Institutional Review Boards ("IRBs") need to maintain meticulous minutes that demonstrate understanding of complex federal regulation and their application. By establishing best practices, including minute and record keeping and adopting template forms that capture the necessary regulatory considerations and key phrases research, institutions and IRBs may minimize legal risk and negative publicity.
IRBs have been required to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings under federal regulations for years.1 However enforcement activity aimed at IRBs' failure to maintain adequate documentation of IRB activities has been a growing trend over the last three years. Both the U.S. Food and Drug Administration (FDA), as well as the Office for Human Research Protections (OHRP) have cited IRBs for failure to maintain compliant meeting minutes.2
In early November 2015 the FDA and OHRP issued draft guidance containing recommendations intended to assist institutions and IRBs in documenting their compliance with applicable regulations. The guidance recommends that IRB meeting minutes provide a summary of what occurred during the meeting and document any findings and determinations with sufficient detail to show: (1) attendance at the meeting; (2) actions taken by the IRB; (3) the vote on these actions; (4) the basis for requiring changes or disapproving research; and (5) a written summary of the discussion of controverted issues and their resolution. Below is a summary of the new guidance requirements. Comments and suggestions regarding this draft guidance should be submitted within 60-days of publication in the Federal Register of the notice announcing the availability of the draft guidance, which is January 4, 2016. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. You may submit electronic comments here.
A. Attendance at the IRB Meeting
FDA and U.S. Department of Health and Human Services (HHS) regulations require IRBs to conduct business at convened meetings in which a quorum exists. A "quorum" means a majority of an IRB’s members are present, and at least one of these members has primary concerns in a nonscientific area. Proposed research that is not expedited must receive the approval of the majority of members present at the meeting under federal regulations. Therefore, IRBs must maintain accurate records of the IRB members who attended each convened meeting and must demonstrate with sufficient detail the maintenance of a quorum throughout the entirety of the meeting, and whether a majority vote was received for each proposed study.
The draft guidance recommends that in documenting the presence of members, alternates, consultants, and guests:
- Minutes should include the full names of the IRB members present and participating in the convened meeting and the representative status for each member (e.g., scientist, nonscientist, unaffiliated).
- Attendance information should be listed at the beginning of the minutes so that it is clear who was present at the meeting.
- Minutes should articulate which members participated in the convened meeting through an alternative mechanism, such as telephone or video conferencing.
- Minutes should document any circumstance in which an IRB-appointed alternative member is present in place of a primary member, even if only for a portion of the meeting, or when another member is recused. Documentation must include the alternate’s name and representative status, the name of the primary member for whom the alternative is substitution, and the reason for the substitution.
- Any consultants present to assist in the review of a particular study should be documented in the minutes by full name and a brief description of his or her area of expertise. The minutes should also note that the consultant(s) did not vote on the study, which is prohibited by FDA and OHRP regulations.
- Minutes must include the name(s) of any nonmembers or guests that the IRB allows to attend a convened meeting. Nonmembers or guests may include, for example, IRB support staff, the investigator whose study is being reviewed, or a study coordinator. The minutes should clearly indicate that the nonvoting, nonmember(s) or guest(s) did not participate in the deliberation or voting. (FDA and OHRP further recommend that the institution or IRB consider having a written policy covering the attendance of nonmembers and guests at a convened meeting.)
B. Actions Taken by the IRB
IRB meeting minutes should summarize all research activities reviewed at the IRB meeting and any “actions taken by the IRB,” which the OHRP and FDA have interpreted as “any vote taken by the IRB related to a proposed research activity.”
1. Approvals, Modifications to Secure Approval, and Disapproval
OHRP and FDA regulations require that an IRB review and have the authority to approve, require modifications to secure approval, or disapprove all proposed research activities. The meeting minutes, or other IRB record, must document the IRBs findings and determinations required under the federal regulation for approval of a study as well as and the effective date and approval period.
2. Suspension or Termination of IRB Approval
Federal regulations authorize an IRB to suspend or terminate approval of human subject research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Such IRB actions, which occur at IRB meetings, must be summarized in the meeting minutes, including the reasons for the IRB’s action and any follow-up actions. The guidance also recommends that if any such action takes place outside of an IRB meeting should be reported to the fully-convened IRB and such communication must be documented in the minutes.
3. Other IRB Regulatory Determinations and Review Responsibilities
IRBs must make specific regulatory findings and determinations in order to comply with relevant regulations summarized in the chart below.
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OHRP and FDA recommend that IRBs also document these findings in the meeting minutes or other IRB record, including a summary of the IRB’s approval criteria considered and whether the criteria was met. Furthermore, IRB discussions and decisions about utilizing the emergency research exception to informed consent must be summarized in the meeting minutes because the FDA has determined that studies relying on this exception are naturally controversial.
C. The Vote on IRB Actions
The guidance recommends that:
- The minutes must be in sufficient detail to show how members voted, including the number of members voting for, against, and abstaining.
- Any member recused from voting due to a conflict of interest may not be counted toward a quorum.
- IRB members who participate via telephone or video conferencing may vote and be counted towards the quorum.
- IRB members may not vote outside of conveyed meetings and email voting is impermissible, nor can an IRB member delegate authority to a third party. While members who do not attend may not vote, opinions of absent members may be considered at IRB meetings as part of the pertinent discussion.
D. Requiring Changes or Disapproving Research
The guidance sets forth four items that must be documented when an IRB requires changes to a protocol or consent or when the IRB disapproves a research study:
- The minutes of IRB meetings must be in sufficient detail to show the basis for requiring changes in (to secure approval) or disapproving research.
- If the IRB requires that the investigator make specified changes to the research protocol or informed consent document(s), and to resubmit such documents to the convened IRB for subsequent review, these IRB decisions must be documented in the minutes.
- If the IRB disapproves a research activity, the IRB must include a statement of the reasons for its decision in the written notification to the investigator and the institution, and provide the investigator with an opportunity to respond in person or in writing.
- The minutes should summarize the IRB’s discussion and deliberations for its decision to disapprove proposed research, and clearly indicate the IRB’s reasons for its decision.
E. Controverted Issues and Their Resolution
The guidance addresses a more sensitive topic, which is documenting controverted or disputed issues and their resolution in the meeting minutes. The guidance defines controverted issues as "those that cause controversy and dispute among the IRB membership during a convened meeting" and are usually "the result of opposition to some aspect of the proposed research." The guidance provides examples of when controverted issues are likely to arise, including emergency research where informed consent may not be obtained for all subjects, or some research involving vulnerable populations.
The meeting minutes must reflect any action that the IRB takes on a controverted issue by indicating whether the IRB resolved controverted issues and concerns with continued discussion and deliberation, decided to seek further clarification from the investigator or sponsor of the proposed research, or decided to settle the issue by vote. Furthermore, if resolution was not reached about a controverted issue and the IRB seeks additional information, the minutes must summarize the IRB’s discussion and plans for seeking resolution.
F. Other Practices
- IRBs should assign responsibility to one person to record and maintain minutes.
- IRBs might want to consider creating templates to assist with compliance.
- IRBs may also document activities such as continuing education of members in the meeting minutes, as well as announcement.
- Some IRBs may videotape or audio record meetings as allowed by law of the relevant state and in accordance with IRB policies, but such tapings should not supplant written IRB meeting minutes.
- All meeting minutes should be retained for a period of three years from the date of the meeting.