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)

VHA Handbook 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 2

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 3

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 4

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 5

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 6

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 7

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.) 8

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 9

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 10

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 11

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)] 12

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 13

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 14

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 15

Research Involving Pregnant Women Document review of additional safeguards in IRB minutes Should document in IRB minutes or protocol file : Criteria of 45 CFR are met Adequate provision made to monitor the risks of subject and fetus Status of waiver from CRADO, if applicable 16

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 – are met in IRB minutes or protocol file 17

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 18

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 19

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 20

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 21

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 22

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 23

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… 24

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 25

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… 26

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 27

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 28

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 29

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 30

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 31

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 32

IRB Records Include: IRB SOPs as described in 38 CFR (b)(4) and (5) IRB Roster and Member Resumes Minutes of IRB meetings Federal Wide Assurance (FWA) Memorandum of Understanding (MOU) 33

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 34

IRB Study File Includes: Records of continuing review activities Copies of all correspondence between the IRB and the investigators 35

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 36

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 , Common Rule, state requirements, and local VA policy 37

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