No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6867 Introduced in House (IH)]
<DOC>
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 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.
(a) Applications.--Beginning on the date of the enactment of this
Act, the Secretary of Health and Human Services, acting through the
Director of the National Institutes of Health (in this section referred
to as the ``Secretary''), 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 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) 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 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;
(B) the role of community partners or community
institutional review boards in reviewing the plans; and
(C) how the trial will recruit a study population
that is--
(i) in proportion to the prevalence of the
disease or condition in such groups relative 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
determinations of the safety and effectiveness
of the drug, device, biological product, or
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 National 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 visits by
nurse trial coordinators (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; and
(5) the sponsor's education and training requirements for
researchers and other individuals conducting or supporting the
clinical trial with respect to diversity and health inequities
in, and the development of, curricula for healthcare
professionals 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 committees, 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 Minority
Health and Health Disparities.
(C) The Advisory Committee on Research on Women's
Health.
(D) The Tribal Health Research Coordinating
Committee of the National Institutes of Health.
(b) Terms.--
(1) In general.--As a condition on the approval of a
protocol to conduct a clinical trial by the National Institutes
of Health, as described in subsection (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 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 sponsor submits to the program officer 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 determines necessary, the
retention rate of participants 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 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.
(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.
(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 targeted in the
clinical trial that is the subject of the application
and the prevalence of such disease across race,
ethnicity, age, sex, and the clinical trial
representation in each such category;
(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 relating to an
application under paragraph (1), the design 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 condition specified
pursuant to subsection (a) by such date as may be agreed upon
by the sponsor of the trial and the program officer and grants
management specialist of the specific National Institutes of
Health national research institute or national center, the
Secretary shall require the sponsor of that clinical trial, not
later than 90 days after such date occurs--
(A) to develop, in consultation with the Secretary
and advocacy and community-based organizations
representing individuals who are members of relevant
demographic groups specified in subsection (a)(1), a
strategic plan to increase participation in such
clinical trial of such individuals; and
(B) to submit to the Secretary such strategic plan.
(2) Publication.--The Secretary shall make publicly
available on the website of the National Institutes 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 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
National 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 Institutes 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 associated 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 section.
(g) Study.--
(1) In general.--The Comptroller General of the United
States shall conduct a study that--
(A) examines which actions Federal agencies have
taken to address barriers to participation in federally
funded clinical trials by the demographic groups
specified in subsection (a)(1); and
(B) identifies challenges, if any, in implementing
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 Congress a report on the findings of the
study conducted under paragraph (1).
(h) Nondiscrimination.--Section 1557 of the Patient 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 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 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,
acting through the Director of the National Institutes of Health and
the Commissioner of Food and Drugs (referred to in this section as the
``Secretary'') and 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
healthcare 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;
(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;
and
(4) the conduct of focus groups to better understand the
concerns and fears of certain underrepresented groups who may
be reluctant to participate in clinical trials.
(c) Health Inequities.--In developing the national campaign under
subsection (a), the Secretary shall recognize and address--
(1) health inequities 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 Health Resources 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 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 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 regulations).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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