Proposed Reforms for Human Subjects Research

Town Hall Meetings:  Proposed Reforms for Human Subjects Research

The U.S. Dept of Health and Human Services has proposed sweeping changes to the regulations that govern research involving human subjects ("The Common Rule"). These include changes to the requirements for informed consent, IRB review of multisite studies, expanded use of exemptions and expedited review, and adverse event reporting. This would represent the first major overhaul of this system in twenty years, with implications for the conduct of research in all areas, including the social, behavioral, and biomedical sciences. The Odum Institute would like to encourage social science researchers and administrators at UNC to attend town hall meetings scheduled to provide an overview of the proposed changes and to solicit your feedback toward a university response during the federal rulemaking process. These sessions, listed below, are open to all comers:

• August 30: 10 a.m., G100 Bondurant Hall (School of Medicine)
• September 6: 1 p.m., Fox Auditorium, Ground Floor Carrington Hall (School of Nursing)
• September 8: 2 p.m., Blue Cross Blue Shield Auditorium, Room 0001, Hooker Research Center (School of Public Health)
• September 14: 9:30 a.m., Pleasants Assembly Room, 1st Floor Wilson Library

For those interested in more details, click here to access the Web portal containing information and the Advance Notice of Proposed Rulemaking (ANPRM) published in the Federal Register. All comments are welcome.

If you have questions about the meetings, please contact Daniel K. Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill.