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Tag: PRIMR comments

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PRIM&R On How FDA Can Improve its Clinical Trial Diversity Guidance

(PRIM&R) Public Responsibility in Medicine and Research

On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.…

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PRIM&R Responds to NIH Strategic Plan Framework

(PRIM&R) Public Responsibility in Medicine and Research

In 2015, NIH solicited public input on an agency-wide strategic plan framework for the subsequent five years in response to…

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PRIM&R’s Comments on NIH’s Draft Policy for Data Management and Sharing and Supplemental Draft Guidance

(PRIM&R) Public Responsibility in Medicine and Research

On November 8, 2019, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing…

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PRIM&R’s Comments on HHS “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care”

(PRIM&R) Public Responsibility in Medicine and Research

The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) recently put out a "Request…

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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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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.