The IRB and the Protection of Human Subjects

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					UT SOUTHWESTERN

 IRB OVERVIEW
                                                                           Table of Contents

The IRB and the Protection of Human Subjects ....................................................................................1
Guiding Principals and Statutory Framework .......................................................................................2
      Ethical Foundation of Human Research Protection ..................................................................................... 2
      Regulatory Foundation of Human Research Protections ............................................................................. 3
      The IRB and Protection of Privacy (HIPAA) ................................................................................................ 4
      UT Southwestern IRB Resources .................................................................................................................... 4
IRB Basics...................................................................................................................................................5
      IRB Purview...................................................................................................................................................... 5
      Composition of IRBs ........................................................................................................................................ 5
      Responsibilities as a Member .......................................................................................................................... 5
      Meeting Attendance and Quorum .................................................................................................................. 6
      Applying Discipline and Regulatory Knowledge ........................................................................................... 6
      Types of Review ................................................................................................................................................ 7
           Initial Review ................................................................................................................................................................ 7
           Request for Modifications Prior to Approval ................................................................................................................ 7
           Continuation Review..................................................................................................................................................... 7
           Request for Modification .............................................................................................................................................. 7
           Unanticipated problems/adverse events (AE) / serious adverse events (SAE) ............................................................. 7
           Alleged or Reported Noncompliance ............................................................................................................................ 7
      Mechanisms of IRB Review ............................................................................................................................. 7
           Exemption ..................................................................................................................................................................... 8
           Expedited Review ......................................................................................................................................................... 8
           Full Review ................................................................................................................................................................... 8
      Meeting Packets ................................................................................................................................................ 9
      Protocol Assignment......................................................................................................................................... 9
      Primary Reviewer System ............................................................................................................................... 9
      Reviewing Protocols in Advance of the Meeting ......................................................................................... 10
      Review Criteria ............................................................................................................................................... 10
      Documentation of Primary Review............................................................................................................... 11
      Reviews at the IRB Meeting .......................................................................................................................... 11
      Study Outcome. .............................................................................................................................................. 11
      Establishing Continuing Review Parameters for Approved Protocols ..................................................... 12
      Conflict of Interest.......................................................................................................................................... 12
      Developing IRB Policies ................................................................................................................................. 13
      Mandatory Education Requirements ........................................................................................................... 13
      Handling Allegations or Reports of Noncompliance ................................................................................... 13
      Confidentiality ................................................................................................................................................ 13
      Federally Mandated Reports ......................................................................................................................... 14
IRB Office Mission Statement ................................................................................................................15




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The IRB and the Protection of Human Subjects
National and international communities have adopted ethical principles to guide the use of human
subjects in research. This reference manual contains copies of the most important of these: the Belmont
Report, the Nuremberg Code and the Declaration of Helsinki. These ethical principals have been
incorporated into regulations that provide for the protection of human subjects in research.

The IRB was created by federal regulations as the institutional body charged with implementing the
regulations on a local level. IRB activities are subject to review by variety of groups, the Office of
Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in the Department
of Health and Human Services (DHHS). UT Southwestern IRB holds a Federal-wide Assurance
(FWA), number FWA00005087 from the Office of Human Research Protections (OHRP) in the
Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS
and UT Southwestern. In this document, UT Southwestern assures the federal government that it will
meet all requirements of Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) for all human
subject research regardless of sponsorship. Additional information regarding the statutory framework
maybe found under the section titled “Regulatory Foundation of Human Research Protections.”

Generally, OHRP audits IRB activities when a particular problem or set of problems has been identified.
The FDA may also audit for cause, but they primarily conduct periodic unannounced, on-site audits.
These audits can include any FDA-regulated areas, such as the pharmacy and investigator files, as well
as all IRB actives. They may include review of IRB policies, handbooks and standard operating
procedures, meeting minutes, agendas, protocol files and other pertinent materials.

The FWA requires the appointment of an Institutional Official (IO) who is ultimately responsible for the
performance and conduct of the IRB.

