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GAO Recommends That FDA Conduct More Robust Audit of IRBs
(Thursday, February 23, 2023) The review by IRBs of clinical protocols is a well-recognized measure to assure protection of clinical trial participants all over the world. Per the regulations, IRBs hold a very important place in assuring ethical conduct of clinical trials, and act as surrogates to the FDA for oversight of clinical trial conduct. But are the IRBs doing their job effectively? An investigation by the Government Accountability Office (GAO) raised several questions about the quality of FDA audits of IRBs. The FDA and IRBs have distinct and interconnected roles to together assure proper clinical trial conduct. The FDA review of clinical protocols is primarily focused on the scientific justification for the design of the trials, while the IRBs are expected to review the ethical and human subject protection aspects. The GAO investigation conducted over several years found that both FDA and the Office of Human Research Protection (OHRP) at the NIH conduct very few audits of the IRBs, and those audits are superficial reviews of IRB standard procedures and documentations. OHRP conducts much fewer audits than the FDA. Based on the review of the FDA and OHRP auditing practices for the IRBs, the GAO concluded that it cannot be confirmed if the IRBs are effective in assuring ethical conduct of clinical trials because neither the FDA nor the OHRP have evaluated this aspect of IRB review. The FDA’s audits of IRBs do not include effectiveness measures. The FDA and OHRP cited lack of resources for the low frequency of IRB audits and for not being able to create approaches to evaluate effectiveness of IRBs. For all we know, the IRBs may be just rubber-stamping approvals on clinical protocols approved by the FDA without doing a thorough review for ethical conduct. In all fairness, the GAO did not say that IRBs are not doing their job, just that due to lack of FDA review, it cannot be confirmed. The GAO report was submitted to the Congress but there is no indication if the Congress would provide resources to the FDA for this task. Among the numerous priorities for healthcare management, the IRBs’ audit may not be as high on the list. For now, the GAO report provides a detailed primer on the existing IRB review process and its limitations. And that’s that. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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