“We write to request a Government Accountability Office (GAO) investigation of the operation of commercial Institutional Review Boards (IRBs), the private, for-profit entities that approve drug research and other studies involving human subjects. As clinical trials related to the coronavirus disease 2019 (COVID-19) pandemic accelerate, ensuring that IRBs are providing adequate patient protection is more important than ever. Our preliminary investigation, opened in November 2019, 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.
Our thanks to STAT that originally posted a link to this letter. And to US Senators Elizabeth Warren, Bernie Sanders and Sherrod Brown for raising this important issue.
In the decade since this GAO investigation, the IRB landscape has shifted in several significant ways. First, while the 2009 GAO study noted “IRBs were historically located at academic institutions,” it found that commercial IRBs “are playing an increasingly prominent role in the protection of human research subjects.”4 That trend has continued in the intervening decade, and commercial, for-profit IRBs now oversee approximately 70% of all drug and medical device 2 trials in the United States.5 This is a particular concern because this private, for-profit model creates an inherent conflict of interest for IRBs, which may incentivize them to approve as many studies as they can as rapidly as possible.6 The urgency of the COVID-19 pandemic may further increase pressure for IRBs to provide rapid approvals that may be inadequate or incomplete. Though conflicts of interest are common among individual IRB reviewers, including at academic IRBs,7 the profit motive and lack of transparency at commercial IRBs make potential conflicts especially worrisome…”
1 Government Accountability Office, “Human Subjects Research: Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation,” March 26, 2009, https://www.gao.gov/assets/130/122142.pdf.
2 Wall Street Journal, “Coast IRB, Caught in Sting, to Close,” Alicia Mundy, April 22, 2009, https://www.wsj.com/articles/SB124042341694744375.
3 Government Accountability Office, “Human Subjects Research: Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation,” March 26, 2009, https://www.gao.gov/assets/130/122142.pdf.
5 Stat News, “In clinical trials, for-profit review boards are taking over for hospitals. Should they?” Sheila Kaplan, July 6, 2016, https://www.statnews.com/2016/07/06/institutional-review-boards-commercial-irbs/.
6 Letter from Senators Elizabeth Warren, Bernard Sanders, and Sherrod Brown to WCG Clinical and Advarra, November 19, 2019, https://www.warren.senate.gov/oversight/letters/senators-warren-brown-and-sanders-investigate-inherent-conflicts-of-interest-of-private-equity-owned-institutional-review-boards.
7 JAMA Internal Medicine, “Industry Relationships Among Academic Institutional Review Board Members: Changes from 2005 Through 2014,” September 2015, E.G. Campbell, C. Vogeli, S.R. Rao, M. Abraham, R. Pierson, and S. Applebaum, https://www.ncbi.nlm.nih.gov/pubmed/26168043.