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Tag: informed consent

> informed consent
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Minding the (db)GaP: Age of Majority and the NIH’s GDS Policy

(PRIM&R) Public Responsibility in Medicine and Research

The 2018 Advancing Ethical Research Conference (AER18) was my second PRIM&R conference, and this year I came armed with questions…

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PRIM&R’s Comments on the FDA’s Proposed Rule, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations”

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or…

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Recommendations for Oversight of Patient-Centered Outcomes Research

(PRIM&R) Public Responsibility in Medicine and Research

In 2010, a little-known research institute, the Patient Centered Outcomes Research Institute (PCORI), began funding hundreds of clinical studies with…

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Clinical Research Ethics Question of the Month: August 2018

(PRIM&R) Public Responsibility in Medicine and Research

In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about…

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Webinar Follow-Up: Forward-Looking Strategies for IRBs in the Genomic Age

(PRIM&R) Public Responsibility in Medicine and Research

Breakthroughs in genomics research hold the potential for significant and wide-reaching clinical, scientific, and societal benefit. However, advances in genetic…

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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.