Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted. Read more
30Jun2020
TAG ARCHIVES FOR diversity in clinical trials
11Jun2020
When I started my research career back in 2004, I was working in the biggest trauma center in the Atlanta area, Grady Healthcare System. I had arrived in the country under a work visa to help with the Department of Orthopaedics' clinical trials. I remember the nervousness of speaking to potential study participants because I was not only new to clinical research, having only done chart review projects in the past, I was also new in America and America’s history of research with minorities. Now, after all these years working as a research coordinator and IRB professional, and living in the United States for more than 15 years, I know how important it is to rebuild trust and increase minority participation in research to ensure not only that we are doing quality studies, but also that we help in diminishing the social injustices our communities still undergo today. Read more
16Sep2019
This edition of Research Ethics Roundup covers a UK political party's position on animal testing, management philosophies for databank access, tariffs' effects on nonhuman primate research, and an activist push for testing Duchenne muscular dystrophy cures in girls. Read more
30Jul2019
PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations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In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs."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