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Tag: biospecimens

> biospecimens
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FDA proposes new rules to harmonize with Common Rule (Part II: protection of human subjects and IRBs) by Elisa A. Hurley, PRIM&R executive director

(PRIM&R) Public Responsibility in Medicine and Research

On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…

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Ready, Set, Go: Implementing the Revised Common Rule

(PRIM&R) Public Responsibility in Medicine and Research

The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of…

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Less (Tissue) is More (Complicated): Rethinking Research Involving Archival Specimens

(PRIM&R) Public Responsibility in Medicine and Research

As research activities go, the use of archival tissue has ranked pretty low on my list of ethical concerns. After…

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Webinar Follow-Up: Return of Individual Research Results

(PRIM&R) Public Responsibility in Medicine and Research

The question of whether and how to return individual research results to subjects has been an ongoing area of uncertainty…

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Elisa Hurley
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From the Director: Taking a look at the National Academies’ report on returning individual research results to participants

(PRIM&R) Public Responsibility in Medicine and Research

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual…

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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.