Report on Research Compliance Volume 20, no 6. (June 2023)
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.”[1] The industry to which the Democratic senator from Massachusetts was referring is institutional review boards (IRBs) and by patients, Warren meant participants in research studies.

The Government Accountability Office (GAO) found gaps in how FDA and the HHS Office for Human Research Protections (OHRP) oversee all types of IRBs; it also examined consolidation by two large, for-profit IRBs.[2] GAO made four recommendations, including that the agencies “examine approaches for measuring IRB effectiveness in protecting human subjects and implement the approaches as appropriate.” How to assess whether IRBs are doing a good job—and first defining what that means—has bedeviled human research protection officials for years. No methods are universally accepted or widely in place today, despite numerous efforts.

Now that task has fallen to the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP), which took a first stab at it during its most recent meeting.[3] Yet, as of this month, SACHRP, whose charter calls for it to have 11 members, was expected to be down to just four due to terms expiring and a lack of new appointments.[4]

“This issue of IRB effectiveness is one that SACHRP has grappled with before, and it remains a difficult” issue, Julie Kaneshiro, acting OHRP director, said at the meeting. She added that OHRP was “really looking for your help and learning from all of you who have been doing some deep thinking about this over the many years.”