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FDA Warns An IRB To Document Its Members And Their Votes


I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete list of members.

Meeting Minutes

The FDA inspectors cited that the IRB’s meeting minutes were not recorded consistently, especially in terms of vote counts. The governing regulation is very specific about recording vote counts; it states that the number of members who voted for, voted against, and abstained from voting all need to be documented in the minutes. However, this IRB often recorded statements like, “The committee acknowledged and approved the submission,” rather than specific numbers.

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List of Members

The inspectors also found that the IRB was not keeping a current and complete list of its members, which is something that is also spelled out in the regulation. It calls for not only members’ names, but their degrees, representative capacity, board certifications, licenses, relationship with the institution, and any other information pertinent to their anticipated contributions to the IRB…as well as their potential conflicts of interest.

Why They Matter

Why do such seemingly minor things warrant an FDA Warning Letter? Because they cast doubt on the IRB’s ability to make the right decisions for the people they’re charged with protecting.

Without a complete and accurate list of IRB members, it wasn’t possible to determine whether the IRB was composed of the right balance of people. What if the collective members lacked important skills or experience that caused them to miss something in the protocol? What if a member had a conflict of interest involved in a voting topic (e.g., a researcher voted on his own proposed study)?

Without detailed documentation of the members, as well as which members cast which votes about each topic, there’s simply no way of knowing that the IRB as a whole was safeguarding the rights and welfare of the subjects involved in the studies…which is, after all, the express purpose of IRBs.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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