Charles Ginsburg, MD, Interim Dean of UT Southwestern Medical School serves as the Institutional
Official for issues related to the protection of human subjects. The IRB and institutional official are
responsible for ensuring compliance with federal regulations, UT Southwestern policies and procedures
and other applicable regulations; for interpreting those regulations and determining local policy and
procedures; and for developing new policy as science and its ethical implications evolve.




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                   Guiding Principals and Statutory Framework
Ethical Foundation of Human Research Protection
The Ethical Principles and Guidelines for the Protection of Human Subjects of Research was written in
1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research to identify the basic ethical principles underlying the conduct of research involving human
subjects. More commonly known as the “Belmont Report”, this report identified the following three
fundamental ethical principles that must be carefully considered to ensure the ethical practice of research
involving human participants:

                                1. Respect for Persons
                                2. Beneficence
                                3. Justice

Each IRB member should read the Belmont Report and apply the ethical principles when conducting
protocol/study review.

         Respect for Persons
         The principle of respect for persons requires the consideration of three ethical standards. First,
         prospective research participants should be treated as autonomous agents capable of making an
         independent decision to enter into a research study. To assist participants in being prepared to
         make such a decision, the researcher must provide accurate information about the study as a part
         of the informed consent process. No pressure to participate should be applied by any involved
         parties and the prospective participants or their legally authorized representative must be given
         the time needed to consider the information provided and decide whether to participate.

         Second, additional provisions must be taken to protect prospective participants that have a
         diminished capacity to act as an autonomous agent. Independent cases arise when a prospective
         subject lacks the capacity to make an informed decision. In other cases, prospective subjects
         represent a class of participants that is considered to have a diminished capacity (for example,
         children). In both cases, additional safeguards must be in place to ensure that prospective
         participants or their legally authorized representative still have the opportunity to decide whether
         to participate.

         Third, respect for persons dictates that the researcher should design procedures and safeguards
         which minimize risk of invasion of privacy and assure confidentiality of data.

         Beneficence
         Beneficence refers to the responsibility of the researcher to maximize possible benefits and
         minimize possible risks. The researcher and the IRB must be able to differentiate between the
         possible benefits and harms for the prospective participants and those for society as a whole.
         During the IRB review of research protocols, the risk to benefit ratio is assessed and a
         determination is made whether this ratio is acceptable.

         Justice
         No individual or group of participants should unduly bear the risks of research nor inequitably
         receive its benefits. By fairly distributing the risks and benefits of research, the researcher is able
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         to adhere to the practice of this principle. Likewise, equitable selection of subjects is of
         importance. The IRB has the responsibility of reviewing any requests by researchers to exclude
         selected subject populations.

Regulatory Foundation of Human Research Protections
There are many regulations and policies that govern research involving human subjects. An IRB
member must apply these regulations and policies in order to determine whether proposed research plans
are in compliance. Reviewing research with human subjects requires a working knowledge of the
following regulations and policies:
            Department for Health and Human Services (DHHS)
              All research involving human subjects must adhere to DHHS regulation 45 CFR 46
              unless the requirement is waived by the IRB. The Office for Human Research Protections
              (OHRP) supports, strengthens and provides leadership to the nation’s system for
              protecting volunteers in research that is conducted or supported by the U.S. Department
              of Health and Human Services (HHS). Their website includes agency guidance on a
              variety of topics such as biological tissue banks, financial conflicts of interest, continuing
              review, and review of research involving prisoners or children. In addition to establishing
              guidelines for human subject research, DHHS regulation also addresses the conduct of
              research with the vulnerable populations of fetuses, neonates and pregnant women,
              prisoners, and children. Particular attention must be given in determining the risk to
              benefit ratio for these subject populations and to applying additional safeguards which are
              listed in the regulations. These sections of the regulation are located at the following
              links: Pregnant Women, Human Fetuses, and Neonate (Subpart B) (46.203, 46.204,
              46.205, 46.206, 46.207); Prisoners (Subpart C) (46.304, 46.305, 46.306); and Children
              (Subpart D) (46.407, 46.408, 46.409).
              
