TAG ARCHIVES FOR diversity in clinical trials

4
Nov2022

But how can IRBs engage communities while operating within the boundaries of their current regulatory role? Do IRBs have an ethical obligation to be proactive in ensuring diversity in clinical trials? Indeed, IRBs are uniquely positioned to influence research practices toward an equitable and more inclusive research world. Perhaps, the FDA and HHS should consider revisiting the scope of responsibilities of IRBs to provide broader latitude for making a greater impact on public health. The questions in this blog are the types of engaging thoughts I plan to discuss during the 2022 PRIM&R Annual Conference. I am most grateful that PRIM&R is providing a forum to discuss these important thoughts and expect more ideas will be generated as we continue the journey of straightening the path towards health equity for all. Read more

21
Sep2022

This week's research ethics roundup covers efforts by Black scientists to develop oxygen sensors for darker skin; the ethical challenges faced by clinical ethicists; new policy guidance for immediate open access to research findings; and the use of electronic health record data to study pregnancy outcomes. Read more

15
Sep2022

National Hispanic Heritage Month takes place from September 15 to October 15. We would like to honor this month by featuring some resources (from PRIM&R and from other organizations) that highlight the importance of the inclusion of the Latinx community in clinical research. Read more

9
Jun2022

On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials. Because the guidance is a draft, its content is open for public discussion and comment. Earlier this week, PRIM&R submitted comment to the FDA explaining how the guidance, while welcome, might be improved. Comments are due June 13, 2022, and we encourage others to submit their own comments (and feel free to borrow from ours)! Read more

3
Jun2022

Diversity, equity, and inclusion have become a focal point since the COVID-19 pandemic exposed the disproportionate —and systemically ingrained— health disparities certain populations suffer from in the United States. IRBs have the difficult responsibility of both protecting participants from harm and ensuring the inclusion of underrepresented participants in research. Read more