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IRBs Warned for Membership, Written Procedures

February 17, 2011
Two institutional review boards (IRBs) have received warning letters for failure to follow written procedures and maintain member quorums during clinical trials for devices. The Marquette General Health System IRB was cited for failure to follow procedures for reviewing research. The Michigan hospital system’s written procedures for conducting review of research require that investigator progress reports must be submitted to and reviewed by the IRB. However, email documents and minutes from a March meeting indicate the IRB approved continuation of research without receiving a report, according to the Jan. 18 warning letter posted online recently.
Clinical Trials Advisor