Town Hall Meetings: Proposed Reforms for Human Subjects Research

Print

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 20 years, with implications for the conduct of research in all areas, including the social, behavioral and biomedical sciences.

A series of Town Hall Meetings has been 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 are open to all comers:

*August 30, 10:00 am, G100 Bondurant Hall (SOM)*

*September 6, 1:00 pm, Fox Auditorium, ground floor Carrington Hall (SON)*

*September 8, 2:00 pm, Blue Cross Blue Shield Auditorium, rm 0001, Hooker Research Center (SPH)*

*September 14, 9:30 am, Pleasants Assembly Room, 1st flr Wilson Library*

For those interested in more details, the web portal below contains information and the Advance Notice of Proposed Rulemaking (ANPRM) published in the Federal Register.  All comments are welcome.

http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

Engage NC TraCS


NC TraCS Institute
NIH CTSA at UNC-CH

Brinkhous-Bullitt
2nd Floor
Phone: (919) 966-6022
or (866) 705-4931
Email: nctracs@unc.edu

Cite the Grant

The Institute is supported by grants UL1TR000083, KL2TR000084, TL1TR000085 from
the National Center for Advancing Translational Sciences, National Institutes of Health. Please help us continue to support your research by citing our grant number(s) in publications we supported. Click here for details.