Applic for Human Res Study GEB 4 28 09 KBW 5 21 09 a 2 H by VI802W

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									                                                           MIAMI VAHCS
                                                  HUMAN STUDIES SUBCOMMITTEE
                                           APPLICATION FOR NEW HUMAN RESEARCH STUDY

                                                 MIAMI VAHCS IRB INVESTIGATOR MANUAL
  Additional information about the IRB submission process is available in Miami VAHCS IRB Investigator Manual available on the Miami
  VA Research website: www.varesearchmiami.org. Please consult the manual for additional guidance about this facility’s human
  research program.
                                              INSTRUCTIONS FOR USING THIS FORM
     This checklist provides guidelines about information that must be included in new research applications involving human subjects
     conducted at the Miami VAHCS that will require IRB review.
          Space is provided on this form for studies that do not contain all applicable information mentioned in the application.
          Fill out only the sections that apply to the type of research you are conducting.
          Please pay special attention to notes or special instructions that may be included in a specific question or section.
          Information that must be submitted on a separate form is indicated. Most forms and information sheets may be found at
           www.varesearchmiami.org. If a form is not listed on the website, it can be obtained from the IRB Office (Room 2B100).
          Information and materials are REQUIRED for all questions, in which “YES” is the only possible answer.
          Investigators who develop their own studies should use this application as a guide in determining which kinds of information
           must be included in their new research application. A Protocol Outline is available at www.varesearchmiami.org.
          The Principal Investigator must complete and return this form along with all accompanying forms.
          Number of Copies to Submit for Full Committee Review:
             10 packets - that include this completed form, all attachments, and complete protocol – DOUBLE-SIDED!
                             (These are distributed to Primary/Scientific Reviewers)
           + 10 packets - that contain only the cover application form, protocol, informed consent document, or waiver of
                             IC/Authorization request, and any advertising materials
           Total = 20 packets PLUS original must be submitted
          Number of Copies to Submit for Exempt and Expedited Review
            10 packets - that include this completed form, all attachments, and complete protocol – DOUBLE-SIDED!
                             (These are distributed to Primary/Scientific Reviewers)
           + 10 packets - that contain only the cover application form, protocol, informed consent document, or waiver of
                             IC/Authorization request, and any advertising materials
                   Total = 20 packets PLUS original must be submitted
          Contact the IRB Office (Mitch Gajardo) if you have any questions:
                    Phone: 305 575-7000 ext. 4465                           E-mail: office@varesearchmiami.org

                                                            TABLE OF CONTENTS
                    Section 1          Type of Submission; Sponsor – Investigator Applications; Forms; Expedited Review
                                       and Exemptions
                    Section 2          Risk/Benefit Information
                    Section 3          Subject Selection and Vulnerable Populations
                    Section 4          Informed Consent
                    Section 5          Safety Monitoring Plan
                    Section 6          Investigational Drugs and Devices
                    Section 7          Biologic and Radioactive Materials
                    Section 8          Study Protocol Elements
                    Section 9          Patient Privacy
                    Section_10         Data Security
                    Section_11         Conflict of Interest
                    Section_12         Credentials to Conduct Human Studies Research
                    Section_13         Before and After the Study Begins; Signatures

                    Appendix A         Recruitment of subjects
                    Appendix B         Investigational Drugs
                    Appendix C         Investigational Devices
                    Appendix D         Biologic and Radioactive Materials



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Principal Investigator:
Protocol Title:

                                                              SECTION 1
                              TYPE OF SUBMISSION/ SPONSOR – INVESTIGATOR APPLICATIONS
                                      /FORMS/EXPEDITED REVIEW AND EXEMPTIONS

     1.    Type of Submission
           a. Please indicate the type of research:
                       Clinical drug trial                 Survey/Questionnaire       Other (please describe):
                       Clinical device trial               Chart Review
                       RSAP - Resident Scholarly Activity Program: applications can be found at www.varesearchmiami.org

           b. International Research
                    Is this research being conducted at international sites (not within the US, its territories, or Commonwealths)?
                               no               yes
                    Does this research involve human biological specimens originating from international sites?
                               no               yes

                   Does this research involve human data originating from international sites?
                             no              yes
                    Note: If you answered “yes” to i, ii, or iii, please contact the IRB before filling out this form.

           c. Is this a tissue or data repository?
                     no
                     yes       If “yes”, please indicate type of repository (tissue or data)
                     Note: If you are submitting an application to establish a tissue/data repository, please contact the IRB before
                             filling out this form.

           d. Is this a Quality Assurance (QA) project?
                    no
                    yes
                    Note: If you are submitting a QA project, please contact the IRB before filling out this form.

           e. Will children or prisoners be recruited for this study?
                    no
                    yes
                    Note: Will require a waiver from VACO. Please contact the IRB before filling out this form.

     2.    Sponsor-Investigator Research Applications
           Are you a “Sponsor-Investigator” (as defined by the F.D.A. – a “Sponsor-Investigator” is an individual who both initiates and
           conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.):
                       no - I am not a Sponsor-Investigator
                       yes – see Section 6 – Investigational Drugs and Devices for instructions.
           .       Note: Please complete this questions only if the study involves investigational drugs or devices
                   Note: Sponsor/Investigators are encouraged to use the information contained in this form to develop new
                          research applications

     3.    Forms: Application For Miami VA Research Project; Project Data Sheet; Location Of Research
           Did you complete and attach copies of the forms listed below?
                   yes     Application for Miami VA Research Project form with all applicable signatures (PI, Co-Investigators, Service
                           Chief or Chief of Staff, Chiefs of any other service that might be affected)?
                   yes     Project Data Sheet
                   yes     Location of Research form with all applicable signatures.
                   Note: All forms are available at: www.varesearchmiami.org).

     4.    Expedited Review /Research Exempt From IRB Review
           If you are requesting either of the following, did you complete and attach copies of the following forms:
                    yes    Request for Expedited Review
                    yes    Request for Exempt Review form
                    Note: Forms and the Miami VAHCS IRB Investigator Manual, which contains instructions about how to request an
                           exemption or expedited review, are available at: www.varesearchmiami.org).
     5.    Did you submit a completed “Location of Research Form” with all required signatures?                  yes



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                                                             SECTION 2
                                                   RISK/ BENEFIT ASSESSMENT
Special Instructions: This section of the application must be filled out for any study submitted.

     1.    Where will the research project be conducted? (Check all that apply)
                  VA Inpatient Setting
                  VA Outpatient Clinic
                  VA Clinician Office
                  VA Laboratories
                  Subject Homes
                  Affiliate Location
                  Attach affiliate IRB approval documents
                  Provide affiliate FWA Assurance number:
                  Other (specify):

           If research is conducted at affiliate location, please specify where and how much of the project will be conducted at that
           location. Check N/A if not applicable:      N/A




     2.    Indicate the type(s) of potential risks related to participation in the study.
                      Type of Risk
                      Physical (e.g. minor pain, discomfort, injury from invasive procedures, drug side effects)
                      Psychological (e.g. undesired changes in thought processes and emotions e.g. stress, guilt,
                               embarrassment, invasion of privacy, breach of confidentiality.
                      Social (e.g. embarrassment in one’s social group, stigmatization, standing in one’s community, invasion of
                               privacy, breach of confidentiality)
                      Legal (e.g. criminal prosecution for having engaged in illegal activities)
                      Economic (e.g. loss of employment, loss of health insurance)


           If you checked any of the above, please describe:


     3.    Have the risks been minimized by any of the following?

                Yes   No
                              PI/staff have adequate credentials to conduct research
                              Consistent with sound research design (e.g. frequent monitoring by data and safety monitoring boards,
                              trained personnel who can respond to emergencies, coding of data, exclude certain individuals or
                              classes of subjects)
                              Does not unnecessarily expose participants to risk
                              Obtains research data from the procedures already performed for diagnosis and treatment of patient’s
                              condition.


