1. IRB Minutes & Records
VA Requirements
Kevin L. Nellis, M.S., M.T. (A.S.C.P.)
Program Analyst
Program for Research Integrity Development and
Education (PRIDE)
2. VHA Handbook 1200.05
Sets the Floor, not the Ceiling
• Follow state and local laws when more stringent
• Follow any additional accreditation requirements
• Local VA policies may be more robust
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3. Draft Minutes
• Must be written and available for review within 3 weeks
of the meeting date
• Approval of minor conditions by the Chair or designated
IRB voting member must be documented in the minutes
of the first IRB meeting that takes place after the date of
the approval of the minor conditions
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4. Draft Minutes
• Approval by voting members at subsequent IRB meeting
• Must be signed by the IRB Chair, or a qualified voting
member of the IRB designated by the Chair
• Final minutes cannot be altered
• May document training members received
• May include adjournment time
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5. Document Attendance
• Members (voting and non-voting)
• Alternate members
• Document who attended through videoconferencing or
teleconferencing
• Clearly indicate they received all relevant material
prior to the meeting and were able to actively
participate in all discussions
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6. Document Attendance
• IRB minutes should demonstrate that IRB meetings were
convened with members who represent regulatory/legal
requirements and general perspective of participants
(AAHRPP Accreditation Element II.1.A.)
NOTE: IRB members cannot participate in the meeting
discussions or voting by email
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7. IRB Member With a Conflict of Interest
• Conflict of interest relative to the proposal can be potential,
actual, or perceived
• Conflicted members recuse themselves and leave room
(terminate call/videoconference)
• Not counted towards quorum
• Document member is not present during the deliberations
or voting on the proposal, and that the quorum was
maintained
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8. IRB Member With a Conflict of Interest
• Conflicted IRB members are documented in the minutes as
absent with an indication that a conflict of interest was the
reason for the absence (AAHRPP Accreditation Element
II.1.D.)
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9. Document Quorum
• Quorum = majority of IRB members present [§38.107(b)]
• Quorum must be present for each vote
• Non-Scientist must be present
• NOTE: Quorum could be indicated in the minutes by
tracking attendance. It does not have to be indicated with
each vote.
• No IRB regulatory actions can take place if quorum is lost
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10. Document IRB Actions
• Approval of minutes of prior meeting
• Approval of research
• Requiring modifications in research (e.g., approve study
contingent on specific minor conditions)
• Deferring approval of study contingent on substantive
modifications
• Disapproval of research
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11. Document IRB Actions (continued)
• Suspension or termination of previously approved
research
• Details requiring observation of consent process
• Administrative actions (e.g., voting on non-regulatory
actions, etc)
• Other actions based on local policy
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12. Document Vote Properly
• Document the vote on actions including the number of
voting members voting
• For
• Against
• Abstaining
• In order for the research to be approved, it shall receive the
approval of a majority of those members present at the
meeting [§38.108(b)]
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13. Format to Consider for Documenting IRB
Vote When Alternate Votes
• Total Voting = 15
• Vote: For-9, Against-3, Abstain-3
• Smith serving as alternate for Jones
• Approved
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14. Format to Consider for Documenting IRB
Vote with Conflict of Interest
• Total Voting = 14 (1 recused)
• Vote: For-7, Against-4, Abstain-3
• Note: Smith not present due to COI; terminated
videoconference connection
• Not approved
NOTE: A recusal means they are not voting
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15. IRB Determinations and Justifications
• Document determinations required by VA and other Federal
requirements
• Waiver or alteration of informed consent
• Waiver of documentation of informed consent
• Research involving vulnerable populations
• Waiver of HIPAA authorization
• Document protocol-specific findings justifying those IRB
determinations
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16. Research Involving Pregnant Women
• Document review of additional safeguards in IRB
minutes
• Should document in IRB minutes or protocol file :
• Criteria of 45 CFR 46.204 are met
• Adequate provision made to monitor the risks of
subject and fetus
• Status of waiver from CRADO, if applicable
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17. Research Involving Prisoners
• Document review of additional safeguards in IRB
minutes
• May wish to document status of waiver from Chief
Research and Development Officer (CRADO)
• Should document that each the conditions of 45 CFR
46.301 – 46.306 are met in IRB minutes or protocol file
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18. Research Involving Children
• Document review of additional safeguards
• Should inform investigator of requirement to obtain
CRADO waiver
• Reflect discussions regarding:
• Level of risk
• Informed consent and assent forms
• Investigators’ qualifications to conduct research
involving children
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19. Research Involving Individuals Who Lack
Decision-Making Capacity
• Document review of additional safeguards
