Introduced in the U.S. House of Representatives on February 3, 2022, H.R. 6584, the DEPICT (Diverse and Equitable Participation in Clinical Trials) Act directs the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity. If enacted, it would trigger revising parts of federal code regulations on investigative drug and medical device applications to include several provisions such as a diversity action plan for how the sponsor will meet certain goals related to:
- Demographic-specific outreach and enrollment strategies
- Study-site selection
- Clinical trial inclusion and exclusion practices
- Diversity training for trial personnel
Another important component would be the creation of community engagement and outreach protocols and tools to improve the inclusion of underrepresented minorities in clinical trials and research. The precise language states, “The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct, coordinate and support activities for purposes of community engagement with, and outreach to, underserved communities to facilitate inclusion of underrepresented minorities in clinical research and clinical trials.”
This would also include grants to increase the capacity of health centers (a key point to follow, comment on and potentially advocate for amendments) to participate in clinical trials and research with an emphasis on community education and outreach strategies. The overall H.R. 6584 suggested fiscal authorization would be $100 million over fiscal years 2022 to 2025.
A link to the DEPICT Act and relevant articles is below. The Foxglove Alliance will continue to monitor H.R. 6584 because of its relevance to its M3R (More Minorities in Medical Research) Campaign.