     4.    Are there any departures from standard procedures or methods of care (or lack thereof)?
           no
           yes     If yes, please describe in the space provided




     6.    If not already in the protocol, provide information about the severity, likelihood, frequency, and reversibility of potential
           adverse actions in the space provided.




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     7.    Does the research have direct benefits to subjects?
                   yes     If “ yes”, please check applicable items.       no

                       ameliorates patient’s disorder
                       provides participant with better understanding of his/her disorder
                       Other (Please describe):


     8.    Does the research have benefits to the community/society?
                   yes       If “ yes”, please check applicable items. no
                      increased knowledge about human physiology or behavior
                      improved safety
                      technological advances
                      better health
                      Other (Please describe):


     9.    Explain how the benefits justify the risks of the study.




                                                             SECTION 3
                                SUBJECT SELECTION AND VULNERABLE POPULATIONS
           Special Instructions: Section 3 must be completed for all studies in which subjects will be recruited.



           Do you plan to recruit subjects for this study?
               no       If “no”, This a Chart-review Study - skip to Section 4 “Informed Consent” on this form
              yes       If “yes”, then complete appendix A (see below)


           Complete appendix A for all studies in which subjects will be recruited.




                                                             SECTION 4
                                                         INFORMED CONSENT
     Note: This Section must be completed for all applications submitted.

     1.    Waiver of IC/Waiver of HIPAA Authorization
           Are you requesting a Waiver or Alteration of Informed Consent/Waiver of HIPAA Authorization as part of a chart review
           study?
                   yes    If “yes”, please attach form, then skip to Section 5 of this application
                   no     If “no”, this is not a “chart review only” study

     2.    Waiver of Documentation of IC
           Are you requesting a Waiver of Documentation of Informed Consent?
                   yes     If “yes” please attach form and informational letter. An informed consent plan is required (see questions
                           below in #5- “Informed Consent Plan”)
                   no

     3.    Informed Consent Document
           Does your protocol require submission of a VA Form 10-1086 - Informed Consent Document?



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                    yes      If “yes”, please complete and attach to submission
                    no       If “no”, skip to question #5

     4.    Checklist for Preparing IC Documents
           Did you use as guidance and complete all items of the Investigator Checklist for Preparation of Informed Consent
           Documents? (an example of an informed consent document is available at: www.varesearchmiami.org)
                   yes       If “yes”, please attach to submission
                   n/a       A Request for Waiver or Alteration of Informed Consent and Waiver of HIPAA Authorization was submitted
                   n/a       A Waiver of Documentation of Informed Consent is being submitted.

     5.    Informed Consent Plan
           Note: An informed consent plan is required when an informed consent document or a waiver for documentation of
           informed consent is part of the study. At a minimum the informed consent plan must include the elements listed
           below. Please provide the following information:

           a.   Will you be recruiting decisionally impaired subjects?
                              no             yes if “yes”, please attach an assent document
           b.   Will anyone other than the subject be authorized to provide consent or permission for the subject’s involvement in
                the research (e.g., parents, court ordered guardian, spouse, etc.)?
                              no             yes (please explain below):

                If you answered “yes” please explain:



           c.   Describe your plan (Informed Consent Plan) on how and where informed consent will be obtained.




           d.   If the study is uses deception in the research, please describe your plan to debrief subjects.




           e.    Describe how you will be providing the information regarding the consent process to the participants? (e.g.
                reading the consent form, explaining what is in the consent document, answering any questions the participant or
                legally authorized representative may have and asking appropriate questions that helps to evaluate the subjects
                understating of the research.)




           f.   If your study involves pregnant women, describe how will you provide information regarding the possible impact of
                the research on the fetus?

                         N/A - Pregnant women will not be recruited for this study.




           g.   Will the participant be given the opportunity to take home the consent document to consider the options and to
                discuss participation with family members before signing the consent document?

                    no       If “no”, please explain         yes




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                If you answered “no” please explain:




           h.   Attach the Report of Research Staff form which includes a list the study personnel who are authorized by you to
                obtain informed consent for this study from subjects or their legally authorized representatives:




           i.   Describe how informed consent will be obtained from subjects who do not read or understand English; identify any
                languages likely to be encountered; and attach a copy of a translated and authenticated informed consent
                document:




           j.   How and by whom will it be determined that the subjects or their legally authorized representatives understand the
                research project and their rights as study subjects?




           j. Informed consent will be sought from each prospective subject or the subject's legally authorized representative?
                (mark NA if a waiver of informed consent is being requested)
                   yes                          no                N/A

           k.   The Informed consent will be documented by obtaining a written consent form that is signed and dated using VA
                Form 10-1086?
                    yes                      no

           l.   A witness to the participant’s signature or the participant’s legally authorized representative’s signature will sign
                and date the consent document (as described in the Investigator’s Manual)?
                    yes                       no




           m. If required by the sponsor or IRB, a witness to the consenting process in addition to the witness to the participant’s
              signature and if the same person needed to serve both capacities, a note to that effect is placed under the
              witness’s signature line?
                   yes                      no       not required by sponsor or IRB

           n.   A copy of the signed and dated consent form will be given to the person signing the consent document?
                    yes                      no

           o.   What steps will be taken to minimize the possibility of coercion or undue influence? Note: Simply reiterating
                information that was in the consent document is not sufficient.




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                                                              Section 5
                                                       Safety Monitoring Plan

     1.    Does the study require a safety monitoring plan? Yes             No    This is a minimal risk study. (skip to section 6)


     2.    If a safety monitoring plan is required, does the safety plan adequately describe the following? (Safety Monitoring Plan
           can be a separate document or be incorporated into the protocol.

                Yes          A plan to monitor research progress and subject reactions, including who will do the monitoring and how
                             monitoring will be accomplished

                Yes          Identification of a Data Monitoring Committee or Data Safety Monitoring Board, where applicable. (You
                             must provide details including the name of the committee, whether it is an independent from the sponsor,
                             how often it meets, whether written reports are available, etc.)

                Yes          A plan for dealing with adverse events and unanticipated problems involving risk to subjects or
                             others. The plan must address all potential adverse events and unanticipated problems.
                             These include: physical, psychological, economic, social, legal
                Yes          A plan to assure compliance with reporting of adverse events and/or unanticipated problems
                             involving risks to participants or others.
                Yes          A plan to assure data accuracy and protocol compliance.




                                                             SECTION 6
                                          INVESTIGATIONAL DRUGS AND DEVICES

           Investigational Drugs/Biologics
           This study involves the use of a drug or a device (either FDA-approved or investigational):
                   yes      If “yes”, complete appendix B and/or C as appropriate (see below)
                   no       If “no”, skip to section 7 “Biologic and Radioactive Materials”


           Complete appendix B if this study involves the use of a drug (either FDA-approved or investigational).

