TAG ARCHIVES FOR human subjects protections

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

30
Dec2015

ARENA Legacy Award Winner Karen HaleAt November’s 2015 Advancing Ethical Research Conference (AER15), PRIM&R recognized the substantial achievements and contributions of longtime PRIM&R member, Karen Hale, RPh, MPH, CIP.

Karen is the recipient of the 2015 Applied Research Ethics National Association (ARENA) Legacy Award (ALA). The ALA was developed to honor not only the chosen individual, but also to honor the living legacy created by ARENA, which was the membership division of PRIM&R [...] 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

27
Oct2015

We're two weeks away from the 2015 Social, Behavioral, and Educational Research Conference (SBER15) and the 2015 Advancing Ethical Research Conference (AER15), so we thought we'd take a look back at a compelling moment from a previous conference. Read on for this week's Time Capsule Tuesday

16037784589_8a63f74811_oConference: The Evolution of Protecting Human Subjects: From Nuremburg to the Nineties, November 1991 
[...] Read more

26
Aug2015

On July 22, the National Institutes of Health (NIH) announced it was seeking comment on a framework for a five-year, NIH-wide Strategic Plan. The plan, which will ultimately be submitted to Congress and is being generated with input from senior leadership and staff across NIH, is intended to “outline a set of unifying principles to guide NIH in pursuit of its mission” and “highlight major trans-NIH themes” in order to help advance the biomedical research enterprise.

In the framework, NIH identifies three areas of opportunity that apply across biomedicine: (1) the promotion of [...] Read more

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