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Tag: DHHS

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OHRP and FDA Issue Draft Guidance on IRB Written Procedures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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PRIM&R’s Comments in Response to OHRP’s and FDA’s Draft Guidance on IRB Meeting Minutes

(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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PRIM&R Circulates Draft of NPRM Comments

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R recently completed a draft of our comments to the Department of Health and Human Services (DHHS) in response to…

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Elisa Hurley
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Unpacking the NPRM: Single IRB Review and Continuing Review

(PRIM&R) Public Responsibility in Medicine and Research

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions…

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Elisa Hurley
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Unpacking the NPRM: Informed Consent

(PRIM&R) Public Responsibility in Medicine and Research

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions…

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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.