The Government Accountability Office (GAO) recently released a report, saying the United States Food and Drug Administration (FDA) and the Department of Health and Human Services Office for Human Research Protections (HHS OHRP) need to do a better job with tracking and monitoring the activities of institutional review boards (IRBs).
According to the report, failure to properly track and monitor IRBs results in compromised safety of research participants who enroll in clinical trials. The report states 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 are reviewing and conducting research studies, particularly those reviewing high volumes of research, and identifying and evaluating how these entities address pertinent federal regulations and conduct research review.”
This is of particular importance given that independent IRBs have grown in popularity in recent years and “available data indicate they are reviewing a larger share of federally conducted or supported drug clinical trials involving human subjects.” The report says that FDA and OHRP are responsible for overseeing roughly 2,300 US-based IRBs and that inspections done by the agencies to determine whether federal regulations are followed by the IRBs “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.”
GAO notes that to the extent that the agencies “rely on inaccurate data on the number of protocols that IRBs review, they are limited in their ability to appropriately select IRBs and to prioritize for selection the IRBs that are reviewing large volumes of research involving human subjects.” Additionally, GAO takes issue with the fact that both agencies determine the number of IRBs to inspect each year based on their own available resources, not whether the number of annual inspections is sufficient to achieve the agencies’ oversight objectives.
Finally, GAO notes that despite longstanding recommendations that FDA and HHS OHRP study the effectiveness of IRB reviews in protecting human rights, neither agency has actually done so.
Specifically turning to the FDA – which conducts more inspections that OHRP does – the agency has not independently reviewed how many routine IRB inspections should be performed, nor has the agency developed a risk-assessment evaluation to determine whether an appropriate number of routine IRB inspections are being performed. The report notes that FDA completed nearly 1,600 inspections of 1,054 IRBs from Fiscal Year 2010 through Fiscal Year 2021. This averages out to about 133 inspections per year, or 13% of IRB organizations in a year.
GAO Recommendations
GAO made four recommendations: three to HHS and one to FDA. Two of the recommendations were the same (one for each agency): that the agency 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 protection of research participants.
The other two recommendations for HHS were: OHRP should take steps to ensure the accuracy of protocol data collected in its IRB registry, including updating instructions to IRBs and examining data accuracy for a sample of IRBs; and for the HHS Secretary to ensure that OHRP and FDA bring together stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects and implementing the approaches as appropriate.
HHS Concurred
HHS concurred with the recommendations, and even had a hand in revising two of the recommendations after GAO provided the agency with a draft report. In its concurring comments, HHS noted that the FDA and OHRP will identify opportunities to convene stakeholders to discuss IRB oversight and implement any approaches that may help IRBs’ oversight to be more protective of research participants.
HHS also noted that OHRP and the FDA will conduct annual risk assessments to determine whether each agency is conducting an adequate number of routine IRB inspections and to optimize the use of IRB inspections.
Finally, HHS noted that OHRP has started exploring ways to improve accuracy of information submitted by institutions during the initial and renewal registrations for IRBs.