• Document IRB deliberations and the criteria used to
approve inclusion of individuals who lack decision-
making capacity in the IRB minutes or IRB protocol file
• Document findings related to the use of surrogate
consent in IRB minutes
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20. Subjects Susceptible to Coercion or Undue
Influence
• Document that safeguards are adequate to protect the
rights and welfare of subjects who are likely to be
susceptible to coercion or undue influences
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21. Risk and Rationale
• Document the IRB’s determination of the level of risk
(e.g., whether or not the research constitutes minimal
risk)
• Document the rationale for the IRB’s determination of the
level of risk
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22. Informed Consent Requirements
• Document the IRB’s determination that all appropriate
elements were included in the informed consent form,
and are included in the informed consent process
• Document findings when IRB does not include or alters
some or all of the elements of informed consent
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23. Frequency of Continuing Review
• IRB must document which protocols require continuing
review more often than annually, as appropriate to the
degree of risk [§§38.103(b)(4);38.109(e)]
• Document the IRB’s determination of the frequency of
continuing review of each study
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24. Document Basis for Requiring
Changes or Disapproval
Examples:
• PI must broaden recruitment pool geographically to
maintain diversity of subjects…
• IRB disapproves research because of investigators
misconduct inquiry; however, he may resubmit, once
inquiry is resolved…
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25. Provide Summary of
Controverted Issues and Resolution
Example:
• IRB debates over whether an Opt-in recruitment
methodology should be required as opposed to the Opt-
out methodology proposed by the investigator
• IRB requires the investigator to submit additional
justification as to why an Opt-in methodology should be
approved for this particular study
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26. Provide Statements of
Significant New Findings
Example: This study demonstrated that anti-HIV drugs
inhibit emerging virus linked to prostate cancer and chronic
fatigue syndrome in Veterans. The study indicates that four
drugs used to treat HIV infection can inhibit a retrovirus
recently linked to prostate cancer and chronic fatigue
syndrome…
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27. Non-Veteran Subjects
• Provide a summary of the justification for including non-
Veterans as subjects in the IRB minutes
• IRB must appropriately document in the IRB minutes or
IRB protocol file its determinations regarding
participation of non-Veterans in the study
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28. Real Social Security Numbers
• Summarize discussion when real Social Security Numbers
(SSNs), scrambled SSNs, or the last four digits of SSNs
will be used in the study
• Include discussion of security measures
• NOTE: Does not apply if the only use of SSNs is on the
informed consent form or the HIPAA authorization
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29. Waiver of HIPAA Authorization
• Documentation of the IRB’s findings for waiver of HIPAA
authorization may be in the IRB minutes or the IRB protocol
file
• If IRB does not document the waiver of authorization as
required, the waiver is not valid
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30. FDA-Regulated Studies
• May document that a physician is present
• May document that an IND/IDE has been validated or one
is not required
• IRB must categorize a device study as either significant risk
(SR) or non-significant risk (NSR) and document its
determination in the IRB minutes
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31. Expedited Review Procedures
• IRB must notify IRB members of research studies approved
• IRB approval must be documented in the IRB minutes or
IRB protocol files
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32. Other Items for Consideration for
IRB Minutes
• May document discussion regarding flagging of medical
records
• Provide summary of: Protocol Deviations, Adverse Events,
Unanticipated Problems Involving Risks to Subjects or
Others, Audits, Reports to ORO, OHRP, FDA
• Document discussion of IRB business
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33. IRB Records Include:
• IRB SOPs as described in 38 CFR 16.103(b)(4) and (5)
• IRB Roster and Member Resumes
• Minutes of IRB meetings
• Federal Wide Assurance (FWA)
• Memorandum of Understanding (MOU)
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34. IRB Study File Includes:
• All research proposals and amendments reviewed
• Scientific evaluations, if any, that accompany the
proposals
• Approved informed consent documents
• Progress reports submitted by investigators
• Reports of injuries to subjects
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35. IRB Study File Includes:
• Records of continuing review activities
• Copies of all correspondence between the IRB and the
investigators
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36. IRB Records
• Must be readily available
• Space needs to be sufficient to provide secure storage of
records
• Investigator must maintain research records that the
protocol is being implemented as approved
• Store according to VA and Federal records retention
requirements
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37. Key Points
• Accurately reflect activities, discussions, and
determinations in IRB minutes
• Record deliberations, actions, and votes for each protocol
in IRB minutes
• Maintain IRB minutes and Records in compliance with VHA
Handbook 1200.05, Common Rule, state requirements, and
local VA policy
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