSPP Staff Responsibilities.
           i. The staff member will review all new study submissions to verify that an
               adequate description of plans for HIV testing and informing participants of test
               results has been detailed in the IRB application and informed consent documents.
           ii. The staff member may request additional information in pre-review, or at the
               request of IRB reviewers for clarification of any issues surrounding the testing of
               HIV in research participants as it pertains to the proposed research.
References:
Policy on Informing Those Tested About HIV Serostatus
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.E Payments to Research Participants
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.E Payments to Research Participants
      Definitions:
      Third-party: Any person or vendor (external to the College) who receives payment for
         providing research-related services and/or products.
      Research Payments: Cash and non-cash payments for reimbursement of time and
         expenses associated with participation in research activities.
      Policy:
      1. The IRB must determine that the risks to subjects are reasonable in relation to
         anticipated benefits and that the consent document contains an adequate description
         of the study procedures as well as the risks and benefits. Payment to research subjects
         for participation in studies is not considered a benefit. Rather, it should be considered
         compensation for time and inconvenience. The amount and schedule of all payments
         should be presented to the IRB at the time of initial review. The IRB should review
         both the amount of payment and the proposed method and timing of disbursement to
         assure that neither are coercive or present undue influence.
         a. Timing of Payments. Credit for payment should accrue as the study progresses
              and not be contingent upon the subject completing the entire study. The subject
              should be paid in proportion to their time and inconvenience as a result of
              participation in the research study. Unless it creates undue inconvenience or a
              coercive practice, payment to subjects who withdraw from the study may be paid
              at the time they would have completed the study (or completed a phase of the
              study) had they not withdrawn. For example, in a study lasting only a few days,
              an IRB may find it permissible to allow a single payment date at the end of the
              study, even to subjects who had withdrawn before that date.
         b. Completion Bonus. While the entire payment should not be contingent upon
              completion of the entire study, payment of a proportion as an incentive for
              completion of the study is acceptable, providing that such incentive is not
              coercive, and is clearly described in the consent document. The IRB should
              determine that the amount paid as a bonus for completion is reasonable and not so
              large as to unduly induce subjects to stay in the study when they would otherwise
              have withdrawn.
         c. Disclosure of Payments. All information concerning payment, including the
              amount and schedule of payment(s) should be set forth in the informed consent
              document.
         d. Advertisement of Payments. Recruitment advertisements may state that subjects
              will be paid or compensated, but should not emphasize the payment or the amount
              to be paid, by such means as larger or bold type. It is against Lindsey Wilson
              College SPC policy to include the actual dollar amount or implied value of
              compensation in recruiting documents. Compensation for participation in a trial
              offered by a sponsor may not include a coupon good for a discount on the
              purchase price of the product once it has been approved for marketing.
2. Alterations in Payments. Any alterations in human research subject payment or
   liberalization of the payment schedule must be reported to the IRB prior to
   implementation as an amendment.
3. Reporting Payments to the IRS. The Internal Revenue Service (IRS) requires that the
   Lindsey Wilson College SPC (or whoever is paying the subjects for their
   participation) report payments in excess of the Federal threshold per calendar year on
   Form 1099-Misc. In the event that Lindsey Wilson College SPC Budget Office
   requires the social security number for subjects, they should be so informed of this in
   the consent document.
4. VA Policy and Payment to Participants. VA policy prohibits payment to research
   participants in studies where the research is integrated with medical care and when it
   makes no special demands on the patient beyond those of usual medical care (IRB –
   approved payment to participants must be made from a VA approved funding
   source.) Payment is permitted in the following circumstances:
   i. No Direct Participant Benefit. When the study will neither enhance diagnosis or
        treatment of the patient‟s medical condition fir which the participant is being
        treated, and when the standard of practice in affiliated non-VA institutions is to
        pay participants in this situation
   ii. Others Being Paid. In multi-institutional studies, when participants at a
        collaborating non-VA institution are paid for the same participation in the same
        study at the same rate proposed.
   iii. Comparable Situations. In other comparable situations in which, in the opinion of
        the IRB payment of participants is appropriate
   iv. Transportation Expenses. When transportation expenses are incurred by the
        participant that would not be incurred in the normal course of receipt of treatment
        and which are not reimbursed by any other mechanism. Investigators who wish to
        pay participants must include the following in the proposal (the IRB Committee
        must review all proposals for payment of participants to ensure conformity with
        VA policies):
        • Substantiate that proposed payments are reasonable and commensurate with
            the expected contributions of the participant;
        • State the terms of the patient‟s participation and the amount of payment in the
            informed consent; and
        • Substantiate that participant‟s payments are fair and appropriate, and that they
            do not constitute (or appear to constitute) undue influence on the prospective
            research participant to volunteer for, or to continue to participate in, the
            research study; and that the payments do not constitute (or appear to
            constitute) coercion to participate in, or continue to participate in, the research
            study
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.E Payments to Research Participants
SUB-PART: X.E.1 Procedure for Payments to Research Participants
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.E.1 Procedure for Payments to Research Participants
       Procedure:
       This procedure provides guidance for payment to research participants under the
       jurisdiction of Lindsey Wilson College SPC LWC) Human Subjects Protection Program
       (HSPP).
       a. Investigator Responsibilities.
           i. The Investigator will provide a detailed description of proposed payments to
                research participants in the initial IRB application. This will include timing of
                payments methods, pro-rating schedule, payment for participants who withdraw
                before completion, and completion bonus plans (if applicable).
           ii. Any alterations in payments to research participants are to be submitted as an
                amendment to the IRB prior to implementation.
           iii. All information concerning payment should be incorporated into the informed
                consent document using the HSPP template. This information should be
                addressed in the “Compensation” section. Payments are not a benefit and are not
                to be included in the benefits section of the informed consent document.
           iv. The Investigator will provide the accounting office the name and social security
                number of participants who receive payments in excess of $600 per calendar year
                on Form W-9 for processing the Form 1099-Misc to be forwarded to the IRS.
                (iv.a) The collection and release of this information must be addressed thoroughly
                     in the informed consent document so that it is clear to participants that their
                     identity will be released for the purpose of payment and IRS reporting.
                (iv.b) The HSPP approved standardized template language will be used to draft
                     the informed consent document.
       b. IRB Committee Responsibilities.
           i. IRB Committee will review payment arrangements among sponsors,
                organizations, investigators and those referring research participants to determine
                if the arrangements are acceptable or unacceptable.
           ii. The IRB will review the amount of payment and the proposed method and timing
                of disbursement to assure that neither are coercive or present undue influence.
           iii. The IRB must assure the entire payment is not contingent upon the participant
                completing the entire study, unless the study is of short duration or only a one-
                time procedure. Payment should accrue as the study progresses.
           iv. The IRB should determine that the amount paid as a bonus for completion is
                reasonable and not so large as to unduly influence participants to stay in the study
                when they would otherwise have withdrawn.
           v. The IRB will review advertisements to assure that they are not coercive or present
                undue influence and do not emphasize the payment aspects of the research or the
                amount to be paid, by such means as larger or bolded type.
           vi. The IRB must determine if payment made directly to a minor is appropriate or
                inappropriate by carrying the risk of undue inducement.
c. HSPP Staff Responsibilities.
   i. The staff member will conduct a pre-review of the IRB application, the informed
      consent documents, and advertisements submitted with a new study application to
      determine that the method of payment for participation in research is consistent
      with IRB policy, as well as ethical standards.
      (i.a) If additional information regarding payments to participants is needed, the
           staff member will contact the Investigator and request the additional
           information.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.F Recruitment/Advertising
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.F Recruitment/Advertising
      Policy Instructions/Explanations:
      1. All Recruiting and Advertising Materials Must be Reviewed and Approved by the
         HSPP. The IRB Committee or Chair, or Chair‟s designee must ensure that appropriate
         safeguards exist to protect the rights and welfare of research participants. In fulfilling
         these responsibilities, the IRB must review all of the research documents and
         activities that bear directly on the rights and welfare of the participants of proposed
         research, including the methods and material that Investigators propose to use to
         recruit participants.
         a. For example, the Investigator must obtain HSPP approval for all television, radio,
             videotape or print advertisements, e-mail solicitations, Internet websites, and
             other recruitment methods and materials intended for the recruitment of
             prospective subjects to a research project(s). All methods of advertisement require
             approval from the HSPP prior to their use.
         b. The following examples do not qualify as an advertisement, but still should be
             reviewed by the IRB: 1) communications intended only to be seen or heard by
             health professionals, such as “dear doctor” letters and doctor-to-doctor letters, 2)
             news stories that do not include recruitment information, and 3) publicity intended
             for other audiences (e.g., media releases regarding types of services available or
             offered by a particular clinic, institute or physician).
         c. The IRB considers advertising or soliciting for study participants to be the start of
             the informed consent and subject selection process. Advertisements must be
             reviewed and approved by the IRB as part of the package for initial review. When
             the Investigator decides after the initial approval to advertise for participants or to
             change the advertisement, the advertising is considered an amendment to the
             ongoing study. The IRB reviews the advertising to assure that it is not unduly
             coercive and does not promise a certainty of cure. This is especially critical when
             a study may involve participants who are likely to be vulnerable to undue
             influence.
         d. When advertising is to be used, the HSPP must review the information contained
             in the advertisement and the mode of its communication, to determine that the
             procedure for recruiting participants is not coercive and does not state or imply a
             certainty of favorable outcome or other benefits beyond what is outlined in the
             consent document and the protocol. The HSPP must review the final copy of
             printed advertisements to evaluate the relative size of type used and other visual
             effects. When advertisements are to be taped for broadcast, the HSPP must review
             the final audio/video tape. The HSPP may review and approve the wording of the
             advertisement prior to taping to preclude re-taping because of inappropriate
             wording. The review of the final taped message prepared from HSPP-approved
             text may be accomplished through expedited procedures.
