Coast IRB: The start of another enforcement trend?
During a March 26, 2009, congressional hearing, “Institutional Review Boards that Oversee Experimental Human Testing for Profit,” a GAO representative testified about GAO’s undercover “tests”
GAO created “a bogus medical device company” and “a research protocol for a fictitious medical device with no proven test history and bogus specifications”
Coast IRB reviewed and approved the bogus research protocol
Coast failed to check the false assertion that FDA had already cleared the device for marketing, which could have been accomplished through a search of FDA’s online database
GAO concluded that the IRB system is vulnerable to unethical
FDA subsequently sent Coast an uncommonly severe Warning Letter
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