Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.
FDA should step up its oversight of institutional review boards (IRBs) to better assure the safety of participants in some 21,000 active clinical trials in the US, according to the Government Accountability Office (GAO). The analysis issued in January examines the fairly limited scope of IRB inspections carried out each year by FDA and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) and the resulting uncertainty created about clinical research activities.1
FDA and OHRP oversee about 2,300 US-based IRBs through routine or for-cause inspections that examine whether these boards appropriately review research protocols and programs to ensure adherence to federal rules and whether human subjects adequately research understand study risks and benefits. A growing concern is that a small number of independent or single IRBs now review nearly 50% of investigational research in the US, up from 25% in 2012. The shift has been spurred by a National Institutes of Health (NIH) rule requiring the use of a single or central IRB to review multi-site funded studies to streamline and facilitate research review and operations. FDA also is considering how a single IRB requirement could apply to regulated research, despite concerns about the independence and integrity of commercial IRBs and whether they conduct hasty or inadequate reviews.
In this light, GAO questions whether FDA and OHRP inspect IRBs sufficiently to determine how well research sponsors and investigators follow federal regulations and ensure data integrity. OHRP conducts only three or four routine IRB inspections each year on the large number of IRBs based at hospitals and academic research organizations, while FDA completed nearly 1,600 inspections on 1,054 IRBs from 2010-2021, an average of 133 inspections a year to reach 13% of IRBs that review research involving regulated drugs and medical devices.
But the analysts are unsure whether that volume of oversight is sufficient to accomplish stated objectives. The report notes that the agencies rely on inaccurate data on the number of protocols that IRBs review, making it difficult to identify those IRBs that monitor large numbers of research programs. An annual risk-based assessment of oversight objectives is needed, says GAO, as well as attention to the broader question of whether IRB reviews actually help protect human subjects.
To better address these issues, GAO advises FDA and the US Department of Health and Human Services (HHS) to bring together multiple stakeholders to identify best methods for evaluating IRB effectiveness and standards and to implement effectiveness measures for IRB operations. Similarly, FDA should conduct an annual risk assessment of whether IRBs are inspected frequently enough to help understand what volume of site inspections are needed to ensure appropriate program oversight, and what kinds of validated measures can further inform the issue. But GAO stepped back from setting a specific number of FDA IRB inspections each year to avoid undermining other agency inspection activities.
