GAO Charts Growth, Consolidation Among ‘Independent’ Institutional Review Boards

In 2020, three members of Congress asked the Government Accountability Office (GAO) to investigate institutional review boards (IRBs), alleging “the for-profit model ... creates an inherent conflict of interest” that may be further exacerbated by COVID-19.[1]

Sens. Bernie Sanders, I-Vt., now chair of the Health, Education, Labor and Pensions Committee, Elizabeth Warren, D-Mass., and Sherrod Brown, D-Ohio, told GAO officials their “preliminary investigation” of IRBs “raises questions about whether the commercial IRBs’ reviews of these studies have significant vulnerabilities that may leave patients exposed to unnecessary risks during their participation in clinical trials.”

Nearly three years later, GAO released its report, which more generally poked holes in how both the HHS Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) conduct oversight of all kinds of IRBs.[2] A future issue of RRC will delve into GAO’s findings and recommendations on this topic and OHRP’s response.

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