On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.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
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
This month's Research Ethics Roundup covers public trust in data sharing, geographical equity efforts, income-based study attrition, and problems with genetic ancestry categories. Read more
The clinical trial workforce's incredible response to the COVID-19 pandemic has generated some of the most positive media coverage and public acclaim the drug and device research and development industry has ever seen. "We need to harness that public awareness," says Elisa Hurley, PhD, executive director of PRIM&R. Read more
The COVID-19 pandemic has brought to light, once again, the ongoing issue of racial health inequalities in the United States and around the globe. As the first vaccines and treatments for COVID-19 were being approved for use around the world, scrutiny of medical research and its oversight has highlighted the fact that there is still much to do to resolve the unending epidemic of racism in healthcare and to ensure diversity in clinical trials. Read more