      2. Any advertisement to recruit participants should be limited to the information the
         prospective participants need to determine their eligibility and interest. When
     appropriately worded, the following items may be included in advertisements.
     Advertisements may not include exculpatory language.
     a. the name, address, and facility/institution of the Investigator or study coordinator
     b. if applicable, include “investigational”, meaning the product is non-FDA
          approved”;
     c. the condition under study and/or the purpose of the research;
     d. in summary form, the criteria that will be used to determine eligibility for the
          study;
     g. a brief list of participation benefits, if any (e.g., a no-cost health examination);
     h. the time or other commitment required of the participants; and
     i. the location of the research and the person or office to contact for further
          information.
3.   Advertising materials should not include the following:
     a. a certainty of favorable outcome or other benefits beyond what is outlined in the
          consent document and the protocol/proposal
     b. claims, either explicitly or implicitly, that the drug, biologic, device or other type
          of intervention is safe or effective for the purposes under investigation;
     c. claims, either explicitly or implicitly, that the test article is known to be
          equivalent or superior to any other drug, biologic, device or intervention;
     d. terms such as "new treatment," "new medication" or "new drug" without
          explaining that the test article is investigational, meaning the product is non FDA
          approved;
     e. no advertisement can include exculpatory language;
     f. promises of "free medical treatment," when the intent is only to say that
          participants will not be charged for taking part in the investigation.
4.   Scripts. The first contact prospective study participants make is often with a
     receptionist or teacher who follows a script to determine basic eligibility for the
     specific study. The HSPP must review the procedures to ensure that they adequately
     protect the rights and welfare of the prospective participants. The IRB must have
     assurance that any information collected about prospective participants will be
     appropriately handled.
5.   Internet Recruitment. All advertisements and recruitment methods must be reviewed
     and approved by the HSPP prior to implementation except for two specific clinical
     trial listing services which do not require prospective IRB approval as determined by
     the Food and Drug Administration. These include the National Cancer Institute's
     cancer clinical trial listing (PDQ) and the government-sponsored AIDS Clinical Trials
     Information Service (ACTIS). For other Internet recruitment sites, HSPP review and
     approval is required to assure that the information does not promise or imply a
     certainty of cure or other benefit beyond what is contained in the protocol and the
     informed consent document. In addition, the Investigator must assure that the
     information shared for Internet recruitment is in accordance with their signed clinical
     trial agreement or grant.
6.   Lindsey Wilson College SPC Mass Communication E-mail. Advertising submitted
     through mass email solicitation at Lindsey Wilson College SPC departmental
     websites and list-serves should be simple, readable, and understandable. It should
    meaningfully and respectfully convey a message to a broad spectrum of Lindsey
    Wilson College SPC community. It should be text-based and written in paragraphs.
7. Students as Participants. The HSPP should exercise oversight with the use of students
    as participants in research. Specifically, the HSPP should ensure:
    • that consent for participation is sought only under circumstances which minimize
         the
    • possibility of coercion or undue influence, such as impact on grades, policies such
         as FERPA aimed at preventing the unauthorized release of private academic or
         personal information, and which clearly identify methods used to maintain
         confidentiality and
    • that genuinely equivalent alternatives to participation are available (i.e., term
         papers
    • or non-human research activities).
         Any HSPP concerns regarding the use of students should be promptly forwarded
             to the Dean of the School of Professional Counseling.
8. Data Base/Primary Care Physician Recruitment. Often times Investigators request to
    use search methods of particular databases looking for potential participants that may
    be eligible for their research projects (e.g., disease, age, sex, etc.), or they request to
    contact primary care providers (PCP) for access to potential participants from the
    PCP‟s patient population. These recruitment methods require IRB approval prior to
    initiation and must be in accordance with applicable HIPAA privacy regulations.
9. Inclusion of Women, Children and Minorities. The inclusion of women, children, and
    minorities in research is important, both to ensure that they receive an appropriate
    share of the benefits of research and that they do not bear a disproportionate burden.
    To the extent that participation in research offers direct benefits to the participants,
    under-representation of children, women or minorities denies them the opportunity to
    benefit. Moreover, for purposes of generalizing research results, Investigators must
    include the widest possible range of population groups.
a. NIH-supported Investigators must provide to the HSPP details of the proposed
    involvement of humans in their research protocols, including the characteristics of the
    subject population, anticipated numbers, age ranges, and health statuses. The
    proposed research should specify the gender and racial/ethnic composition of the
    subject population, as well as criteria for inclusion or exclusion of any subpopulation.
    If ethnic, racial, and gender estimates and continuing review numbers are not
    included in the background data for a protocol, the Investigators must provide a clear
    rationale for exclusion of this information.
10. Finder‟s Fees and Bonus Payments. Research sponsors may offer to pay Investigators
    or study personnel an additional fee to encourage recruitment efforts and the timely or
    accelerated opening of research studies. These payments are generally not permitted.
    Each situation should be reviewed to be sure that it complies with Federal regulations,
    ethical opinions, and LWC IRB policy.
    a. It is not permissible to pay or accept “finder‟s fees” (payment from the
         Investigator or Sponsor to a person who refers a potential participant).
