NIH Clinical Trial Integrity Act

The NIH Clinical Trial Integrity Act requires sponsors of clinical trials approved by the National Institutes of Health (NIH) to set and meet specific goals for including participants from diverse racial, ethnic, age, and sex groups. This includes submitting detailed plans for recruitment and retention - such as using telemedicine for follow-ups or flexible scheduling - and reporting annual demographic data without personally identifiable information. Trials failing to meet these goals must develop a community-informed strategic plan to improve participation, which the NIH will publish. The bill also mandates a national awareness campaign to promote diverse trial participation and a study on reducing cost barriers for participants.