IRB Permits Member to Vote on Own Study, FDA Says

An institutional review board (IRB) allowed a member to vote on his own study and waited at least 17 months before conducting required annual reviews of more than one-third of the studies it had approved, according to an FDA warning letter. In its response, the Sierra Providence Health Network IRB said it has hired a temporary employee to update its files. The FDA says that is inadequate because the board did not include a corrective and preventive action plan.
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