The NIH Clinical Trial Integrity Act requires the National Institutes of Health to strengthen diversity in federally funded clinical trials by mandating that research organizations include clear recruitment and retention goals reflecting the race, ethnicity, age, and sex of patients with the disease being studied. Organizations must submit detailed plans showing how they will achieve these goals, implement less burdensome follow-up methods (such as telehealth or home visits), and annually report participant demographics to the NIH. The bill also directs the NIH to conduct a two-year study on removing financial barriers to participation, such as reimbursing out-of-pocket expenses and updating compensation rules. Additionally, it authorizes $10 million annually through 2029 for a public awareness campaign and grants to community organizations to increase awareness of clinical trial participation among underrepresented populations. The legislation applies to all NIH-funded clinical trials investigating drugs, devices, biological products, and behavioral interventions, with exceptions available if diversity recruitment is scientifically unjustified.
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