Bill > HR6867

This bill, titled the "NIH Clinical Trial Integrity Act," directs the Secretary of Health and Human Services, through the Director of the National Institutes of Health (NIH), to implement measures to increase diversity in clinical trials, which are research studies involving human subjects to test the effects of interventions on health outcomes. Specifically, it requires sponsors seeking NIH approval for clinical trials involving drugs, devices, biological products, or behavioral interventions to submit applications that include clear goals for recruiting and retaining participants reflecting the race, ethnicity, age, and sex of patients with the studied disease or the general U.S. population if disease prevalence is unknown, along with a rationale and detailed plan for achieving these goals. The bill also mandates that sponsors provide aggregate demographic data of trial participants annually, report participant retention rates disaggregated by demographic groups, ensure researchers and reviewers receive diversity training, and submit final disaggregated demographic data upon trial completion, all while protecting participant privacy. Furthermore, it allows for exceptions if recruitment is not scientifically justified or possible, requires the NIH to publish trial summaries and diversity goals, and outlines a remediation process for trials that fail to meet their diversity objectives, including the development and public release of strategic plans to improve participation. The bill also mandates a study on eliminating cost barriers to participation and a national campaign to raise awareness about the need for diverse clinical trials, including grants to non-profit organizations to support outreach and education efforts, with specific funding authorized for this campaign.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/6867/all-info