Jim Gearhart

by Jim Gearhart

OHRP and the FDA Share Expectations for IRB Minutes

In November 2015, the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) teamed up to provide joint guidance about minutes from IRB (Institutional Review Board, also known as ethics committees) meetings. In effect, the guidance (which is in draft and currently open for comments) provides two agencies’ views of best practices regarding IRB meeting minutes.

It is not hard to see how important proper IRB minutes are to the FDA and to OHRP. Check out their list of common findings of noncompliance (this list comes from the draft guidance):

  • 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 minutes seriously. It also suggests that OHRP and the FDA offices are making good on their pledge to improve policy harmonization. In this case, sharing the stage emphasizes the overlap in the agencies’ regulations.

As with most draft guidance documents from the FDA or OHRP, this one distinguishes between what the regulations specifically require and what FDA/OHRP expects to see beyond that. These typically show up in the announcement as “must-do’s” and “should-do’s.” Must-dos reflect the letter of the regulations, and should-do’s essentially reflect what the FDA and OHRP see as  IRB minute best practices.

While most of the policy statements here apply to both OHRP and FDA, the guidance document also notes where the agencies’ rules diverge. The most notable sections here are in waivers of informed consent, where OHRP has more categories, and in medical devices, where FDA has some unique requirements.

The table below summarizes highlights of the guidance to help sort through its particulars (an empty box means the draft guidance did not mention a specific requirement or recommendation regarding IRB minutes).

Topic FDA, OHRP, or Both The IRB or institution must… The IRB or institution should…
Attendance
IRB Members Both Keep an accurate record of who attended a convened meeting. Include IRB members’ full names

Document who, if anyone, attends remotely, such as by video- or teleconference, versus attending in person

Alternate members Both Provide name and status of an alternative member who substitutes

Provide reason for substitution

Record the circumstances for any substitution, regardless how long the substitution lasted.
Consultants Both Include the name of the consultant

Include consultant’s expertise

Confirm that the consultant did not vote

Non-members Both Record the name of all non-members who attend. State that attending non-members do not participate in discussion or vote.

Consider 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)

Both Include sufficient information to show quorum was maintained throughout the meeting.

For IRBs with an even number of members, calculate a majority (quorum) with ‘half-plus-one’ for a majority.

For odd-numbers, majority (quorum) should round up from half.

IRB Actions
General Both Include enough detail to show all “IRB actions at a convened meeting.” Consider “IRB actions” to include any vote in a convened meeting regarding a proposed research activity.

Consider the minutes as a central repository for IRB decisions on proposed research activities.

Approvals Show that the IRB made all required findings and determinations.

Include the effective date of approval.

Include the approval period.

Approvals with Conditions State the process for ensuring that all IRB-required conditions are met.
Suspension/Termination Both Summarize any convened meeting decisions to suspend or terminate IRB approval Include reasons for the suspension/termination of research.

Should refer to a convened meeting any decisions to suspend or terminate that happen outside of a meeting.

Document the IRB discussion regarding the referred suspension or termination

Regulatory Determinations
General Both Show whether the IRB found that the proposed research met all relevant criteria.
Informed Consent Both Indicate that the IRB reviewed all consent forms and determined they met applicable requirements.
Waivers of Documentation of Consent Both Document the IRB’s approval and the protocol-specific reasons which justify it.
Waiver or Alteration of Consent OHRP Document the approval of any such waivers Record each decision regarding waiver of consent as well as the protocol-specific reasons for doing so.
Studies Involving Children Both Document the IRBs discussion and all determinations regarding research in children.
Emergency Research FDA Include in the minutes all discussion and decisions regarding emergency research that does not obtain consent for all individuals.
FDA-Regulated Devices FDA Include in the minutes all discussions regarding a Significant Risk/Non-Significant Risk (SR/NSR) determination.
Pregnant Women

Human Fetuses

Neonates

OHRP Record all findings and protocol-specific justifications whenever a convened IRB approves such research
Studies Involving Prisoners OHRP Record all findings and protocol-specific justifications whenever a convened IRB approves such research.
Expedited Review Activities Both Record whenever the convened IRB reviews Expedited Review Activities.

Show that the members had opportunities to discuss the Expedited Review activities.

Unanticipated Problems

Serious/Continuing Non-compliance

Suspension/Termination

Both Summarize any report that comes before the board, and record the decision.

Refer any decisions made outside of the meeting to the board and record the referral in the minutes.

Votes on IRB Actions   
Number of Votes Both Show the number of votes for, against, and abstaining. Names of individual members are not required.
Conflicts of Interest In the case of a conflict of interest, include the name of the member and note the member’s recusal.
Conflict of Interest, 2 Both Not count conflict of interest recusals as votes. Distinguish between abstentions and recusals due to conflicts of interest.
Communications Outside of the Meeting Both 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 Changes Both Include enough details to show reasons for requiring any changes in research.
Disapproving Research Both Include enough details to show the reasons for disapproving research. Summarize the IRB’s discussion and indicate clearly the reasons for disapproval.
Resubmissions Both Include what, if any, changes or additions the IRB requires for approval.
Controverted Issues   
Decision without resolution (e.g., Postponement, Table, etc.) Both Summarize the IRB’s discussion and include any proposal for resolution in the minutes. Note when the meeting had no controverted issues.
Resolution Both Summarize the discussion and decision when the IRB resolves controverted issues.
Bonus Material
Responsibility for minutes Both Designate who is responsible for preparing and maintaining minutes.
Written Procedures Both Include in written procedures the responsibilities and processes for IRB minutes.
Approving Minutes Both Record any routine IRB approvals of minutes (if IRB review of the minutes is a written procedure).
Continuing Education, Announcements, etc. Both May document other activities in the minutes.
Recordings Both Prepare and maintain written minutes, even if meetings are recorded. Document in IRB procedures that meetings are recorded, if it is policy to record meetings.
Records Retention Both Keep 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.

So those are the highlights of what the FDA and OHRP emphasizes as required for IRB minutes and what the agencies consider important beyond the regulations. This draft guidance provides a good opportunity for an IRB or an institution to confirm whether it conforms with everything these agencies require and what they expect to see. It’s a good time to check the should-dos and the must-dos for IRB minutes.


References

See the regulations for IRB minutes at 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2)

Check out the draft guidance at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm.

The FDA and OHRP are accepting comments at  http://www.regulations.gov until February 3, 2016.

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