The U.S. Government Accountability Office Recommends Actions to Improve Federal Oversight of Institutional Review Boards for Human Research

Lexology February 17, 2023
Ropes & Gray LLP

On June 16, 2020, Senators Elizabeth Warren, Bernie Sanders, and Sherrod Brown issued a letter (the “2020 Letter”) to the U.S. Government Accountability Office (the “GAO”) requesting that the GAO investigate the operations of so-called “commercial” institutional review boards (“IRBs”).¹ The 2020 Letter asked the GAO to address a series of questions regarding the market dynamics in the IRB industry, the adequacy of existing processes and procedures utilized by “commercial IRBs,” how federal agencies can “address any shortcomings” in existing IRB standards, and to compare “commercial IRBs” to “academic IRBs.”²

The GAO accepted the request on August 10, 2020³ and conducted an investigation focused on the following: (i) composition of the IRB market; (ii) practices IRBs have implemented to strengthen...

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