            Food and Drug Administration (FDA)
              Any clinical investigation that involves the use of a test article (e.g. drug, device,
              biologic, or food product) and one or more human subjects fall under the Food and Drug
              Administration Human Subjects Protection regulations. Three pertinent sections of FDA
              regulations are located at the following links: FDA 21 CFR 50 IRB; and FDA 21 CFR 56
              Informed Consent. Additional FDA regulations may apply, such as 21 CFR 312
              (Investigational New Drugs), 21 CFR 812, 814 (Investigational New Devices), and 21
              CFR 54 (Financial Disclosure by Clinical Investigators).

               Sponsors
                Many research projects are funded by federal, state or industry sponsors that have issued
                additional human research requirements. Examples of sponsors who have issued
                additional human research protection requirements include Department of Defense, U.S.
                Department of Education, National Science Foundation, Centers for Disease Control,
                U.S. Department of Justice, Bureau of Prisons, the National Institutes of Health, and
                selected NIH funded programs such as the General Clinical Research Center (GCRC).

               The University of Texas Southwestern Medical Center (UT Southwestern)
                UT Southwestern has established policies that govern human subject research conducted
                under the jurisdiction of the UT Southwestern IRB. UT Southwestern has numerous
                policies that govern IRB review such as additional procedures for reviewing research
                involving decisionally impaired subjects. Every IRB member should have a working

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               knowledge of these policies and procedures. The most current policies are located online
               at http://www.utsouthwestern.edu/irb


The IRB and Protection of Privacy (HIPAA)
The Health Insurance Portability & Accountability Act, commonly known as HIPAA, is another federal
regulation that impacts the conduct of human subjects research. The HIPAA Privacy Rule establishes
national standards for the protection of private health information known as Protected Health
Information (PHI). PHI is defined as any individually identifiable health information that is created or
maintained by a Covered Entity. UT Southwestern functions as a covered entity regulated by the Privacy
Rule. Information on HIPAA is located at the following link: http://www8.utsouthwestern.edu/hipaa

HIPAA applies to research activities when:
    Protected Health Information is being used or disclosed for research purposes.

The HIPAA regulations require a Privacy Board to review proposed HIPAA authorization forms, and
requests to waive the authorization process for research projects, at UT Southwestern the IRB serves as
the Privacy Board.

The Security Rule, an important part of HIPAA, went into effect April 20, 2005. The rule's intention is
to protect the confidentiality, integrity, and availability of electronic protected health information, which
UT Southwestern creates, accesses, transmits, or receives in both research and patient care settings. It
sets forth specific requirements for the adoption of administrative, physical, and technical safeguards for
the protection of electronic protected health information. Additional information can be found on the
UT Southwestern Information Security Home Page located at
http://inside.utsouthwestern.edu/irweb/infosec/infosec.htm

UT Southwestern IRB Resources
The IRB Office maintains a website that IRB members and investigators alike can use as a valuable
resource. The IRB web at http://www.utsouthwestern.edu/irb contains the most current guidance, forms
and information available. Examples of key documents and guidance made available to IRB members
include:
            English and Spanish version Informed Consent templates and instructions
            Creating the Project Summary template and instructions
            Guidance on Reporting Protocol Violations and Deviations
            Guidance on the applicability and process for acquiring a Certificate of Confidentiality




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                                            IRB Basics
IRB Purview
The IRB is responsible for reviewing all research in which humans participate as research subjects at UT
Southwestern. The primary mandate of an IRB is to protect the rights and welfare of human
participants. To carry out this mandate, the IRB is given authority to perform the following tasks:
        Approve, modify, or disapprove research protocols
        Conduct continuing reviews of approved research protocols
        Review and approve changes in research procedures
        Suspend or terminate approval of research protocols


Composition of IRBs
Federal regulation as set forth in DHHS 45 CFR 46 and FDA 21 CFR 56 provides guidance on the
membership composition of IRB committees. Committees must be composed of at least five members
and preferably have members of both genders. IRB committees are expected to have members with
appropriate expertise based upon the types of research reviewed. Federal regulation requires that at least
one member be someone whose primary concerns are in nonscientific areas. At least one member must
be someone whose primary concerns are in scientific areas and at least one member must be someone
who is not otherwise affiliated with the university. If FDA clinical investigations are reviewed, IRB
membership must include a physician.

