A Tentative Introduction to the Revised Common Rule for the Protection of Human Subjects
Jeremy Sugarman, MD, MPH, MA, Harvey M. Meyerhoff Professor of Bioethics & Medicine, Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University
Common Rule; Research ethics; Bioethics; Informed consent; Human subjects protection; Pragmatic clinical trials; Minimal risk
- Presentation provides a cursory introduction to the revised Common Rule, with a particular focus on those aspects that are relevant for those engaged in planning and conducting pragmatic clinical trials.
- Changes to requirements for informed consent include a specified order of disclosure, emphasis on comprehension, a new basic element, and posting of consent forms
- No change in definition of minimal risk.
For More Information
Resources from PRIM&R on the revised Common Rule
OHRP commentary in NEJM
#pctGR, #CommonRule, #InformedConsent