When in doubt, document. That may be the best default position for IRBs based on draft federal guidelines created in part because some boards were being cited or warned about having inadequate meeting minutes.
The draft was issued jointly on Nov. 5 by the Office of Human Research Protections and the Food and Drug Administration under the title “Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards.” The draft is open for comment through January 4, 2016.
“Because IRBs have been cited in OHRP determination letters and FDA warning letters as having inadequate minutes, OHRP and FDA are providing recommendations on the type and amount of information to include in minutes in order to help IRBs meet the regulatory requirements for minutes,” according to the guidance.
Examples of noncompliance related to minutes include:
- 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.
Recommendations unless regs cited
The draft guidance is a product of the two agencies’ ongoing effort to “harmonize” their regulatory expectations and requirements for human subject research.
“The draft guidance, when finalized, will represent the current thinking of OHRP and FDA on minutes of IRB meetings,” the agencies stated. “You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
In that regard, the guidance describes OHRP’s and FDA’s “current thinking on a topic” and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
That said, IRBs that review research subject to HHS and FDA regulations (45 CFR part 46 and 21 CFR parts 50 and 56, respectively) must comply with the requirements in those regulations. Both the HHS regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically require that institutions, or where appropriate, an IRB, prepare and maintain adequate documentation of IRB activities, including minutes in sufficient detail to show:
- attendance at the meetings,
- actions taken by the IRB,
- the vote on these actions, including the number of members voting for, against, and abstaining,
- the basis for requiring changes in or disapproving research, and
- a written summary of the discussion of controverted issues and their resolution.
Designate person responsible
The agencies recommend that institutions and IRBs decide who is responsible for preparing and maintaining minutes at their institutions and outline the process in the IRB’s written procedures. If the institution and IRB have a process for review and either acceptance or approval of minutes, this process should be covered in the IRB’s written procedures. Institutions and IRBs may consider creating a standard template to assist in the preparation of their minutes.
OHRP and FDA recognize that in addition to documenting the IRB’s findings and determinations in the minutes, or elsewhere in the IRB records, IRBs may also choose to document other activities that occur during the meeting. For example, some IRBs provide continuing education and training to the IRB members at a convened meeting and document such training in the minutes. IRBs may also communicate announcements or other information to the IRB members and attendees at the meeting and document this in the minutes (e.g., upcoming meeting schedule, staff or membership changes). This practice is acceptable to OHRP and FDA.
IRBs may choose to record IRB meetings (e.g., video, audio tape) and use the recording as a tool to assist in the preparation of written minutes. This process, if used, should be described in the IRB’s written procedures. However, retention of complete recordings of meetings does not relieve an IRB of its obligation to keep written minutes in accordance with the requirements of 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2).
“We do not expect the minutes to include a verbatim transcription of what each member said during the course of the meeting,” the draft states.
Records required by the regulations, including meeting minutes, must be retained for at least 3 years after completion of the research subject of the review and must be accessible for inspection and copying by authorized representatives from OHRP and FDA at reasonable times and in a reasonable manner.
IRB members should review the full draft guidance for specific details, recommendations, and requirements. Some of the key areas outlined include the following:
- Actions taken by the IRB. The minutes of IRB meetings must be in sufficient detail to show the actions taken by the IRB at the convened meeting. OHRP and FDA interpret “actions taken by the IRB” to refer to any vote taken by the IRB related to a proposed research activity. The minutes must summarize all research activities being reviewed by the IRB at that meeting, and must document actions taken by the IRB. The minutes should serve as a central repository for IRB decisions on proposed research activities.
- Criteria for IRB approval of research. The minutes, or other IRB record, should summarize the IRB’s consideration of the approval criteria and should include a determination as to whether the criteria were met, as applicable.
- Informed consent. The minutes should indicate that, as part of its review and approval of a study, the IRB reviewed the informed consent form(s) and determined that the form(s) meet the applicable regulatory requirements. The minutes, or other IRB record, must also summarize any changes to the informed consent form(s) required by the IRB. Both OHRP and FDA regulations permit an IRB to waive the requirement that the subject or the subject’s LAR sign a written consent if the IRB determines that certain criteria are met. The agencies recommend that any such waiver of documentation of informed consent be documented in the minutes with protocol-specific information justifying the IRB’s decision(s).
- Unanticipated problems, serious or continuing noncompliance, suspension or termination of IRB approval. If at a convened meeting, the IRB reviews an issue that requires prompt reporting to the IRB, the minutes should summarize the report and must document the IRB’s action, if any, resulting from that review. Any review of such information and any decisions made outside of a convened meeting (e.g., as determined by the IRB chair or institutional official for subject safety reasons) should be reported to the convened IRB and documented.
Editor’s note: The full draft guidance on IRB minutes is available at http://1.usa.gov/1iOdsnU. Comments on the draft document should include the docket number FR Doc No: 2015-27986 and be submitted by Jan 4, 2016. Submit electronic comments to http://www.regulations.gov.