         Additionally, it is not permissible for Lindsey Wilson College SPC employees or
         students to accept personal payments from sponsors or other researchers in
         exchange for accelerated recruitment or referrals of patients.
    b. It is not permissible to accept recruitment bonus payments (payment from the
       Sponsor to an investigator or organization based on the rate or timing of
       recruitment).
    c. It is acceptable to receive compensation for recruitment and screening related
       activities that are unrelated to whether the participant ultimately enrolls or
       completes the research study (i.e., payments that support advertising,
       administrative and personnel costs). Investigators should be sure to determine a
       reasonable budget amount that is directly related to the value of the services
       provided to the study, and to document how that amount was determined. For
       example, individuals could be paid on a flat hourly basis for the time spent
       recruiting and screening potential research participants (regardless of whether
       they are successful in recruiting those participants) and time sheets should be kept
       documenting this effort. Staff should not be paid a per participant recruitment fee
       for (e.g., $10 for every participant who signs the consent document to participate
       in the study).
    d. This policy is not intended to prohibit re-negotiation of contract fees when
       recruitment is progressing much more slowly than anticipated such that additional
       time and effort are required for recruitment activities than initially anticipated.
11. Legal Implications.
    a. The Council on Ethical and Judicial Affairs of the American Medical Association
       denounced the practice of finder‟s fees in December 1994; and
    b. The Federal anti-kickback statute is relevant.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.F Recruitment/Advertising
SUB-PART: X.F.1 Procedure for Recruitment/Advertising
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.F.1 Procedure for Recruitment/Advertising
       Procedure:
       This procedure provides guidance for advertising associated with the recruitment of
       human participants for research conducted under the jurisdiction of Lindsey Wilson
       College SPC (LWC) Human Subjects Protection Program (HSPP).
       a. Investigator responsibilities.
          i. The Investigator will submit all types of advertisements (e.g., television ads,
               radio, videotape, print advertisements, e-mail solicitations, and Internet websites)
               associated with the recruitment of research participants to the IRB for review and
               approval. This includes any sponsor-provided advertisements or Investigator-
               drafted advertisements.
          ii. Advertisements must be submitted to the IRB in their final form in order to
               receive IRB final approval for use.
          iii. The IRB Committee considers advertising or soliciting for study participants to be
               the start of the informed consent and participant selection processes. Therefore,
               advertisements must be included as part of the initial application.
          iv. IRB Committee members review and approval for additional advertisements or
               changes in currently approved advertisements or recruitment methods will be
               submitted in the form of an amendment to the IRB for approval prior to
               implementation.
          v. Mass e-mail solicitations are first submitted to the IRB for review and approval.
       b. IRB Committee Responsibilities.
          i. The IRB Committee reviews recruitment processes in order to determine whether
               potential participants have sufficient time to consider whether or not they wish to
               participate and minimize the possibility of undue influence or coercion of
               participants.
          ii. The IRB will review and approve the content of all advertisements or means of
               soliciting participants in human subjects research to assure that the rights and
               welfare of the prospective participants are protected and that information
               collected about prospective participants will be appropriately handled.
          iii. The IRB must review the final copy of printed advertisements to evaluate the
               relative size of type used and other visual effects.
          iv. When advertisements are to be taped for broadcast, the IRB must review the final
               audio or video tape prior to approval.
          v. The IRB may review and approve the wording of an advertisement prior to taping
               to preclude re-taping because of inappropriate wording. The review of the final
               taped message prepared from the IRB approved script may be conducted via
               expedited procedures.
          vi. The IRB Committee Chair or designated Committee member may review changes
               to advertisements. However, the Chair or designated Committee member may
       refer the advertisement to the full, convened IRB Committee if the advertisement
       contains subjective material which in his or her opinion needs further review.
c. HSPP Staff Responsibilities.
   i. The staff member will review all initial study submissions to determine what type
       of advertisements will be used for recruitment. If advertisements are planned, but
       not provided, the staff member will contact the Investigator and request
       submission for IRB review and approval prior to use.
   ii. Advertisements submitted as amendments may be approved by the IRB Chair or
       designated Committee member.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.F Recruitment/Advertising
SUB-PART: X.F.2 Procedure for Recruitment of Students and Employees as Research Participants
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.F.2 Procedure for Recruitment of Students and Employees as Research Participants
       Procedure:
       This procedure outlines the responsibilities of Lindsey Wilson College SPC (LWC)
       Human Subjects Protection Program (HSPP) and Investigators when recruiting students
       and employees as participants in research conducted under the LWC IRB‟s jurisdiction.
