Life Sciences Horizons Brochure 2025 - Flipbook - Page 47
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2025 Horizons Life Sciences and Health Care
FDA increasing IRB enforcement efforts
Throughout 2024, FDA’s Bioresearch Monitoring
(BIMO) program increased its efforts to ensure that
Institutional Review Boards (IRBs) adhere to FDA’s
human subject protection regulations, issuing four
warning letters to address non-compliance, up from
only one warning letter issued in 2023.
FDA’s enforcement actions against IRBs also demonstrate the
agency’s reliance on IRB meeting minutes in BIMO inspections.
FDA cited IRBs for failing to maintain adequate documentation
of IRB activities, identifying instances where the IRB failed to
have an up-to-date list of board members and where the meeting
minutes failed to reflect an accurate vote tally. FDA also relied on
an IRB’s meeting minutes to cite the IRB for reviewing research at
meetings where an IRB member was absent.
BIMO inspections of IRBs are generally focused on IRB written
procedures, IRB membership, IRB meeting minutes, and study
records (protocols, informed consent documents, correspondence
between the IRB and the investigator, study sponsor, or FDA). FDA
has described the deficiencies found in its 2023 IRB inspections as
centered on four themes:
The increased number of warning letters and the cited violations
reflect FDA’s heightened focus on IRB documentation practices
and IRB prompt reporting of serious compliance issues and risks
to study subjects to the agency. Moving forward, it is increasingly
paramount that IRBs ensure their BIMO inspection readiness,
including reviewing written procedures and conducting
mock inspections.
IRB communications / meeting minute deficiencies;
failure to develop or follow written procedures;
IRB membership deficiencies; and
operational deficiencies.
The 2024 warning letters, issued to two academic medical center
IRBs and two hospital IRBs, demonstrate the agency’s continued
focus on IRB meeting minutes and written procedures.
The most reoccurring violation detailed in the recent warning
letters was the failure to prepare, maintain, and follow written
procedures. FDA’s regulations require IRBs to prepare and
maintain adequate documentation of their activities, including
written procedures describing IRB functions and operations and
the reporting to FDA of unanticipated risks to study subjects,
investigator noncompliance, or the termination of IRB approval.
BIMO cited IRBs for failing to follow their own policies on
reporting serious adverse events and investigator noncompliance
(e.g., enrollment of an ineligible participant) to FDA, and for
failing to have written procedures providing a procedure for
reporting events to FDA.
Heidi Forster
Gertner
Partner
Washington, D.C.
Deborah Cho
Counsel
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
