The Government Accountability Office has issued an analysis suggesting that the FDA should increase its oversight of institutional review boards (IRBs) to better protect the safety of participants across clinical trials. The analysis has gone on to find that the current scope of IRB inspections is fairly limited and creates uncertainty about clinical research activities.
The FDA, as well as OHRP, are responsible for overseeing around 2300 IRBs in the US. These IRBs are subject to routine or for-cause inspections so as to ensure that they are appropriately reviewing research protocols and programmes and that human subjects are adequately informed of the risks and benefits of a study. However, there is a growing concern that a small number of independent or single IRBs are now reviewing nearly 50% of investigational research in the US, up from 25% in 2012. A National Institutes of Health- NIH rule mandating the use of a single or central IRB to evaluate multi-site sponsored studies has prompted this change in order to streamline and facilitate research review and operations. Although there were doubts regarding the impartiality and integrity of commercial IRBs and whether they conducted hurried or insufficient assessments, the FDA is also thinking about how a single IRB requirement could apply to regulated research.
The GAO questions the adequacy of FDA and OHRP inspections of IRBs to ensure compliance with federal regulations and data integrity. OHRP conducts only three or four routine IRB inspections each year, while FDA completed nearly 1600 inspections on 1054 IRBs from 2010 to 2021, an average of 133 inspections a year. This represents a small fraction of the total number of IRBs based at hospitals and academic research organizations.
The analysts happen to be unsure whether the current level of oversight is sufficient to accomplish the stated objectives. The paper points out that the agencies rely on erroneous data regarding the volume of protocols that IRBs examine, making it challenging to pinpoint IRBs that oversee umpteen research activities. The GAO suggests conducting an annual risk-based evaluation of supervision goals and paying attention to the more general issue of whether IRB evaluations contribute to the protection of human subjects.
The GAO encourages FDA and HHS to involve numerous stakeholders in order to determine the best techniques for assessing the performance and standards of IRBs and to put into place efficient measures for IRB operations. Similarly, to this, FDA should undertake an annual risk assessment to determine how frequently IRBs are inspected in order to gauge the number of site inspections necessary to maintain proper program oversight and the kinds of validated measures that can provide additional insight. To prevent undermining other agency inspection initiatives, the GAO withdrew from setting a fixed number of FDA IRB inspections each year.