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Tag: public policy

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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On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.…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 calls for NIH to deepen engagement with the public on data sharing rules

(PRIM&R) Public Responsibility in Medicine and Research

In November 2021, the National Institutes of Health (NIH) Office of Science Policy (OSP) published a Request for Information (RFI)…

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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PRIM&R’s Response to FDA’s Draft Guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients”

(PRIM&R) Public Responsibility in Medicine and Research

In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric…

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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 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.