In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs."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
TAG ARCHIVES FOR justice
Today is the 40th anniversary of the Belmont Report, the foundational document on which our federal oversight system for human subjects research is based. This milestone warrants a pause in our busy day to reflect on its impact and its legacy. Read more
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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by Joan Rachlin, JD, MPH, Executive Director
The eight days since Nelson Mandela’s death on December 5 have been among the most inspiring of my life. The words and images that have poured forth from South Africa have caused me to experience several “driveway moments” (Read more