       1. Investigator Responsibilities.
          The Investigator must take into consideration the following when recruiting students
          and employees as participants in human subjects research.
          a. Recruitment of students by Investigators who are also faculty members or
              instructors at the LWC.
              i. Investigators are to advertise and recruit student-participants in a collective,
                   rather than recruiting individual students individually.
              ii. An exception to this rule may be allowed when the use of one‟s own students
                   is integral to the research. For example, research into teaching methods may
                   be allowed by the IRB when sufficient precautions have been taken to protect
                   the student-participant (e.g., using a third party to obtain informed consent
                   who is part of the research team).
          b. Student Participation as a Class Component.
              i. The IRB may approve the awarding of course credit or extra credit to students
                   who are expected to participate in research activities as part of a class
                   curriculum only when alternative means of obtaining course credit or extra
                   credit is made available to students who do not wish to volunteer as research
                   participants. Students must be given other options for fulfilling the research
                   participation component that are comparable in terms of time, effort, and
                   educational benefit. For example, short papers, special projects, book reports,
                   and brief quizzes on additional reading may be offered in lieu of research
                   participation.
              ii. These research studies may not involve more than minimal risk and students
                   must be told that they can withdraw from the study at any time without losing
                   the extra credit.
              iii. Students should be recruited through general announcements, bulletin board
                   postings, email listservs or advertisements, rather than individual solicitations.
          c. Student Recruitment.
              i. Although IRB approval is granted, research activities that are targeted for or
                   designed specifically to address students from a particular Department or
                   School may require the approval of the appropriate official before the study
                   may commence.
          d. Student Records.
              i. Lindsey Wilson College SPC is subject to the provisions of Federal law
                   known as the Family Educational Rights and Privacy Act (also referred to as
                  the Buckley Amendment or FERPA). This act affords matriculated students
                  certain rights with respect to their educational records.
             ii. Generally, students have the right to consent to disclosures of personally
                  identifiable information contained in the student‟s education records to third
                  parties (such as researchers). Therefore, Investigators must obtain student‟s
                  consent to access personally identifiable information in the student‟s
                  educational records, even if consent to participate in the research may have
                  been waived by the IRB.
          e. Employees.
             i. Investigators should minimize the likelihood that employees who participate
                  in research programs perceive that the decision will affect performance
                  evaluations or job advancement.
             ii. Employees should be recruited through general announcements, listservs or
                  advertisements, rather than individual solicitations.
             iii. Employees of a particular Investigator should not be directly recruited for
                  participation in any study conducted by that Investigator or laboratory,
                  although such employees may, on their own, volunteer to participate.
             iv. Investigators who include colleagues or subordinates as research participants
                  should be able to provide a rationale other than convenience for selecting
                  those individuals and should show that the recruitment methods do not lead
                  colleagues to think that they will be compromised by not participating.
      2. IRB Committee Responsibilities.
          a. The IRB should exercise oversight with the use of faculty, instructors, students,
             medical students, and employees as the targeted population in research.
          b. The IRB will review the proposed involvement of faculty, instructors, students,
             medical students, and employees as the targeted population in research activities
             and when making its final determination assure that:
             i. Consent for participation is sought only under circumstances which minimize
                  the possibility of coercion or undue influence, which, clearly identify methods
                  used to maintain confidentiality;
             ii. There are genuinely equivalent alternatives to participation available;
             iii. The selection of participants is equitable;
             iv. The risk of coercion is minimized; and
             v. If applicable, added protections for vulnerable populations have been assured.
          c. Any concerns regarding the use of students should be promptly forwarded to the
             Dean of the School of Professional Counseling.
      3. HSPP Staff Responsibilities.
          a. The staff member will conduct a pre-review of all initial applications or
             amendments that propose the use of students, medical students, or employees as a
             targeted population.
          b. The staff member will assure that the IRB Committee is aware of the inclusion of
             students, medical students, or employees as a targeted population.
          c. If necessary, the staff member will facilitate communication between the IRB
             Committee and the Dean of the School of Professional Counseling.
References:
45 CFR 46.111
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.G Research Conducted at International Performance Sites
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.G Research Conducted at International Performance Sites
      Definitions:
      Assurance: A contract or agreement that establishes standards for human subjects
           research as approved by the Office for Human Research Protections (OHRP).
      Independent Ethics Committee (IEC): A specially constituted review body whose
           responsibility is to ensure the protection of the rights, welfare and safety of research
           participants. An IEC shares the same composition and operations as an Institutional
           Review Board.
      Institutional Review Board (IRB): A specially constituted review body established or
           designated by an entity to protect the rights and welfare of human subjects recruited
           to participate in biomedical or behavioral/social science research.
      Local Research Context: Knowledge of the institution and community environment in
           which human research will be conducted.
      Office for Human Research Protections (OHRP): The office under the Department of
           Health and Human Services (DHHS) responsible for implementing the DHHS
           regulations (45 CFR 46) governing biomedical and social/behavioral sciences
           research involving human participants.
      Policy:
      It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
      Program (HSPP) to assure that adequate provisions are in place for research under its
      jurisdiction conducted at international sites.
