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Tag: fda guidance

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IRB

Guidance Document Summary: Unpacking FDA’s Guidance Document on Informed Consent

(PRIM&R) Public Responsibility in Medicine and Research

The FDA issued guidance in August 2023 to provide more clarity to IRBs, clinical investigators, and sponsors in complying with FDA’s informed…

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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.