by Jim Gearhart

OHRP and FDA Share Expectations for IRB Minutes

The Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) recently issued final joint guidance about minutes for IRB meetings. The agencies issued a draft of these guidelines in 2015, and the final version serves at least two purposes: it covers the basic requirements of IRB meeting minutes and it collects the agencies’ views of best practices for IRB record-keeping.

The guidance distinguishes between what the regulations specifically require and what the FDA or OHRP expect to see beyond that. These typically show up as what an IRB or institution “must do” or “should do.” Must-dos represent the fundamental letter of the regulations, and should-dos reflect what else the FDA and OHRP expect.

This new joint guidance serves an additional purpose, too: mixed in with what the IRB note-keeper must and should document are reminders about what the IRB itself must and should do during a meeting. To name a few examples, the guidance includes procedural prompts about maintaining quorum, ensuring recusals because of conflicts of interest, and making all required determinations about pediatric studies. Alongside these numerous reminders appear the corresponding expectations for documenting those actions.

It is not hard to see how important proper IRB minutes are to the FDA and to OHRP. The guidance has a ready list of what minutes-related problems inspectors commonly find:

  • Minutes are missing
  • Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining
  • Minutes are incomplete and only describe voting actions as “passed unanimously”
  • Minutes do not clearly indicate, or contain discrepancies about what the IRB approved
  • The IRB maintains multiple sets of minutes with different information for the same meeting and
  • Minutes fail to include a summary of the discussion of controverted issues.

The joint announcement shows that both agencies take IRB records seriously, and that they are serious about their pledge of harmonization. Of course, harmonization is now more than good policy. Now it’s the law. With 2016’s 21st Century Cures Act, better coordination between the agencies’ regulations became a legal mandate.


So, What Does the Guidance Say?

The table below summarizes the joint guidance on IRB minutes, noting whether the topic applies to OHRP, the FDA, or both (which is most of them). It also separates must-dos from should-dos, and shows whether another IRB record can substitute for minutes. An empty box means the guidance does not mention a specific requirement or recommendation.

Not sure how your IRB processes and procedures are impacted? Kinetiq has on-demand regulatory consultants who can help clarify any changes your IRB must make to comply.

TopicFDA, OHRP, or BothMust Do...Should Do...Other IRB Record is Acceptable
IRB MembersBothKeep a clear and accurate record of who attended a convened meeting

Ensure members participating remotely received a copy of relevant protocol documents in advance of the meeting
Include IRB members’ full names

Document who attends remotely, such as by video- or teleconference

List attendance information at the beginning of the minutes and include full name and representative capacity
An appended roster can provide some member information
Alternate members
(i.e., for either the entire meeting or particular items)
BothProvide name and status of the alternative member who substitutesWhen substituting due to a conflicting interest, identify the name of the primary member and state this as the reason for the substitution
ConsultantsBothInclude name of the

Ensure the consultant does not vote
Describe the consultant’s expertise
Non-membersBothRecord the name of all non-members who attendConsider creating a written policy about non-member attendance
Maintaining quorum
(i.e., a majority of IRB members attending, including at least one non-scientific member)
BothKeep an accurate record of who attended a convened meeting (this will likely include those who arrive late, leave early, leave temporarily, etc.)Include sufficient information in the minutes to show quorum was maintained throughout the meeting
IRB Actions
GeneralBothInclude enough detail to identify the research activities reviewed and show all IRB actions taken.Serve as a central repository for IRB actions.

Develop written procedures that lists all possible IRB actions
Initial and Continuing ApprovalsBothDocument all findings of approvalShow that the IRB made all required findings and determinations

Include the effective date of approval

Include the period of IRB approval
Records other than minutes may show effective date of approval and approval period
Modifications, Approvals with Conditions, and DisapprovalsBothInclude sufficient detail to show the action and basis for requiring changes or for disapproving researchState the process for ensuring that all IRB-required conditions are met
BothIdentify the reasons for convened IRB action to suspend or terminate IRB approval

Document any subsequent lifting of suspension or termination
Should refer any decisions to suspend or terminate that happen outside of a meeting to a convened meeting

Document the IRB discussion regarding the referred suspension
Regulatory Determinations
(such as criteria for IRB approval of research)
BothDocument all IRB actionsDocument all approvals satisfy the 111 criteria for IRB approval of research Satisfaction of criteria of IRB approval can appear elsewhere to avoid redundancy (e.g., checklists, data entry, or other records)
Informed ConsentBothDetermine informed consent will be appropriately sought by participants or their legally authorized representatives, and that consent will be appropriately documented
• Document any changes to the informed consent that the IRB required
Indicate that the IRB reviewed all consent forms and determined they met applicable requirements

