To rush through reviews or approve inadequate protocols.” These conflicts put organizations at risk of placing undue pressure on the IRB Indicated that “Previous reports have suggested that unless properly managed, Protocol and do so expediently in order to satisfy a client.” And GAO also Noted for-profit IRBs, in particular, may be more inclined to approve a Private investment in IRBs,” said the report. “Most experts and some stakeholders described potential negative effects of Including finding that they have not conducted routine site visits. Independent IRBs to effectively monitor approved human research projects , GAO also revealed failures by at least four of six IRB models, and identified at least one IRB that reported no policies to In particular, the report identified potential conflicts of interest in private Investment in IRBs.” This raises significant concerns about their effectivenessĪnd overall ability to protect human subjects enrolled in IRB-approved trials. Largely due to consolidation this is, in part, related to private equity The report revealed that “the number of independent IRBs has decreased HHS should clean up the industry to keep patients safe.” Studies and other human research is performed ethically and safely, and FDA and Privatization of these review boards creates panels that are ‘beholden to theirĬlients,’ and increase the risk of harm to research subjects – are alarming.” “The report’s findings – that private-equity-driven consolidation and IRBs have appropriate protections in place to address conflicts of interest and Participants in IRB-approved clinical trials, and to examine whether commercial Of quality, efficiency, and effectiveness provide adequate protection for In June 2020, the lawmakers asked GAO to evaluate whether existing standards (FDA) and the Department of Health and Human Services (HHS). IRBs are overseen by the Food and Drug Administration The GAO report raised concerns aboutĬonflicts of interest and oversight gaps, both exacerbated by the privateĮquity takeover of IRBs. Panels that review drug studies and other research involving human subjects toĮnsure they are safe and ethical. Privatization and consolidation of Institutional Review Boards (IRBs), the Warren (D-Mass.), Sherrod Brown (D-Ohio), and Bernie Sanders (I-Vt.), releasedĪ new Government Accountability Office (GAO) report revealing extensive
– Today, United States Senators Elizabeth Warren: “We rely on Institutional Review Boards to make sure that drug studies and other human research is performed ethically and safely - FDA and HHS must clean up the IRB industry to keep patients safe”
FebruGovernment Watchdog Report Reveals Conflicts of Interest and Flawed Oversight of Drug Research Approval Boards Senator Warren requested the report from the GAO
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