      1. IRB Review of International Research.
           a. When the foreign institution or site is a performance site “engaged” in research.
               i. The IRB will review all international research utilizing human participants to
                    assure adequate provisions are in place to protect the rights and welfare of the
                    participants.
               ii. Because the LWC holds an assurance with OHRP, the foreign institution or
                    site must file an Assurance of compliance (FWA) with OHRP if the study is
                    federally funded.
               iii. Approval of research is permitted if “the procedures prescribed by the foreign
                    institution afford protections that are at least equivalent to those provided in
                    45 CFR 46.”
               iv. The LWC IRB must receive and review the foreign institution or site‟s
                    IRB/IEC review and approval of each study prior to the commencement of the
                    research at the foreign institution or site.
           b. When the foreign institution or site is a performance site “not engaged” in
               research.
               i. When the foreign institution or site has an established IRB/IEC, the
                    Investigator must obtain approval to conduct the research at the "not engaged"
                    site from the site‟s IRB/IEC or provide documentation that the site‟s IRB/IEC
                    has determined that approval is not necessary for the Investigator to conduct
                    the proposed research at the site.
             ii. When the foreign institution or site does not have an established IRB/IEC, a
                  site authorization letter must be obtained demonstrating that the appropriate
                  institutional or oversight officials are permitting the research to be conducted
                  at the performance site.
             iii. Lindsey Wilson College SPC IRB approval to conduct research at the foreign
                  institution or site is contingent upon receiving documentation of the
                  performance site‟s IRB/IEC review or site authorization letter, as applicable.
             iv. It is the responsibility of the LWC Investigator and the foreign institution or
                  site to assure that the resources and facilities are appropriate for the nature of
                  the research.
             v. It is the responsibility of the LWC Investigator and the foreign institution or
                  site to notify the LWC IRB promptly if a change in research activities alters
                  the performance site‟s engagement in the research (e.g., performance site “not
                  engaged” begins consenting research participants, etc.).
      2. IRB Considerations for Approval.
          a. For Federally funded research, approval of research for foreign institutions or
             sites “engaged” in research is only permitted if the foreign institution or site holds
             an Assurance with OHRP and local IRB review and approval is obtained.
          b. The IRB will consider local research context when reviewing international studies
             to assure protections are in place that are appropriate to the setting in which the
             research will be conducted. The IRB may require an expert consultant to address
             issues of local research context if the IRB does not have a Committee member
             with the expertise or knowledge required to adequately evaluate the research in
             light of local context.
          c. The informed consent documents must be in a language understandable to the
             proposed participants. The IRB encourages a back translation of the exact content
             contained in the foreign language informed consent document provided by the
             Investigator, with the credentials of the translator detailed in the IRB application
             or amendment form.
      3. Monitoring of Approved International Research.
          a. The IRB is responsible for the ongoing review of international research conducted
             under its jurisdiction.
          b. The IRB will require documentation of regular correspondence between the
             Investigator and the foreign institution or site.
          c. The IRB may require verification from sources other than the Investigator that
             there have been no substantial changes in the research since its last review.
References:
45 CFR 46
21 CFR 50 & 56
OHRP, IRB Guidebook, Chapter VI, “Special Classes of Subjects”
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.G Research Conducted at International Performance Sites
SUB-PART: X.G.1 Procedure for Research Conducted at International Performance Sites
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.G.1 Procedure for Research Conducted at International Performance Sites
      Procedure:
      This procedure outlines the responsibilities of Lindsey Wilson College SPC (LWC)
      Human Subjects Protection Program (HSPP) and the Investigator for human subjects
      research conducted at international performance sites.
      1. Investigator Responsibilities.
          a. It is the Investigator‟s responsibility to provide the following to the LWC IRB for
             international performance sites “engaged” in research:
             i. An Office of Human Research Protections (OHRP) approved Federalwide
                  Assurance (FWA) for the foreign institution or site, if federally funded;
             ii. An OHRP registered local IRB/IEC approval letter for the proposed research
                  if an IRB/IEC exists;
             iii. A translated informed consent document encompassing all of the required
                  elements of informed consent in the language appropriate to the location of
                  the research. It is recommended that an English language back translation of
                  the exact content be presented as well. The HSPP encourages the inclusion of
                  the qualifications of the translator in the IRB application or amendment form;
                  and
             iv. Adequate information and materials are provided to evaluate local research
                  context in the location in which the proposed research will be conducted.
          b. It is the Investigators responsibility to provide to the LWC IRB the following for
             international performance sites “ not engaged” in research:
             i. IRB/IEC Approval or Letters of Cooperation.
