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Coast IRB to Close in Wake of GAO Investigation

Monday, April 27, 2009 09:31 AM

Coast IRB, the institutional review board (IRB) that was the target of an undercover investigation by the Government Accountability Office (GAO), is closing its doors, according to reports published last week.

The FDA had issued a warning letter to Coast earlier this month, outlining five “serious violations” to FDA laws and regulations and questioning the IRB’s ability to protect human subjects participating in clinical trials. In response to the letter, Coast voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies and planned to issue a corrective action plan to the FDA by the end of April.

Plans changed last week, however, when the IRB issued a statement saying it was closing and would work to transfer its ongoing trials (about 300 active trials, according to reports) to other accredited IRBs.

The FDA’s warning letter stemmed from an undercover investigation conducted by the Government Accountability Office (GAO) between January 2008 and March 2009 to test whether IRBs adequately review studies submitted for their approval. Coast was one of three IRBs selected by the GAO to receive a research study for approval for a “fictitious medical device with no proven test history and bogus specifications,” according to the GAO, and it was the only IRB to approve the research protocol.

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