FDA Policy/General

GAO Identifies FDA Gaps in IRB Oversight

David McFarland

— 2 min read
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The Government Accountability Office (GAO) is making four recommendations it says are needed to improve federal oversight of institutional review boards (IRBs) and examine their effectiveness. The GAO report says the agency was asked to examine independent IRBs, processes used to protect human subjects, and standards of IRB quality, among other things. It says the report “describes the composition of the IRB market and examines the oversight of IRBs by FDA and the HHS Office for Human Research Protections (OHRP).

FDA and OHRP oversee about 2,300 U.S.-based IRBs operated by about 1,800 separate organizations through routine or for-cause inspections, GAO says. The report says GAO determined that the two agencies inspect “relatively few IRBs.”

FDA says it conducted an average of 133 inspections annually between FY 2010 and FY 2021, while OHRP says it aims to conduct three to four routine inspections annually. “Neither agency has conducted a risk-based assessment of their IRB inspection program to help ensure they inspect enough IRBs annually and to optimize their responsibilities in protecting human subjects,” GAO reports. “Such an approach would be consistent with federal risk management principles.”

The report says FDA and OHRP also have not assessed to what extent IRB reviews are effective in protecting human subjects. “This is because the agencies have not determined the best approaches for doing so,” it says. “Evaluating effectiveness is challenging in part due to an absence of validated measures and because IRBs are only one part of the framework of stakeholders responsible for protecting human subjects.”

The report makes four recommendations:

  • FDA should conduct an annual risk assessment to determine whether it is conducting an adequate number of routine IRB inspections and to optimize the use of IRB inspections in the oversight of IRBs and protection of research participants;
  • FDA and OHRP should convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects and implement the approaches as appropriate;
  • OHRP should take steps to ensure the accuracy of protocol data collected in its IRB registry; and
  • OHRP should conduct an annual risk assessment to determine whether the agency is conducting an adequate number of routine IRB inspections and to optimize the use of IRB inspections in the oversight of IRBs and the protection of research participants.

The report says HHS concurs with the recommendations, two of which were modified while HHS was reviewing a draft. The modified recommendations involved FDA and OHRP conducting a risk assessment of the adequacy of the number of IRB inspections and optimizing the use of inspections. GAO says it initially recommended that FDA and OHRP develop a standard defining the minimum number of routine IRB inspections each agency should annually conduct based on a risk assessment.

FDA officials expressed concern about the practicality and feasibility of implementing such a recommendation, GAO says. FDA reportedly was concerned that establishing a mandated number of IRB inspections each year would pull resources away from the agency’s ability to inspect other entities with responsibilities for ensuring the protection of research participants that also fall under FDA oversight responsibilities.

“We acknowledged these concerns and modified our recommendations accordingly, as reflected in our final report,” GAO concludes.

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