TAG ARCHIVES FOR NPRM

1
Jul2016

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

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

25
Jan2016

The last few months have been a bit of blur. The long-awaited NPRM to revise the Common Rule was released in September, setting off something of a firestorm of commentary, concern, and clamor around what was in the proposal, and what wasn’t; what might work, and what wouldn’t; and of course, how it would all look in the "real world" of ethical research oversight. Here at PRIM&R we spent a good deal of time over the three-month comment period crafting our response to the NPRM, and [...] Read more

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