June 18, 2020

Senators Warren, Brown, and Sanders Call for the Government Watchdog to Investigate For-Profit Institutional Review Boards (IRBs)

IRBs review clinical research proposals to ensure that participant rights are protected and the research is conducted ethically; GAO request follows lawmakers' initial investigation of the two largest, private-equity-owned IRBs, which raised concerns about whether they are keeping research safe and maintaining ethics standards; "The urgency of the COVID-19 pandemic may further increase pressure for IRBs to provide rapid approvals that may be inadequate or incomplete"

Text of Letter to GAO (PDF) | Responses from WCG Clinical and Advarra (PDFs) 

Washington, DC - United States Senators Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), Ranking Member of the Senate Banking Committee, and Bernie Sanders (I-Vt.), Ranking Member of the Senate Budget Committee, requested that the Government Accountability Office (GAO) study for-profit Institutional Review Boards (IRBs), which review clinical research proposals to ensure that participant rights are protected and the research is conducted ethically. They are asking GAO to evaluate whether existing standards of quality, efficiency, and effectiveness provide adequate protection for participants in IRB-approved clinical trials, and to examine whether commercial IRBs have appropriate protections in place to address conflicts of interest and "pay to participate" clinical trials. 

Their request follows inadequate responses they received to their initial investigation in 2019 by the two largest for-profit IRBs, WCG Clinical and Advarra. Both firms are owned by private equity investors, raising questions about whether they are under pressure to reduce costs and ramp up profits, trends that often accompany private equity's entry into a market. Commercial, for-profit IRBs now oversee approximately 70% of all drug and medical device trials in the United States. 

"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. The urgency of the COVID-19 pandemic may further increase pressure for IRBs to provide rapid approvals that may be inadequate or incomplete," the senators wrote. 

WCG Clinical and Advarra responded to the senators' initial questions with generalities, assuring them that their review process is thorough and high-quality, but provided little data to corroborate these claims. WCG's response failed to address key concerns about conflicts of interest, "pay for participation" trials, and quality metrics. Advarra provided some information about its conflict of interest policies and the number of "pay for participation" trials it has reviewed, but did not provide specific data or examples. The senators are releasing WCG and Advarra's responses publicly for the first time.

"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," wrote the senators. "To address these unanswered questions, we request a GAO investigation of the operation of commercial IRBs." 

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 investors:

  • 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 last month 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.

 

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