NIH Clinical Trial Diversity Act of 2023

II 118TH CONGRESS 1ST SESSION S. 1701 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 MAY 18, 2023 Mr. MENENDEZ (for himself and Ms. COLLINS) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘NIH Clinical Trial Di- 4 versity Act of 2023’’. 5 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1701 IS SEC. 2. DIVERSITY GOALS FOR CLINICAL TRIALS FUNDED 1 BY THE NATIONAL INSTITUTES OF HEALTH. 2 (a) APPLICATIONS.—Beginning on the date of enact- 3 ment of this Act, the Secretary of Health and Human 4 Services, acting through the Director of the National In- 5 stitutes of Health (referred to in this section as the ‘‘Sec- 6 retary’’), shall require that a research organization or enti- 7 ty funded by the National Institutes of Health (referred 8 to in this section as an ‘‘NIH-funded research organiza- 9 tion or entity’’) seeking to conduct a clinical trial inves- 10 tigating a drug or device (as those terms are defined in 11 section 201 of the Federal Food, Drug, and Cosmetic Act 12 (21 U.S.C. 321)) or a biological product (as defined in 13 section 351(i) of the Public Health Service Act (42 U.S.C. 14 262(i))) that is funded by the National Institutes of 15 Health or a behavioral intervention, the protocol for which 16 is approved by the National Institutes of Health, submit 17 an application (or renewal thereof) for such funding or 18 approval that includes— 19 (1) clear and measurable goals for the recruit- 20 ment and retention of participants that reflect— 21 (A) the race, ethnicity, age, and sex of pa- 22 tients with the disease or condition being inves- 23 tigated; or 24 (B) as scientifically or ethically justified 25 and appropriate, the race, ethnicity, age, and 26 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1701 IS sex of the general population of the United 1 States if the prevalence of the disease or condi- 2 tion is not known; 3 (2) a rationale for the goals specified under 4 paragraph (1) that specifies— 5 (A) how investigators will determine the 6 number of participants for each population cat- 7 egory that reflect the population groups speci- 8 fied in paragraph (1); or 9 (B) strategies that will be used to enroll 10 and retain participants across the different 11 race, ethnicity, age, and sex categories; 12 (3) a detailed plan for how the clinical trial will 13 achieve the goals specified under paragraph (1) that 14 specifies— 15 (A) the requirements for researchers, in 16 conducting the trial, to analyze the population 17 groups specified in paragraph (1) separately; 18 and 19 (B) how the trial will recruit a study popu- 20 lation that is— 21 (i) scientifically and ethically appro- 22 priate in terms of the scientific objectives 23 and proposed study design; and 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1701 IS (ii) in sufficient numbers to obtain 1 clinically and statistically meaningful de- 2 terminations of the safety and effectiveness 3 of the drug, device, or behavioral interven- 4 tion being studied in the respective race, 5 ethnicity, age, and sex groups; and 6 (4) the NIH-funded research organization or 7 entity’s plan for implementing, or an explanation of 8 why the NIH-funded research organization or entity 9 cannot implement, alternative clinical trial follow-up 10 requirements that are less burdensome for trial par- 11 ticipants, such as— 12 (A) requiring fewer follow-up visits; 13 (B) allowing phone follow-up or home vis- 14 its by appropriately qualified staff (in lieu of in- 15 person visits by patients); 16 (C) allowing for online follow-up options; 17 (D) permitting the patient’s primary care 18 provider to perform some of the follow-up visit 19 requirements; 20 (E) allowing for evening and weekend 21 hours for required follow-up visits; 22 (F) allowing virtual or telemedicine visits; 23 (G) use of wearable technology to record 24 key health parameters; and 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1701 IS (H) use of alternate labs or imaging cen- 1 ters, which may be closer to the residence of the 2 patients participating in the trial. 3 (b) TERMS.— 4 (1) IN GENERAL.—As a condition on the receipt 5 of funding through the National Institutes of 6 Health, as described in subsection (a), with respect 7 to a clinical trial, the NIH-funded research organiza- 8 tion or entity of the clinical trial shall agree to terms 9 requiring that— 10 (A) the aggregate demographic information 11 of trial participants be shared on an annual 12 basis with the Secretary while participant re- 13 cruitment and data collection in such trial is 14 ongoing, and that such information is provided 15 with respect to— 16 (i) underrepresented populations, in- 17 cluding populations grouped by race, eth- 18 nicity, age, and sex; and 19 (ii) such populations that reflect the 20 prevalence of the disease or condition that 21 is the subject of the clinical trial involved 22 (as available and as appropriate to the sci- 23 entific objective for the study, as deter- 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1701 IS mined by the Director of the National In- 1 stitutes of Health); 2 (B) the NIH-funded research organization 3 or entity submits to the program officer and 4 grants management specialist of the specific in- 5 stitute, center, or office of the National Insti- 6 tutes of Health, annually or as frequently as 7 such officer or specialist determines necessary, 8 the retention rate of participants in the clinical 9 trial, disaggregated by race, ethnicity, age, and 10 sex; 11 (C) the clinical trial researchers complete 12 education and training programs on diversity in 13 clinical trials; and 14 (D) at the conclusion of the trial, the spon- 15 sor submits to the Secretary the number of par- 16 ticipants in the trial, disaggregated by race, 17 ethnicity, age, and sex. 18 (2) PRIVACY PROTECTIONS.