Boston—The last year and a half was an embarrassing and humbling period for institutional review boards (IRBs).
First came reports and recommendations by the President's National Bioethics Advisory Commission, the General Accounting Office, and the National Institutes of Health (NIH) Office of the Inspector General, all of which were critical of the current IRB system's ability to deal effectively with increasing workloads and changes in the way research is conducted and of its ability to adequately protect human subjects participating in research.
Then, to general surprise, the NIH Office for Protection from Research Risks (OPRR) shut down clinical research for brief periods at some of the nation's most prominent medical centers because their IRBs failed to follow all the rules regarding the research review process.
With this background of low confidence ratings and a sudden push into the limelight with disclosures of shirked responsibilities, IRB members . . . [Full Text of this Article]