Federal policy also allows IRBs to have “alternate” members. IRB members may be appointed as
alternates for more than one of the primary IRB members. Alternate IRB members have the same
authority and responsibilities as the primary IRB members. If the primary and alternate members attend
the same meeting only one individual may vote. New members who are not sure whether they are
appointed as primary or alternative members should contact the IRB Office at (214) 648-3060 for
clarification.

On occasion, non IRB members with expertise in a particular field may be invited to a meeting to
provide consultation on specific protocols; such individuals are not included in the quorum and do not
vote.

UT Southwestern does not publish or provide a copy of the IRB Board membership roster.


Responsibilities as a Member
IRB members will be asked to attend meetings, serve as a primary reviewer on protocols, amendments,
adverse events and continuing reviews. IRB members have nine primary responsibilities that, when
met, assist the IRB as a whole in achieving its mandate and carrying out its authority. The nine IRB
member responsibilities are:
         1)   attending meetings;
         2)   applying discipline and regulatory knowledge;
         3)   conducting protocol reviews;
         4)   avoiding conflicts of interest;
         5)   completing training requirements;
         6)   maintaining confidentiality;
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         7)   developing policies (Executive Committee);
         8)   determining whether federal reports are required (Executive Committee) and
         9)   handling allegations or reports of noncompliance (Executive Committee).

The Executive Committee (EC) meets at least monthly and is comprised of the IRB Chairs and Vice-
Chairs from each of the four IRBs, the IRB Manager and the Assistant Vice President for Research
Services and representatives from the affiliated hospitals.


Meeting Attendance and Quorum
In order for an IRB meeting to be officially convened for full review, a quorum must be present. A
quorum consists of more than half the number of regular members, including at least one non-scientist.
If a quorum is not established, formal actions requiring voting for approval cannot be undertaken and
vital research may be delayed. Also, Continuing Review approvals are likely to lapse if a quorum is
unavailable. Each IRB member brings a specific expertise to the review of research protocols. Each
member has an important and unique contribution to make in the overall conduct of full reviews. If a
quorum is lost during a meeting, then the Board cannot conduct official business until quorum is
restored. If the quorum is not restored, the meeting is concluded and the remaining business will
continue at the next scheduled meeting. It is crucial that members and alternates notify their IRB
Coordinator of their availability for meetings. This is important to allow appropriate assignment of
protocols to available reviewers and that a quorum of members will be present. Generally, this is
accomplished by e-mail or a phone call to your IRB Coordinator in the IRB office.


Applying Discipline and Regulatory Knowledge
IRB members must exhibit expertise and be willing to apply that knowledge in the review of research
protocols. There are three primary areas of expertise that an IRB member should practice. These are as
follows:
     Specialized experience – Many IRB members have scientific, medical, or other professional
       backgrounds and are expected to apply this knowledge in the review of research. This often
       proves useful to the IRB in its review of research that involves vulnerable subject populations
       such as children, prisoners, pregnant women, or decisionally challenged persons. Other members
       of the IRB are members of the community and not affiliated with UT Southwestern. These
       members serve as a rich resource to the IRB by reflecting the interests of the community
       including the interests of many prospective and current research participants.
     UT Southwestern policies and procedures – The IRB member must exhibit knowledge and
       application of UT Southwestern policies and procedures. UT Southwestern IRB Review Policies
       are accessed from the IRB website at http://www.utsouthwestern.edu/irb and including the IRB
       applications and forms.
     Federal regulations – There are several sets of federal regulations that apply to the review of
       research involving human subjects. It is the responsibility of the IRB member to be familiar with
       these regulations and understand when each set applies to protocols based upon the nature of the
       research. A summary of the core regulations is included in the IRB Resource Guide (i.e. 45 CFR
       46 Subpart A, 21 CFR 50 and 56). The IRB distributes copies of the regulations and FDA
       Information Sheets to each member by providing a copy of the Regulations and Guidance on the
       Protection of Human Subjects: Clinical Investigator, IRB and Sponsor Responsibilities, Clinical
       Research Resources, LLC


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Types of Review
There are six types of review conducted by the UT Southwestern IRBs.

