Coast IRB to Close Permanently Following Approval of Fake Medical TrialApr 24, 2009 | Parker Waichman LLP
Coast IRB, the medical reviewing firm that approved a study for a fake medical device, has been permanently shuttered. According to The Wall Street Journal, several of the firm's high-profile customers had pulled their business following revelations that Coast IRB had approved the fictitious study that was part of a government sting operation.
As we reported last month, Coast IRB is an independent company that is paid by drug and device makers to insure the safety of humans in trials involving medical products. Under current federal law, clinical research involving human subjects and federally-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an “institutional review board” (IRB). Historically, such reviews have been done by academic review boards, but increasingly medical device and drug makers are relying on boards run by firms like Coast IRB.
The "sting" responsible for bringing down Coast IRB was conducted by the Government Accountability Office (GAO). The GAO's investigation was prompted by concerns that for-profit IRB's like Coast routinely approve the design and conduct of clinical trials for clients without adequately monitoring the safety of patients.
During the sting operation, a Coast IRB private review panel unanimously approved a fake medical protocol for testing which called for a full liter of a fictitious product to be poured into a woman’s stomach after surgery. Coast IRB’s minutes of the approval meeting showed that board members thought the protocol was “probably very safe.” According to the GAO, the Coast IRB approval came after two other private boards rejected the protocol. One called it “junk”, while a member of another board said it was the “riskiest thing I’ve ever seen on this board.”
In response to the GAO investigation, the Food & Drug Administration (FDA) sent Coast IRB a warning letter, and the company agreed to temporarily stop reviewing new FDA-regulated studies and halt enrollment in ongoing studies. But according to Coast IRB announcement, the firm's "owners decided, through counsel, to cease future company operations." The announcement said that a transition strategy would be finalized by April 22. Coast IRB told its customers that it would have a transition team in place to make "the transition of your studies smooth and seamless."
According to The Wall Street Journal, about 300 trials involving as many as 3,000 researchers around the country could be affected by the closure.