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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3564 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3564
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 18, 2025
Mr. Kim (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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``NIH Clinical Trial Integrity Act''.
SEC. 2. DIVERSITY GOALS FOR CLINICAL TRIALS FUNDED BY THE NATIONAL
INSTITUTES OF HEALTH.
(a) Applications.--Beginning on the date of enactment of this Act,
the Secretary of Health and Human Services, acting through the Director
of the National Institutes of Health (referred to in this section as
the ``Secretary''), shall require that a research organization or
entity funded by the National Institutes of Health (referred to in this
section as an ``NIH-funded research organization or entity'') seeking
to conduct a clinical trial investigating a drug or device (as those
terms are defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) or a biological product (as defined in
section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)))
that is funded by the National Institutes of Health or a behavioral
intervention, the protocol for which is approved by the National
Institutes of Health, submit an application (or renewal thereof) for
such funding or approval that includes--
(1) clear and measurable goals for the recruitment and
retention of participants that reflect--
(A) the race, ethnicity, age, and sex of patients
with the disease or condition being investigated; or
(B) as scientifically or ethically justified and
appropriate, 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 determine the number of
participants for each population category that reflect
the population groups specified 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; and
(B) how the trial will recruit a study population
that is--
(i) scientifically and ethically
appropriate in terms of the scientific
objectives and proposed study design; and
(ii) in sufficient numbers to obtain
clinically and statistically meaningful
determinations of the safety and effectiveness
of the drug, device, or behavioral intervention
being studied in the respective race,
ethnicity, age, and sex groups; and
(4) the NIH-funded research organization or entity's plan
for implementing, or an explanation of why the NIH-funded
research organization or entity 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 visits by
appropriately qualified staff (in lieu of in-person
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;
(G) use of wearable technology to record key health
parameters; and
(H) use of alternate labs or imaging centers, which
may be closer to the residence of the patients
participating in the trial.
(b) Terms.--
(1) In general.--As a condition on the receipt of funding
through the National Institutes of Health, as described in
subsection (a), with respect to a clinical trial, the NIH-
funded research organization or entity 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 recruitment and data
collection in such trial is ongoing, and that such
information is provided with respect to--
(i) underrepresented populations, including
populations grouped by race, ethnicity, 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 scientific
objective for the study, as determined by the
Director of the National Institutes of Health);
(B) the NIH-funded research organization or entity
submits to the program officer and grants management
specialist of the specific institute, center, or office
of the National Institutes of Health, annually or as
frequently as such officer or specialist determines
necessary, the retention rate of participants in the
clinical trial, disaggregated by race, ethnicity, age,
and sex;
(C) the clinical trial researchers complete
education and training programs on diversity in
clinical trials; and
(D) at the conclusion of the trial, the sponsor
submits to the Secretary the number of participants in
the trial, disaggregated by race, ethnicity, age, and
sex.
(2) Privacy protections.--Any data shared under paragraph
(1) may not include any individually identifiable information
or protected health information with respect to clinical trial
participants and shall only be disclosed to the extent allowed
under Federal privacy laws and by National Institutes of Health
policy.
(c) Exception.--In lieu of submitting an application under
subsection (a) and documentation of goals as required by paragraph (1)
of such subsection, an applicant may provide reasoning for why the
recruitment of each of the population groups specified in paragraph (1)
of subsection (a) is not necessary and why such recruitment is not
scientifically justified or possible.
SEC. 3. ELIMINATING COST BARRIERS.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Director of
the National Institutes of Health, shall conduct and complete a study
on--
(1) the need for review of human subject regulations
specified in part 46 of title 45, Code of Federal Regulations
(or successor regulations), and related guidance;
(2) the modernization of such regulations and guidance to
establish updated guidelines for reimbursement of out-of-pocket
expenses of human subjects, compensation of human subjects for
time spent participating in the clinical trial, and incentives
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 referred 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
(referred to in this section as the ``Secretary''), in consultation
with the stakeholders specified in subsection (e), shall carry out a
national campaign to increase the awareness and knowledge of
individuals in the United States, including health care professionals,
patients, and others, with respect to the need for diverse clinical
trials among the demographic groups identified pursuant to section
2(a)(1).
(b) Requirements.--The national campaign conducted under this
section shall include--
(1)(A) the development and distribution of written
educational materials;
(B) the development and placing of public service
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 patients in
trials;
(2) such efforts as are reasonable and necessary to ensure
meaningful access by consumers with limited English
proficiency; and
(3) the development and distribution of best practices and
training for recruiting underrepresented study populations,
including a method for sharing such best practices among
clinical trial sponsors, providers, community-based
organizations who assist with recruitment, and with the public.
(c) Health Disparities.--In developing the national campaign under
subsection (a), the Secretary shall recognize and address--
(1) health disparities among individuals who are members of
the population groups specified in section 2(b)(1)(A) with
respect to access to care and participation in clinical trials;
and
(2) any barriers in access to care and participation in
clinical trials that are specific to individuals who are
members of such groups.
(d) Grants.--The Secretary shall establish a program to award
grants to nonprofit private entities (including community-based
organizations and faith communities, 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 pharmacies) to enable such
entities--
(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 disease 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 Food and Drug Administration,
the Health Resources and Services Administration, the Office on
Minority Health of the Department of Health and Human Services,
the Centers for Disease Control and Prevention, 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 2026 through 2029.
SEC. 5. DEFINITION.
In this Act, the term ``clinical trial'' means a research study in
which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to
evaluate the effects of those interventions on health-related
biomedical or behavioral outcomes.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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