           Complete appendix C if this study involves the use of a device (either FDA-approved or investigational).




                                                         SECTION 7
                                         BIOLOGIC AND RADIOACTIVE MATERIALS

           Does this research involve the use of biologics (human tissue, cells, or fluid) or radioactive materials?
                      yes   If “yes”, complete appendix D (see below)
                      no    If “no”, skip to section 8 “Study Protocol Element”


           Complete appendix D if the study involve Biologic and/or Radioactive Materials. Biologics can be defined
           as any human specimen including tissue, cells or fluids.




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                                                                  SECTION 8
                                                      STUDY PROTOCOL ELEMENTS

1. Does your protocol contain an adequate description of the following required elements?

                  a.   Research objectives, purpose, specific aims and hypotheses             Yes            No
                  b.   Background and significance section state the problem to be
                       investigated, the rationale for the proposed research, current state
                       of knowledge relevant to the proposal and potential contribution
                       of this research to the problem(s) addressed?                          Yes            No
                  c.   Literature references                                                  Yes            No
                  d.   Procedures to be performed, (Research methods)                         Yes            No
                  e.   A description of the procedures being performed for
                       diagnostic or treatment purposes (as opposed to research purposes)     Yes            No
                  f.   A description of how risks to participants are minimized by using
                       procedures that are consistent with sound research design and
                       do not unnecessarily expose participants to risk                       Yes            No
                  g.   Projected start and completion times                                   Yes            No
                  h.   Target population(s)                                                   Yes            No
                  i.   Inclusion and exclusion criteria listed                                Yes            No
                  j.   If appropriate, is the sample size justified to show that the proposed
                       number of subjects is at least the minimum needed to achieve the
                       research objectives?                                                   Yes            No
                  k.   Data analysis plan is consistent with the study objectives             Yes            No
                  l.   Provisions to maintain human subject privacy
                       and the confidentiality of data?                                       Yes            No


                   If any of the elements above (in # 1) were not included, or if they were not adequately justified in the protocol, please
                   provide the information here:

2.   Does your protocol contain an adequate description of the following optional elements?

                  a. Use of deception or incomplete disclosure                  no       yes        N/A
                  b. If yes,
                       Does study meet the 4 criteria for waiver of IC or waiver of some of the elements of the IC?
                                                no       yes    if “yes”, attach waiver of IC
                       Are debriefing procedures described in the protocol?
                                                no       yes
                  c.   Subjects’ behavior will be recorded unknowingly           no       yes      N/A
                  d.   Double-blinding          no       yes         N/A
                       If yes, is there a provision for:
                                  Trending                   no         yes
                                  Unlocking the code         no         yes
                  d.   Randomization                         no         yes               N/A
                  e.   Washout period                        no         yes               N/A
                  f.   Radiation exposure                    no         yes               N/A
                  g.   Deviation from standard care          no         yes               N/A
                  h.   Is this a challenge study?            no         yes               N/A

                If the study protocol does not adequately justify the optional elements you listed above (in #2), please provide a full
                explain of the element here:


     3.    Surveys/Questionnaires
           If your study includes the use of any surveys/questionnaires, have you included them?
                     n/a      There are no surveys/questionnaires for this study
                     yes




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                                                               SECTION 9
                                                            PATIENT PRIVACY

     1. Provide an explanation of the provisions to protect privacy interests of subjects (include the time and place
        where they give information, the nature of the information they give, who will receive and who will use the
        information, and the purposes for collecting their information):
          Please explain provisions to protect privacy interests of subjects




                                                              SECTION 10
                                                      CONFIDENTIALITY OF DATA
     1. Access to PHI
         Note: HIPAA Privacy Rule (45 CFR 164.508) includes the following “Protected Health Information” (PHI): is individually
         identifiable health information transmitted or maintained electronically or in any other form or medium, except for
         education records or employment records, as excluded in the Privacy Rule.
         Does this new research application require access to PHI?
             yes        If “yes”, fill out the “Data Security Checklist for Principal Investigators form” - required for all studies (see
                        forms in this section)
             no         Data will be de-identified (i.e. data stripped of all identifiers and no codes exist that could link it
                        back to the identifying information)
     2. Data Collection
         Note: Provide specific and meaningful description of what protected health information (PHI) will be gathered for the
         research study. Specify PHI (physical and/or mental) that predates enrollment as well as PHI that will be gathered
         during the subject’s participation in the study (e.g. information in medical charts, specific test results, previous medical
         history records, survey instruments, etc. that were taken in a specified time period, such as “in the last 6 months”).

           Note: This information should not differ from any other forms you submit that describe PHI to be accessed (e.g.
           consent document, Application for New Human Research Project, etc).

           a. Type of Data to be Collected
              Check all that apply – provide details in the space provided below.
                       Personal data (name, address, PCP, SSN)                  Laboratory data
                       Demographic data (age, gender, vital status)            Billing data              Reports, CPRS notes
                       Encounter data w/codes (e.g. CDT, ICD9)                 Images (x-rays, MRI, photographs, etc)
                       Other

                Please provide details about the type(s) of data you checked above



           b. What is the source of the data? (Check all that apply)            Electronic               Non-electronic
                       Data will be extracted from Miami VAHCS files.
                       Data will be requested from other VA facilities.
                       Data will be extracted from national database.***
                       Data will be collected from subject interviews
                   ***Note: Principal Investigator is responsible for requesting appropriate access to national databases.
                       Please contact IRMS for more information.

           Please provide details about the data source you checked above (e.g. name of facility, name of database, etc):




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      3.    Data Storage
           a. Electronic Computer Files
              Please check any you will be using:

                i. VA Server and VA Firewall and Sensitive Data
                       All information/data will remain on VA computers within a server behind the VA firewall.

                ii. USB Drives that do not contain sensitive data (please specify what level):
                       Encrypted VA-issued thumb drives with 1 gigabyte must be signed by: Supervisor, ACOS/R&D and ISO
                       Encrypted VA-issued thumb drives with 2 gigabytes requires justification and must be signed by: Supervisor,
                      ACOS/R&D, and ISO
                       Encrypted VA-issued thumb drives larger than 2 gigabytes must be signed by an official in Washington

                iii. Other Removable Media and Sensitive Data
                     Employees are prohibited from taking equipment, information, or software off-site that contains sensitive information
                      without authorization from the officials listed below:
                        1) Your immediate supervisor
                        2) ACOS/R&D
                        3) VA Information Security Officer (ISO)
                        4) VA Privacy Officer
                        5) Medical Center Director (or designee)

                     Equipment with 4 gigabytes (or larger) that contains sensitive information and will be taken off-site requires
                      authorization from an official in Washington.

                 Other removable media (please specify).
                    Thumb drive
                    Laptop
                    Personal computer
                    Blackberry
                    External Drive
                    Non-VA Server
                    CD; Zip Disk; Floppy Disk
                    Other (please specify):

                  Note: These regulations apply to all VA-issued and non-VA electronic equipment issued used to transmit,
                        transport, access, process or store sensitive VA data.

