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Tag: minimal risk

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Webinar Follow-Up: Pediatric Risk Determination – IRB Considerations and Cases

(PRIM&R) Public Responsibility in Medicine and Research

Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal…

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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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What To Do With Continuing Review

(PRIM&R) Public Responsibility in Medicine and Research

At the 2017 Advancing Ethical Research Conference (AER17), I caught the plenary session, “New Frontiers: The Changing Landscape of Research…

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Webinar Follow-up: Common Rule Informed Consent, Part I

(PRIM&R) Public Responsibility in Medicine and Research

In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics…

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Exploring the complexity of protecting human subjects in social and behavioral research

(PRIM&R) Public Responsibility in Medicine and Research

by David R. Van Houten, MS, research integrity advocate During PRIM&R’s Best Practices for Assessing Risk in Social and Behavioral…

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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.