Evaluation of the NIH Program for Human Subjects Protection
This study was the most recent full-scale nationally representative examination of the adequacy of protections afforded through Institutional Review Boards (IRBs) operating under Federal Regulations 45CFR46. As such, the final report was disseminated widely to inform ongoing discussions about strengthening protections in response to enormous increases in the volume of human research protocols, shifts in the issues encountered during IRB reviews, and inconsistencies within and among IRBs.