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FDA puts restrictions on an institutional review board after secret investigation

BMJ 2009; 338 doi: http://dx.doi.org/10.1136/bmj.b1618 (Published 20 April 2009) Cite this as: BMJ 2009;338:b1618

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  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration said last week that Coast Institutional Review Board, of Colorado Springs, Colorado, had agreed to stop some aspects of its operations in oversight of clinical trials because of “serious concerns about the company’s ability to protect human subjects participating in clinical trials.”

    The FDA issued a warning letter to the company (www.fda.gov/cder/warn/2009/Coast_IRB_letter.pdf), and the company subsequently agreed that no new studies subject to certain requirements would be approved, and no new participants would be added to some ongoing studies.

    “According to the company’s records, these actions may involve 300 active human research studies conducted by some 3000 clinical investigators,” the FDA said in a press release.

    The issue began when the Government Accountability Office (GAO), the regulator of the US Congress, found that the institutional review board …

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