Note any requested changes to the informed consent document
Changes to the informed consent document may appear outside the minutes (e.g., as part of an annotated informed consent document)
Waivers of Documentation of Informed ConsentBothDocument the IRB’s approval and the protocol-specific reasons which justify it
Waiver or Alteration of Informed ConsentOHRPDocument the approval and satisfaction of regulatory requirements of any such waivers are metRecord each decision regarding waiver of consent, as well as the protocol-specific reasons for doing soDocumentation can be in minutes or other IRB record
Studies Involving ChildrenBothEnsure proposed research involving children is approvable under the applicable governing rules, (child risk category, parental permission, assent requirements, etc.)Document the IRB’s discussion and all determinations regarding research in children (e.g., 45 CFR 46, subpart D) Documentation can be in minutes or other IRB record
Emergency ResearchBothEnsure research requesting exception from informed consent for some or all participants satisfies the applicable criteria

Include in the minutes a summary of the discussion and all decisions regarding required elements for these studies
FDA-Regulated DevicesFDAMake a risk determination for a study that involve Significant Risk/Non-Significant Risk (SR/NSR) devices (unless done by FDA)Include in the minutes all discussions regarding a Significant Risk/Non-Significant Risk (SR/NSR) determination
Pregnant Women,
Human Fetuses, and
OHRPEnsure research involving pregnant women, human fetuses and Neonates satisfies the applicable regulatory criteria Record all findings and protocol-specific justifications whenever a convened IRB approves such research (e.g., 45 CFR 46, subpart B)Documentation can be in minutes or other IRB record
Studies Involving PrisonersOHRPEnsure research involving prisoners satisfies the applicable regulatory criteriaHave prisoner research reviewed by the convened IRB

Record all findings and protocol-specific justifications related to such research (e.g., 45 CFR 46, subpart C)
Documentation can be in minutes or other IRB record
Expedited Review ActivitiesBothEstablish method to keep IRB members advised of research approved under expedited reviewPresent a report of expedited review procedures to the convened IRB and document in the minutes what information was presented, the provided opportunity to raise concerns, and any ensuing deliberation
Unanticipated Problems
Serious/Continuing Non-compliance
BothDocument any IRB actions based on a report based on issues requiring prompt reporting to the IRB Summarize issues requiring prompt reporting to the IRB that comes before the board

Refer any related decisions made outside of the meeting (e.g., by IRB Chair or IO) to the board and record the referral in the minutes
Votes on IRB Actions
Number of VotesBothShow the number of votes for, against, and abstainingVoting records by names are not required
Conflicts of InterestBothReflect a vote count that is consistent with any recusalsn the case of a conflict of interest, include the name of the member and note the member’s recusal for this reason
Conflict of Interest, 2BothNot count conflict of interest recusals towards quorum or as votesDistinguish between abstentions and recusals due to conflicts of interest
Communications Outside of the MeetingBoth Not vote on items outside of a convened meeting (e.g., a pre-meeting vote by email)
• Not consider as votes any opinions or comments that come from members who are not present
May consider for discussion information provided by members outside of the meeting
Changes and Disapprovals
Requiring ChangesBothInclude enough details to show reasons for requiring any changes in research
Disapproving ResearchBothAction of disapproval and enough detail to establish the basis for the disapprovalWritten communication with investigator and institution must include reasons for disapproval

The IRB must provide the investigator to respond in person and/or in writing
ResubmissionsBothInclude what, if any, changes or additions the IRB requires for approval
Controverted Issues
Decision without resolution
(e.g., Postponement, Table, etc.)
BothSummarize the IRB’s discussion and what further clarification is being requested
ResolutionBothSummarize the discussion and record when and how the controversial issue was ultimately resolved
Additional Considerations
Responsibility for MinutesBothDesignate who is responsible for preparing and maintaining minutes

Consider creating a standard minutes template to assist in preparing IRB minutes
Written ProceduresBothInclude in written procedures the responsibilities and processes for IRB minutes
Approving MinutesBothRecord any routine IRB approvals of minutes (if IRB review of the minutes is a written procedure)
Continuing Education, Announcements, etc.BothMay document other activities such as these in the minutes
RecordingsBothPrepare and maintain written minutes, even if meetings are recorded
Records RetentionBothKeep minutes for at least three years after completion of the research.

Make records accessible for inspection by OHRP or FDA
Expect OHRP and FDA representatives to request IRB minutes during an inspection or assessment

For details, please see the final guidance documents or the regulations for IRB minutes at 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2)

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