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The Office for Human Research Protections (OHRP) and the FDA prepared guidance to inform IRBs about how best to prepare and maintain IRB meeting minutes under both agencies’ regulatory requirements.
The guidance, titled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs,” was issued Sept. 26, 2017.
The joint guidance is part of the agencies’ efforts to harmonize differences in human subjects protection regulations between the U.S. Department of Health and Human Services and the FDA. They are required to harmonize by the 21st Century Cures Act’s Title III, section 3023. The Cures Act was signed into law on Dec. 13, 2016.
The guidance discusses examples of noncompliance as it relates to minutes, and includes these examples:
• minutes are missing;
• minutes reflect an inaccurate account of meeting attendance;
• minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting 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;
• minutes fail to include a summary of the discussion of controverted issues.
The guidance also discusses informed consent and how it is addressed in meeting minutes: “The minutes of IRB meetings must be sufficient in detail to show the basis for requiring changes in (to secure approval) or disapproving research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). The IRB may summarize any changes to informed consent form(s) required by the IRB in the minutes, or other IRB record (e.g., an annotated informed consent form that includes IRB-required changes that gets appended to the minutes).”
The OHRP guidance can be found at: http://bit.ly/2AmXqyf.
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