Informed consent waiver decisions should rest with IRBs, researchers argue.
This article was originally published in The Gray Sheet
Executive Summary
INFORMED CONSENT WAIVER RULES SHOULD BE CHANGED TO GIVE IRBs MORE FLEXIBILITY, James Crapo, MD, Duke University Medical Center, Durham, North Carolina, asserted Jan. 9 at an FDA/National Institutes of Health-sponsored conference on use of informed consent in emergency research in Bethesda, Maryland. Federal regulations should give institutional review boards greater latitude to waive patient informed consent requirements for clinical trials in which subjects are physically unable to give consent, Crapo said.