I

117TH CONGRESS
1ST SESSION

H. R. 5030

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

IN THE HOUSE OF REPRESENTATIVES
AUGUST 13, 2021
Mr. RUIZ (for himself and Mr. BUCSHON) introduced the following bill; which
was referred 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

A BILLTo improve diversity in clinical trials and data collection
for COVID–19 and future public health threats to address social determinants of health.
1Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,
3

SECTION 1. SHORT TITLE.

4This Act may be cited as the ‘‘Diversifying Investiga-

5 tions Via Equitable Research Studies for Everyone Trials
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6 Act’’ or the ‘‘DIVERSE Trials Act’’.

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21SEC. 2. GUIDANCE ON DECENTRALIZED CLINICAL TRIALS.

2(a) DEFINITIONS.—In this section, the term ‘‘decen-3 tralized clinical trials’’ includes clinical trials that are exe4 cuted through a broad spectrum of options, such as tele5 medicine or other mobile or digital technologies, to allow
6 for the remote collection and assessment of clinical trial
7 data from participants, including in the home or office set8 ting.
9(b) GUIDANCE.—Not later than 6 months after the10 date of enactment of this Act, the Secretary of Health and
11 Human Services (referred to in this Act as the ‘‘Sec12 retary’’), acting through the Commissioner of Food and
13 Drugs (referred to in this Act as the ‘‘Commissioner’’),14 shall issue a draft guidance that addresses how to conduct
15 decentralized clinical trials with meaningful demographic
16 diversity, including racial, ethnic, age, gender, and geo17 graphic diversity in patient engagement, enrollment, and18 participation, including how to appropriately use digital
19 health technologies or other remote assessment options,
20 such as telemedicine, to support such trials. Not later than
21 6 months after the date the public comment period for
22 the draft guidance ends, the Secretary shall issue a final

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23 guidance.
24(c) CONTENT OF GUIDANCE.—The guidance under

25 subsection (b) shall address the following:•HR 5030 IH
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(1) Strategies to engage with prospective clin-2ical trial participants and community partners, such3

as patient advocacy groups with diverse representa-

4tion, to incorporate input of such patients and part-

5ners into the design of decentralized clinical trials.

6(2) Recommendations for—7(A) protocol design approaches;

8(B) appropriate clinical endpoints;

9(C) institutional review board composition

10and ensuring that such boards include members

11with expertise in decentralized clinical trials;

12(D) delegation of clinical research organi-

13zation responsibilities and suitable proxies for14

clinical research organizations; andkjohnson on DSK79L0C42PROD with BILLS

15(E) simplifying informed consent.

16(3) Recommendations for how digital health17

technology or other remote assessment options, such18

as telemedicine, could support decentralized clinical

19

trials, including guidance on appropriate techno-

20

logical platforms and mediums, data collection and21use, data integrity, and communication to study par-22

ticipants through digital technology.

23(4) Recommendations for appropriate methods

24of patient recruitment and retention, including insti-25

tutional review board oversight, patient communica-•HR 5030 IH
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4
1tion, and the role of study participants and commu-

2nity partners as advocates to facilitate clinical trial

3

recruitment, particularly with respect to underrep-

4

resented populations.

5(5) Information regarding when and how a6

study sponsor may solicit a meeting with the Sec-7

retary regarding the issues described in paragraphs8(1) through (4).

9(d)

INTERNATIONAL

HARMONIZATION.—After

10 issuing the final guidance under subsection (b), the Sec11 retary, acting through the Commissioner, may work with
12 foreign regulators pursuant to existing memoranda of un13 derstanding governing exchange of information to facili14 tate international harmonization of the regulation of de15 centralized clinical trials and use of digital health tech16 nology or other remote assessment options.
17SEC. 3. ENCOURAGEMENT OF CLINICAL TRIAL ENROLL-

18MENT BY RACIALLY AND ETHNICALLY DI-

19VERSE POPULATIONS.

