Monitoring Human Subjects and Clinical Trials

Institutional review boards (IRBs)--whether independent or located at hospitals, academic health centers, or universities--have an imposing charge: They must sift through and analyze a profusion of clinical research trials to ensure that participating human subjects will be treated ethically and without undue risk. But for a variety of reasons, many IRBs aren't getting the job done--this according to an April report from the Office of Inspector General (OIG) in the U.S. Department of Health and Human Services (HHS).¹

The report, which was the focus of a May 3 congressional hearing, was intended to be an update on the reaction of the National Institutes of Health and the Food and Drug Administration (FDA) to a 1998 OIG report. Based on investigations of more than 75 IRBs, discussions with IRB members and institution leadership, and a review of relevant documents, the report harshly criticized the IRB process. Two additional follow-up reports...