NIH Clinical Trial Integrity Act

The NIH Clinical Trial Integrity Act requires NIH-funded research organizations conducting clinical trials (for drugs, devices, biological products, or behavioral interventions) to set specific, measurable diversity goals for participant recruitment and retention, focusing on race, ethnicity, age, and sex to reflect affected populations or the general U.S. population where appropriate. It mandates annual reporting of demographic data and retention rates by these groups, researcher training on diversity, and detailed plans for analyzing results across these categories. The bill also includes a study to modernize regulations on reimbursing participants' out-of-pocket costs and compensation, plus a national awareness campaign and grants to community organizations to improve outreach to underrepresented groups. This directly affects NIH-funded trial sponsors and aims to make clinical research more representative.