This bill mandates that sponsors seeking National Institutes of Health (NIH) approval for clinical trials must submit applications with clear, measurable goals for recruiting and retaining participants based on race, ethnicity, age, and sex . These goals must reflect either the prevalence of the disease in specific demographic groups or the general U.S. population if prevalence is unknown. Applications must also include detailed plans for achieving these diversity goals, specifying how investigators will analyze population groups separately and involve community partners or institutional review boards. As a condition of approval, sponsors must agree to share annual aggregate demographic data of participants and their retention rates, disaggregated by race, ethnicity, age, and sex, while protecting individual privacy. The legislation requires sponsors to propose alternative, less burdensome follow-up requirements for participants, such as virtual visits, home care, or flexible scheduling, and mandates diversity training for researchers and reviewers. It establishes a remediation process for trials failing to meet diversity goals, requiring strategic plans to increase participation, and directs the NIH to conduct a national public awareness campaign to highlight the importance of diverse clinical trials. Additionally, the bill calls for a study on eliminating cost barriers for participants and authorizes grants for outreach strategies.
Referred to the House Committee on Energy and Commerce.
Health
NIH Clinical Trial Integrity Act
USA119th CongressHR-6867| House
| Updated: 12/18/2025
This bill mandates that sponsors seeking National Institutes of Health (NIH) approval for clinical trials must submit applications with clear, measurable goals for recruiting and retaining participants based on race, ethnicity, age, and sex . These goals must reflect either the prevalence of the disease in specific demographic groups or the general U.S. population if prevalence is unknown. Applications must also include detailed plans for achieving these diversity goals, specifying how investigators will analyze population groups separately and involve community partners or institutional review boards. As a condition of approval, sponsors must agree to share annual aggregate demographic data of participants and their retention rates, disaggregated by race, ethnicity, age, and sex, while protecting individual privacy. The legislation requires sponsors to propose alternative, less burdensome follow-up requirements for participants, such as virtual visits, home care, or flexible scheduling, and mandates diversity training for researchers and reviewers. It establishes a remediation process for trials failing to meet diversity goals, requiring strategic plans to increase participation, and directs the NIH to conduct a national public awareness campaign to highlight the importance of diverse clinical trials. Additionally, the bill calls for a study on eliminating cost barriers for participants and authorizes grants for outreach strategies.