NIH Clinical Trial Diversity Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3503 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 HOUSE OF REPRESENTATIVES MAY 18, 2023 Ms. KELLY of Illinois (for herself and Mr. FITZPATRICK) introduced the following bill; which was referred to the Committee on Energy and Commerce 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 SEC. 2. DIVERSITY GOALS FOR CLINICAL TRIALS. 6 (a) APPLICATIONS.—Beginning on the date of the en- 7 actment of this Act, the Secretary of Health and Human 8 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3503 IH Services, acting through the Director of the National In- 1 stitutes of Health (in this section referred to as the ‘‘Sec- 2 retary’’), shall require that a sponsor seeking to conduct 3 a clinical trial investigating a drug, device (as those terms 4 are defined in section 201 of the Federal Food, Drug, and 5 Cosmetic Act (21 U.S.C. 321 et seq.)) biological product 6 (as defined in section 351(i) of the Public Health Service 7 Act (42 U.S.C. 262(i))), or behavioral intervention, the 8 protocol for which is approved by the National Institutes 9 of Health, to submit an application (or renewal thereof) 10 for such approval that includes— 11 (1) clear and measurable goals for the recruit- 12 ment and retention of participants that reflect— 13 (A) the race, ethnicity, age, and sex of pa- 14 tients with the disease or condition being inves- 15 tigated; or 16 (B) the race, ethnicity, age, and sex of the 17 general population of the United States if the 18 prevalence of the disease or condition is not 19 known; 20 (2) a rationale for the goals specified under 21 paragraph (1) that specifies— 22 (A) how investigators will calculate the 23 number of participants for each population cat- 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3503 IH egory that reflect the population groups speci- 1 fied in paragraph (1); or 2 (B) strategies that will be used to enroll 3 and retain participants across the different 4 race, ethnicity, age, and sex categories; 5 (3) a detailed plan for how the clinical trial will 6 achieve the goals specified under paragraph (1) that 7 specifies— 8 (A) the requirements for researchers, in 9 conducting the trial, to analyze the population 10 groups specified in paragraph (1) separately; 11 (B) the role of community partners or 12 community institutional review boards in re- 13 viewing the plans; and 14 (C) how the trial will recruit a study popu- 15 lation that is— 16 (i) in proportion to the prevalence of 17 the disease or condition in such groups rel- 18 ative to the prevalence of the disease or 19 condition in the overall population of the 20 United States; 21 (ii) in sufficient numbers to obtain 22 clinically and statistically meaningful de- 23 terminations of the safety and effectiveness 24 of the drug, device, biological product, or 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3503 IH behavioral intervention being studied in the 1 respective race, ethnicity, age, and sex 2 groups; and 3 (iii) consistent with the guidance 4 under section 505(b)(1) of the Federal 5 Food, Drug, and Cosmetic Act (21 U.S.C. 6 355(b)(1)) and guidance issued by the Na- 7 tional Institutes of Health on the inclusion 8 of women and minorities in clinical trials; 9 (4) the sponsor’s plan for implementing, or an 10 explanation of why the sponsor cannot implement, 11 alternative clinical trial follow-up requirements that 12 are less burdensome for trial participants, such as— 13 (A) requiring fewer follow-up visits; 14 (B) allowing phone follow-up or home vis- 15 its by nurse trial coordinators (in lieu of in-per- 16 son visits by patients); 17 (C) allowing for online follow-up options; 18 (D) permitting the patient’s primary care 19 provider to perform some of the follow-up visit 20 requirements; 21 (E) allowing for evening and weekend 22 hours for required follow-up visits; 23 (F) allowing virtual or telemedicine visits; 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3503 IH (G) use of wearable technology to record 1 key health parameters; and 2 (H) use of alternate labs or imaging cen- 3 ters, which may be closer to the residence of the 4 patients participating in the trial; and 5 (5) the sponsor’s education and training re- 6 quirements for researchers and other individuals 7 conducting or supporting the clinical trial with re- 8 spect to diversity and health inequities in, and the 9 development of, curricula for healthcare profes- 10 sionals on how to participate in clinical trials as an 11 investigator and how they can enroll patients in 12 trials, which may include consultation with, and the 13 review of materials made available by, such commit- 14 tees, task forces, working groups, and other entities 15 the Director determines are appropriate, including 16 the following: 17 (A) The Equity Committee of the National 18 Institutes of Health. 