The Future of Human Subjects Research Regulation
Conference Description
The U.S. Department of Health and Human Services recently released an Advanced Notice of Proposed Rulemaking (ANPRM), titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” which proposes to substantially amend the Common Rule for the first time in twenty years. This development, as well as attention by the Presidential Commission for the Study of Bioethical Issues, suggests we are at a moment when the regulation of human subjects research is ripe for re-thinking. The annual conference of the Petrie-Flom Center gathered leading experts from the U.S. and across the globe to assist in that endeavor.
Over the course of a day and a half of panels, plenaries, and extensive Q&A, conference attendees heard from a wide range of presenters, from the former director of the Office for Human Research Protections, Greg Koski, to social science researchers, lawyers, clinicians, and federal employees. Although the ANPRM served as a jumping off point, presentations and discussions were not so limited. A driving theme, however, was the tension between whether to accept the ANPRM’s approach of tweaking the current system but keeping its primary elements in tact, or simply starting from scratch.
Conference Agenda:
Note: All keynote, plenary, and panel sessions included time for Q & A.