                 Note: Employees must obtain property pass for the equipment from Acquisition & Materials Management Service;
                 Employees must obtain authorization from their supervisor for remote (VPN) access to VA Intranet.

           b. Media
                 Audio Tape                                    Video Tape
                 Other (please specify):

           c. Paper Files
              Please check any you will be using:
                 Cabinets (describe where files will be stored)
                 Other (please specify)

      4.    Personnel Authorized to Access Data
           a.    yes Only authorized personnel will access and use data related to VA-approved research.
           b. Indicate who will have access to the data:
               Research Team (only authorized personnel listed on the Report of Research Staff may access the data):
                        Principle Investigator            Research Coordinator                Co-Investigators
                        Other Miami VA Research members (please list)

                Other Research Staff:
                         Please describe – e.g. BioStats, outside multicenter collaborators, or other colleagues not listed on the
                          summary Report of Research Staff.
                Sponsor:
                         Research Sponsor
                Monitors:
                         DSMB (Provide list of names):




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           5. Protection of Patient Data Security
           Describe how patient confidentiality of data will be protected throughout the study (e.g. data collection, storage and sharing).
           Confidentiality is defined as methods used to ensure that information obtained by researchers about their subjects is not
           improperly divulged. The confidentiality plan must include protections for PHI/sensitive data stored in electronic computer files,
           media and paper files. When reviewing the new research application, the IRB will review the adequacy of your plan.

           The menu below lists minimum requirements for protecting patient privacy and confidentiality of data.
           Select the procedures from the menu that apply to your research study. If you have other procedures not listed, they may be
           added as needed. See the Investigator Manual of the Miami VAHCS for detailed guidelines about ensuring data security.

           After developing your plan, fill out “Data Security Checklist for Principal Investigators form” on this application form.

           Before submitting your new research application, if you have questions about whether your procedures to protect patient privacy
           and confidentiality of data meet VA requirements, please contact the Miami VAHCS ISO and Privacy Office.

                      Privacy Officer (PO): Cristina Gonzalez 305-575-7000 ext. 6464, Cristina.Gonzalez@va.gov

                      Information Security Officer (ISO): Carl Lindsey 305-575-3361, Carl.Lindsey@va.gov

    Describe the plan for protecting confidentiality of data:




           Procedures for Protecting Data Security – select all that apply to your research
                Devices are encrypted.
                Password protection
                Behind VA firewall
                Data are not transmitted as an attachment to unprotected e-mail messages.
                For data that will reside on a non-VA server: The server has be certified and accredited as required by Federal Information and Security Management
                 Act of 2002 (FISMA). Note: your facilities ISO should be consulted.
                Access to the data is only by those who are authorized to access it and the access is related to VA-approved research.
                Procedures for reporting theft or loss of sensitive data or the media such as a laptop, containing sensitive data are in place and familiar to the researcher
                 and all others who have access to, use, store, or transport the data.
                Non-electronic records (e.g. Paper files, disks, videos, etc.) are maintained in locked cabinets and behind locked doors.
                Information is located in an area with limited public access
                Portable computers that have sensitive information on their storage device(s) or have software that provides access to VA private networks are secured
                 under lock and key when not in the immediate vicinity of the responsible employee.
                Employees use physical locks to secure portable computers to immovable objects when the computers must be left in a meeting room, or other semi-
                 public area to which individuals other than the authorized employee have access.
                When traveling, employees keep portable computers or storage devices in their possession, not in check-in baggage.
                ISO disables the remote access account if it is not used for a period of 90 days and removes the account if it is not used for 6 months.
                Names, addresses, and Social Security Numbers (real and scrambled) have been replaced with a code. Note: Names, addresses, and Social Security
                 Numbers (real or scrambled) may only be maintained on a VA server and documentation of the procedure by which the data were coded must remain
                 within the VA
                Data collection instruments such as questionnaires must not be constructed in such a way that the identity of the respondent can be easily determined.
                 Removing or coding names, particularly for small data sets, may not be sufficient when other identifiable information is collected such as age, gender,
                 job title, etc.
                Only access data authorized through the research project; collecting data that is not part of the IRB approved study is prohibited.
                Do not walk away from computers without locking them.
                Do not print patient data and leave it on computer.

     6.    Sharing Data
           Note: Definition: For this purpose, sharing may include releasing, transmitting or providing access to research and
           health data outside of the research team, outside the VA Medical Center, to research sponsors, etc.
           a. Will you share data in any of the following formats?
                  Non-Health Data only
                  De-identified Data (data stripped of all identifiers and no codes exist that could link back to the identifying information)
                  Limited Data Set. (NOTE: A Data Use Agreement may be required)
                  Identifiable Data (i.e. includes patient identifiers, names, initials, Subject ID numbers, etc.
                 Data will not be shared – Please explain:

           You must use reasonable safeguards when sharing any form of research data, health or non-health.
              Secured web site.
              Certified mail or other courier services, information must be placed in a sealed envelope within another sealed envelope.
               Data sent via mail or delivery service must be encrypted. Note: It is preferable to send data on CDs or other media by
               a delivery service where there is a “chain of custody”.



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                Mailing of documents that are not part of the standard procedures of the protocol requires permission by the following:
                                1. Associate Chief of Staff of Research and development (ACOS/R&D)
                                2. Information Security Officer (ISO)
                                3. Privacy Officer (PO)
                                4. Your Immediate Supervisor

               Fax in a secured area; ensure fax number is correct; and verify receipt of fax. This option should only be used for date
                sensitive material.
               Shared drive with password protection.
               Personal delivery by authorized research personnel to authorized personal in secured envelope.
               Private telephone conversation to authorized personnel.
               Other (e.g. VPN):


           b. Will you share identifiable health data with anyone outside of VHA? (This does not include study monitors, sponsors).
                         no
                         If “yes” – a Data Use Agreement is required. Please contact the IRB Office.

     7.    Maintaining and Destroying Data - Data Archiving

           Media and Paper Records
           Non-electronic record study records must be maintained indefinitely (VHA Handbook 1200.05) after the study closes. Non-
           electronic records (e.g. paper files, videos, disks, etc.) of closed studies are archived by the Miami VAHCS Medical
           Administration Service. Contact the Miami VAHCS Medical Administration Service for information about how to archive records.

           Contact IRM Service for guidance about how to destroy electronic records containing VA-sensitive information.




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                                                            FORM
                                       Data Security Checklist for Principal Investigators
Date:
Name of Protocol:
Name of PI:
PI’s Phone Number and e-mail address:
Name of Privacy Officer (PO):                        Cristina Gonzalez
PO’s Phone & e-mail address                          305-575-7000 ext. 6464, Christina Gonzalez@va.gov
Name of ISO:                                         Carl Lindsey
ISO’s Phone Number and e-mail address                305-575-3361; Carl.Lindsey@va.gov

Supervisor’s Name                                     _____________________________________
Phone number and e-mail address                       __________________________________
Special Instructions for Loss or Theft of Confidential Data or Patient Privacy Immediately report loss of confidential data or patient privacy to (1) your
immediate supervisor and (2) the Miami VAHCS ISO.
If the loss occurs after hours, contact your immediate supervisor and the Miami VAHCS Acting Officer on Duty (AOD): The AOD can be reached through
the Miami VAHCS operator at (305) 575-7000.
If the loss or theft occurs off-site immediately report loss it to the security/police officers at the institution where the breach occurred (e.g. hotel security,
hospital security, university security, etc). Obtain the case number and the name and badge number of the investigating officer(s) and if possible secure a
copy of the case report.
Instructions: If you answer NO to any one of the statements, you may not remove or transmit the data outside the VA and you must consult with
your supervisor, ISO and Privacy Officer.


