Changes to human subjects protection regulations

The Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, proposing substantial changes to the federal regulations governing human subjects protections known as the 'Common Rule.’

The public comment period is scheduled to be open through September 26, 2011.

The attached a table from OHRP that compares the changes of the current regulations and the proposed wording.