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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘NIH Clinical Trial Di-
versity Act of 2023’’. 
SEC. 2. DIVERSITY GOALS FOR CLINICAL TRIALS. 
(a) APPLICATIONS.—Beginning on the date of the en-
actment of this Act, the Secretary of Health and Human 
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Services, acting through the Director of the National In-
stitutes of Health (in this section referred to as the ‘‘Sec-
retary’’), shall require that a sponsor seeking to conduct 
a clinical trial investigating a drug, device (as those terms 
are defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.)) biological product 
(as defined in section 351(i) of the Public Health Service 
Act (42 U.S.C. 262(i))), or behavioral intervention, the 
protocol for which is approved by the National Institutes 
of Health, to submit an application (or renewal thereof) 
for such approval that includes— 
(1) clear and measurable goals for the recruit-
ment and retention of participants that reflect— 
(A) the race, ethnicity, age, and sex of pa-
tients with the disease or condition being inves-
tigated; or 
(B) the race, ethnicity, age, and sex of the 
general population of the United States if the 
prevalence of the disease or condition is not 
known; 
(2) a rationale for the goals specified under 
paragraph (1) that specifies— 
(A) how investigators will calculate the 
number of participants for each population cat-
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egory that reflect the population groups speci-
fied in paragraph (1); or 
(B) strategies that will be used to enroll 
and retain participants across the different 
race, ethnicity, age, and sex categories; 
(3) a detailed plan for how the clinical trial will 
achieve the goals specified under paragraph (1) that 
specifies— 
(A) the requirements for researchers, in 
conducting the trial, to analyze the population 
groups specified in paragraph (1) separately; 
(B) the role of community partners or 
community institutional review boards in re-
viewing the plans; and 
(C) how the trial will recruit a study popu-
lation that is— 
(i) in proportion to the prevalence of 
the disease or condition in such groups rel-
ative to the prevalence of the disease or 
condition in the overall population of the 
United States; 
(ii) in sufficient numbers to obtain 
clinically and statistically meaningful de-
terminations of the safety and effectiveness 
of the drug, device, biological product, or 
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behavioral intervention being studied in the 
respective race, ethnicity, age, and sex 
groups; and 
(iii) consistent with the guidance 
under section 505(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(1)) and guidance issued by the Na-
tional Institutes of Health on the inclusion 
of women and minorities in clinical trials; 
(4) the sponsor’s plan for implementing, or an 
explanation of why the sponsor cannot implement, 
alternative clinical trial follow-up requirements that 
are less burdensome for trial participants, such as— 
(A) requiring fewer follow-up visits; 
(B) allowing phone follow-up or home vis-
its by nurse trial coordinators (in lieu of in-per-
son visits by patients); 
(C) allowing for online follow-up options; 
(D) permitting the patient’s primary care 
provider to perform some of the follow-up visit 
requirements; 
(E) allowing for evening and weekend 
hours for required follow-up visits; 
(F) allowing virtual or telemedicine visits; 
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(G) use of wearable technology to record 
key health parameters; and 
(H) use of alternate labs or imaging cen-
ters, which may be closer to the residence of the 
patients participating in the trial; and 
(5) the sponsor’s education and training re-
quirements for researchers and other individuals 
conducting or supporting the clinical trial with re-
spect to diversity and health inequities in, and the 
development of, curricula for healthcare profes-
sionals on how to participate in clinical trials as an 
investigator and how they can enroll patients in 
trials, which may include consultation with, and the 
review of materials made available by, such commit-
tees, task forces, working groups, and other entities 
the Director determines are appropriate, including 
the following: 
(A) The Equity Committee of the National 
Institutes of Health. 
(B) The National Advisory Council on Mi-
nority Health and Health Disparities. 
(C) The Advisory Committee on Research 
on Women’s Health. 
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(D) The Tribal Health Research Coordi-
nating Committee of the National Institutes of 
Health. 
(b) TERMS.— 
(1) IN GENERAL.—As a condition on the ap-
proval of a protocol to conduct a clinical trial by the 
National Institutes of Health, as described in sub-
section (a), the sponsor of the clinical trial shall 
agree to terms requiring that— 
(A) the aggregate demographic information 
of trial participants be shared on an annual 
basis with the Secretary while participant re-
cruitment and data collection in such trial is 
ongoing, and that such information is provided 
with respect to— 
(i) underrepresented populations, in-
cluding populations grouped by race, eth-
nicity, age, and sex; and 
(ii) such populations that reflect the 
prevalence of the disease or condition that 
is the subject of the clinical trial involved 
(as available and as appropriate to the sci-
entific objective for the study, as deter-
mined by the Director of the National In-
stitutes of Health); 
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(B) the sponsor submits to the program of-
ficer and grants management specialist of the 
specific National Institutes of Health national 
research institute or national center, annually 
or as frequently as such officer or specialist de-
termines necessary, the retention rate of par-
ticipants in the clinical trial, disaggregated by 
race, ethnicity, age, and sex; 
(C) both the clinical trial researchers and 
the applicant reviewers complete education and 
training programs on diversity in clinical trials; 
and 
(D) at the conclusion of the trial, the spon-
sor submits to the Secretary the number of par-
ticipants in the trial, disaggregated by race, 
ethnicity, age, and sex. 
