TAG ARCHIVES FOR NPRM

24
Aug2016

ICYMI: Unpacking the NPRM – Biospecimens Research and Broad Consent

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24 Aug
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In Case You Missed It (ICYMI): From time-to-time, Ampersand will feature particularly well-received posts from the recent past.  These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, part of a series of posts working through the Notice of Proposed Rulemaking for revisions to the Federal Policy for the Protection of Human Subjects, PRIM&R Executive Director Elisa Hurley explains the impetus for [...] Read more

22
Jul2016

Research Ethics Roundup: The FDA as an Independent Agency, Criticism of Proposed Revisions to the Common Rule, and More

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22 Jul
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In this week’s Research Ethics Roundup, a collection of articles explore debates on regulations and regulators: NPR covers a critique of revisions to the Common Rule, a Nature editorial responds to legislation that would loosen FDA regulations, and former FDA commissioners ask Congress to make the agency more independent. Read more

1
Jul2016

From the Director: National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

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1 Jul
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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

6
Apr2016

NPRM Symposium: Consent and Consistency in the NPRM

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6 Apr
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This piece, which originally appeared on the Petrie-Flom Center's Bill of Health blog, was written by Luke Gelinas, and has been reposted with permission.

1. Interpreting the proposed consent requirement

One of the most discussed and controversial aspects of the Department of Health and Human Services’ recent notice of proposed rule-making (NPRM), which stands to change the federal regulations [...] Read more