August 19, 2020

GAO Accepts Warren, Brown, and Sanders’ Request to Investigate For-Profit Institutional Review Boards (IRBs)

Response from GAO (PDF) | Text of Letter to GAO (PDF)


Washington, DC - United States Senators Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Sherrod Brown (D-Ohio), Ranking Member of the Senate Banking Committee, and Bernie Sanders (I-Vt.), Ranking Member of the Senate Budget Committee, applauded the Government Accountability Office (GAO) for agreeing to their June 16, 2020 request to investigate the operations of commercial Institutional Review Boards (IRBs), the private, for-profit entities that approve drug research and other studies involving human subjects.


"We’re glad to hear that the Government Accountability Office has approved our request to investigate the operation of commercial IRBs, as the for-profit model of these IRBs creates an inherent conflict of interest that may be further exacerbated by COVID-19. As clinical trials related to the pandemic accelerate, ensuring that IRBs provide adequate patient protection and conduct research ethically is more critical than ever," said the Senators in a joint statement.


Senators Warren. Brown, and Sanders asked the GAO to address several questions in the investigation including:


1. What is the current market structure for IRBs? To what extent has the use of commercial IRBs increased relative to the use of academic or other non-profit IRBs? What has driven the market consolidation of for-profit IRBs, what role does private equity play in this process, and how does it affect the ability of IRBs to appropriately review research proposals and protect patients and scientific integrity? 


2. Do commercial IRBs have appropriate protections in place to address the inherent conflicts of interest posed by their profit-seeking mission? Do they have appropriate procedures in place to address and ensure transparency regarding conflicts of interest among panel members that may have industry ties? 


3. Do commercial IRBs have appropriate processes and procedures in place to protect patients and ensure the scientific integrity of “pay for participation” studies? 


4. Do existing standards of quality, efficiency, and effectiveness provide adequate protection for participants in IRB-approved clinical trials? How can IRBs, the FDA, and the Department of Health and Human Services address any shortcomings in the current system to improve quality and patient outcomes? 


5. How do procedures and outcomes differ between academic and commercial IRBs? 


The GAO has estimated the investigation will commence in approximately six months.


Senator Warren has conducted a series of investigations into private equity abuses in health care and other industries throughout her time in the Senate and is fighting for reforms that protect students, workers, communities, and patients:

  • Senators Warren, Brown and Tammy Baldwin (D-Wis.), along with Representatives Mark Pocan (D-Wis.), and Pramila Jayapal (D-Wash.), introduced the Stop Wall Street Looting Act, a comprehensive bill to fundamentally reform the private equity industry and level the playing field by forcing private equity firms to take responsibility for the outcomes of companies they take over, empowering workers, and protecting investors. 

  • Senators Warren, Brown, and Representative Pocan wrote to four private equity firms that currently invest or have recently invested in companies providing nursing home care and other long-term care services, citing reports that show private equity investment has played a role in the declining quality of care in nursing homes and requesting information about each firms' management of this sector. 

  • Senator Warren, Representatives Pocan, and Lloyd Doggett (D-Texas) wrote to five private equity firms with investments and physician staffing and emergency transport companies, questioning the role these companies play in patients receiving exorbitant surprise bills for out-of-network medical treatment.