OHRP and FDA should conduct risk assessments annually to ensure they are routinely inspecting enough IRBs, according to a newly released report from the federal General Accounting Office (GAO).
The GAO was asked to review independent IRBs, the processes used to protect human subjects, and standards of IRB quality. The agency found that independent IRBs reviewed 48 percent of investigational drug research in 2021, up from 25 percent in 2012. The number of independent IRBs is also shrinking, due largely to consolidation, giving a handful of IRBs a large share of the available reviews. Concerns were raised in Congress about the quality IRB reviews and the extent to which human subjects’ rights, safety, and welfare are being maintained.
The report also recommends convening stakeholders to develop ways of evaluating IRB effectiveness in protecting human subjects. Developing ways to quantify IRB effectiveness has long been an area of interest, as there are no standard measures used in this area.