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DIVERSE Trials Act

USA117th CongressS-2706| Senate 
| Updated: 8/10/2021
Robert Menendez

Robert Menendez

Democratic Senator

New Jersey

Cosponsors (26)
Mike Braun (Republican)Tammy Duckworth (Democratic)Catherine Cortez Masto (Democratic)Patrick J. Leahy (Democratic)Edward J. Markey (Democratic)Jack Reed (Democratic)Jerry Moran (Republican)Alex Padilla (Democratic)Marsha Blackburn (Republican)Todd Young (Republican)Thomas R. Carper (Democratic)Angus S. King (Independent)Amy Klobuchar (Democratic)Robert P. Casey (Democratic)Kyrsten Sinema (Independent)Chris Van Hollen (Democratic)Tim Scott (Republican)Jon Tester (Democratic)Debbie Stabenow (Democratic)Tina Smith (Democratic)Sherrod Brown (Democratic)Cory A. Booker (Democratic)Benjamin L. Cardin (Democratic)Susan M. Collins (Republican)Richard Blumenthal (Democratic)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies. Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology. In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials. The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs. Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.
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Timeline
Aug 10, 2021
Introduced in Senate
Aug 10, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Aug 16, 2021

Latest Companion Bill Action

HR 117-5030
Referred to the Subcommittee on Health.
  • August 10, 2021
    Introduced in Senate


  • August 10, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • August 16, 2021

    Latest Companion Bill Action

    HR 117-5030
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 117-4486: Health Equity and Accountability Act of 2022
  • HR 117-5030: DIVERSE Trials Act
Administrative law and regulatory proceduresCardiovascular and respiratory healthChild healthCommunity life and organizationCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careGovernment studies and investigationsHealth care coverage and accessHealth information and medical recordsHealth personnelHealth programs administration and fundingHealth technology, devices, suppliesImmunology and vaccinationInfectious and parasitic diseasesMedical educationMedical researchMedical tests and diagnostic methodsMinority employmentMinority healthPublic contracts and procurement

DIVERSE Trials Act

USA117th CongressS-2706| Senate 
| Updated: 8/10/2021
Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies. Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology. In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials. The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs. Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.
View Full Text

Suggested Questions

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

Timeline
Aug 10, 2021
Introduced in Senate
Aug 10, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Aug 16, 2021

Latest Companion Bill Action

HR 117-5030
Referred to the Subcommittee on Health.
  • August 10, 2021
    Introduced in Senate


  • August 10, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • August 16, 2021

    Latest Companion Bill Action

    HR 117-5030
    Referred to the Subcommittee on Health.
Robert Menendez

Robert Menendez

Democratic Senator

New Jersey

Cosponsors (26)
Mike Braun (Republican)Tammy Duckworth (Democratic)Catherine Cortez Masto (Democratic)Patrick J. Leahy (Democratic)Edward J. Markey (Democratic)Jack Reed (Democratic)Jerry Moran (Republican)Alex Padilla (Democratic)Marsha Blackburn (Republican)Todd Young (Republican)Thomas R. Carper (Democratic)Angus S. King (Independent)Amy Klobuchar (Democratic)Robert P. Casey (Democratic)Kyrsten Sinema (Independent)Chris Van Hollen (Democratic)Tim Scott (Republican)Jon Tester (Democratic)Debbie Stabenow (Democratic)Tina Smith (Democratic)Sherrod Brown (Democratic)Cory A. Booker (Democratic)Benjamin L. Cardin (Democratic)Susan M. Collins (Republican)Richard Blumenthal (Democratic)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-4486: Health Equity and Accountability Act of 2022
  • HR 117-5030: DIVERSE Trials Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCardiovascular and respiratory healthChild healthCommunity life and organizationCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careGovernment studies and investigationsHealth care coverage and accessHealth information and medical recordsHealth personnelHealth programs administration and fundingHealth technology, devices, suppliesImmunology and vaccinationInfectious and parasitic diseasesMedical educationMedical researchMedical tests and diagnostic methodsMinority employmentMinority healthPublic contracts and procurement