Title: DIVERSE Trials Act
Policy area: Health

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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2706 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2706

 To improve diversity in clinical trials and data collection for COVID-
 19 and future public health threats to address social determinants of 
                                health.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            August 10, 2021

 Mr. Menendez (for himself and Mr. Scott of South Carolina) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To improve diversity in clinical trials and data collection for COVID-
 19 and future public health threats to address social determinants of 
                                health.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Diversifying Investigations Via 
Equitable Research Studies for Everyone Trials Act'' or the ``DIVERSE 
Trials Act''.

SEC. 2. GUIDANCE ON DECENTRALIZED CLINICAL TRIALS.

    (a) Definitions.--In this section, the term ``decentralized 
clinical trials'' includes clinical trials that are executed through a 
broad spectrum of options, such as telemedicine or other mobile or 
digital technologies, to allow for the remote collection and assessment 
of clinical trial data from participants, including in the home or 
office setting.
    (b) Guidance.--Not later than 6 months after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this Act as the ``Secretary''), acting through the Commissioner of Food 
and Drugs (referred to in this Act as the ``Commissioner''), shall 
issue a draft guidance that addresses how to conduct decentralized 
clinical trials with meaningful demographic diversity, including 
racial, ethnic, age, gender, and geographic diversity in patient 
engagement, enrollment, and participation, including how to 
appropriately use digital health technologies or other remote 
assessment options, such as telemedicine, to support such trials. Not 
later than 6 months after the date the public comment period for the 
draft guidance ends, the Secretary shall issue a final guidance.
    (c) Content of Guidance.--The guidance under subsection (b) shall 
address the following:
            (1) Strategies to engage with prospective clinical trial 
        participants and community partners, such as patient advocacy 
        groups with diverse representation, to incorporate input of 
        such patients and partners into the design of decentralized 
        clinical trials.
            (2) Recommendations for--
                    (A) protocol design approaches;
                    (B) appropriate clinical endpoints;
                    (C) institutional review board composition and 
                ensuring that such boards include members with 
                expertise in decentralized clinical trials;
                    (D) delegation of clinical research organization 
                responsibilities and suitable proxies for clinical 
                research organizations; and
                    (E) simplifying informed consent.
            (3) Recommendations for how digital health technology or 
        other remote assessment options, such as telemedicine, could 
        support decentralized clinical trials, including guidance on 
        appropriate technological platforms and mediums, data 
        collection and use, data integrity, and communication to study 
        participants through digital technology.
            (4) Recommendations for appropriate methods of patient 
        recruitment and retention, including institutional review board 
        oversight, patient communication, and the role of study 
        participants and community partners as advocates to facilitate 
        clinical trial recruitment, particularly with respect to 
        underrepresented populations.
            (5) Information regarding when and how a study sponsor may 
        solicit a meeting with the Secretary regarding the issues 
        described in paragraphs (1) through (4).
    (d) International Harmonization.--After issuing the final guidance 
under subsection (b), the Secretary, acting through the Commissioner, 
may work with foreign regulators pursuant to existing memoranda of 
understanding governing exchange of information to facilitate 
international harmonization of the regulation of decentralized clinical 
trials and use of digital health technology or other remote assessment 
options.

SEC. 3. ENCOURAGEMENT OF CLINICAL TRIAL ENROLLMENT BY RACIALLY AND 
              ETHNICALLY DIVERSE POPULATIONS.

    (a) No Cost Provision of Digital Health Technologies.--The free 
provision of digital health technologies by drug or device 
manufacturers to their clinical trial participants shall not be 
considered a violation of section 1128A of the Social Security Act 
(commonly known as the ``Civil Monetary Penalties Law'') (42 U.S.C. 
1320a-7a), section 1128B of the Social Security Act (42 U.S.C. 1320a-
7b), or sections 3729 through 3733 of title 31, United States Code, 
(commonly known as the ``False Claims Act''), provided that--
            (1) the use of digital health technologies will facilitate 
        in any phase of clinical development the inclusion of diversity 
        of patient populations, such as underrepresented racial and 
        ethnic minorities, low-income populations, and the elderly;
            (2) the digital health technologies will facilitate 
        individuals participation, or are necessary to such 
        participation;
            (3) all features of the digital health technologies that 
        are unrelated to use in the clinical trial are disabled or only 
        allowed to remain activated to model real-world usage of the 
        digital technology; and
            (4) the clinical trial sponsor requires participants to 
        return, purchase, or disable the digital health technologies by 
        the conclusion of the trial.
    (b) Grants and Contracts.--
            (1) In general.--The Secretary may issue grants to and 
        enter into contracts with entities to support community 
        education, outreach, and recruitment activities for clinical 
        trials with respect to drugs, including vaccines for diseases 
        or conditions which have a disproportionate impact on 
        underrepresented populations (including on racial and ethnic 
        minority populations), including for the diagnosis, prevention, 
        or treatment of COVID-19. Such activities may include--
                    (A) working with community clinical trial sites, 
                including community health centers, academic health 
                centers, and other facilities;
                    (B) training health care personnel including 
                potential clinical trial investigators, with a focus on 
                significantly increasing the number of underrepresented 
                racial and ethnic minority healthcare personnel who are 
                clinical trial investigators at the community sites for 
                ongoing clinical trials;
                    (C) engaging community stakeholders to encourage 
                participation in clinical trials, especially in 
                underrepresented racial and ethnic minority 
                communities; and
                    (D) fostering partnerships with community-based 
                organizations serving underrepresented racial and 
                ethnical minority populations, including employee 
                unions and frontline health care workers.
            (2) Priority for grant and contract awards.--In awarding 
        grants and contracts under this subsection, the Secretary shall 
        prioritize entities that--
                    (A) develop educational, recruitment, and training 
                materials in multiple languages; or
                    (B) undertake clinical trial outreach efforts in 
                more diverse racial and ethnic communities that are 
                traditionally underrepresented in clinical trials, such 
                as tribal areas.
            (3) Authorization of appropriations.--There is authorized 
        to be appropriated for fiscal years 2020 and 2021 such sums as 
        may be necessary to carry out this subsection.

