TAG ARCHIVES FOR Common Rule

24
Nov2015

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.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of Read more

17
Nov2015

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.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of <[...] Read more

29
Oct2015

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.

In an earlier post, we explored the rationale for the proposed changes, as well as a new category of [...] Read more

13
Oct2015

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. Over the next few weeks, we will be exploring the proposals put forward in the NPRM, including some of the questions that have already emerged about the potential impact of the [...] Read more

8
Oct2015

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

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