TAG ARCHIVES FOR ANPRM

8
Oct2015

#TBT: PRIM&R’s Comments on the ANPRM from July 26, 2011

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8 Oct
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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

3
Sep2015

DHHS Releases Long-awaited Proposed Changes to the Common Rule

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3 Sep
Comments: 1

On September 2, the Office of the Federal Register made available a pre-publication version of a much-anticipated Notice of Proposed Rulemaking (NPRM) that proposes changes to the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”

The release of the NPRM comes four years after the publication of an Advance Notice of Proposed Rulemaking (ANPRM), which first put forward proposals to modernize the regulations governing human subjects research in the United States. The NPRM, which was issued by the Department of Health and Human Services (DHHS), [...] Read more

8
Jun2015

PRIM&R Meets with OMB to Offer Input on Proposed Changes to the “Common Rule”

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8 Jun
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By Elisa A. Hurley, PhD, executive director

It has been nearly four years since the Department of Health and Human Services (DHHS) released for public comment an Advance Notice of Proposed Rulemaking (ANPRM), titled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. The ANPRM, which proposed the first changes to the "Common Rule" since it was published in 1991, catalyzed considerable debate and discussion about the appropriate regulation of human subjects research.

In the Read more

3
Feb2015

PRIM&R’s Response to NIH’s Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research

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3 Feb
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by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens. In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with [...] Read more

13
Jan2015

NIH Releases Draft Policy on Use of Single IRB for Multi-Site Research

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13 Jan
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by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On December 3, the National Institutes of Health (NIH) issued a request for comments on its "Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research," which "proposes that all NIH-funded multi-site studies carried out in the [United States], whether supported through grants, contracts, or the NIH intramural program, should use a single IRB."

Citing a changed research landscape, the background section of the policy suggests [...] Read more