I 
119TH CONGRESS 
1ST SESSION H. R. 6867 
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 
DECEMBER 18, 2025 
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 In-
tegrity Act’’. 
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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(1) the need for review of human subject regu-
lations specified in part 46 of title 45, Code of Fed-
eral Regulations (or successor regulations), and re-
lated guidance; 
(2) the modernization of such regulations and 
guidance to establish updated guidelines for reim-
bursement of out-of-pocket expenses of human sub-
jects, compensation of human subjects for time 
spent participating in the clinical trial, and incen-
tives for recruitment of human subjects; and 
(3) the need for updated safe harbor rules 
under section 1001.952 of title 42, Code of Federal 
Regulations (or successor regulations) and section 
1128B of the Social Security Act (commonly re-
ferred to as the Federal Anti-Kickback Statute (42 
U.S.C. 1320a–7b)) with respect to the assistance 
provided under this section. 
SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 
(a) NATIONAL CAMPAIGN.—The Secretary of Health 
and Human Services, acting through the Director of the 
National Institutes of Health and the Commissioner of 
Food and Drugs (referred to in this section as the ‘‘Sec-
retary’’) and in consultation with the stakeholders speci-
fied in subsection (e), shall carry out a national campaign 
to increase the awareness and knowledge of individuals in 
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the United States, including healthcare professionals, pa-
tients, and others, with respect to the need for diverse clin-
ical trials among the demographic groups identified pursu-
ant to section 2(a)(1). 
(b) REQUIREMENTS.—The national campaign con-
ducted under this section shall include— 
(1)(A) the development and distribution of writ-
ten educational materials; 
(B) the development and placing of public serv-
ice announcements that are intended to encourage 
individuals who are members of the demographic 
groups identified pursuant to section 2(b)(1)(A)(I) 
to seek to participate in clinical trials; and 
(C) the development of curricula for health care 
professionals on— 
(i) how to participate in clinical trials as 
an investigator; and 
(ii) how such professionals can enroll pa-
tients in trials; 
(2) such efforts as are reasonable and necessary 
to ensure meaningful access by consumers with lim-
ited English proficiency; 
(3) the development and distribution of best 
practices and training for recruiting underrep-
resented study populations, including a method for 
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sharing such best practices among clinical trial spon-
sors, providers, community-based organizations who 
assist with recruitment, and with the public; and 
(4) the conduct of focus groups to better under-
stand the concerns and fears of certain underrep-
resented groups who may be reluctant to participate 
in clinical trials. 
(c) HEALTH INEQUITIES.—In developing the national 
campaign under subsection (a), the Secretary shall recog-
nize and address— 
(1) health inequities among individuals who are 
members of the population groups specified in sec-
tion 2(b)(1)(A) with respect to access to care and 
participation in clinical trials; and 
(2) any barriers in access to care and participa-
tion in clinical trials that are specific to individuals 
who are members of such groups. 
(d) GRANTS.—The Secretary shall establish a pro-
gram to award grants to nonprofit private entities (includ-
ing community based organizations and faith commu-
nities, institutions of higher education eligible to receive 
funds under section 371 of the Higher Education Act of 
1965 (20 U.S.C. 1067q), national organizations that serve 
underrepresented populations, and community phar-
macies) to enable such entities— 
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(1) to test alternative outreach and education 
strategies to increase the awareness and knowledge 
of individuals in the United States, with respect to 
the need for diverse clinical trials that reflect the 
race, ethnicity, age, and sex of patients with the dis-
ease or condition being investigated; and 
(2) to cover administrative costs of such entities 
in assisting in diversifying clinical trials subject to 
section 2. 
(e) STAKEHOLDERS SPECIFIED.—The stakeholders 
specified in this subsection are the following: 
(1) Representatives of the Health Resources 
Services Administration, the Office on Minority 
Health of the Department of Health and Human 
Services, the Centers for Disease Control and Pre-
vention, and the National Institutes of Health. 
(2) Community-based resources and advocates. 
(f) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section 
$10,000,000 for each of fiscal years 2027 through 2030. 
SEC. 5. DEFINITIONS. 
In this Act: 
(1) CLINICAL TRIAL.—The term ‘‘clinical trial’’ 
means a research study in which one or more human 
subjects are prospectively assigned to one or more 
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interventions (which may include placebo or other 
control) to evaluate the effects of those interventions 
on health-related biomedical or behavioral outcomes. 
(2) SPONSOR.—The term ‘‘sponsor’’ has the 
meaning given such term in section 50.3 of title 21, 
Code of Federal Regulations (or successor regula-
tions). 
Æ 
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