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NIH Clinical Trial Diversity Act of 2023

USA118th CongressHR-3503| House 
| Updated: 5/19/2023
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (40)
Becca Balint (Democratic)Mark Pocan (Democratic)Lisa Blunt Rochester (Democratic)Jennifer L. McClellan (Democratic)Sheila Jackson Lee (Democratic)Melanie A. Stansbury (Democratic)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Paul Tonko (Democratic)Ted Lieu (Democratic)Henry C. "Hank" Johnson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Jill N. Tokuda (Democratic)Joseph D. Morelle (Democratic)Dean Phillips (Democratic)James A. Himes (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Alma S. Adams (Democratic)Anna G. Eshoo (Democratic)Pramila Jayapal (Democratic)Eleanor Holmes Norton (Democratic)Bonnie Watson Coleman (Democratic)Joe Neguse (Democratic)Sean Casten (Democratic)Andy Kim (Democratic)William R. Keating (Democratic)Seth Magaziner (Democratic)Yvette D. Clarke (Democratic)Brian K. Fitzpatrick (Republican)Colin Z. Allred (Democratic)Mary Sattler Peltola (Democratic)Yadira Caraveo (Democratic)Josh Gottheimer (Democratic)Nanette Diaz Barragán (Democratic)Jason Crow (Democratic)Gwen Moore (Democratic)Debbie Wasserman Schultz (Democratic)Grace F. Napolitano (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
NIH Clinical Trial Diversity Act of 2023 This bill sets out requirements to increase the diversity of clinical trial participants and requires other activities to foster participation in clinical trials. As a condition of approval from the National Institutes of Health (NIH) for a clinical trial investigating a drug, device, or behavioral intervention, a sponsor's application must include certain information related to diversity in its trial, such as goals for recruiting and retaining trial participants, plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements, and requirements for researchers and other individuals involved with the trial to complete education and training about diversity in clinical trials. A sponsor must also annually share demographic data of clinical trial participants with the NIH. The NIH must publish on its website information about the diversity of and other information concerning the clinical trials it funds. If a sponsor fails to meet its diversity goals or related requirements, the sponsor must develop and implement a strategic plan to increase the diversity of the clinical trial participants. Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials. The bill also requires studies on barriers to participation in clinical trials. The Government Accountability Office must study actions taken by federal agencies to address such barriers while the NIH must study regulations that govern reimbursements of out-of-pocket expenses of and incentives for clinical trial participants.
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Timeline

Bill from Previous Congress

HR 117-7845
NIH Clinical Trial Diversity Act of 2022
May 18, 2023

Latest Companion Bill Action

S 118-1701
Introduced in Senate
May 18, 2023
Introduced in House
May 18, 2023
Referred to the House Committee on Energy and Commerce.
May 19, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 117-7845
    NIH Clinical Trial Diversity Act of 2022


  • May 18, 2023

    Latest Companion Bill Action

    S 118-1701
    Introduced in Senate


  • May 18, 2023
    Introduced in House


  • May 18, 2023
    Referred to the House Committee on Energy and Commerce.


  • May 19, 2023
    Referred to the Subcommittee on Health.

Health

Congressional oversightGovernment information and archivesGovernment studies and investigationsHealth information and medical recordsMedical researchMinority healthNational Institutes of Health (NIH)Research administration and fundingWomen's health

NIH Clinical Trial Diversity Act of 2023

USA118th CongressHR-3503| House 
| Updated: 5/19/2023
NIH Clinical Trial Diversity Act of 2023 This bill sets out requirements to increase the diversity of clinical trial participants and requires other activities to foster participation in clinical trials. As a condition of approval from the National Institutes of Health (NIH) for a clinical trial investigating a drug, device, or behavioral intervention, a sponsor's application must include certain information related to diversity in its trial, such as goals for recruiting and retaining trial participants, plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements, and requirements for researchers and other individuals involved with the trial to complete education and training about diversity in clinical trials. A sponsor must also annually share demographic data of clinical trial participants with the NIH. The NIH must publish on its website information about the diversity of and other information concerning the clinical trials it funds. If a sponsor fails to meet its diversity goals or related requirements, the sponsor must develop and implement a strategic plan to increase the diversity of the clinical trial participants. Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials. The bill also requires studies on barriers to participation in clinical trials. The Government Accountability Office must study actions taken by federal agencies to address such barriers while the NIH must study regulations that govern reimbursements of out-of-pocket expenses of and incentives for clinical trial participants.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 117-7845
NIH Clinical Trial Diversity Act of 2022
May 18, 2023

Latest Companion Bill Action

S 118-1701
Introduced in Senate
May 18, 2023
Introduced in House
May 18, 2023
Referred to the House Committee on Energy and Commerce.
May 19, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 117-7845
    NIH Clinical Trial Diversity Act of 2022


  • May 18, 2023

    Latest Companion Bill Action

    S 118-1701
    Introduced in Senate


  • May 18, 2023
    Introduced in House


  • May 18, 2023
    Referred to the House Committee on Energy and Commerce.


  • May 19, 2023
    Referred to the Subcommittee on Health.
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (40)
Becca Balint (Democratic)Mark Pocan (Democratic)Lisa Blunt Rochester (Democratic)Jennifer L. McClellan (Democratic)Sheila Jackson Lee (Democratic)Melanie A. Stansbury (Democratic)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Paul Tonko (Democratic)Ted Lieu (Democratic)Henry C. "Hank" Johnson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Jill N. Tokuda (Democratic)Joseph D. Morelle (Democratic)Dean Phillips (Democratic)James A. Himes (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Alma S. Adams (Democratic)Anna G. Eshoo (Democratic)Pramila Jayapal (Democratic)Eleanor Holmes Norton (Democratic)Bonnie Watson Coleman (Democratic)Joe Neguse (Democratic)Sean Casten (Democratic)Andy Kim (Democratic)William R. Keating (Democratic)Seth Magaziner (Democratic)Yvette D. Clarke (Democratic)Brian K. Fitzpatrick (Republican)Colin Z. Allred (Democratic)Mary Sattler Peltola (Democratic)Yadira Caraveo (Democratic)Josh Gottheimer (Democratic)Nanette Diaz Barragán (Democratic)Jason Crow (Democratic)Gwen Moore (Democratic)Debbie Wasserman Schultz (Democratic)Grace F. Napolitano (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightGovernment information and archivesGovernment studies and investigationsHealth information and medical recordsMedical researchMinority healthNational Institutes of Health (NIH)Research administration and fundingWomen's health