What would you change if you could improve the regulatory requirements for human subjects research? In 2011, the Department of Health and Human Services and fifteen other federal departments and agencies began the lengthy process of revising the Common Rule, the section of the Code of Federal Regulations that relates to human subjects research (45 CFR 46).  The recent “Notice of Proposed Rulemaking” (NPRM), published in October 2015, proposes changes to increase subjects’ ability to make informed decisions and to reduce the potential risks of harm to human research subjects.  The changes to the Common Rule are also intended to the facilitate current and evolving types of research by reducing ambiguity in interpretation of the regulations.

In this ICTS Clinical Lecture Series presentation, Kelly O’Berry, IRB Education and Outreach Program Manager, will provide an overview of the proposed changes included in the NPRM.