                  (i.a) When the foreign institution or site has an established IRB/IEC, the
                       Investigator must submit to the LWC IRB approval to conduct the
                       research at the "not engaged" site from the site‟s IRB/IEC or provide
                       documentation that the site‟s IRB/IEC has determined that approval is not
                       necessary for the Investigator to conduct the proposed research at the site;
                       or
                  (i.b) When the foreign institution or site does not have an established
                       IRB/IEC, the Investigator must submit to the LWC IRB a letter of
                       cooperation demonstrating that the appropriate institutional or oversight
                       officials are permitting the research to be conducted at the performance
                       site.
             ii. It is the responsibility of the LWC Investigator and the foreign institution or
                  site to assure that the resources and facilities are appropriate for the nature of
                  the research;
             iii. A translated informed consent document encompassing all of the required
                  elements of informed consent in the language appropriate to the location of
                  the research must be submitted to the LWC IRB for review and approval. It is
                  recommended that with an English language back translation of the exact
             content of the informed consent form be submitted as well. The HSPP
             encourages the inclusion of the qualifications of the translator in the IRB
             application or amendment form; and
         iv. Adequate information and materials are provided to evaluate local research
             context in the location in which the proposed research will be conducted.
         v. It is the responsibility of the LWC Investigator and the foreign institution or
             site to notify the LWC IRB promptly if a change in research activities alters
             the performance site‟s engagement in the research (e.g., performance site “not
             engaged” begins consenting research participants, etc.).
     d. The Investigator is responsible for providing to the IRB any reports of
         correspondence with the foreign institution or site and appropriate documentation
         of data and safety measures throughout the course of the study, including serious
         and unexpected adverse events and unanticipated problems to participants or
         others (e.g. a breach of participant confidentiality resulting in local ramifications).
3. IRB Committee Responsibilities.
a. The IRB Committee must demonstrate that it has obtained necessary information
     about the local research context through written material or discussions with either
     Committee members knowledgeable of the local context or appropriate expert
     consultants. The level of local knowledge required is based on the degree of risk
     presented by the research. Extra considerations may include the following to enhance
     human research protections:
i. The economic prosperity of the area;
ii. The influence of local officials on the population;
iii. Whether the country or area allows foreign visitors;
iv. The nature of the procedures conducted (some may not allow invasive procedures
     such as in poorer regions);
v. The literacy rate of the area;
vi. The local legal rights of the population;
vii. How complaints will be reported and to whom;
viii. The relevance of the research to the area‟s health needs;
ix. The possibility of including officials from the area in the monitoring of the research;
     and
x. The growth rate of sociology and medicine in that area.
b. The IRB Committee will review the consent process taking into consideration the
     following additional issues:
i. Disclosure of scientific and medical facts to individuals who may be unfamiliar with
     and distrustful of the concepts;
ii. Differences in cultural and societal norms;
iii. Differences in the role of women in society;
iv. Differences in the role of family and community in the consent process;
v. Multiple local languages; and
vi. Literacy level.
c. The IRB Committee must assure that adequate provisions are outlined for data and
     safety monitoring keeping in mind that some foreign Ethics Committees may not
     require continuing review of approved research.
d. The LWC IRB approval to conduct research at the foreign institution or site is
     contingent upon receiving documentation of the foreign performance site‟s IRB/IEC
     determination, or letter of cooperation, as applicable.
4. HSPP Staff Responsibilities.
i. The staff member will pre-review the proposed research according to applicable IRB
     policies and procedures.
ii. The staff member will assure the required documents are present for adequate review
     by the IRB Committee.
iii. The staff member will provide guidance to the Investigator as needed (e.g., verifying
     OHRP IRB registration and FWA approval for the foreign site).
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.H Research Involving Use of the Internet
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.H Research Involving the Use of the Internet
      Policy:
      It is the policy of Lindsey Wilson College SPC (LWC) Human Subjects Protection
      Program (HSPP) to review the use of the internet for human research activities, including
      participant recruitment, in human subjects research conducted under its jurisdiction.
      1. IRB Considerations in Review and Approval of Research Activities Involving the use
           of the internet.
           a. The IRB must review all research activities involving the use of the internet with
               the same considerations and standards for approval of research (45 CFR 46.111),
               for informed consent, and voluntary participation as all other research activities
               under the jurisdiction of the LWC IRB.
           b. The informed consent process and documentation of such must include all
               relevant elements of informed consent as listed in the Federal regulations.
           c. The IRB review must include a consideration for the delineation of boundaries
               (i.e., would the participant consider the access private or public space of the
               internet).
           d. The IRB review must consider the risks to the participants and must assure that
               there is an appropriate level of protection.
               i. The IRB must consider that each communication carries the risk of a breach
               ii. of confidentiality. Even when data is collected without names, web sites or
                    email programs may still be capable of collecting identifiers.
               iii. The IRB must consider that admonishing participants that they must be 18
                    years of age to participate, does not guarantee compliance.
               iv. The IRB must consider all additional requirements for the approval of
                    research that involves a vulnerable population as all other studies recruiting
                    those populations.
           e. The use of online surveys must include mechanisms, if applicable, for withdrawal
               such as how to retrieve and discard responses from a participant who has decided
               to withdraw.
           f. Because there is no standard for identifying distressed participants online, the IRB
               must take into consideration potential participant experiences (the sensitive nature
               of the research) that may be distressing when evaluating the risk/benefit ratio.
      2. Requirements for Evaluating the Use of the Internet for Participant Recruitment.
           a. The IRB must review and approve all materials used for posting recruitment
               materials on the internet, e.g. through a website, a banner advertisement, or an
               email solicitation.
           b. Investigators requesting to recruit through the mass email system must follow the
               appropriate Lindsey Wilson College SPC procedures.
           c. Lindsey Wilson College SPC has a variety of list services that are available via
               website. If this method is used in recruitment of potential participants, the IRB
               application must include this information as a method of recruitment or must be
               submitted as an amendment to the already approved proposal.
