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Tag: FDA

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Research Ethics Roundup: Enrolling Women in Concussion Studies, China Tests CRISPR Gene-Editing in Humans, Contentious FDA Hearing on Off-Label Promotion, and Social Housing for Lab Mice

(PRIM&R) Public Responsibility in Medicine and Research

This week’s Research Ethics Roundup reviews researchers’ efforts to learn about how traumatic brain injury affects women’s brains, the first…

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Elisa Hurley
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From the Director: PRIM&R’s Comments in Response to OHRP’s and FDA’s Draft Guidance on IRB Written Procedures

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the…

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OHRP and FDA Issue Draft Guidance on IRB Written Procedures

(PRIM&R) Public Responsibility in Medicine and Research

On August 2, 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the…

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Elisa Hurley
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ICYMI – From the Director: Clinical Trial Data Sharing, the Law, and Reality

(PRIM&R) Public Responsibility in Medicine and Research

In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past.  These posts…

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

(PRIM&R) Public Responsibility in Medicine and Research

This week’s Research Ethics Roundup explores debates on regulations and regulators: NPR covers a critique of revisions to the Common…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.