II 

117TH CONGRESS 

2D SESSION S. 5268 

To direct the Secretary of Health and Human Services, acting through 

the Director of the National Institutes of Health, to take certain steps 

to increase clinical trial diversity, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 15, 2022 

Mr. MENENDEZ (for himself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To direct the Secretary of Health and Human Services, 

acting through the Director of the National Institutes 

of Health, to take certain steps to increase clinical trial 

diversity, and for other purposes. 

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 ‘‘NIH Clinical Trial Di5 versity Act of 2022’’. 


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1 SEC. 2. DIVERSITY GOALS FOR NIH FUNDED CLINICAL 

2 TRIALS. 

3 (a) APPLICATIONS.—Beginning on the date of the en4 actment of this Act, the Secretary of Health and Human 

5 Services, acting through the Director of the National In6 stitutes of Health (in this section referred to as the ‘‘Sec7 retary’’), shall require that a NIH-funded research organi8 zation or entity seeking to conduct a clinical trial inves9 tigating a drug or device (as those terms are defined in 

10 section 201 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 321 et seq.)) or biological product (as defined 

12 in section 351(i) of the Public Health Service Act (42 

13 U.S.C. 262(i))) that is funded by the National Institutes 

14 of Health, submit an application (or renewal thereof) for 

15 such funding that includes— 

16 (1) clear and measurable goals for the recruit17 ment and retention of participants that reflect— 

18 (A) the race, ethnicity, age, and sex of pa19 tients with the disease or condition being inves20 tigated; or 

21 (B) as scientifically or ethically justified 

22 and appropriate, the race, ethnicity, age, and 

23 sex of the general population of the United 

24 States if the prevalence of the disease or condi25 tion is not known; 


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1 (2) a rationale for the goals specified under 

2 paragraph (1) that specifies— 

3 (A) how investigators will determine the 

4 number of participants for each population cat5 egory that reflect the population groups speci6 fied in paragraph (1); or 

7 (B) strategies that will be used to enroll 

8 and retain participants across the different 

9 race, ethnicity, age, and sex categories; 

10 (3) a detailed plan for how the clinical trial will 

11 achieve the goals specified under paragraph (1) that 

12 specifies— 

13 (A) the requirements for researchers, in 

14 conducting the trial, to analyze the population 

15 groups specified in paragraph (1) separately; 

16 and 

17 (B) how the trial will recruit a study popu18 lation that is— 

19 (i) scientifically and ethically appro20 priate in terms of the scientific objectives 

21 and proposed study design; and 

22 (ii) in sufficient numbers to obtain 

23 clinically and statistically meaningful de24 terminations of the safety and effectiveness 

25 of the drug or device being studied in the 


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1 respective race, ethnicity, age, and sex 

2 groups; and 

3 (4) the NIH-funded research organization or 

4 entity’s plan for implementing, or an explanation of 

5 why the NIH-funded research organization or entity 

6 cannot implement, alternative clinical trial follow-up 

7 requirements that are less burdensome for trial par8 ticipants, such as— 

9 (A) requiring fewer follow-up visits; 

10 (B) allowing phone follow-up or home vis11 its by appropriately qualified staff (in lieu of in12 person visits by patients); 

13 (C) allowing for online follow-up options; 

14 (D) permitting the patient’s primary care 

15 provider to perform some of the follow-up visit 

16 requirements; 

17 (E) allowing for evening and weekend 

18 hours for required follow-up visits; 

19 (F) allowing virtual or telemedicine visits; 

20 (G) use of wearable technology to record 

21 key health parameters; and 

22 (H) use of alternate labs or imaging cen23 ters, which may be closer to the residence of the 

24 patients participating in the trial. 

25 (b) TERMS.— 


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1 (1) IN GENERAL.—As a condition on the receipt 

2 of funding through the National Institutes of 

3 Health, as described in subsection (a), with respect 

4 to a clinical trial, the NIH-funded research organiza5 tion or entity of the clinical trial shall agree to terms 

6 requiring that— 

7 (A) the aggregate demographic information 

8 of trial participants be shared on an annual 

9 basis with the Secretary while participant re10 cruitment and data collection in such trial is 

11 ongoing, and that such information is provided 

12 with respect to— 

13 (i) underrepresented populations, in14 cluding populations grouped by race, eth15 nicity, age, and sex; and 

16 (ii) such populations that reflect the 

17 prevalence of the disease or condition that 

18 is the subject of the clinical trial involved 

19 (as available and as appropriate to the sci20 entific objective for the study, as deter21 mined by the Director of the National In22 stitutes of Health); 

23 (B) the NIH-funded research organization 

24 or entity submits to the program officer and 

25 grants management specialist of the specific inVerDate Sep 11 2014 20:57 Dec 28, 2022 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S5268.IS S5268

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1 stitute, center, or office of the National Insti2 tutes of Health, annually or as frequently as 

3 such officer or specialist determines necessary, 

4 the retention rate of participants in the clinical 

5 trial, disaggregated by race, ethnicity, age, and 

6 sex; 

7 (C) the clinical trial researchers complete 

8 education and training programs on diversity in 

9 clinical trials; and 

10 (D) at the conclusion of the trial, the spon11 sor submits to the Secretary the number of par12 ticipants in the trial, disaggregated by race, 

13 ethnicity, age, and sex. 

