TAG ARCHIVES FOR justice

30
Jul2019

PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

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30 Jul
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In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week, and we wanted to share them with you and encourage you to consider submitting your own comments on this important topic—the FDA is accepting comments until August 6. Read more

10
Mar2014

40 Years of Research Ethics: The Drafting of the Belmont Report

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10 Mar
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by Meryn Robinson, education and membership services,  and Avery Avrakotos, education and policy manager

Since its founding in 1974, PRIM&R’s highest priority has been to provide those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with the education, practical tools, and cutting-edge strategies needed for their work protecting subjects. As we celebrate our 40th anniversary, we are reflecting upon four decades of connecting and protecting and recounting some of the events that have shaped the field’s rich history in our 40 Years of Research Ethics series.

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