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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

manipulation

  • FDA subsequently sent Coast an uncommonly severe Warning Letter

© 2009 Hogan & Hartson LLP. All rights reserved.

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