II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Diversifying Investiga5 tions Via Equitable Research Studies for Everyone Trials 

6 Act’’ or the ‘‘DIVERSE Trials Act’’. 

7 SEC. 2. GUIDANCE ON DECENTRALIZED CLINICAL TRIALS. 

8 (a) DEFINITIONS.—In this section, the term ‘‘decen9 tralized clinical trials’’ includes clinical trials that are exeVerDate Sep 11 2014 19:33 Aug 12, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2706.IS S2706

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1 cuted through a broad spectrum of options, such as tele2 medicine or other mobile or digital technologies, to allow 

3 for the remote collection and assessment of clinical trial 

4 data from participants, including in the home or office set5 ting. 

6 (b) GUIDANCE.—Not later than 6 months after the 

7 date of enactment of this Act, the Secretary of Health and 

8 Human Services (referred to in this Act as the ‘‘Sec9 retary’’), acting through the Commissioner of Food and 

10 Drugs (referred to in this Act as the ‘‘Commissioner’’), 

11 shall issue a draft guidance that addresses how to conduct 

12 decentralized clinical trials with meaningful demographic 

13 diversity, including racial, ethnic, age, gender, and geo14 graphic diversity in patient engagement, enrollment, and 

15 participation, including how to appropriately use digital 

16 health technologies or other remote assessment options, 

17 such as telemedicine, to support such trials. Not later than 

18 6 months after the date the public comment period for 

19 the draft guidance ends, the Secretary shall issue a final 

20 guidance. 

21 (c) CONTENT OF GUIDANCE.—The guidance under 

22 subsection (b) shall address the following: 

23 (1) Strategies to engage with prospective clin24 ical trial participants and community partners, such 

25 as patient advocacy groups with diverse representaVerDate Sep 11 2014 19:33 Aug 12, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2706.IS S2706

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1 tion, to incorporate input of such patients and part2 ners into the design of decentralized clinical trials. 

3 (2) Recommendations for— 

4 (A) protocol design approaches; 

5 (B) appropriate clinical endpoints; 

6 (C) institutional review board composition 

7 and ensuring that such boards include members 

8 with expertise in decentralized clinical trials; 

9 (D) delegation of clinical research organi10 zation responsibilities and suitable proxies for 

11 clinical research organizations; and 

12 (E) simplifying informed consent. 

13 (3) Recommendations for how digital health 

14 technology or other remote assessment options, such 

15 as telemedicine, could support decentralized clinical 

16 trials, including guidance on appropriate techno17 logical platforms and mediums, data collection and 

18 use, data integrity, and communication to study par19 ticipants through digital technology. 

20 (4) Recommendations for appropriate methods 

21 of patient recruitment and retention, including insti22 tutional review board oversight, patient communica23 tion, and the role of study participants and commu24 nity partners as advocates to facilitate clinical trial 


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1 recruitment, particularly with respect to underrep2 resented populations. 

3 (5) Information regarding when and how a 

4 study sponsor may solicit a meeting with the Sec5 retary regarding the issues described in paragraphs 

6 (1) through (4). 

7 (d) INTERNATIONAL HARMONIZATION.—After 

8 issuing the final guidance under subsection (b), the Sec9 retary, acting through the Commissioner, may work with 

10 foreign regulators pursuant to existing memoranda of un11 derstanding governing exchange of information to facili12 tate international harmonization of the regulation of de13 centralized clinical trials and use of digital health tech14 nology or other remote assessment options. 

15 SEC. 3. ENCOURAGEMENT OF CLINICAL TRIAL ENROLL16 MENT BY RACIALLY AND ETHNICALLY DI17 VERSE POPULATIONS. 

18 (a) NO COST PROVISION OF DIGITAL HEALTH TECH19 NOLOGIES.—The free provision of digital health tech20 nologies by drug or device manufacturers to their clinical 

21 trial participants shall not be considered a violation of sec22 tion 1128A of the Social Security Act (commonly known 

23 as the ‘‘Civil Monetary Penalties Law’’) (42 U.S.C. 

24 1320a–7a), section 1128B of the Social Security Act (42 

25 U.S.C. 1320a–7b), or sections 3729 through 3733 of title 


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1 31, United States Code, (commonly known as the ‘‘False 

2 Claims Act’’), provided that— 

3 (1) the use of digital health technologies will fa4 cilitate in any phase of clinical development the in5 clusion of diversity of patient populations, such as 

6 underrepresented racial and ethnic minorities, low7 income populations, and the elderly; 

8 (2) the digital health technologies will facilitate 

9 individuals participation, or are necessary to such 

10 participation; 

11 (3) all features of the digital health technologies 

12 that are unrelated to use in the clinical trial are dis13 abled or only allowed to remain activated to model 

14 real-world usage of the digital technology; and 

15 (4) the clinical trial sponsor requires partici16 pants to return, purchase, or disable the digital 

17 health technologies by the conclusion of the trial. 

18 (b) GRANTS AND CONTRACTS.— 

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

20 grants to and enter into contracts with entities to 

21 support community education, outreach, and recruit22 ment activities for clinical trials with respect to 

23 drugs, including vaccines for diseases or conditions 

24 which have a disproportionate impact on underrep25 resented populations (including on racial and ethnic 


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1 minority populations), including for the diagnosis, 

2 prevention, or treatment of COVID–19. Such activi3 ties may include— 

4 (A) working with community clinical trial 

5 sites, including community health centers, aca6 demic health centers, and other facilities; 

7 (B) training health care personnel includ8 ing potential clinical trial investigators, with a 

9 focus on significantly increasing the number of 

10 underrepresented racial and ethnic minority 

11 healthcare personnel who are clinical trial inves12 tigators at the community sites for ongoing 

13 clinical trials; 

14 (C) engaging community stakeholders to 

15 encourage participation in clinical trials, espe16 cially in underrepresented racial and ethnic mi17 nority communities; and 

18 (D) fostering partnerships with commu19 nity-based organizations serving underrep20 resented racial and ethnical minority popu21 lations, including employee unions and frontline 

22 health care workers. 

