DIVERSE Trials Act

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 10 August 2021

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 10 August 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 10 August 2021 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 August 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 August 2021

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in Senate

  summary · EN · 10 August 2021

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Menendez, Robert [D-NJ] · D · Sponsor
• Sen. Scott, Tim [R-SC] · R · Sponsor
• Sen. Braun, Mike [R-IN] · R · Cosponsor
• Sen. Smith, Tina [D-MN] · D · Cosponsor
• Sen. Booker, Cory A. [D-NJ] · D · Cosponsor
• Sen. Padilla, Alex [D-CA] · D · Cosponsor
• Sen. Blackburn, Marsha [R-TN] · R · Cosponsor
• Sen. Van Hollen, Chris [D-MD] · D · Cosponsor
• Sen. Reed, Jack [D-RI] · D · Cosponsor
• Sen. Markey, Edward J. [D-MA] · D · Cosponsor
• Sen. Murkowski, Lisa [R-AK] · R · Cosponsor
• Sen. Cardin, Benjamin L. [D-MD] · D · Cosponsor
• Sen. Young, Todd [R-IN] · R · Cosponsor
• Sen. Sinema, Kyrsten [I-AZ] · D · Cosponsor
• Sen. Klobuchar, Amy [D-MN] · D · Cosponsor
• Sen. Moran, Jerry [R-KS] · R · Cosponsor
• Sen. Blumenthal, Richard [D-CT] · D · Cosponsor
• Sen. Cortez Masto, Catherine [D-NV] · D · Cosponsor
• Sen. Duckworth, Tammy [D-IL] · D · Cosponsor
• Sen. Brown, Sherrod [D-OH] · D · Cosponsor
• Sen. Collins, Susan M. [R-ME] · R · Cosponsor
• Sen. Stabenow, Debbie [D-MI] · D · Cosponsor
• Sen. Carper, Thomas R. [D-DE] · D · Cosponsor
• Sen. Casey, Robert P., Jr. [D-PA] · D · Cosponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Cosponsor
• Sen. Tester, Jon [D-MT] · D · Cosponsor
• Sen. King, Angus S., Jr. [I-ME] · I · Cosponsor
• · sshr00 · Standing

Related records

• related to ← DIVERSE Trials Act
• related to ← Health Equity and Accountability Act of 2022