by Elisa Hurley, PhD, education director

As many of you may know, the Department of Health and Human Services (DHHS) has extended the public comment period on the advance notice of proposed rulemaking (ANPRM). The revised closing date for submitting comments to DHHS is October 26, 2011.

If you are interested in what others having been saying about the proposed changes to the “Common Rule,” instructions for browsing comments may be found here.

PRIM&R’s ANPRM Task Force is still hard at work drafting and compiling comments. We [...] Read more


PRIM&R is proud to have hosted two webinars on the Advance Notice of Proposed Rulemaking (ANPRM) that the Department of Health and Human Services released last month.
If you were unable to participate in the PRIM&R’s Primer on the ANPRM, please download the presentation slides, or purchase the archived webinar.

PRIM&R is in the process of generating comments, which are due by September 26, 2011, and encourages all of our members and supporters to participate. More information on comments we’ve already submitted [...] Read more


by Elisa Hurley, PhD
PRIM&R Education Director

On July 26, 2011, 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, and PRIM&R is acting quickly to organize a response. As part of this effort, PRIM&R [...] Read more


Josh Glickenhaus, Swarthmore College senior and PRIM&R intern The U.S. Department of Health and Human Services recently released an Advance Notice of Proposed Rulemaking (ANPRM), which outlines major proposed changes to the ‘Common Rule’ regulations for human subjects research. The ANPRM proposes changes across a broad range of issues, including a proposal to excuse all survey/interview-based research from IRB review. Part of its justification for this move is the ANPRM’s creation of new standards for data security that would minimize the risk of informational breaches, which compose the main source of risk to subjects in such studies. But the document also implies that most research of this sort poses only minimal risk to [...] Read more