If the research will not obtain any VA sensitive information/data the statements below should be marked as not applicable (N/A).
Yes      No    N/A      Specific Requirement
                        Definition of VA Sensitive Information:
                        All VA sensitive research information is used and stored within the VA

                         All copies of VA sensitive research information are used and remain within the VA (define VA Sensitive
                         research information – here?)
If you have answered yes or N/A to both statements above, stop here.


If the original or copies of VA research information are removed from the VA, the following apply:

Yes     No      N/A    Specific Requirements

                       Permission to remove the data has been obtained from 1) your immediate supervisor, 2) your ACOS/R&D, 3)
                       the VA Information Security Officer (ISO), and 4) the VA Privacy Officer.

                       A property pass for the equipment (Laptop etc.) has been obtained.

                       The laptop or other portable media is encrypted and password protected.

                       Data are not transmitted as an attachment to unprotected e-mail messages.

                       Names, addresses, and Social Security Numbers (real and scrambled) have been replaced with a code.


                       Data sent via mail or delivery service have been encrypted. Note: It is preferable to send data on CDs or
                       other media by a delivery service where there is a “chain of custody”.

                       For data that will reside on a non-VA server: The server has be certified and accredited as required by
                       Federal Information and Security Management Act of 2002 (FISMA). Note: your facilities ISO should be
                       consulted.
                       Access to the data is only by those who are authorized to access it and the access is related to VA-approved
                       research.

                       Procedures for reporting theft or loss of sensitive data or the media such as a laptop, containing sensitive data
                       are in place and familiar to the researcher and all others who have access to, use, store, or transport the data.




5-19-08 draft                                                                                                          13 of 27
                                                              SECTION 11
                                                CONFLICT OF INTEREST
                                      FUNDING SUPPORT AND FINANCIAL DISCLOSURE

     1. Is there any funding support, current or pending, for this project (financial or other support)?
                yes     If “yes, and the funds are being administered by SFVAFRE, you must submit a CRADA to the
                        Research Office with all applicable forms. Please contact the Research Office for guidance on
                        developing the CRADA.
                n/a      This project is not being submitted for funding
                                          or
                         Funds are being administered by:
                                    VA      or         University of Miami


     2. Do any members of the research team or any of their immediate family members have any potential financial
             interest in the sponsor of this research and/or in the results of this research? (e.g. stock in sponsor’s
             company, consulting services)
                 Note: the Principal Investigator is responsible for reporting any potential COI of all research staff.
                 no
                 yes       If yes, please attach a completed Disclosure of Available Funds and Financial Interests form for
                           staff member who may have a potential conflict of interest.


     3. Do any members of the research team or any of their immediate family members have any potential non-
             financial interest in the sponsor of this research and/or in the results of this research? (e.g. family
             member works for sponsor).
                 Note: the Principal Investigator is responsible for reporting any potential COI of all research staff.
                 no
                 yes       If yes, please attach a completed Disclosure of Available Funds and Financial Interests form for
                           staff member who may have a potential conflict of interest.




                                                              SECTION 12
                                 CREDENTIALS TO CONDUCT HUMAN STUDIES RESEARCH
     Special Instructions: Completion of Section 12 is required for all studies submitted

     1.    Research Personnel – Qualifications; Research Privileges; Warnings
                  a. Did you attach all of the following?:
                  yes    Bio-sketches or CV’s for the Principal Investigator and any Co-Investigator(s)
                  yes Report of Research Staff Members form
                  yes     n/a    Completed FDA Form 1572 – Statement of Investigator (required for industry-sponsored research only)


                     b. Did you attach completed Scope of Practice forms for all individuals listed on the Report of Research Staff
                     form? (Exceptions are: physicians and residents already licensed and credentialed through VA credentialing
                     and privileging). Attach signed copies for review by AO/R&D.
                     yes
                     no      All personnel already have an appropriate research scope of practice on file for this PI.
                     n/a     All staff are credentialed/privileged (M.D.s)

     2.    a. Has this protocol been reviewed by any other IRB committee or do you intend to submit it for review to another IRB?
                    no
                    yes    If “yes”, please explain in the space provided

                If this protocol has been reviewed by another IRB or if you intend to submit it for review, please provide details:




5-19-08 draft                                                                                              14 of 27
           b. If this protocol has been reviewed by any other IRB committee, what was the IRB’s determination (e.g. approved,
               disapproved, tabled, etc.)
                       n/a
                If this protocol was reviewed by another IRB, please provide the outcome:


     3.    Have you been given a warning or received any other action from the FDA, another U.S. government agency or any
           global regulatory agency within the last five years regarding behavior by you or anyone else in a clinical study you
           participated.
                    no     Neither I, nor persons associated with a clinical study in which I have been involved with have received this
                            type of correspondence.
                    yes     If “yes”, please explain and attach any documentation associated with the warning.


                If you have received any warnings, please explain:


     4.    Identification of Qualified Healthcare Provider
           Please identify the qualified healthcare provider who will be responsible for all study-related healthcare decisions of study
           participants:


     5.    Identification Badges
                    yes Did you attach copies of VA ID badges for all personnel listed on the Report of Staff Members form?

     6.    Training
           Did you attach current copies of the certificates of completion for all annual trainings listed below?
                    yes    CITI/GCP or equivalent training
                    yes    Information Security 201 for Research Personnel

                     Note: Certificates must be submitted for all research personnel.




                                                                SECTION 13
                     BEFORE AND AFTER THE STUDY BEGINS ACKNOWLEDGEMENTS; SIGNATURES
                                                            Before the Study Begins
       The Principal Investigator may initiate the study only after receiving the documentation listed below.
       Additional information about these policies and procedures can be found in the Miami VAHCS IRB Investigator Manual.
       Please read and initial each of the following statements to indicate your awareness of these policies and
       requirements.
       PI Initials                                                   Approval Document
                       Approval memorandum signed by the ACOS/R&D
                       Signed VA Form 10-1223 - Report of Subcommittee on Human Studies
                       Signed VA Form 10-9012 - Investigational Drug Information Record, if applicable
                       VA Form 10-1086 - Informed Consent Document stamped by the IRB (if a waiver has not been granted)
                       Documentation of Request for Waiver of Informed Consent/Waiver of HIPAA Authorization, if applicable
                       Documentation of Waiver of Authorization for Recruitment Purposes, if applicable
                       Completion of Pharmacy/ PI Review of Initial Study Drug Stock at Pharmacy service, if applicable


                                                               After the Study Begins
       After the initiating the study, the Principal Investigator has various reporting responsibilities. Additional information about these
       policies and procedures can be found in the Miami VAHCS IRB Investigator Manual. Please refer to the manual to determine
       which forms or information needs to be submitted.

       Please read and initial each of the following statements to indicate your awareness of these policies and requirements.
       PI Initials                                                            Item
                    Continuing review must be achieved at the interval determined by the IRB.




