DIVERSE Trials Act
Latest action · Aug 16, 2021 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedAug 13, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 54
Members who signed on, in the order they did. Signatures ran from Aug 13, 2021 to Dec 23, 2022, with 1 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IN | Larry Bucshon | Original | Aug 13, 2021 |
| D-IL | Bobby L. Rush | May 6, 2022 | |
| D-NY | Brian Higgins | May 6, 2022 | |
| D-FL | Darren Soto | May 6, 2022 | |
| D-NC | Deborah K. Ross | May 6, 2022 | |
| D-CT | John B. Larson | May 6, 2022 | |
| D-CA | Julia Brownley | May 6, 2022 | |
| D-MD | Kweisi Mfume | May 6, 2022 | |
| R-FL | Maria Elvira Salazar | May 6, 2022 | |
| D-OR | Suzanne Bonamici | May 6, 2022 | |
| D-PA | Dwight Evans | Jul 1, 2022 | |
| D-TX | Eddie Bernice Johnson | Jul 1, 2022 | |
| D-CA | Grace F. Napolitano | Jul 1, 2022 | |
| R-FL | John H. Rutherford | Jul 1, 2022 | |
| D-OH | Joyce Beatty | Jul 1, 2022 |
Actions 4
Everything that happened, newest first.
- Aug 16, 2021Referred to the Subcommittee on Health.
- Aug 13, 2021Introduced in House
- Aug 13, 2021Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Aug 13, 2021Referred to the Subcommittee on Health.
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 2706 | DIVERSE Trials Act | Identical bill | Aug 10, 2021 |
| S 4486 | Health Equity and Accountability Act of 2022 | Related bill | Jun 23, 2022 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Cardiovascular and respiratory health
- Child health
- Community life and organization
- Congressional oversight
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Emergency medical services and trauma care
- Government studies and investigations
- Health
- Health care coverage and access
- Health information and medical records
- Health personnel
- Health programs administration and funding
- Health technology, devices, supplies
- Immunology and vaccination
- Infectious and parasitic diseases
- Medical education
- Medical research
- Medical tests and diagnostic methods
- Minority employment
- Minority health
- Public contracts and procurement
Text 1
Each version as it was printed, newest first.
- Aug 13, 2021Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.