Bill > S3564

This bill, titled the "NIH Clinical Trial Integrity Act," aims to increase diversity in clinical trials funded by the National Institutes of Health (NIH), which are research studies involving human participants to test the effects of interventions on health outcomes. Starting immediately, any organization receiving NIH funding to conduct clinical trials for drugs, devices, or biological products, or behavioral interventions approved by the NIH, must submit applications that include clear, measurable goals for recruiting and retaining participants that reflect the race, ethnicity, age, and sex of patients with the disease being studied, or the general U.S. population if disease prevalence is unknown. These applications must also detail the rationale for these goals, how participant numbers will be determined for each demographic group, and a plan for achieving these recruitment and retention goals, including analyzing data separately for different population groups to ensure statistically meaningful results for all. Furthermore, the bill requires NIH-funded research organizations to consider and propose less burdensome follow-up options for participants, such as fewer in-person visits, phone or virtual follow-ups, or allowing primary care providers to conduct some follow-up tasks. As a condition of receiving NIH funding, these organizations must agree to share aggregate demographic information of trial participants annually, report participant retention rates disaggregated by race, ethnicity, age, and sex, ensure researchers complete training on diversity in clinical trials, and submit final participant numbers by demographic group. The bill also mandates a study on eliminating cost barriers for participants, such as out-of-pocket expenses and compensation for time, and proposes a national public awareness and education campaign to encourage participation from underrepresented groups, including grants to community organizations to help diversify clinical trials.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3564/all-info