On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional [...] Read more
TAG ARCHIVES FOR OHRP
Many thanks to my Blog Squad colleague Courtney Zweig for exploring the proposed changes to the Common Rule involving single IRB review processes. That particular proposal is Issue #6 of 19 of the Office of Human Research Protections’ (OHRP) summary of the proposed regulatory changes in ANPRM.
If you’re reviewing the other proposed changes as well, don’t miss Issue #5 of 19 involving informed consent. According to the OHRP, modifications may be necessary because consent documents are currently "too long and hard to understand." Under the proposed regulations, these documents would be "shorter, more readily understood [and] less [...] Read more
By Elisa A. Hurley, PhD, and Avery Avrakotos
On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.
By Lauren Solberg, JD, MTS
Member, Knowledge Center Advisory Group
PRIM&R’s Knowledge Center Advisory Group recently developed an online tool that connects users to Office for Human Research Protections (OHRP) materials that can be used to understand the regulations at 45 CFR 46 Subpart A. In developing and finalizing this educational resource, we realized that while we frequently use terms like “statutes,” “regulations,” and “guidance,” it isn’t always clear what they mean or how they differ. This summary should clarify these differences and help you to use the annotated regulations tool effectively.
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In this week's Throwback Thursday, take a look back at PRIM&R's comments in response to the Advance Notice of Proposed Rulemaking (ANPRM), which was released on July 26, 2011. Read the original post, written by current executive director, Elisa A. Hurley, when she was PRIM&R's director of education, here.
On October 26, 2011, PRIM&R submitted to the Office for Human Research Protections (OHRP) comments in response to the Advance Notice of Proposed Rulemaking (ANPRM) titled, "Human Subjects Research Protections: Enhancing Protections for Research [...] Read more