2021(a) NO COST PROVISION OF DIGITAL HEALTH TECHNOLOGIES.—Thefree provision of digital health tech-

22 nologies by drug or device manufacturers to their clinicalkjohnson on DSK79L0C42PROD with BILLS

23 trial participants shall not be considered a violation of sec24 tion 1128A of the Social Security Act (commonly known
25 as the ‘‘Civil Monetary Penalties Law’’) (42 U.S.C.
•HR 5030 IH
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51 1320a–7a), section 1128B of the Social Security Act (422 U.S.C. 1320a–7b), or sections 3729 through 3733 of title
3 31, United States Code, (commonly known as the ‘‘False

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4 Claims Act’’), provided that—
5(1) the use of digital health technologies will fa-6cilitate in any phase of clinical development the in-7clusion of diversity of patient populations, such as

8underrepresented racial and ethnic minorities, low-9income populations, and the elderly;

10(2) the digital health technologies will facilitate

11individuals participation, or are necessary to such

12participation;13(3) all features of the digital health technologies

14

that are unrelated to use in the clinical trial are dis-15

abled or only allowed to remain activated to model

16

real-world usage of the digital technology; and17(4) the clinical trial sponsor requires partici-

18

pants to return, purchase, or disable the digital

19

health technologies by the conclusion of the trial.

20(b) GRANTS AND CONTRACTS.—

21(1) IN GENERAL.—The Secretary may issue

22grants to and enter into contracts with entities to23support community education, outreach, and recruit-

24

ment activities for clinical trials with respect to25drugs, including vaccines for diseases or conditions•HR 5030 IH
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61

which have a disproportionate impact on underrep-2

resented populations (including on racial and ethnic

3

minority populations), including for the diagnosis,

4

prevention, or treatment of COVID–19. Such activi-

5ties may include—

6(A) working with community clinical trial

7sites, including community health centers, aca-8

demic health centers, and other facilities;

9(B) training health care personnel includ-

10ing potential clinical trial investigators, with a11

focus on significantly increasing the number of

12

underrepresented racial and ethnic minority

13

healthcare personnel who are clinical trial inves-

14

tigators at the community sites for ongoing

15

clinical trials;

16(C) engaging community stakeholders to17

encourage participation in clinical trials, espe-

18

cially in underrepresented racial and ethnic mi-

19

nority communities; andkjohnson on DSK79L0C42PROD with BILLS20(D) fostering partnerships with commu-

21nity-based

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resented racial and ethnical minority popu-

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lations, including employee unions and frontline

24

health care workers.

organizations

serving•HR 5030 IH
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underrep-7
1(2) PRIORITY

FORGRANTAND

CONTRACT2

AWARDS.—In awarding grants and contracts under3

this subsection, the Secretary shall prioritize entities

4that—

5(A) develop educational, recruitment, and6

training materials in multiple languages; or7(B) undertake clinical trial outreach efforts

8in more diverse racial and ethnic communities

9that are traditionally underrepresented in clin-

10ical trials, such as tribal areas.

11(3) AUTHORIZATIONOFAPPROPRIATIONS.—

12

There is authorized to be appropriated for fiscal

13years 2020 and 2021 such sums as may be nec-

14

essary to carry out this subsection.

15SEC. 4. ENHANCEMENT OF COVID–19 DATA COLLECTION TO

16ADDRESS DEMOGRAPHIC DATA GAPS AND SO-

17

CIAL DETERMINANTS OF HEALTH.

18(a) DATA COLLECTION TO ADDRESS DEMOGRAPHIC

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19 DATA GAPS.—
20(1) IN GENERAL.—The Secretary shall require21

laboratories that are subject to the reporting re-22

quirements

23

Coronavirus Aid, Relief, and Economic Security Act

24(Public Law 116–136), to include with reports made25

under such section 18115(a) information to enhance

undersection

18115(a)•HR 5030 IH
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1such existing COVID–19 data collection activities

2and to advance policies to address social deter-3minants of health, including additional identifiers,

4such as those identified by the Commissioner, in-5cluding building on guidance existing on the date of

6enactment of this Act, for the collection of race and7ethnicity data in clinical trials, as determined appro-

8

priate by the Secretary.