3. Requirements for Consideration of Data Collection and Security.
   a. All data must be protected as it moves along the communication pathways (e.g.,
      from the participant to the server, from the server to the Investigator).
      Additionally, all databases storing identifiable information or data must be
      protected regardless of the source creating the data (e.g., encryption of the
      database, de-identifying the data).
   b. The IRB must review and approve the method and procedures for data collection
      and security.
   c. Investigators must provide information regarding the transmission and storage of
      the data.
PROGRAM: Human Subjects Protection Program
SECTION: X Conduct of Research
POLICY NUMBER: X.H Research Involving Use of the Internet
SUB-PART: X.H.1 Procedure for Research Involving the Use of the Internet
REVIEW RESPONSIBILITY: IRB Policy and Procedures Sub-Committee
ORIGINAL CREATION DATE: October 2007


X.H.1 Procedure for Research Involving the Use of the Internet
      Procedure:
      This procedure provides guidance for the review of Lindsey Wilson College SPC (LWC)
      Human Subjects Protection Program (HSPP) of the use of the internet for human research
      activities, including participant recruitment, in human subjects research conducted under
      its jurisdiction.
      1. Investigator Responsibilities.
           a. Should the Investigator wish to use the internet for research activities, he or she
               will submit the application for review and approval with additional information
               regarding the specific information and activities to be accessed via the internet.
           b. The Investigator must address the method for obtaining and documenting, when
               appropriate, informed consent from each participant and provide a mechanism for
               assuring that participants are of the legal age to consent.
               i. The consent method and materials in final form must be included in the
                    application for review and approval.
               ii. The investigator may consider a request a waiver of consent or a waiver of
                    documentation of consent.
               iii. When anyone who has access to the internet is a potential participant, it may
                    be difficult to assure comprehension of the consent information. To assure
                    comprehension the Investigator may want to:
                    (iii.a) Incorporate short questionnaires into the consent process to assess the
                         potential participant‟s understanding of the informed consent content.
                    (iii.b) Asking participants to contact the Investigator to discuss the
                         information presented before beginning the study, if applicable.
               iv. When sensitive information is gathered via the internet, the Investigator must
                    provide a mechanism for identifying serious distress and providing assistance
                    to participants who may become distressed by the nature of the questions
                    asked.
           c. Copies of the materials, in final form, to be posted on the internet must be
               submitted for IRB review and approval.
           d. Mechanisms for participants to withdraw. This should include options for
               retrieving and discarding responses or allowing “no response” as an option for
               survey questions.
           e. The Investigator should include a description of the security measures in place
               regarding data collection and storage. The Investigator must keep in mind that
               even if the data will be collected without names, websites and email programs are
               capable of collecting identifiers.
               i. When appropriate, the data collection should be transmitted in an encrypted
                    format.
               ii. Encryption is also required when a server will be used for data storage.
          (ii.a) The server must be stored in a secure location with limited access only to
               the Investigator and key study personnel.
          (ii.b) The administration of the server must be maintained by a professionally
               trained person with expertise in computer and internet security.
          (ii.c) Back-ups of the data should be made, as deemed appropriate, and stored
               in a secure location.
          (ii.d) A plan for destruction of the data must be included in the IRB
               application or amendment for review and approval.
   f. Should the Investigator wish to use the internet for posting of recruitment
      materials, all documents must be submitted in final form to the IRB for review
      and approval, prior to its use.
2. IRB Committee Responsibilities.
   a. The IRB Chair, a designated Committee member, or the convened IRB
      Committee will review the use of the internet for research. Consideration will be
      given for potential risks to participants and to assure that proper protections are in
      place to address issues of confidentiality and privacy.
   b. Sensitive data must be protected as it moves along communication pathways. The
      IRB must consider that all communication carries the risk of a breach of
      confidentiality.
   c. The IRB will review all materials in final form to be posted on the internet and
      used for recruitment of participants.
3. HSPP Staff Responsibilities.
   a. The staff member will pre-review and request any necessary revisions of
      submitted documents for the use of the internet as outlined for new study
      submissions.
   b. Once the pre-review revisions are received from the Investigator, the staff
      member will route the study for review following expedited procedures, or when
      applicable, place the new study on the next available IRB Committee agenda,
      assign reviewers, and prepare the reviewer and IRB Committee member packets.
   c. The staff member will assist reviewers in obtaining additional information that
      may be requested regarding the use of the internet for research activities.
   d. The staff member will notify the Investigator in writing of the IRB Committee‟s
      determinations. This letter requires a signature of the Chair or designated
      Committee member.
   e. The staff member will process all requests for amendments, serious and
      unexpected adverse events or unanticipated problems to participants or others,
      and continuing reviews per corresponding IRB policies and procedures.

								
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