How ethical are for-profit institutional review boards?
Committee on Energy and Commerce
On April 14, the US Food and Drug Administration (FDA) sent a warning letter to Coast IRB of Colorado Springs, CO, a for-profit institutional review board (IRB), in which it outlined serious failings in the company’s processes to approve research studies in human beings. Coast agreed to the FDA’s demand to halt new enrolments to ongoing FDA-regulated studies, to approve no new studies, and to outline plans for corrective actions within 15 days. This letter follows a congressional hearing by a subcommittee of the Committee on Energy and Commerce last month. In that hearing, the findings of a 14-month undercover operation by the US Government Accountability Office (GAO) were discussed. GAO investigated so-called independent IRBs that operate for profit and largely serve industry-funded research in private offices or hospitals. As part of that operation, GAO submitted a fictitious protocol of a high-risk intervention with serious gaps, especially on safety information. The study involved application of 1 L of an ill-defined substance to the abdominal cavity of women after surgery to minimise adhesions. The protocol was sent to three independent IRBs. Two sent it back immediately because of serious safety concerns. Coast IRB approved it unanimously (7:0) with only minor changes, concluding that the intervention is “probably very safe”. In the hearing, the Committee’s Chairman, Henry Waxman, explained how Coast had reviewed 356 protocols in the past 5 years and approved all of them, and all but one unanimously. Coast aggressively marketed its approval as very fast and offered a “get your first one free worth US$1300” coupon, then “coast through your next one”. Its revenue has almost doubled to $9·3 million in the past 4 years. Commercial IRBs approve only a small proportion of all research studies. Yet Coast alone approved 300 studies that are ongoing, and questions remain about how many of these have shortcomings. Protecting research participants is an extremely important part of research governance. Without adequate rigorous oversight, trust in research will be seriously undermined. Commercial considerations must not be allowed to override thorough ethical approval processes.