H.R. 6867

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6867 Introduced in House (IH)]

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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).
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