   Initial Review – Occurs when a research protocol is first submitted for IRB review. Initial Review
   applications (Form NR1) may be found on the IRB website in the Forms section. New members
   should be familiar with the forms and templates. The templates were created to assist investigators
   with complying with the regulations and university requirements.

   Request for Modifications Prior to Approval –The IRB has the authority to require
   revisions be made to a research protocol in order to achieve approval (e.g., stipulations) and are
   responsible for reviewing the response to stipulations that are submitted by the investigator. This
   task may also be administratively delegated to the IRB Coordinators for non-risk related responses.
   Once protocol approval has been granted by the IRB, no modifications can be made to the approved
   research without IRB approval. Form MOD, available on the IRB website in the Forms section, is
   used by investigators seeking approval for revisions to already approved protocols.

   Continuation Review – Once approved by the IRB, a research protocol must be re-reviewed at
   least once every year, or at a greater frequency based on degree of risk as determined by the IRB.

   Continuation Review applications (Form CR) and instructions, outlining investigator responsibility
   may be found on the IRB website in the Forms section.

   Request for Modification – Once protocol approval has been granted by the IRB,
   modifications to the approved research can not be made without IRB approval. Form MOD,
   available on the IRB website in the Forms section, is used by investigators seeking approval for
   revisions to already approved protocols. Modifications to approved research are typically reviewed
   and approved by the Chair unless the Chair determines the modification should be referred to a full
   board for review. Any modifications that are greater than minimal risk or negatively impact the risk-
   benefit ratio should be reviewed by the full board.

   Unanticipated problems/adverse events (AE) / serious adverse events (SAE) –
   Unforeseeable events may arise when conducting research with human subjects. These may include
   unexpected harms or injuries to participants. When such events occur, researchers are required to
   promptly report them to the IRB for review. The IRB policy for reporting AE/SAE is located in the
   Study Management section of the website.

   Alleged or Reported Noncompliance – The Executive Committee of the IRB reviews
   alleged or reported incidents of noncompliance, including the initial allegation/reports, any
   subsequent quality assurance reviews, post-approval monitoring reports, or correspondence or
   information submitted in the course of handling the alleged or reported incident of noncompliance.
   Procedures for managing allegations are outlined in the online Compliance section.


Mechanisms of IRB Review
Federal regulations recognize differences between types of research and provide three categories of
review. While the default is review by the full board at a schedule meeting, certain minimal risk
projects may be eligible for expedited review or may be exempt from review requirements.


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         Exemption
         The federal regulations mandating IRB review (46 CFR 46) recognize that not all research rises
         to the level of full board review. In some cases, a study needs IRB approval but the level of risk
         in the protocol is considered to have no risk or virtually no risk and may be eligible for exempt
         review. In order for your study to be classified as exempt research it must fall into one or more
         of the six exempt categories outlined in the federal regulations. The IRB may not alter these
         categories.

         At UT Southwestern, proposed studies falling into one or more of the exempt categories are
         required to undergo review by an IRB Chair or designee to verify that the research meets the
         criteria for exemption.

         Exempt submissions are first reviewed by the IRB Coordinator. If there are missing documents
         or if further information is required, the IRB Coordinator will contact the PI and/or Research
         Coordinator. Once the file is complete, the IRB Chair or designee will review the submission and
         either verify that the exempt criteria are met, request changes or additional information, or
         require review under expedited or full-board review procedures.


         Expedited Review
         Federal regulation, as authorized by 45 CFR 46.110, 21 CFR 56.110, and 38 CFR 16.110, has
         established categories of research that may be granted review by one or more designated
         members. Research activities that present no more than “minimal risk” to human subjects and
         involve procedures that fall solely within those expedited categories may be reviewed by the IRB
         through the expedited review procedure. “Minimal risk” is defined as “the probability and
         magnitude of harm or discomfort anticipated in the research are not greater in and of themselves
         from those ordinarily encountered in daily life or during the performance of routine physical or
         psychological examination or tests”. The IRB Coordinator conducting initial expedited reviews,
         along with the Chair, may receive or request comments from consultants for reviews involving
         special subject populations (e.g., prisoners) or other issues.

