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NIH Clinical Trial Integrity Act

USA119th CongressHR-6867| House 
| Updated: 12/18/2025
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (11)
Mark Pocan (Democratic)Jennifer L. McClellan (Democratic)Melanie A. Stansbury (Democratic)Paul Tonko (Democratic)Pramila Jayapal (Democratic)Eleanor Holmes Norton (Democratic)Sean Casten (Democratic)Brian K. Fitzpatrick (Republican)Josh Gottheimer (Democratic)Jason Crow (Democratic)Gwen Moore (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Dec 18, 2025

Latest Companion Bill Action

S 119-3564
Introduced in Senate
Dec 18, 2025
Introduced in House
Dec 18, 2025
Referred to the House Committee on Energy and Commerce.
  • December 18, 2025

    Latest Companion Bill Action

    S 119-3564
    Introduced in Senate


  • December 18, 2025
    Introduced in House


  • December 18, 2025
    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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Dec 18, 2025

Latest Companion Bill Action

S 119-3564
Introduced in Senate
Dec 18, 2025
Introduced in House
Dec 18, 2025
Referred to the House Committee on Energy and Commerce.
  • December 18, 2025

    Latest Companion Bill Action

    S 119-3564
    Introduced in Senate


  • December 18, 2025
    Introduced in House


  • December 18, 2025
    Referred to the House Committee on Energy and Commerce.
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (11)
Mark Pocan (Democratic)Jennifer L. McClellan (Democratic)Melanie A. Stansbury (Democratic)Paul Tonko (Democratic)Pramila Jayapal (Democratic)Eleanor Holmes Norton (Democratic)Sean Casten (Democratic)Brian K. Fitzpatrick (Republican)Josh Gottheimer (Democratic)Jason Crow (Democratic)Gwen Moore (Democratic)

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted