Report card faults institutional review boards

WASHINGTON - An investigation of the testing of four investigational devices led by June Gibbs Brown, inspector general (IG) of the Department of Health and Human Services, found problems with accounting and tracking of the devices, local oversight by institutional review boards (IRBs) and informed consent procedures.

The report comes amid calls from industry and some policy analysts to increase the reliance on IRBs and other non-government entities in an effort to reform the FDA approval process. However, the IG's report did not include recommendations for modifying FDA policies to prevent the problems cited by the investigation, which was released last week...