SEC. 4. ENHANCEMENT OF COVID-19 DATA COLLECTION TO ADDRESS DEMOGRAPHIC 
              DATA GAPS AND SOCIAL DETERMINANTS OF HEALTH.

    (a) Data Collection To Address Demographic Data Gaps.--
            (1) In general.--The Secretary shall require laboratories 
        that are subject to the reporting requirements under section 
        18115(a) of the Coronavirus Aid, Relief, and Economic Security 
        Act (Public Law 116-136), to include with reports made under 
        such section 18115(a) information to enhance such existing 
        COVID-19 data collection activities and to advance policies to 
        address social determinants of health, including additional 
        identifiers, such as those identified by the Commissioner, 
        including building on guidance existing on the date of 
        enactment of this Act, for the collection of race and ethnicity 
        data in clinical trials, as determined appropriate by the 
        Secretary.
            (2) Additional use of data.--The data collected under 
        paragraph (1) may be used to inform--
                    (A) clinical trial recruitment;
                    (B) resource allocations;
                    (C) treatment strategies; and
                    (D) other public health activities.
            (3) Collection via grants or contracts.--
                    (A) In general.--The Secretary may issue grants to, 
                and enter into contracts with, States, local public 
                health departments, or other entities supplying data to 
                the Secretary as required under this subsection, to 
                support the activities under this subsection.
                    (B) Guidance for use of funds.--In issuing grants 
                or contracts under subparagraph (A), the Secretary may 
                issue guidance regarding best practices for collecting 
                data pursuant to paragraph (1) and track the 
                performance of entities receiving grants or contracts.
            (4) Use and disclosure for public health activities.--The 
        submission and use of data collected pursuant to this 
        subsection shall be considered a permitted disclosure and use 
        for public health activities as set forth in section 
        164.512(b)(1)(i) of 45, Code of Federal Regulations (or any 
        successor regulations).
    (b) Data Collection Regarding Enhanced Risk for COVID-19.--The 
Secretary shall--
            (1) conduct a study on best practices for laboratories that 
        are subject to the reporting requirements under section 
        18115(a) of the Coronavirus Aid, Relief, and Economic Security 
        Act (Public Law 116-136) to aid such laboratories in collecting 
        data elements related to enhanced risk for COVID-19, such as 
        data, with respect to a patient, regarding income, education, 
        employment, disability, community resources, and social 
        support;
            (2) consider which governmental entities (including 
        Federal, State, and local governmental entities) would be best 
        suited to aiding in collecting such data elements in 
        coordination with such laboratories; and
            (3) issue guidance on such best practices.

SEC. 5. CLARIFICATION THAT CERTAIN REMUNERATION RELATED TO 
              PARTICIPATION IN CLINICAL TRIALS DOES NOT CONSTITUTE 
              REMUNERATION UNDER THE FEDERAL CIVIL MONEY PENALTIES LAW.

    (a) In General.--Section 1128A(i)(6)(F) of the Social Security Act 
(42 U.S.C. 1320a-7a(i)(6)(F)) is amended by inserting ``(including 
remuneration offered or transferred to an individual to promote the 
participation in an approved clinical trial, as defined in subsection 
(d) of the first section 2709 of the Public Health Service Act, that is 
registered with the database of clinical trials maintained by the 
National Library of Medicine (or any successor database), so long as 
such remuneration facilitates equitable inclusion of patients from all 
relevant demographic and socioeconomic populations and is related to 
patient participation in the approved clinical trial)'' after 
``promotes access to care''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to remuneration provided on or after the date of the enactment of 
this Act.

SEC. 6. NATIONAL ACADEMY OF MEDICINE STUDY.

    (a) In General.--The Secretary shall enter into an arrangement with 
the National Academy of Medicine under which the National Academy 
agrees to study and propose a design for a national interoperable data 
platform to improve access to health data, and other relevant data 
needs, during public health emergencies.
    (b) Report.--The arrangement under subsection (a) shall provide for 
submission by the National Academy of Medicine to the Secretary and 
Congress, not later than 120 days after the date of enactment of this 
Act, of a report on the results of the study under subsection (a) and 
the design proposed based on such study.
                                 <all>