TAG ARCHIVES FOR human subjects protections


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


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 
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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


By Megan Frame, membership manager

Welcome to another of our featured member interviews where we continue to introduce you to our members—individuals who work to advance ethical research on a daily basis. May is Member Appreciation Month at PRIM&R , and we will be featuring a new member interview every week! Please read on to learn about Haihong Zhang, PhD, coordinator of Peking University Human Research Protection Program (HRPP) in Beijing, China. 

Megan Frame (MF): What's one specific challenge that you have faced during your career, and how did you overcome it?
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By Avery Avrakotos, education and policy manager

Last year, I was fortunate to have an opportunity to attend Ethical Issues in Global Health Research (EIGHR): Blending Cultures, Building Capacities, and Bolstering Collaboration. The four-day program, offered by the Harvard T.H. Chan School of Public Health, examined the unique issues that face institutional review boards (IRBs) and researchers reviewing and conducting international research.

As education and policy manager at PRIM&R, I regularly prepare written updates on federal laws, regulations, and news stories related to human subjects protections for distribution to PRIM&R's members, the majority of whom are [...] Read more

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