NIH Clinical Trial Diversity Act of 2023



<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3503 Introduced in House (IH)]

&lt;DOC&gt;






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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``NIH Clinical Trial Diversity Act of 
2023''.

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 2025 through 2028.

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).
                                 &lt;all&gt;
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