5-19-08 draft                                                                                              15 of 27
                     Unanticipated problems must be reported to the IRB within 10 working days of occurrence (or receipt of
                     notification).
                     Note regarding Unanticipated problems: The IRB must receive a report, even if serious and unexpected
                     adverse events have already been reported to the FDA or other regulatory agencies and the study sponsor.
                     The sponsor is responsible for sharing these reports with all IRBs as they could affect the benefit-risk ratio
                     for a subject participating in a trial.

                     Breaches in data security and patient privacy must be reported immediately as described in the MCPM 00-108-07-
                     InformationSystems Security Report and reported to the IRB as described in the Miami VAHCS Investigator
                     Manual.
                     Protocol deviations must be reported to the IRB as soon as they are discovered.

                     Allegations of non-compliance with pertinent regulations and/or policies

                     Allegations of research misconduct must be reported immediately to the IRB.

                         
                     Except where the safety of the patient is at stake, the following proposed changes and any others not listed, must
                     be submitted for IRB review approval before they are implemented:
                                        research plan
                                        informed consent document
                                        Informed consent plan
                                        recruitment plan
                                        data collection/storage/sharing
                                        conflict of interest/financial disclosure information
                                        investigator brochure
                                        research personnel
                                        location of the research

                     A subject is not allowed to participate in more than one active research study without prior approval by the IRB and
                     R&D Committee.

                     Auditors and monitors must register with the Research Office before beginning the audit.

                     Reports of audits/site visit/monitoring visit and DSMB reports must be forwarded to the IRB as soon they are
                     received.
                     Correspondence from the sponsor or any regulatory agency must be forwarded to the IRB as soon as it is received

                     The following informed consent items must be documented or submitted to the IRB Office:
                                          A copy of the executed informed consent form must be submitted to the IRB Office.
                                          The informed consent process must be documented in the “CPRS Template for
                                           Documentation of Informed Consent Discussion for Research Study” that is contained in the
                                           subject’s medical chart.
                                          A copy of the completed informed consent discussion template must be submitted to the
                                           IRB Office.
                                          For studies involving investigational drugs, a copy of the VA Form 10-9012 must be
                                           submitted to the IRB Office.

                     When a study has ended you must (1) make a note indicating the subject’s participation in the study has endedin
                     the CPRS; (3) submit study closure documents to the IRB; archive all study documents as appropriate.

                     Maintain “medical chart documentation as required in the PI Manual




     SIGNATURE



           __________________________________                             _______________________
           Principal Investigator Signature                                            Date




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                                                       HUMAN STUDIES SUBCOMMITTEE
                                                APPLICATION FOR NEW HUMAN RESEARCH STUDY

                                                                     Appendix A
                                                                    Recruitment Plan


                                                                 Recruitment Methods


     1.    Recruitment Methods
           Please indicate which of the following recruitment methods you plan to use:

           a. The Principal Investigator will recruit his/her own patients to participate in this study:
                     yes      If “yes”, explain in the space provided
                              If “yes”, you must complete Waiver of Informed Consent /HIPAA Authorization form (required when using
                              patient records or databases to identify potential participants for a study).
                     no
                If “yes”, explain here:



           b. (i)      Patients will be recruited using advertising (e.g. print ads, flyers, radio):
                        yes        If “yes”, explain in the space provided. Be sure to answer the questions #b(i) through b(iv)
                                   below.
                        no        If “no”, skip to c.
                       Note: Ads may be submitted after the study has been initiated.
                    If “yes”, explain here:



           b. (ii)      Does the recruitment materials meet the following criteria?
                        yes      no     title of study
                        yes      no     name/address of PI and/or research facility
                        yes      no     condition under study and/or purpose of study
                        yes      no     summary of criteria that will be used to determine eligibility for the study
                        yes      no     time or other commitment required of subjects
                        yes      no     location of research and the person or office to contact for further information
                        yes      no     clear statement that this is research and not treatment
                        yes      no     statement of any compensation the subject may receive
                        yes      no     Does not include any exculpatory language through which the subject or legally
                                         authorized representative is made to waive legal rights or release the investigator, institution or its
                                        agents from liability or negligence.
                        yes      no     Does not overstate benefits.
                        yes      no     Does not emphasize amount of money to be paid.
                        yes      no     Does not state it is safe for effective for the purpose under investigation.
                        yes      no     Does not state it is superior than other drugs/devices.
                        yes      no     Does not use terms such as “new” without explaining test article is investigation.
                        yes      no     Does not Promise “free” medical treatment.

                    If “no” to any of the questions in “b(ii)”, explain here



           b. (iii)     Did you attach a copy of the recruitment materials?
                                yes
                                no

                    If you did not attach a copy, explain here



           b. (iv)      Explain how and where the recruitment materials will be published, posted or distributed




5-19-08 draft                                                                                                 17 of 27
           c. The Principal Investigator (or designee) will approach subjects in VA clinics (e.g. appropriate specialty) to ask
               subjects about their interest in participating in the study:
                    yes        If “yes”, explain in the space provided
                    no

                  If “yes” explain here



           d. VA practitioners not involved in this research will be asked to refer their own patients to the study:
                     yes       If “yes”, explain in the space provided
                     no
                If “yes”, explain here




           e. Potential study participants will be identified/recruited from patient records or databases:
                       yes     If “yes”, explain in the space provided.
                                If “yes”, you must complete a Waiver of Informed Consent/HIPAA Waiver (required when using patient
                                records or databases to identify potential participants for a study).
                       no
                  If “yes”, explain here:



           f. (i)Subjects will be recruited for phone surveys.
                      yes     If “yes”, explain in the space provided.
                      no      If “no”, go to question g.
                Note: In order to recruit subjects for phone surveys, the Principal Investigator should first send a letter along with
                an informed consent document to the potential subject explaining the purpose of the study and any other
                information he/she may need to make a decision about whether or not to participate. Simply agreeing to participate
                during the initial phone contact does not constitute informed consent in and of itself. If the patient returns the
                signed consent form, the study may proceed. Similar procedures are applicable for studies employing centralized
                informed consent phone systems. However, an alternative to this informed consent process may be granted which
                would not require return of an informed consent document.

                If “yes”, explain here:



          f. (ii) Did you include a phone script for IRB review?
                      yes
                       no      If “no” explain in the space provided.
               If “no”, explain here:



          g. Potential study participants will be recruited in a manner other than the methods listed in questions a-f above:
                  yes      If “yes”, explain in the space provided.
                  no
                If “yes”, explain here:




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                                                             Vulnerable Populations

     2.    Vulnerable Populations
           a. Will any of the following potentially vulnerable population(s) be recruited?

                     no      yes     Mentally Disabled Persons
                     no      yes     Economically or Educationally Disadvantaged Persons
                     no      yes     Pregnant Women and fetuses
                     no      yes     Prisoners (requires waiver from VACO – consult IRB Office)
                     no      yes     Children (requires waiver from VACO – consult IRB Office)
                     no      yes     Other (e.g. fluctuating decision-making capacity, impaired decision making capacity,
                                     students, employees).