23 (2) PRIORITY FOR GRANT AND CONTRACT

24 AWARDS.—In awarding grants and contracts under 


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1 this subsection, the Secretary shall prioritize entities 

2 that— 

3 (A) develop educational, recruitment, and 

4 training materials in multiple languages; or 

5 (B) undertake clinical trial outreach efforts 

6 in more diverse racial and ethnic communities 

7 that are traditionally underrepresented in clin8 ical trials, such as tribal areas. 

9 (3) AUTHORIZATION OF APPROPRIATIONS.— 

10 There is authorized to be appropriated for fiscal 

11 years 2020 and 2021 such sums as may be nec12 essary to carry out this subsection. 

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

14 ADDRESS DEMOGRAPHIC DATA GAPS AND SO15 CIAL DETERMINANTS OF HEALTH. 

16 (a) DATA COLLECTION TO ADDRESS DEMOGRAPHIC

17 DATA GAPS.— 

18 (1) IN GENERAL.—The Secretary shall require 

19 laboratories that are subject to the reporting re20 quirements under section 18115(a) of the 

21 Coronavirus Aid, Relief, and Economic Security Act 

22 (Public Law 116–136), to include with reports made 

23 under such section 18115(a) information to enhance 

24 such existing COVID–19 data collection activities 

25 and to advance policies to address social deterVerDate Sep 11 2014 19:33 Aug 12, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2706.IS S2706

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1 minants of health, including additional identifiers, 

2 such as those identified by the Commissioner, in3 cluding building on guidance existing on the date of 

4 enactment of this Act, for the collection of race and 

5 ethnicity data in clinical trials, as determined appro6 priate by the Secretary. 

7 (2) ADDITIONAL USE OF DATA.—The data col8 lected under paragraph (1) may be used to inform— 

9 (A) clinical trial recruitment; 

10 (B) resource allocations; 

11 (C) treatment strategies; and 

12 (D) other public health activities. 

13 (3) COLLECTION VIA GRANTS OR CONTRACTS.— 

14 (A) IN GENERAL.—The Secretary may 

15 issue grants to, and enter into contracts with, 

16 States, local public health departments, or other 

17 entities supplying data to the Secretary as re18 quired under this subsection, to support the ac19 tivities under this subsection. 

20 (B) GUIDANCE FOR USE OF FUNDS.—In 

21 issuing grants or contracts under subparagraph 

22 (A), the Secretary may issue guidance regard23 ing best practices for collecting data pursuant 

24 to paragraph (1) and track the performance of 

25 entities receiving grants or contracts. 


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1 (4) USE AND DISCLOSURE FOR PUBLIC HEALTH

2 ACTIVITIES.—The submission and use of data col3 lected pursuant to this subsection shall be consid4 ered a permitted disclosure and use for public health 

5 activities as set forth in section 164.512(b)(1)(i) of 

6 45, Code of Federal Regulations (or any successor 

7 regulations). 

8 (b) DATA COLLECTION REGARDING ENHANCED RISK

9 FOR COVID–19.—The Secretary shall— 

10 (1) conduct a study on best practices for lab11 oratories that are subject to the reporting require12 ments under section 18115(a) of the Coronavirus 

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

14 116–136) to aid such laboratories in collecting data 

15 elements related to enhanced risk for COVID–19, 

16 such as data, with respect to a patient, regarding in17 come, education, employment, disability, community 

18 resources, and social support; 

19 (2) consider which governmental entities (in20 cluding Federal, State, and local governmental enti21 ties) would be best suited to aiding in collecting such 

22 data elements in coordination with such laboratories; 

23 and 

24 (3) issue guidance on such best practices. 


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1 SEC. 5. CLARIFICATION THAT CERTAIN REMUNERATION 

2 RELATED TO PARTICIPATION IN CLINICAL 

3 TRIALS DOES NOT CONSTITUTE REMUNERA4 TION UNDER THE FEDERAL CIVIL MONEY 

5 PENALTIES LAW. 

6 (a) IN GENERAL.—Section 1128A(i)(6)(F) of the So7 cial Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amend8 ed by inserting ‘‘(including remuneration offered or trans9 ferred to an individual to promote the participation in an 

10 approved clinical trial, as defined in subsection (d) of the 

11 first section 2709 of the Public Health Service Act, that 

12 is registered with the database of clinical trials maintained 

13 by the National Library of Medicine (or any successor 

14 database), so long as such remuneration facilitates equi15 table inclusion of patients from all relevant demographic 

16 and socioeconomic populations and is related to patient 

17 participation in the approved clinical trial)’’ after ‘‘pro18 motes access to care’’. 

19 (b) EFFECTIVE DATE.—The amendment made by 

20 subsection (a) shall apply to remuneration provided on or 

21 after the date of the enactment of this Act. 

22 SEC. 6. NATIONAL ACADEMY OF MEDICINE STUDY. 

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

24 arrangement with the National Academy of Medicine 

25 under which the National Academy agrees to study and 

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1 form to improve access to health data, and other relevant 

2 data needs, during public health emergencies. 

3 (b) REPORT.—The arrangement under subsection (a) 

4 shall provide for submission by the National Academy of 

5 Medicine to the Secretary and Congress, not later than 

6 120 days after the date of enactment of this Act, of a 

7 report on the results of the study under subsection (a) 

8 and the design proposed based on such study. 

Æ 


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