This bill aims to significantly enhance diversity in clinical trials funded by the National Institutes of Health. It mandates that research organizations applying for funding must submit applications with clear and measurable goals for recruiting and retaining participants that reflect diverse demographics, along with a detailed plan for achieving these goals and analyzing data separately. These applications must also include plans for less burdensome participant follow-up, such as virtual visits, to improve retention. As a condition of receiving NIH funding, organizations must agree to share aggregate demographic information and participant retention rates annually, disaggregated by race, ethnicity, age, and sex, while ensuring privacy. Researchers will also be required to complete diversity education and training, though exceptions are allowed if diverse recruitment is not scientifically justified. Additionally, the bill directs a study on modernizing regulations for reimbursement of out-of-pocket expenses , compensation for time, and recruitment incentives, including updated safe harbor rules, to eliminate cost barriers. Finally, the legislation establishes a national public awareness and education campaign to highlight the importance of diverse clinical trials. This campaign will develop educational materials, public service announcements, and curricula for healthcare professionals, and provide grants to non-profit entities to test alternative outreach strategies and assist in diversifying trials. The campaign aims to address health disparities and barriers to participation, with an authorization of $10 million annually for fiscal years 2026 through 2029.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
NIH Clinical Trial Integrity Act
USA119th CongressS-3564| Senate
| Updated: 12/18/2025
This bill aims to significantly enhance diversity in clinical trials funded by the National Institutes of Health. It mandates that research organizations applying for funding must submit applications with clear and measurable goals for recruiting and retaining participants that reflect diverse demographics, along with a detailed plan for achieving these goals and analyzing data separately. These applications must also include plans for less burdensome participant follow-up, such as virtual visits, to improve retention. As a condition of receiving NIH funding, organizations must agree to share aggregate demographic information and participant retention rates annually, disaggregated by race, ethnicity, age, and sex, while ensuring privacy. Researchers will also be required to complete diversity education and training, though exceptions are allowed if diverse recruitment is not scientifically justified. Additionally, the bill directs a study on modernizing regulations for reimbursement of out-of-pocket expenses , compensation for time, and recruitment incentives, including updated safe harbor rules, to eliminate cost barriers. Finally, the legislation establishes a national public awareness and education campaign to highlight the importance of diverse clinical trials. This campaign will develop educational materials, public service announcements, and curricula for healthcare professionals, and provide grants to non-profit entities to test alternative outreach strategies and assist in diversifying trials. The campaign aims to address health disparities and barriers to participation, with an authorization of $10 million annually for fiscal years 2026 through 2029.