—Any data shared 19 under paragraph (1) may not include any individ- 20 ually identifiable information or protected health in- 21 formation with respect to clinical trial participants 22 and shall only be disclosed to the extent allowed 23 under Federal privacy laws and by National Insti- 24 tutes of Health policy. 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1701 IS (c) EXCEPTION.—In lieu of submitting an application 1 under subsection (a) and documentation of goals as re- 2 quired by paragraph (1) of such subsection, an applicant 3 may provide reasoning for why the recruitment of each 4 of the population groups specified in paragraph (1) of sub- 5 section (a) is not necessary and why such recruitment is 6 not scientifically justified or possible. 7 SEC. 3. ELIMINATING COST BARRIERS. 8 Not later than 2 years after the date of enactment 9 of this Act, the Secretary of Health and Human Services, 10 acting through the Director of the National Institutes of 11 Health, shall conduct and complete a study on— 12 (1) the need for review of human subject regu- 13 lations specified in part 46 of title 45, Code of Fed- 14 eral Regulations (or successor regulations), and re- 15 lated guidance; 16 (2) the modernization of such regulations and 17 guidance to establish updated guidelines for reim- 18 bursement of out-of-pocket expenses of human sub- 19 jects, compensation of human subjects for time 20 spent participating in the clinical trial, and incen- 21 tives for recruitment of human subjects; and 22 (3) the need for updated safe harbor rules 23 under section 1001.952 of title 42, Code of Federal 24 Regulations (or successor regulations), and section 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 1701 IS 1128B of the Social Security Act (commonly re- 1 ferred to as the ‘‘Federal Anti-Kickback Statute’’ 2 (42 U.S.C. 1320a–7b)) with respect to the assist- 3 ance provided under this section. 4 SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 5 (a) NATIONAL CAMPAIGN.—The Secretary of Health 6 and Human Services (referred to in this section as the 7 ‘‘Secretary’’), in consultation with the stakeholders speci- 8 fied in subsection (e), shall carry out a national campaign 9 to increase the awareness and knowledge of individuals in 10 the United States, including health care professionals, pa- 11 tients, and others, with respect to the need for diverse clin- 12 ical trials among the demographic groups identified pursu- 13 ant to section 2(a)(1). 14 (b) REQUIREMENTS.—The national campaign con- 15 ducted under this section shall include— 16 (1)(A) the development and distribution of writ- 17 ten educational materials; 18 (B) the development and placing of public serv- 19 ice announcements that are intended to encourage 20 individuals who are members of the demographic 21 groups identified pursuant to section 2(b)(1)(A)(i) 22 to seek to participate in clinical trials; and 23 (C) the development of curricula for health care 24 professionals on— 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 1701 IS (i) how to participate in clinical trials as 1 an investigator; and 2 (ii) how such professionals can enroll pa- 3 tients in trials; 4 (2) such efforts as are reasonable and necessary 5 to ensure meaningful access by consumers with lim- 6 ited English proficiency; and 7 (3) the development and distribution of best 8 practices and training for recruiting underrep- 9 resented study populations, including a method for 10 sharing such best practices among clinical trial spon- 11 sors, providers, community-based organizations who 12 assist with recruitment, and with the public. 13 (c) HEALTH DISPARITIES.—In developing the na- 14 tional campaign under subsection (a), the Secretary shall 15 recognize and address— 16 (1) health disparities among individuals who 17 are members of the population groups specified in 18 section 2(b)(1)(A) with respect to access to care and 19 participation in clinical trials; and 20 (2) any barriers in access to care and participa- 21 tion in clinical trials that are specific to individuals 22 who are members of such groups. 23 (d) GRANTS.—The Secretary shall establish a pro- 24 gram to award grants to nonprofit private entities (includ- 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 1701 IS ing community-based organizations and faith commu- 1 nities, institutions of higher education eligible to receive 2 funds under section 371 of the Higher Education Act of 3 1965 (20 U.S.C. 1067q), national organizations that serve 4 underrepresented populations, and community phar- 5 macies) to enable such entities— 6 (1) to test alternative outreach and education 7 strategies to increase the awareness and knowledge 8 of individuals in the United States, with respect to 9 the need for diverse clinical trials that reflect the 10 race, ethnicity, age, and sex of patients with the dis- 11 ease or condition being investigated; and 12 (2) to cover administrative costs of such entities 13 in assisting in diversifying clinical trials subject to 14 section 2. 15 (e) STAKEHOLDERS SPECIFIED.—The stakeholders 16 specified in this subsection are the following: 17 (1) Representatives of the Food and Drug Ad- 18 ministration, the Health Resources and Services Ad- 19 ministration, the Office on Minority Health of the 20 Department of Health and Human Services, the 21 Centers for Disease Control and Prevention, and the 22 National Institutes of Health. 23 (2) Community-based resources and advocates. 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 1701 IS (f) AUTHORIZATION OF APPROPRIATIONS.—There is 1 authorized to be appropriated to carry out this section 2 $10,000,000 for each of fiscal years 2024 through 2027. 3 SEC. 5. DEFINITION. 4 In this Act, the term ‘‘clinical trial’’ means a research 5 study in which one or more human subjects are prospec- 6 tively assigned to one or more interventions (which may 7 include placebo or other control) to evaluate the effects 8 of those interventions on health-related biomedical or be- 9 havioral outcomes. 10 Æ VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\S1701.IS S1701 pbinns on DSKJLVW7X2PROD with $$_JOB