Institutional Review Boards, or IRBs, backed by private equity deserve more scrutiny, GAO says

Institutional Review Boards, or IRBs, backed by private equity deserve more scrutiny, GAO says


A government watchdog called for greater federal oversight of ethics boards that sign off on scientific studies, finding that for-profit companies have taken an outsize role in approving certain research and questioning whether financial motivations could put human subjects at risk.

Federal regulations require that certain research on human subjects — including those testing the safety of new drugs — first get approval from a registered institutional research board. These boards, which are made up of at least five members and can include researchers and academics, are designed to make sure that a study poses as little risk as possible and that participants have enough information to give consent.

While the majority of these boards are affiliated with universities, a small number have no affiliation with institutions conducting research. But according to a new report from the U.S. Government Accountability Office, these independent boards now account for the largest share of reviews of studies involving new drugs and biologics. Independent boards conducted 48 percent of such research regulated by the Food and Drug Administration in 2021, up from 25 percent a decade earlier, despite making up just 2 percent of all U.S. review boards.

Moreover, the GAO found that boards controlled by two for-profit companies dominated the universe of independent panels approving drug research. Of the reviews by such boards regarding drugs in 2021, private-equity backed WCG Clinical and Advarra represented about 92 percent, according to GAO’s report, which is set to be released Friday.

The GAO found that federal agencies overseeing the ethics panels inspect relatively few of them and lack ways to evaluate how well they protect people participating in research.

“The report’s findings — that private-equity-driven consolidation and privatization of these review boards creates panels that are ‘beholden to their clients,’ and increase the risk of harm to research subjects — are alarming,” Sen. Elizabeth Warren (D-Mass.). She called for the GAO investigation along with Sen. Sherrod Brown (D-Ohio) and Sen. Bernie Sanders (I-Vermont).

GAO cited advantages of the growing prevalence of independent IRBs, which also include nonprofits, such as more resources and expertise. But it also found a downside expressed by experts in the field: an emphasis on speed and profit that “may have resulted in independent IRBs with private equity investment being less focused on potential harms of research to human subjects.”

David Borasky, a vice president at WCG, said his company is assiduous about protecting human subjects. “Protecting the rights and welfare of research participants remains our first priority as an independent IRB,” he said in a statement.

Advarra didn’t respond to requests for comment.

The scrutiny comes as the coronavirus pandemic focused attention on how institutional research boards balance their duty to protect people participating in studies with the pressure to quickly advance trials of potentially lifesaving medicine in a public health emergency.

Universities, hospitals and government agencies have IRBs, but boards unaffiliated with any organization have had the most notable rise in recent years. The ascendance of independent boards is partly the result of more privately sponsored clinical trials that created demand for faster reviews, according to the GAO report.

As independent IRBs became profitable, the report notes, private equity companies entered the picture and began building giant companies through mergers.

WCG Clinical, based in Princeton, N.J., reported $194.2 million in gross profit from its IRB business in 2020, while its consulting services garnered $100 million in gross profit that year, according to a securities filing in 2021, when the company filed to go public before withdrawing its plans.

University-affiliated IRBs may have slowed research activities when the pandemic hit, according to the GAO report, but the WCG filing said the company “supported and contributed to over 723 COVID-19 trials, including many of the most highly impactful vaccines and antivirals.” The company listed this work as a driver of profits for its IRB services.

As of August 2021, WCG was majority owned by four private equity and investment funds.

Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, said the profit motive of companies that control these boards has long presented a troubling conflict of interest when it comes to assessing drug company research.

Commercial IRBs, he said, “advertise, ‘Go with us, we can get your [research] protocol approved much more quickly,’ which is exactly what drug companies want to hear.”

Wolfe acknowledged that members of nonprofit IRBs at universities and hospitals also face conflicts, such as deciding whether to approve studies run by colleagues, though he contends this presents a less serious conflict than IRBs-for-hire.

“I think it’s a false dichotomy that one is conflicted and the other is not conflicted,” said Holly Fernandez Lynch, assistant professor of medical ethics and law at the University of Pennsylvania.

Although commercial IRBs face financial pressures in attracting clients who want their protocols to gain approval, “they have the resources to hire full-time board members.” When board members are paid to assess the ethics of research, “you get good at it,” Fernandez Lynch said. “They can turn things around quickly because they have multiple IRB meetings in a single day.”

For the volunteers who serve on IRBs at universities and other institutions, “it’s one more responsibility. It’s not their full-time job.”

GAO has previously pointed to shortcomings in the IRB process. For a 2009 investigation, the watchdog submitted a protocol for a fictitious medical device to three independent IRBs, falsely presenting it as cleared by the FDA. One of them approved it.


Rachel Meadows

Rachel Meadows

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