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 [...]
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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
