HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research
06 February 2017Pharmaceutical and Biotechnology Alert
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the regulations intended to safeguard individuals participating in research, often referred to as the "Common Rule." The rule aims to enhance protections to participants and to modernize the oversight system. This rule has been a long time coming.