From The Washington Post: “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).”
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