TAG ARCHIVES FOR Belmont Principles

3
Nov2020

Amid both promising and worrying signs in the development of treatments and vaccines for COVID-19, and in the context of a considerable amount of scrutiny of medical research, some researchers, ethicists, and advocates are working to make sure science doesn’t lose sight of a critical issue: diversity in the clinical trial participant pool. The distribution of research benefits to participants—and the consideration of race in subject selection—is tightly woven into the Belmont Report and has been a mainstay in research ethics discussion ever since. But despite the decades-long consideration of race and ethnicity in clinical trials, many trials still don’t enroll populations that reflect the diversity of the general populace or the group affected by the condition being studied. Read more

30
Jul2019

In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs."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

12
Apr2019

Despite their significant importance in society and communities, there is a scarcity of research on the undocumented immigrant population. In addition, only a handful of studies address the social and emotional concerns of undocumented immigrants and students. At AER18, panelists Gene Gloeckner, PhD; Elizabeth Jach, MA; and Colleen Kohashi, MA, CIP, presented ways to ethically and sensitively conduct research with undocumented immigrants. Read more