A US company that provides ethical reviews of clinical trials agreed to halt operations after being warned by the US Food and Drug Administration (FDA) about violating federal guidelines.
The company, Coast IRB of Colorado Springs, Colorado, was ensnared by a governmental investigation unveiled before Congress last month (see Nature 458, 557; 2009). Investigators submitted a fictitious clinical-trial protocol to three independent institutional review boards. Two boards rejected the protocol, with one member calling it "the riskiest thing I've ever seen on this board". But Coast IRB voted unanimously to approve the trial.
On 14 April, the FDA announced that Coast IRB would not approve new studies or add additional subjects to ongoing studies until the agency was satisfied that the company had corrected its procedures. The company has been warned by the FDA before, in 2008, for inappropriately expediting review of a clinical-trial protocol.
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Company offering ethical reviews suspends activity. Nature 458, 958 (2009). https://doi.org/10.1038/458958b
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DOI: https://doi.org/10.1038/458958b