The Wall Street Journal Health blog had an article today about Coast IRB, a for-profit Institutional Review Board that approved a fake study posed by the Government Accountability Office. The GAO conducted the sting operation to see if for-profit IRBs adequately review and supervise medical trials and the interest of research subjects. The approved study had a fake company, falsified records and an unapproved product. The company failed to ensure that risks to subjects were minimized and whether the research would be conducted under acceptable legal and professional guidelines. As such, the company has agreed to stop reviewing new FDA-regulated studies and halt enrollment to previously approved studies. The company itself will undergo complete restructuring, with a new board, new standards of practice and frequent internal audits.
The case shows the importance of institutional review of clinical research studies and the importance of knowing that the reviewers are capable of doing their jobs.
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