                  If you answered “no” to all of the questions, go to Section 4
                  If you answered “yes” to any of the questions, go to “b”.

           b. If vulnerable populations will be recruited, please provide adequate justification in the space below. Note: Research in
                which the subject is a fetus, in utero or ex-utero (including human fetal tissue) and research related to invitro fertilization
                must not be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.
                   Adequate justification:


           c. Which of the following measures will be taken to assure that the rights of vulnerable populations are adequately
              protected:

                          Surrogate consent
                          Requirement that someone from the IRB oversee the consent process
                          A waiting period between initial contact and enrollment to allow time for family discussion and questions.
                          Involvement of subject advocates
                          Someone not involved in the research will obtain the consent
                          Independent monitoring
                          Formal capacity assessment
                          Tests of comprehension.
                          Reading the consent form to subjects slowly and ensuring their understanding paragraph by paragraph.
                          Interpreter for hearing-impaired subjects
                          Translation of informed consent forms
                          Use of audio-visual aids during the informed consent process
                          Consultation with subject matter expert
                          Study needs patient record flag
                          Certificate of Confidentiality (COC)
                          Additional measures to protect the privacy of students/employees.
                          Mother and Father consent
                          Other

                     Provide an explanation for the items checked above:



           d.     Will you be enrolling other classes or groups of prospective subjects who might be vulnerable to coercion or
                  undue influence (e.g. students or employees)?
                       yes     If “yes”, explain in the space provided.
                       no
                If “yes”, please describe the class or group of prospective subjects and any specific measures or special
                considerations, steps, or safeguards to ensure that these classes or groups are adequately protected:


           e.     Will subjects with impaired decision making capacity and/or fluctuating capacity be recruited?
                  (Note: VHA Handbook 1200.05: Persons with impaired decision-making capability may only participate in research
                  studies that are specifically approved for this vulnerability)

                       No      If “no”, skip to # f
                       Yes     If “yes”, complete i- viii.




5-19-08 draft                                                                                                19 of 27
                  i.       Incompetent subjects or subjects with impaired decision making capacity must not be subjects in research
                           simply because they are readily available. Justify that there is a compelling reason to include incompetent
                           persons or persons with impaired decision making capacity in your study.




                 ii.       Does the research entail more than minimal risk?
                       Minimal Risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
                       search 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.
                               No        If “no”, continue to question iii. Yes       If “yes”, answer next question.

                       If yes, is there a greater probability of direct benefit to the subject?
                                 No       If “no”, please comment below Yes




                iii.    Describe your plan for determining whether the subject has impaired decision-making capacity and
                        requires consent by a surrogate (when, how, who (names), qualifications, relationship to proposal).
                  Note: The “Recruitment” section of the Miami VAHCS IRB Investigator Manual describes additional VA
                  requirements for determining and documenting decision-making capacity.




                iv.        How will you document impaired decision making capacity?
                               Consent by a legally authorized representative will be limited to situations where the prospective participant
                               is incompetent or has impaired decision-making capacity, as determined and documented in the person’s
                               medical record in a signed and dated progress note.
                               A determination that a participant is incompetent or has an impaired decision-making capacity will be made
                               by a legal determination or a determination by the practitioner, in consultation with the Chief of Service or
                               Chief of Staff, after appropriate medical evaluation that the prospective participant lacked decision-making
                               capacity and is unlikely to regain it within a reasonable period of time.
                               The investigator will obtain consultation with a psychiatrist or licensed psychologist if the determination that
                               the prospective participant lacked decision-making capacity was based on a diagnosis of mental illness.

                 v.        Decision making capacity may fluctuate during the course of the study. Describe your plan for monitoring
                           decision making capacity during the course of the study.




                vi.        What procedures have been devised to ensure that subjects’ representatives are well-informed regarding
                           their roles and obligations to protect incompetent subjects or persons with impaired decision-making
                           capacity?




                vii.       Will you obtain assent (explaining the proposed research to the prospective participant), in addition to
                           surrogate consent?
                                Yes             No      If “no”, please adequately justify in the space provided
                       Note: Under no circumstances must a subject be forced or coerced into participating




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                viii.      What procedures have been devised to ensure that the participants will not be forced or coerced to
                           participate in a research study?



           f.   Will pregnant women be recruited?
                     No     If “no”, skip to # g
                     Yes    If “yes”, complete i- iii.

                    i.     Describe the provisions to monitor the risk to the participant and the fetus.




                    ii. Describe the manner in which the potential participants will be selected




                    iii. Have studies on animals and non-pregnant individuals been completed, and has data for
                         assessing potential risks to pregnant women and fetuses been provided in the background and
                         rational for the study.
                             Yes             No     If “no”, please adequately justify in the space provided




           g.   Non-Veteran Subjects
                     Will non-Veteran patients be recruited?
                     yes      If “yes”, did you submit an Admission of Non Veteran Patients form?
                     no       If “no”, skip to #8.
                Note: If VA Services are being used as part of the research, a CPRS chart must be established for non-veteran
                subjects. A $384 fee will be charged to the Principal Investigator’s research project account. Please contact the IRB
                Office if you have any questions.

                Note: Non-veteran subjects may only be recruited when there are not sufficient VA subjects to conduct
                the study.

           h.   Limited Enrollment
                Does the study limit the enrollment of patients based on age, gender or ethnic classification?
                    yes     If “yes”, provide adequate justification in the space provided.
                    no

                   If “yes”, provide adequate justification:


           i.   Compensation to Subjects
                   i. Will subjects be paid or receive some other compensation for their participation (e.g. coupon)?
                  yes      If “yes” , describe in the space provided.
                  no        If “no”, skip to #j

                        If “yes”, describe what compensation will be provided:




                    ii. Describe the compensation schedule in the space below (compensation must be equitably distributed over
                           the course of the study if subject will be participating longer than three months.

                        Compensation Schedule:




5-19-08 draft                                                                                         21 of 27
                    iii. Does the plan for compensation meet the following criteria:
                    yes     no      All compensation information is in the informed consent document (e.g.
                                    amount, schedule, etc.).
                    yes     no      Compensation is not considered and described as a benefit.
                    yes     no      Compensation is on a schedule. Exceptions may be considered when
                                    participation in the study is short-term.
                    yes      no     Compensation may not be withheld has a condition of completing the
                                    study
                    yes      no     Compensation must be prorated for patients who withdraw early from
                                    the study.
                    yes      no     Compensation for completing a small proportion of the study is not
                                    coercive.
                    yes      no     Compensation does not include finders’ fee.
                    yes      no     If a bonus is offered, amount of bonus for completion is not coercive.
                    yes      no     A coupon for purchase of study item is not offered. For example,
                                    participants are not offered coupons for purchasing the study drug
                    yes      no     Payment is appropriate because procedures are not part of patient’s
                                    medical care and makes special demands upon the patient.
                    yes      no     Payment is acceptable because it is standard practice of non-VA
                                    institution or other comparable situation.
                    yes      no     Payment is acceptable for transportation expenses that would not be
                                    incurred in the normal course of receiving treatment and are not reimbursed by any other
                                    mechanism.

                     If you answered “no” to any of the questions above please explain:



           j.   Recruitment Plan Minimizes Coercion
                During the recruitment phase of this study, patients interested in participating in the study must be told in the
                informed consent document and verbally that their participation is:
                    yes      Participation is voluntary
                    yes      Participants will not experience a loss of benefits for refusing to participate.
                    yes      Once enrolled, participant may discontinue at any time with no loss of benefits.



           Click here to continue filling out form




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HUMAN STUDIES SUBCOMMITTEE
                                            APPLICATION FOR NEW HUMAN RESEARCH STUDY

                                                              Appendix B
                                                          Investigational Drugs

Complete appendix B if this study involves the use of a drug (either FDA-approved or investigational).


