FDA and HHS should improve institutional review board inspection practices, GAO says

2023-02-17

The US Government Accountability Office has made four recommendations to the FDA and HHS to improve their oversight of institutional review boards’ (IRBs) own inspections of research studies, according to a new report . IRBs are meant to keep a sharp eye on the ethics and safety of research studies involving human patients, from behavioral studies to clinical trials, including overseeing overall conduct and maintaining data integrity. The FDA and the HHS’ Office for Human Research Protections (OHRP) oversees IRBs using either routine or for-cause inspections to make sure the IRBs, in turn, are following federal laws when they’re reviewing research that involves humans. The issue with the current system, according to the GAO, is that “few” of the 2,300 US-based IRBs are inspected by the HHS and FDA each year. The agencies also lack self-reflection, the GAO says in its report — the agencies haven’t taken a look at themselves to see if they are doing the necessary number of inspections or if how inspections are done should be changed to reduce risks to patients during trials. OHRP’s “aim” is to do three or four IRB routine inspections each year and the FDA has done, on average, 133 inspections annually between fiscal years 2010 and 2021. That might not be enough, according to the GAO. Neither agency is doing internal reviews to make sure that their work overseeing the IRBs is effective, with the report adding that “Such an approach would be consistent with federal risk management principles.” The GAO made three recommendations for HHS, including that the assistant secretary for HHS should make sure that protocol data collected in OHRP’s IRB registry are accurate and ensure that the OHRP conducts an annual risk assessment to determine whether the agency is doing enough routine IRB inspections. The secretary of HHS should make sure that the FDA and HHS look at whether the IRB is effective in protecting human patients by bringing together multiple stakeholders and potentially implement effectiveness measures or peer audits of IRB meetings and decisions, according to the GAO. The FDA is also included in the recommendations — the GAO says the FDA commissioner should conduct a risk assessment annually to make sure the agency is inspecting IRBs frequently enough. Just last month, the FDA warned an IRB in South Florida after the agency found the Larkin Community Hospital Institutional Review Board went against requirements by reviewing and approving research at meetings that did not have a majority of members present.

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