(2) PRIVACY PROTECTIONS.—Any data shared 
under paragraph (1) may not include any individ-
ually identifiable information or protected health in-
formation with respect to clinical trial participants 
and shall only be disclosed to the extent allowed 
under Federal privacy laws. 
(c) EXCEPTION.—In lieu of submitting an application 
under subsection (a) and documentation of goals as re-
quired by paragraph (1) of such subsection, an applicant 
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may provide reasoning for why the recruitment of each 
of the population groups specified in paragraph (1) of sub-
section (a) is not necessary and why such recruitment is 
not scientifically justified or possible. 
(d) PUBLICATION.—The Secretary shall— 
(1) publish on a public website of the National 
Institutes of Health, upon receipt of an application 
to which subsection (a) applies— 
(A) a summary of the disease being tar-
geted in the clinical trial that is the subject of 
the application and the prevalence of such dis-
ease across race, ethnicity, age, sex, and the 
clinical trial representation in each such cat-
egory; 
(B) the goals specified in such application, 
as required by subsection (a)(1); or 
(C) the reasoning described in subsection 
(c); and 
(2) ensure that, in publishing information relat-
ing to an application under paragraph (1), the de-
sign of the study involved is not disclosed. 
(e) REMEDIATION.— 
(1) IN GENERAL.—In the case of a clinical trial 
subject to subsection (a) that fails to meet the condi-
tion specified pursuant to subsection (a) by such 
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date as may be agreed upon by the sponsor of the 
trial and the program officer and grants manage-
ment specialist of the specific National Institutes of 
Health national research institute or national center, 
the Secretary shall require the sponsor of that clin-
ical trial, not later than 90 days after such date oc-
curs— 
(A) to develop, in consultation with the 
Secretary and advocacy and community-based 
organizations representing individuals who are 
members of relevant demographic groups speci-
fied in subsection (a)(1), a strategic plan to in-
crease participation in such clinical trial of such 
individuals; and 
(B) to submit to the Secretary such stra-
tegic plan. 
(2) PUBLICATION.—The Secretary shall make 
publicly available on the website of the National In-
stitutes of Health, the strategic plan received under 
paragraph (1) as soon as possible after receipt. The 
Secretary shall ensure that, in publishing such plan 
under the preceding sentence, the design of the 
study involved is not disclosed. 
(3) IMPLEMENTATION.—The sponsor of the 
clinical trial that is the subject of the strategic plan 
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published under paragraph (2), shall, not later than 
90 days after such date as may be agreed upon by 
the sponsor of the trial and the appropriate program 
officer and grants management specialist of the Na-
tional Institutes of Health, implement the strategic 
plan. 
(4) TECHNICAL
ASSISTANCE.—The Secretary 
may provide technical assistance to a sponsor of a 
clinical trial, as necessary for the sponsor to meet 
the requirements of paragraph (3). 
(f) WAIVER FOR CERTAIN CLINICAL TRIALS.— 
(1) IN GENERAL.—In the case of a clinical trial 
that received funding through the National Insti-
tutes of Health and is ongoing as of the date of the 
enactment of this Act, the sponsor of such clinical 
trial is exempt from the requirements of (and associ-
ated penalties imposed by) this Act. 
(2) REPORT.—The Secretary shall include in 
the triennial report required to be submitted under 
section 403 of the Public Health Service Act (42 
U.S.C. 283), a list of all clinical trials receiving 
funding through the National Institutes of Health 
that requested and received waivers under this sec-
tion. 
(g) STUDY.— 
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(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study that— 
(A) examines which actions Federal agen-
cies have taken to address barriers to participa-
tion in federally funded clinical trials by the de-
mographic groups specified in subsection (a)(1); 
and 
(B) identifies challenges, if any, in imple-
menting such actions. 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General of the United States shall submit to Con-
gress a report on the findings of the study con-
ducted under paragraph (1). 
(h) NONDISCRIMINATION.—Section 1557 of the Pa-
tient Protection and Affordable Care Act (42 U.S.C. 
18116) shall apply with respect to a clinical trial subject 
to subsection (a). 
SEC. 3. ELIMINATING COST BARRIERS. 
Not later than 2 years after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, acting through the Director of the National In-
stitutes of Health (referred to in this section as the ‘‘Sec-
retary’’), shall conduct and complete a study on— 
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