         The outcome of the review may include any of the following: 1) approval; 2) request for
         additional information; 3) request for changes; 4) request that the review be conducted by the full
         IRB. Under expedited review procedures the protocol cannot be “disapproved”; only the “Full
         Board” IRB can disapprove a research project.

         Minor changes that do not significantly affect the risk/benefit ratio or substantially change the
         study design or specific aims of the study in previously approved research (requests for
         modification approvals) can also be reviewed using expedited procedures.

         At least once per month, the Full Board agenda that is sent to the IRB before each meeting will
         include a list of studies/minor changes reviewed using expedited procedures. IRB members may
         request a copy of any expedited review by contacting their designated IRB Coordinator or by
         calling the IRB Office at (214) 648-3060.


         Full Review
         Research that does not meet the criteria for exempt or expedited review must be submitted to the
         IRB for review at a convened meeting at which a quorum of the members are present. Each IRB
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         committee meets twice per month. The dates of the meetings for each IRB are as follows, and are
         also listed on the IRB web site at http://www.utsouthwestern.edu. The maximum number of
         protocols generally accepted for review per meeting is 12.
               IRB #1 meets each 1st and 3rd Monday
               IRB #2 meets each 2nd and 4th Monday
               IRB #3 meets each 1st and 3rd Wednesday
               IRB #4 meets each 2nd and 4th Wednesday


Meeting Packets
Approximately ten days prior to each meeting, IRB members are sent a packet which contains the
following information:
        Meeting Agenda
        Prior Meeting Minutes
        IRB NR1 (new) applications for initial and/or Form CRs for continuing full review including
         concise project summaries, consent forms, HIPAA forms, information regarding local AE/SAE,
         withdrawals, etc.
        List of expedited protocols reviewed and approved including initial, continuations, modifications
         and external reports of unanticipated problems/adverse events
        Board continuing education or business materials


Protocol Assignment
All protocols submitted for full review are reviewed for completeness by the IRB staff. Often, the staff
will try to resolve administrative issues prior to the distribution of the protocols to reviewers. The IRB
Coordinator reviews all protocols and the list of members available to attend a given meeting. Based on
this review, the IRB Coordinator will make assignments of the protocols and amendments in accordance
with member areas of expertise, interest, and/or conflicts of interest. Packets for the primary review will
contain a copy of the protocol, required IRB forms, consent forms, HIPAA forms and a reviewer sheet.


Primary Reviewer System
A Primary Reviewer System is used to ensure a proper review is conducted on each protocol. One
member is assigned a specific protocol to review in detail and present the protocol including their
questions and concerns, during the IRB meeting. Primary reviewers are provided with an electronic
checklist and are responsible for:
         1. conducting a substantive review of the protocol;
         2. informing the full IRB of any discrepancies between the detailed protocol summary and other
            application materials;
         3. identifying key issues, related to subject safety or risks, that require clarification or bear
            further discussion;
         4. presenting suggested or required stipulations for protocol approval; and
         5. making a recommendation regarding the approval of the study.

The primary reviewer is also encouraged to contact the principal investigator (or asking the IRB
Coordinator to contact the PI) as needed to obtain clarification prior to the IRB meeting.

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After this presentation, the IRB Board will discuss the protocol and make a determination.


Reviewing Protocols in Advance of the Meeting
Serving on the IRB requires a commitment to actively participate in the review of research protocols or
project descriptions. IRB members are expected to review all the submitted protocol documents in
detail and be prepared to raise/discuss any concerns.

IRB members may request to see the entire file for any of the items listed in the agenda.


Review Criteria
       There are many issues that must be addressed before an initial or continuing research protocol
       can be approved. The guiding ethical principles of respect for persons (autonomy), beneficence,
       and justice must be considered in conducting each review. (See the Belmont Report)

       The criteria for approval of research are set forth in the federal regulation 45 CFR Part 46.111
       and 50 CFR 56.111. To approve research, the IRB should determine that ALL of the following
       conditions exist:

               1. 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.
               2. 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 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
                  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.
               3. Selection of subjects is equitable. In making this assessment the IRB 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.
               4. 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
                  regulations.
               5. Informed consent will be appropriately documented, in accordance with, and to the
                  extent required by federal regulations.
               6. When the study is greater than minimal risk, clinical research, or an NIH funded/FDA
                  regulated clinical trial, the research plan makes adequate provision for monitoring the
                  data collected to ensure the safety of subjects.


