Human Subjects Regulatory Change (7/26/2011)

The Office of Science and Technology Policy (OSTP) and the Department of Health and Human Services (HHS) through the Office for Human Research Protections (OHRP) announced the availability of an Advanced Notice of Proposed Rulemaking (ANPRM) on the Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators

Currently the ANPRM is available on the OHRP website at:  The 90+ page text is being published in the Federal Register on Tuesday, July 26, 2011. I encourage you to make comments as you see fit. The proposed changes, the most extensive since 1979, are available for public comment until September 26, 2011. The ANPRM is jointly issued by OSTP and HHS/OHRP because it proposes significant, fundamental changes to Subpart A of 45 CFR 46, the Common Rule used, formally, by 15 Federal agencies and as a framework for other private industry and non-profit organization research sponsors as well. 

The ANPRM is structured to pose a series of questions under seven principal categories:  shifting to risk-based protections; streamlining multi-site reviews; improving informed consent; strengthening data protections to minimize information risks; creating data collections for oversight of unanticipated events; extending the federal regulations to all research conducted at Federally funded organizations;  and harmonizing regulations and guidance.  The nature of the questions offers significant insight into the direction for potential changes to the Subpart A of 45 CFR 46.