Deadline Extended to October 26th for Comments on the Proposed Changes to the Common Rule
Posted by Michael Jay on Fri, Oct 21, 2011
RxTrials welcomes Diana Caldwell with Pearl Pathways as a guest blogger who wrote the below post:
Health and Human Services announced in July a proposal to improve provisions of the Common Rule. This set of regulations has remained basically unchanged since the ‘80s. See the proposed changes in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. Clearly, the agency wants more feedback. The original deadline was September 26th and now the deadline has been extended until Wednesday, October 26, 2011. These rules impact many aspects of the research we do each day, so we encourage our readers to review the proposed changes and provide commentary here. Learn more on the HHS site.
Last week at the Site Solutions Summit, many of us heard Ken Getz’s thoughts on implications of these changes. Some of the most interesting changes are noted below:
- Requiring the use of a central IRB for multi-site studies
- Updated content regarding informed consents, and proposed limitations on length
- Unifying consent requirements for the use of biospecimens in studies
Submit your comments now at www.regulations.gov and use the identification number HHS-OPHS-2011-0005.