Proposed Revisions to Protection of Human Subjects Federal Policy

Sixteen federal agencies, including the U.S. Department of Health and Human Services (HHS), recently proposed “revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.” (80 Fed. Reg. 53933, 9/8/15)  Some of the significant revisions concern informed consent, making consent forms more concise and understandable as well as mandating public posting of consent forms.  Other significant revisions will tailor the level of oversight and review to the level of potential harm and risk.  Public comment on the proposed revisions will be received until 5pm, December 7th, 2015.  If promulgated, these proposed revisions will be the first change to the “Common Rule” (45 CFR 46) in 25 years.