I 
117TH CONGRESS 
1ST SESSION H. R. 5030 
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 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 provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To improve diversity in clinical trials and data collection 
for COVID–19 and future public health threats to ad-
dress social determinants of health. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Diversifying Investiga-
tions Via Equitable Research Studies for Everyone Trials 
Act’’ or the ‘‘DIVERSE Trials Act’’. 
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SEC. 2. GUIDANCE ON DECENTRALIZED CLINICAL TRIALS. 
(a) DEFINITIONS.—In this section, the term ‘‘decen-
tralized clinical trials’’ includes clinical trials that are exe-
cuted through a broad spectrum of options, such as tele-
medicine 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 set-
ting. 
(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 ‘‘Sec-
retary’’), 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shall issue a draft guidance that addresses how to conduct 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 geo-
graphic 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the draft guidance ends, the Secretary shall issue a final 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: 
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(1) Strategies to engage with prospective clin-
ical trial participants and community partners, such 
as patient advocacy groups with diverse representa-
tion, to incorporate input of such patients and part-
ners 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 organi-
zation 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 techno-
logical platforms and mediums, data collection and 
use, data integrity, and communication to study par-
ticipants through digital technology. 
(4) Recommendations for appropriate methods 
of patient recruitment and retention, including insti-
tutional review board oversight, patient communica-
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tion, and the role of study participants and commu-
nity partners as advocates to facilitate clinical trial 
recruitment, particularly with respect to underrep-
resented populations. 
(5) Information regarding when and how a 
study sponsor may solicit a meeting with the Sec-
retary regarding the issues described in paragraphs 
(1) through (4). 
(d) 
INTERNATIONAL
HARMONIZATION.—After 
issuing the final guidance under subsection (b), the Sec-
retary, acting through the Commissioner, may work with 
foreign regulators pursuant to existing memoranda of un-
derstanding governing exchange of information to facili-
tate international harmonization of the regulation of de-
centralized clinical trials and use of digital health tech-
nology or other remote assessment options. 
SEC. 3. ENCOURAGEMENT OF CLINICAL TRIAL ENROLL-
MENT BY RACIALLY AND ETHNICALLY DI-
VERSE POPULATIONS. 
(a) NO COST PROVISION OF DIGITAL HEALTH TECH-
NOLOGIES.—The free provision of digital health tech-
nologies by drug or device manufacturers to their clinical 
trial participants shall not be considered a violation of sec-
tion 1128A of the Social Security Act (commonly known 
as the ‘‘Civil Monetary Penalties Law’’) (42 U.S.C. 
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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 fa-
cilitate in any phase of clinical development the in-
clusion 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 dis-
abled or only allowed to remain activated to model 
real-world usage of the digital technology; and 
(4) the clinical trial sponsor requires partici-
pants 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 recruit-
ment activities for clinical trials with respect to 
drugs, including vaccines for diseases or conditions 
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which have a disproportionate impact on underrep-
resented populations (including on racial and ethnic 
minority populations), including for the diagnosis, 
prevention, or treatment of COVID–19. Such activi-
ties may include— 
(A) working with community clinical trial 
sites, including community health centers, aca-
demic health centers, and other facilities; 
(B) training health care personnel includ-
ing potential clinical trial investigators, with a 
focus on significantly increasing the number of 
underrepresented racial and ethnic minority 
healthcare personnel who are clinical trial inves-
tigators at the community sites for ongoing 
clinical trials; 
(C) engaging community stakeholders to 
encourage participation in clinical trials, espe-
cially in underrepresented racial and ethnic mi-
nority communities; and 
(D) fostering partnerships with commu-
nity-based 
organizations 
serving 
underrep-
resented racial and ethnical minority popu-
lations, including employee unions and frontline 
health care workers. 
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(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 clin-
ical 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 nec-
essary to carry out this subsection. 
SEC. 4. ENHANCEMENT OF COVID–19 DATA COLLECTION TO 
ADDRESS DEMOGRAPHIC DATA GAPS AND SO-
CIAL 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 re-
quirements 
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 
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