9(2) ADDITIONAL USE OF DATA.—The data col-10lected under paragraph (1) may be used to inform—11(A) clinical trial recruitment;

12(B) resource allocations;13(C) treatment strategies; and14(D) other public health activities.

15(3) COLLECTION VIA GRANTS OR CONTRACTS.—

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16(A) INGENERAL.—The

Secretary may

17issue grants to, and enter into contracts with,

18

States, local public health departments, or other19

entities supplying data to the Secretary as re-20

quired under this subsection, to support the ac-

21

tivities under this subsection.

22(B) GUIDANCE FOR USE OF FUNDS.—In

23

issuing grants or contracts under subparagraph

24(A), the Secretary may issue guidance regard-25

ing best practices for collecting data pursuant•HR 5030 IH
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1to paragraph (1) and track the performance of2entities receiving grants or contracts.

3(4) USE AND DISCLOSURE FOR PUBLIC HEALTH

4ACTIVITIES.—The5

lected pursuant to this subsection shall be consid-6

ered a permitted disclosure and use for public health7activities as set forth in section 164.512(b)(1)(i) of845, Code of Federal Regulations (or any successor

9regulations).

10(b) DATA COLLECTION REGARDING ENHANCED RISKkjohnson on DSK79L0C42PROD with BILLS

11submission and use of data col-FOR COVID–19.—The Secretary shall—

12(1) conduct a study on best practices for lab-

13

oratories that are subject to the reporting require-

14

ments under section 18115(a) of the Coronavirus

15Aid, Relief, and Economic Security Act (Public Law

16116–136) to aid such laboratories in collecting data17elements related to enhanced risk for COVID–19,

18

such as data, with respect to a patient, regarding in-19

come, education, employment, disability, community

20

resources, and social support;

21(2) consider which governmental entities (in-22

cluding Federal, State, and local governmental enti-23ties) would be best suited to aiding in collecting such24

data elements in coordination with such laboratories;

25

and

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101(3) issue guidance on such best practices.

2SEC. 5. CLARIFICATION THAT CERTAIN REMUNERATION

3RELATED TO PARTICIPATION IN CLINICAL

4TRIALS DOES NOT CONSTITUTE REMUNERA-5TION UNDER THE FEDERAL CIVIL MONEY

6PENALTIES LAW.

7(a) IN GENERAL.—Section 1128A(i)(6)(F) of the So-

8 cial Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amend9 ed by inserting ‘‘(including remuneration offered or trans10 ferred to an individual to promote the participation in an
11 approved clinical trial, as defined in subsection (d) of the12 first section 2709 of the Public Health Service Act, that
13 is registered with the database of clinical trials maintained
14 by the National Library of Medicine (or any successor
15 database), so long as such remuneration facilitates equi16 table inclusion of patients from all relevant demographic
17 and socioeconomic populations and is related to patient
18 participation in the approved clinical trial)’’ after ‘‘pro19 motes access to care’’.
20(b) EFFECTIVE DATE.—The amendment made by

21 subsection (a) shall apply to remuneration provided on or
22 after the date of the enactment of this Act.

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23SEC. 6. NATIONAL ACADEMY OF MEDICINE STUDY.

24(a) IN GENERAL.—The Secretary shall enter into an

25 arrangement with the National Academy of Medicine•HR 5030 IH
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1 under which the National Academy agrees to study and2 propose a design for a national interoperable data plat3 form to improve access to health data, and other relevant
4 data needs, during public health emergencies.
5(b) REPORT.—The arrangement under subsection (a)6 shall provide for submission by the National Academy of
7 Medicine to the Secretary and Congress, not later than
8 120 days after the date of enactment of this Act, of a
9 report on the results of the study under subsection (a)10 and the design proposed based on such study.

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