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               7. When appropriate, there are adequate provisions to protect the privacy of subjects and
                  to maintain the confidentiality of data.
               8. Where any of the subjects are likely to be vulnerable to coercion or undue influence,
                  additional safeguards have been included in the study to protect subjects.

       Included in the regulations are also the review criteria, elements of informed consent, criteria for
       waiving consent process, and criteria for waiving documentation of consent. The IRB Office has
       several documents available to assist IRB members and investigators in applying the review
       criteria. Examples may be seen throughout the Forms page on the IRB website.

       Federal regulations and UT Southwestern policy includes additional safeguards that must be
       applied when reviewing research involving the following:
              Pregnant women, human fetuses, or neonates
              Prisoners
              Children/minors
              Cognitively impaired

       The guidance for conducting reviews involving these vulnerable populations and others can be
       found in the Special Topics section of the IRB website under Vulnerable Populations.


Documentation of Primary Review
The Primary Reviewer Sheet is provided to assist the reviewers in the organization and documentation
of their concerns in preparation for the meeting discussion and to assist in preparation of the IRB
meetings. Since the sheets are not updated to reflect the conversations of the meetings, they are merely
to provide guidance in initiating the review process.


Reviews at the IRB Meeting
Members should bring their documents to the scheduled meeting. At the beginning of the meeting, all
members will receive a copy of the study comments which has been prepared by the IRB staff and
incorporates all the primary reviewers’ comments for the studies which are scheduled to be reviewed.

During the meeting, the chair will call upon the primary reviewer to give a brief presentation of their
assigned study at the meeting and lead the discussion. The presentation should focus on questions and
concerns. Administrative items such as typographical and grammatical errors do not need to be
discussed unless they present a risk to the subject.

All members are encouraged to participate in open discussion of the proposed study.


Study Outcome.
These are four possible outcomes of IRB full review:
        Approval: If the research meets the eight federal criteria of approval, the IRB can approve the
           research. An approval period must be set based upon degree of risk but the period cannot be
           greater than a year.


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          Approval with Minor Stipulations (Stips)/Additional Information Required: Investigator
           responses to the minor revision/additional information request are generally reviewed using
           expedited procedures by the IRB Coordinator for the meeting.
          Deferral: A protocol is deferred if the requests for revisions/additional information are
           considered significant or major. The investigator is not required to attend the meeting but the
           investigator’s response to the specific stipulation(s) is reviewed by the IRB at a convened
           meeting.
          Disapproval: The full IRB has the authority to disapprove proposed research projects that do
           not meet the federal criteria for approval.


Establishing Continuing Review Parameters for Approved Protocols
In approving a protocol, the IRB determines how frequently the protocol should be submitted for
continuing review or oversight. Federal Regulations state that approvals may be granted for no longer
than a one-year period, but the IRB may recommend more frequent review based upon time intervals or
enrollment numbers for high-risk protocols. When determining the interval for continuing review,
members should consider:
      studies that are pilot studies and for which little preliminary data exists.
      the experience of the investigator.
      studies that pose a special risk to the subject.
      emergency waiver of consent protocols.
      studies in which the subjects are gravely ill and the risk/benefit ratio is unclear.
      studies in which the preliminary data indicate special element of risk for the subject.

Conflict of Interest
A conflict of interest involves any situation where an IRB member has significant personal, financial or
non-financial interest which has the potential to bias the design, conduct, reporting, or reviewing of the
research.
Examples of a conflicting interest would be if the IRB member is:
      Principal Investigator (PI);
      Co-Investigator;
      Receiving funding from the study, as listed in the study budget;
      In a supervisory role over the PI of the study (e.g. faculty advisor); or
      Family member of the PI.
Federal regulations at 45 CFR 46.107(e) prohibit a member of the IRB from participating in the initial or
continuing review of any project in which the member has a “conflicting interest,” except to provide
information at the Board’s request.