14 (2) PRIVACY PROTECTIONS.—Any data shared 

15 under paragraph (1) may not include any individ16 ually identifiable information or protected health in17 formation with respect to clinical trial participants 

18 and shall only be disclosed to the extent allowed 

19 under Federal privacy laws and by National Insti20 tutes of Health policy. 

21 (c) EXCEPTION.—In lieu of submitting an application 

22 under subsection (a) and documentation of goals as re23 quired by paragraph (1) of such subsection, an applicant 

24 may provide reasoning for why the recruitment of each 

25 of the population groups specified in paragraph (1) of subVerDate Sep 11 2014 20:57 Dec 28, 2022 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S5268.IS S5268

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1 section (a) is not necessary and why such recruitment is 

2 not scientifically justified or possible. 

3 SEC. 3. ELIMINATING COST BARRIERS. 

4 Not later than 2 years after the date of the enact5 ment of this Act, the Secretary of Health and Human 

6 Services, acting through the Director of the National In7 stitutes of Health, shall conduct and complete a study 

8 on— 

9 (1) the need for review of human subject regu10 lations specified in part 46 of title 45, Code of Fed11 eral Regulations (or successor regulations), and re12 lated guidance; 

13 (2) the modernization of such regulations and 

14 guidance to establish updated guidelines for reim15 bursement of out-of-pocket expenses of human sub16 jects, compensation of human subjects for time 

17 spent participating in the clinical trial, and incen18 tives for recruitment of human subjects; and 

19 (3) the need for updated safe harbor rules 

20 under section 1001.952 of title 42, Code of Federal 

21 Regulations (or successor regulations), and section 

22 1128B of the Social Security Act (commonly re23 ferred to as the ‘‘Federal Anti-Kickback Statute’’ 

24 (42 U.S.C. 1320a–7b)) with respect to the assist25 ance provided under this section. 


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1 SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 

2 (a) NATIONAL CAMPAIGN.—The Secretary of Health 

3 and Human Services (referred to in this section as the 

4 ‘‘Secretary’’), in consultation with the stakeholders speci5 fied in subsection (e), shall carry out a national campaign 

6 to increase the awareness and knowledge of individuals in 

7 the United States, including health care professionals, pa8 tients, and others, with respect to the need for diverse clin9 ical trials among the demographic groups identified pursu10 ant to section 2(a)(1). 

11 (b) REQUIREMENTS.—The national campaign con12 ducted under this section shall include— 

13 (1)(A) the development and distribution of writ14 ten educational materials; 

15 (B) the development and placing of public serv16 ice announcements that are intended to encourage 

17 individuals who are members of the demographic 

18 groups identified pursuant to section 2(b)(1)(A)(i) 

19 to seek to participate in clinical trials; and 

20 (C) the development of curricula for health care 

21 professionals on— 

22 (i) how to participate in clinical trials as 

23 an investigator; and 

24 (ii) how such professionals can enroll pa25 tients in trials; 


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1 (2) such efforts as are reasonable and necessary 

2 to ensure meaningful access by consumers with lim3 ited English proficiency; and 

4 (3) the development and distribution of best 

5 practices and training for recruiting underrep6 resented study populations, including a method for 

7 sharing such best practices among clinical trial spon8 sors, providers, community-based organizations who 

9 assist with recruitment, and with the public. 

10 (c) HEALTH DISPARITIES.—In developing the na11 tional campaign under subsection (a), the Secretary shall 

12 recognize and address— 

13 (1) health disparities among individuals who 

14 are members of the population groups specified in 

15 section 2(b)(1)(A) with respect to access to care and 

16 participation in clinical trials; and 

17 (2) any barriers in access to care and participa18 tion in clinical trials that are specific to individuals 

19 who are members of such groups. 

20 (d) GRANTS.—The Secretary shall establish a pro21 gram to award grants to nonprofit private entities (includ22 ing community-based organizations and faith commu23 nities, institutions of higher education eligible to receive 

24 funds under section 371 of the Higher Education Act of 

25 1965 (20 U.S.C. 1067q), national organizations that serve 


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1 underrepresented populations, and community phar2 macies) to enable such entities— 

3 (1) to test alternative outreach and education 

4 strategies to increase the awareness and knowledge 

5 of individuals in the United States, with respect to 

6 the need for diverse clinical trials that reflect the 

7 race, ethnicity, age, and sex of patients with the dis8 ease or condition being investigated; and 

9 (2) to cover administrative costs of such entities 

10 in assisting in diversifying clinical trials subject to 

11 section 2. 

12 (e) STAKEHOLDERS SPECIFIED.—The stakeholders 

13 specified in this subsection are the following: 

14 (1) Representatives of the Food and Drug Ad15 ministration, the Health Resources and Services Ad16 ministration, the Office on Minority Health of the 

17 Department of Health and Human Services, the 

18 Centers for Disease Control and Prevention, and the 

19 National Institutes of Health. 

20 (2) Community-based resources and advocates. 

21 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

22 authorized to be appropriated to carry out this section 

23 $10,000,000 for each of fiscal years 2023 through 2026. 


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1 SEC. 5. DEFINITION. 

2 In this Act, the term ‘‘clinical trial’’ means a research 

3 study in which one or more human subjects are prospec4 tively assigned to one or more interventions (which may 

5 include placebo or other control) to evaluate the effects 

6 of those interventions on health-related biomedical or be7 havioral outcomes. 

Æ 


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