     1. List all drugs/biologics used in this research (including active placebos). For each indicate:

                         Name                       Dosage Strength    Method Route of Admin.




     2. Did you include copies of VA Form 10-9012-Investigational Drug Information Record for each drug listed
        above? Note: please list on form all authorized prescribers where indicated
               yes      No       If “no”, explain below
            Explain why VA Form 10-9012 was not submitted:


     3. a. Does this study involve any of the following?
               yes      no    There are any therapies, diagnostics, or preventatives in your protocol that are not approved
                              for general use in the doses you will use,
                                               or
                   yes      no       You are using this drug in a population which is not indicated in the approved labeling for
                                     the drug product,
                                               or
                   yes      no       There are any doses to be used currently outside the approved labeling for the indication
                                     you will give it for
                                               or
                   yes      no       The route of administration you will use is not FDA-approved

           b. If you answered “yes” to any of the questions above, provide the IND Number(s):
                       If yes, did you provide evidence of the IND, i.e., a copy of the industry sponsored
                        protocol with the IND number; or a letter from the FDA or industry sponsor setting forth the IND
                        number?

                   Who holds the IND? (check one):
                     Sponsor
                     Investigator

                   If the Investigator holds the IND, is the investigator aware of the applicable FDA sponsor regulations and
                   ensures that research is conducted according to the signed agreement and the approved protocol? (See
                   Guidance document for Sponsor Investigators found on www.varesearchmiami.org.)

           c. If you answered “no” to all of the above, did you attach a Waiver from the Requirement to Submit an IND
             Application to the FDA form? yes

     4. Did you include 3 copies of the Study Drug Brochure or Drug Package Insert for each drug used in the
        protocol (study drug plus comparator drugs? yes

  Click here to continue filling out form


5-19-08 draft                                                                                     23 of 27
HUMAN STUDIES SUBCOMMITTEE
                                             APPLICATION FOR NEW HUMAN RESEARCH STUDY

                                                                Appendix C
                                                           Investigational Devices

Complete appendix C if this study involves the use of a device (either FDA-approved or investigational).

     1. This research involves the following test articles (check all that apply and complete the appropriate
        sections below):
                   FDA approved medical device
                   Investigational (Non-FDA approved) medical device

     2. Provide a plan for the storage, dispensing, handling, and disposal of investigational and FDA-approved
        medical devices. Where this is being done by the investigator, include a description of the procedures for
        inventory control and documentation

                Provide details about storage procedures, inventory control and documentation:




     3. List all FDA-approved medical devices used in this research. For each indicate:
                   Name            Mechanism      Manufacturer        Name of         Location of
                                       of action                      Supplier          Supply




     4. These devises will be used according to the FDA labeling without modification.
           Yes       No       (If “No”, they may be Investigational Devises and the following section must be completed).

     5. The Investigator or sponsor MUST provide a risk determination (“non-significant risk” or ”significant risk”) for any
           device study, and depending on the determination, submit the information and/or documents requested below.

                                                        PI or Sponsor’s Risk Assessment
                                               Select One – Non-Significant Risk or Significant Risk
                          Non-significant Risk
                          Provide justification and documentation:

                          Significant Risk
                     Provide evidence of the IDE, i.e., a copy of the industry sponsored protocol with the IDE
                   number; or a letter from the FDA or industry sponsor setting forth the IDE number.



     6. Is there an IDE for this research? Yes                    No     If “no”, go to “7

                     i.    If yes, provide the IDE Number(s):

                     ii. Who holds the IDE?
                              Sponsor
                              Investigator

                     iii. If the Investigator holds the IDE, is the investigator aware of the applicable FDA regulations and
                          ensures that research is conducted according to the signed agreement and the approved
                          protocol.



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                                        Yes
                                        No


     7. If there is no IDE, check the reason below and provide documentation establishing that the clinical
        investigation of the medical device at issue falls within one of the following categories:

                          A clinical investigation of a FDA-approved, legally marketed device that is being used in accordance
                           with its labeling.
                          A clinical investigation of a device that the FDA has determined to be substantially equivalent to a
                           device in commercial distribution immediately before May 8, 1976 and that is used or investigated in
                           accordance with the labeling FDA reviewed under Subpart E of 21 CFR Part 807 in determining
                           substantial equivalence;
                          Clinical investigation of a Non-Significant Risk Device.
                          A clinical investigation involving a Diagnostic Medical Device if it complies with FDA labeling
                           requirements and if the testing: (a) is noninvasive; (b) does not require an invasive sampling procedure
                           that presents significant risk; (c) does not by design or intention introduce energy into a subject; and (d)
                           is not used as a diagnostic procedure without confirmation by another medically established diagnostic
                           product or procedure.

                          Consumer preference testing, testing of a modification or testing of a combination of devices if the
                          devices(s) are legally marketed devices and if the testing is not for the purpose of determining safety or
                          effectiveness and does not put subjects at risk.
                          Clinical investigation of a device intended solely for veterinary use.
                          Clinical investigation of a device solely intended for Research with laboratory animals that contains the
                          labeling “Caution – Device for investigational use in laboratory animals or other tests that do not
                          involve human subjects.”


     8. Did you include 3 copies of the Study Device Brochure or Device Package Insert for each device used in the protocol?

                    yes




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HUMAN STUDIES SUBCOMMITTEE
                                            APPLICATION FOR NEW HUMAN RESEARCH STUDY

                                                                Appendix D
                                                     Biologic and Radioactive Materials

Complete appendix D if this study involves the use of Biologic and/or Radioactive Materials


                                                 Biologic Materials
     1. Biologic Materials
        a. Does this research include the withdrawal of blood or other body fluids, or the use of any biohazard or
           chemical hazard materials?
               yes       Attach the Biohazard/Chemical Hazard Information Involving Research form.
               no

           b. Does this research include taking biopsies or removal of other tissues?
                  yes       Attach the Biohazard/Chemical Hazard Information Involving Research form.
                  no

           c. Will biological samples be processed outside of the Miami VA Medical Center:
                    yes      Attach a Biological Sample Statement on entity’s letterhead signed by
                            appropriate official.
                    no

           d. Does this research consist of storing (as opposed to “banking”) tissue, blood, or other biological
              materials at the VA or other sites for purposes related to this protocol:
                  yes
                  no         Biological samples will not be stored.

                  If “yes’, please provide details about storage procedures:


     2. Tissue Banking
        Note: regarding tissue banking: You must obtain approval from VACO for any off-site banking facilities.
        Does this research consist of “banking” tissue, blood, or other biological materials at the VA or other sites for future
        studies:
                 yes     Attach copies of “Tissue Banking” form.
                 no      Samples will not be “banked”.


                                                           Radioactive Materials

     Note: Required for All Studies that Involve the Use of Radioactive Materials
     1. Radioactive Materials
        a. Does this research involve the use of radioactive materials?
               yes       If yes, attach copies of the Application for the Use of Radioactive Materials form.
               no

        b. If you answered “yes” to the previous question, does your protocol clearly describe how radioisotopes
will be used?
                 yes
                 no      If no, please describe how radioisotopes will be used in the space provided.

                Describe how radioisotopes will be used:



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5-19-08 draft   27 of 27

								
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