Title: NIH Clinical Trial Diversity Act of 2022
Policy area: Health

Summary:
NIH Clinical Trial Diversity Act of 2022
This bill sets out requirements to increase the diversity of clinical trial participants. The bill also requires other activities to foster participation in clinical trials.
As a condition of funding from the National Institutes of Health (NIH) for a clinical trial investigating a drug or device, a sponsor's application must include certain information related to diversity in its trial, such as goals for recruiting and retaining trial participants and plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements. A sponsor must also annually share demographic data of clinical trial participants with the NIH.
Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5268 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 5268

 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 15, 2022

  Mr. Menendez (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 Diversity Act of 
2022''.

SEC. 2. DIVERSITY GOALS FOR NIH FUNDED 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 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 et 
seq.)) or 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, submit an application (or renewal 
thereof) for such funding 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 or device 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 the 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 2023 through 2026.

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.
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