All IRB members must understand and follow the UT Southwestern Conflict of Interest Policy located
at http://www8.utsouthwestern.edu/utsw/cda/dept41605/files/43763.html Any IRB member with a
conflicting interest in a project scheduled for Board review must disclose it to the IRB Coordinator or
Chair and leave the room during the discussion of the project and the related vote, unless the member is
merely providing information at the IRB’s request. The meeting minutes will document the recusal (i.e.,
the temporary absence of the IRB member during the deliberation and vote on the project with respect to
which the member has a conflict). In the case of expedited IRB review (outside of a convened meeting,
by a designated reviewer), the reviewer must disclose any conflicting interest in a project to the IRB
Coordinator or Chair and should not review the project. If the IRB Chair is the reviewer with a
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conflicting interest, then disclosure should be made to the IRB Coordinator or to the Manager of the IRB
so the review can be reassigned.


Developing IRB Policies
Establishing policy that impacts UT Southwestern’s research is the responsibility of the institutional
official, Dr. Charles Ginsburg, the assistant vice president for research, Suzanne Rivera, the IRB
manager, Diane Sheppard, the Executive Committee, and the IRB.

The role of the IRB in developing policy usually focuses upon specific protocol review issues such as
review of research involving decisionally challenged subjects. IRB members may be asked to serve on
IRB policy subcommittees or to review and comment on selected proposed policies.


Mandatory Education Requirements
UT Southwestern’s requirement for education in human subjects protection was initially implemented in
response to the National Institute of Health (NIH) and Veterans Administration (VA) requirements
(effective with October 2000 awards) for training. All investigators/study personnel conducting research
under the IRB’s jurisdiction are required to be trained in the protection of human subjects, and HIPAA
Research. Each IRB member is also required to complete this education requirement.

The requirement may be met by one of two (2) means:
       a) Successful completion of the Medelearn web-based human subjects’ protection (HSP) training
program. https://www.medelearn.org/ut/students.cfm

       b) Attend a Day-2 Session titled “Human Subject Protection and Using and Disclosing PHI in
Research.” The sessions are generally held on each 2nd and 4th Tuesday on North Campus and are
scheduled through the Department of Human Resources.


Handling Allegations or Reports of Noncompliance
Incidents of alleged noncompliance with federal or IRB policy and procedures are periodically reported
to the IRB by subjects, family members, research staff, colleagues, IRB staff or other individuals at UT
Southwestern or from the community. Also, researchers report incidents of noncompliance with either
approved IRB protocol procedures or University policy and procedures. Along with the Executive
Committee, the IRB Chairs, Manager, Legal Counsel, and/or IRB members may be asked to serve on an
investigation committee to collect information, interview respondents or complainants, review and/or
inspect research records.


Confidentiality
IRB members must maintain the confidentiality of any subject data that is presented to them in the
review of research protocols. In addition, IRB members should maintain the confidentiality of all
information collected from the researchers during the review. The IRB committee also handles sensitive
information regarding noncompliance issues, and members are asked not to discuss these topics outside
of the IRB meetings.



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Federally Mandated Reports
The IRB is subject to federal requirements to report certain issues that arise in the conduct of research.
The UT Southwestern IRB Office provides support to the IRB committee in the preparation of such
reports. Per federal regulation, the Food and Drug Administration (FDA) and/or the Office for Human
Research Protections (OHRP) should be notified when any of the following are directly related to the
conduct of federally funded or FDA regulated research protocol:
      Any unanticipated problem involving risks to subjects or others
      Any serious or continuing noncompliance with the regulations or requirements of the IRB
      Any suspension or termination of IRB approval for research due to noncompliance
The IRB, through the Executive Committee, is responsible for making a determination whether an
incident meets these federal criteria for reporting to FDA or OHRP.




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                               IRB Office Mission Statement

We are a dedicated team of professionals who partner with the research community to facilitate quality
human research in a way that protects the rights, safety and welfare of study participants and complies
with ethical and legal standards for the conduct of science.

                                            Our Values
          Honesty    Integrity    Efficiency Team Work      Flexibility       Service to Others
                            Quality Performance   Enjoyable Workplace




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