19 (B) The National Advisory Council on Mi- 20 nority Health and Health Disparities. 21 (C) The Advisory Committee on Research 22 on Women’s Health. 23 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3503 IH (D) The Tribal Health Research Coordi- 1 nating Committee of the National Institutes of 2 Health. 3 (b) TERMS.— 4 (1) IN GENERAL.—As a condition on the ap- 5 proval of a protocol to conduct a clinical trial by the 6 National Institutes of Health, as described in sub- 7 section (a), the sponsor of the clinical trial shall 8 agree to terms requiring that— 9 (A) the aggregate demographic information 10 of trial participants be shared on an annual 11 basis with the Secretary while participant re- 12 cruitment and data collection in such trial is 13 ongoing, and that such information is provided 14 with respect to— 15 (i) underrepresented populations, in- 16 cluding populations grouped by race, eth- 17 nicity, age, and sex; and 18 (ii) such populations that reflect the 19 prevalence of the disease or condition that 20 is the subject of the clinical trial involved 21 (as available and as appropriate to the sci- 22 entific objective for the study, as deter- 23 mined by the Director of the National In- 24 stitutes of Health); 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3503 IH (B) the sponsor submits to the program of- 1 ficer and grants management specialist of the 2 specific National Institutes of Health national 3 research institute or national center, annually 4 or as frequently as such officer or specialist de- 5 termines necessary, the retention rate of par- 6 ticipants in the clinical trial, disaggregated by 7 race, ethnicity, age, and sex; 8 (C) both the clinical trial researchers and 9 the applicant reviewers complete education and 10 training programs on diversity in clinical trials; 11 and 12 (D) at the conclusion of the trial, the spon- 13 sor submits to the Secretary the number of par- 14 ticipants in the trial, disaggregated by race, 15 ethnicity, age, and sex. 16 (2) PRIVACY PROTECTIONS.—Any data shared 17 under paragraph (1) may not include any individ- 18 ually identifiable information or protected health in- 19 formation with respect to clinical trial participants 20 and shall only be disclosed to the extent allowed 21 under Federal privacy laws. 22 (c) EXCEPTION.—In lieu of submitting an application 23 under subsection (a) and documentation of goals as re- 24 quired by paragraph (1) of such subsection, an applicant 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3503 IH may provide reasoning for why the recruitment of each 1 of the population groups specified in paragraph (1) of sub- 2 section (a) is not necessary and why such recruitment is 3 not scientifically justified or possible. 4 (d) PUBLICATION.—The Secretary shall— 5 (1) publish on a public website of the National 6 Institutes of Health, upon receipt of an application 7 to which subsection (a) applies— 8 (A) a summary of the disease being tar- 9 geted in the clinical trial that is the subject of 10 the application and the prevalence of such dis- 11 ease across race, ethnicity, age, sex, and the 12 clinical trial representation in each such cat- 13 egory; 14 (B) the goals specified in such application, 15 as required by subsection (a)(1); or 16 (C) the reasoning described in subsection 17 (c); and 18 (2) ensure that, in publishing information relat- 19 ing to an application under paragraph (1), the de- 20 sign of the study involved is not disclosed. 21 (e) REMEDIATION.— 22 (1) IN GENERAL.