GAO calls for better FDA oversight of IRBs

Regulatory NewsRegulatory News | 20 February 2023 |  By 

The US Food and Drug Administration (FDA) needs to do a better job of tracking and monitoring the activities of institutional review boards (IRBs); not doing so compromises the safety of research participants enrolled in clinical trials, according to a new report from the Government Accountability Office (GAO). These findings also apply to the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP).
The 16 February report describes the composition of the IRB landscape and examines OHRP and FDA oversight of IRBs. GAO was asked by Congress to examine independent IRBs, processes used to protect human subjects and standards used to assess IRB quality.
The report notes that “the ability of OHRP and FDA to fulfill their charge of protecting human research subjects is dependent on their success in monitoring” which entities they are reviewing, “particularly those reviewing high volumes of research.” It adds that “over time, independent IRBs have grown in prominence, and available data indicate they are reviewing a larger share of federally conducted or supported drug clinical trials involving human subjects.”
FDA and OHRP oversee about 2,300 US-based IRBs, and inspections assess whether IRBs follow federal regulations when reviewing research.
The government watchdog agency asserted  that inspections by these two agencies “are limited by inaccuracies in the data used to inform them, and the agencies have not conducted a risk-based assessment of their IRB inspection program. Further, while OHRP and FDA use inspections to assess whether IRBs are following regulations, the agencies have not examined the effectiveness of IRBs in protecting human subjects.”
Although FDA conducts more inspections than OHRP, the agency has also not independently examined how many routine IRB inspections it should conduct, nor has it developed a risk-assessment to determine whether an adequate number of routine IRB inspections are being conducted.
Such a risk assessment could consider the number of IRBs registered in OHRP’s IRB registry that review research protocols under each agency’s purview.
GAO said conducting annual risk-based assessments would be consistent with the Office of Management and Budget’s Circular A-123, which requires federal agencies to integrate risk management activities into their program management.
From FY 2010-2021, FDA completed 1,599 inspections of 1,054 IRBs, an average of about 133 inspections per year, inspecting roughly 13 percent of IRB organizations a year.
University-based IRBs are the most prevalent type of IRB, and of the about 2,300 IRBs operating in the US, 56% were based at universities. Another 24% were based in hospitals or health-care organizations, and the remainder were either private organizations, government entities or independent organizations.
 GAO report


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Tags: clinical, FDA, GAO, IRBs, trials

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