NIH Clinical Trial Integrity Act

This bill would require sponsors seeking National Institutes of Health (NIH) approval of a clinical trial protocol to include goals for recruiting and retaining participants that reflect the race, ethnicity, age, and sex of patients with the disease being studied, along with a plan to meet those goals. Sponsors would have to report participant demographics and retention rates to the government, and the NIH would post summaries of the goals online without revealing study design. Trials that miss their goals would have to create and carry out a plan to increase participation. The bill also calls for federal studies on barriers and participant costs, and authorizes $10 million per year from 2027 through 2030 for a national awareness campaign and grants to nonprofit groups.

Full text and official record on Congress.gov

Sponsors

• Robin L. Kelly Democrat sponsor
• 11 cosponsors