—In the case of a clinical trial 23 subject to subsection (a) that fails to meet the condi- 24 tion specified pursuant to subsection (a) by such 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 3503 IH date as may be agreed upon by the sponsor of the 1 trial and the program officer and grants manage- 2 ment specialist of the specific National Institutes of 3 Health national research institute or national center, 4 the Secretary shall require the sponsor of that clin- 5 ical trial, not later than 90 days after such date oc- 6 curs— 7 (A) to develop, in consultation with the 8 Secretary and advocacy and community-based 9 organizations representing individuals who are 10 members of relevant demographic groups speci- 11 fied in subsection (a)(1), a strategic plan to in- 12 crease participation in such clinical trial of such 13 individuals; and 14 (B) to submit to the Secretary such stra- 15 tegic plan. 16 (2) PUBLICATION.—The Secretary shall make 17 publicly available on the website of the National In- 18 stitutes of Health, the strategic plan received under 19 paragraph (1) as soon as possible after receipt. The 20 Secretary shall ensure that, in publishing such plan 21 under the preceding sentence, the design of the 22 study involved is not disclosed. 23 (3) IMPLEMENTATION.—The sponsor of the 24 clinical trial that is the subject of the strategic plan 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 3503 IH published under paragraph (2), shall, not later than 1 90 days after such date as may be agreed upon by 2 the sponsor of the trial and the appropriate program 3 officer and grants management specialist of the Na- 4 tional Institutes of Health, implement the strategic 5 plan. 6 (4) TECHNICAL ASSISTANCE.—The Secretary 7 may provide technical assistance to a sponsor of a 8 clinical trial, as necessary for the sponsor to meet 9 the requirements of paragraph (3). 10 (f) WAIVER FOR CERTAIN CLINICAL TRIALS.— 11 (1) IN GENERAL.—In the case of a clinical trial 12 that received funding through the National Insti- 13 tutes of Health and is ongoing as of the date of the 14 enactment of this Act, the sponsor of such clinical 15 trial is exempt from the requirements of (and associ- 16 ated penalties imposed by) this Act. 17 (2) REPORT.—The Secretary shall include in 18 the triennial report required to be submitted under 19 section 403 of the Public Health Service Act (42 20 U.S.C. 283), a list of all clinical trials receiving 21 funding through the National Institutes of Health 22 that requested and received waivers under this sec- 23 tion. 24 (g) STUDY.— 25 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 3503 IH (1) IN GENERAL.—The Comptroller General of 1 the United States shall conduct a study that— 2 (A) examines which actions Federal agen- 3 cies have taken to address barriers to participa- 4 tion in federally funded clinical trials by the de- 5 mographic groups specified in subsection (a)(1); 6 and 7 (B) identifies challenges, if any, in imple- 8 menting such actions. 9 (2) REPORT.—Not later than 1 year after the 10 date of the enactment of this Act, the Comptroller 11 General of the United States shall submit to Con- 12 gress a report on the findings of the study con- 13 ducted under paragraph (1). 14 (h) NONDISCRIMINATION.—Section 1557 of the Pa- 15 tient Protection and Affordable Care Act (42 U.S.C. 16 18116) shall apply with respect to a clinical trial subject 17 to subsection (a). 18 SEC. 3. ELIMINATING COST BARRIERS. 19 Not later than 2 years after the date of the enact- 20 ment of this Act, the Secretary of Health and Human 21 Services, acting through the Director of the National In- 22 stitutes of Health (referred to in this section as the ‘‘Sec- 23 retary’’), shall conduct and complete a study on— 24 VerDate Sep 11 2014 02:09 Jun 10, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3503.IH H3503 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •HR 3503 IH (1) the need for review of human subject regu- 1 lations specified in part 46 of title 45, Code of Fed- 2 eral Regulations (or successor regulations), and re- 3 lated guidance; 4 (2) the modernization of such regulations and 5 guidance to establish updated guidelines for reim- 6 bursement of out-of-pocket expenses of human sub- 7 jects, compensation of human subjects for time 8 spent participating in the clinical trial, and incen- 9 tives for recruitment of human subjects; and 10 (3) the need for updated safe harbor rules 11 under section 1001.952 of title 42, Code of Federal 12 Regulations (or successor regulations) and section 13 1128B of the Social Security Act (commonly re- 14 ferred to as the Federal Anti-Kickback Statute (42 15 U.S.C. 1320a–7b)) with respect to the assistance 16 provided under [Text truncated for display. 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