Sec. 7553. Clinical trial diversity

2,943 words·~13 min read·/bill/117/s/4486/is/section-7553

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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 subsection referred to as the Secretary ), shall require that an 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 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 and conducted at any national research institute or national center, submit an application (or renewal thereof) for such funding that includes— clear and measurable goals for the recruitment and retention of participants that reflect— the race, ethnicity, age, and gender or sex of patients with the disease or condition being investigated; or the race, ethnicity, age, and gender or sex of the general population of the United States if the prevalence of the disease or condition is not known; a rationale for the goals specified under subparagraph

(A)that specifies— how investigators will calculate the number of participants for each population category that reflect the population groups specified in subparagraph (A); and strategies that will be used to enroll and retain participants across the different racial, ethnic, age, and gender or sex categories; a detailed plan for how the clinical trial will achieve the goals specified under subparagraph

(A)that specifies— the requirements for researchers, in conducting the trial to analyze the population groups specified in subparagraph

(A)separately; the role of community partners or community institutional review boards in reviewing the plans; and how the trial will recruit a study population that is— 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; in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug being studied in the respective race, ethnicity, age, and gender or sex groups; and 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; the entity’s plan for implementing, or an explanation of why the entity cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants, such as— requiring fewer follow-up visits; allowing phone follow-up or home visits by nurse trial coordinators (in lieu of in-person visits by patients); allowing for online follow-up options; permitting the patient’s primary care provider to perform some of the follow-up visit requirements and to reimburse the patient for any out-of-pocket costs incurred by the patient for such follow-up visits; allowing for weekend hours for required follow-up visits; allowing virtual or telemedicine visits; use of wearable technology to record key health parameters; and use of alternate labs or imaging centers, which may be closer to the residence of the patients participating in the trial; and the entity’s education and training requirements for researchers and other individuals conducting or supporting the clinical trial with respect to diversity and health inequities in underrepresented populations, including a requirement to consult with, and review materials made available by, such committees, task forces, and working groups other entities the Secretary determines are appropriate, including the following: The Equity Committee of the National Institutes of Health. The National Advisory Council on Minority Health and Health Disparities. The Advisory Committee on Research on Women's Health. The Sexual & Gender Minority Research Coordinating Committee of the National Institutes of Health. The Tribal Health Research Coordinating Committee of the National Institutes of Health. As a condition on the receipt of funding through the National Institutes of Health, as described in paragraph (1), with respect to a clinical trial, the sponsor of the clinical trial shall agree to terms requiring that— 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— underrepresented populations, including populations grouped by race, ethnicity, age, sex, gender identity and expression, geographic region, primary written and spoken language, disability status, sexual orientation, socioeconomic status, occupation, and other relevant factors; and 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); the sponsor submits to the program officer and grants management specialist of the specific National Institutes of Health national research institute or national center, as frequently as such officer or specialist determines necessary, the retention rate of participants in the clinical trial, disaggregated by race, ethnicity, gender or sex, and age; both the clinical trial researchers and the applicant reviewers complete education and training programs on diversity in clinical trials; and 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 gender or sex. Any data shared under subparagraph

(A)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. In lieu of submitting an application under paragraph

(1)and documentation of goals as required by subparagraph

(A)of such paragraph, an applicant may provide reasoning (other than cost) for why the recruitment of each of the population groups specified in subparagraph

(A)of paragraph

(1)is not necessary and why such recruitment is not scientifically justified or possible. The Secretary shall— publish on a public website of the National Institutes of Health, upon receipt of an application to which paragraph

(1)applies or reasoning under paragraph (3)— 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, gender or sex, age, and clinical trial representation in each such category; the goals specified in such application, as required by paragraph (1)(A); or the reasoning described in paragraph (3); and ensure that, in publishing information relating to an application or reasoning under subparagraph (A), the design of the study involved is not disclosed. In the case of a clinical trial subject to paragraph

(1)that fails to meet the condition specified pursuant to paragraph

(1)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 60 days after such date occurs— to develop, in consultation with the Secretary and advocacy and community-based organizations representing individuals who are members of relevant demographic groups specified in paragraph (1)(A), a strategic plan to increase participation in such clinical trial of such individuals; and to submit to the Secretary, such strategic plan. The Secretary shall make publicly available on the website of the National Institutes of Health, the strategic plan received under subparagraph

(A)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. The sponsor of the clinical trial that is the subject of the strategic plan published under subparagraph (B), shall, not later than 60 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. The Secretary may provide technical assistance to a sponsor of a clinical trial, as necessary for the sponsor to meet the requirements of subparagraph (C). In the case of a clinical trial subject to paragraph

(1)that, after the close of the 60-day period specified in paragraph (5)(C), continues to fail to meet the condition specified pursuant to paragraph (1)(A), the Secretary shall— hold the noncompeting continuation of funding received through the grant involved; apply specific conditions on the award of funds to such sponsor to conduct such clinical trial; or terminate such funding. In the case of a clinical trial subject to the penalty under subparagraph

(A)that fails to meet the condition referred to in such subparagraph, the sponsor of such clinical trial may, prior to the conclusion of the 60-day period referred to in subparagraph (A), submit an application to the relevant program officer and grants specialist requesting a waiver of such condition. Such an application shall specify reasoning for why the recruitment of each of the population groups specified in subparagraph

(A)of paragraph

(1)is not necessary or why such recruitment is not scientifically justified or possible. Not later than 30 days after a date agreed upon by the sponsor of the trial and the appropriate program officer and grants management specialist of the National Institutes of Health, the Secretary shall— complete the review of such application; and make a determination to approve or deny the application. No additional penalties may be applied with respect to a sponsor of a clinical trial under subparagraph

(A)during the 30-day period specified in clause (ii). In the case of a clinical trial described in subparagraph (B)(i), the Secretary may elect to terminate funding described in paragraph

(1)for the clinical trial if no request for a waiver under subparagraph

(B)is received by the conclusion 60-day period referred to in subparagraph (A). 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 section. 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 subsection; or with respect to which funding has been terminated pursuant to this subsection. The Comptroller General of the United States shall conduct a study that— examines which actions Federal agencies have taken to address barriers to participation in federally funded clinical trials by the demographic groups specified in paragraph (1)(A); and identifies challenges, if any, in implementing such actions. 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 subparagraph (A). 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 paragraph (1). 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 subsection as the Secretary ), shall conduct and complete a study on— 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; 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 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 subsection. As a condition on receipt of any funding provided through the National Institutes of Health 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 biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), the Secretary shall require that the sponsor of such clinical trial— works with institutional review boards and program officers of the National Institutes of Health to determine when reimbursement for the costs associated with clinical trial participation is warranted; and subject to paragraph (3), provides to clinical trial participants reimbursement for expenses (using funds other than funds supplied through the National Institutes of Health) incurred as a result of that participation, which may include— missed or forgone salary; language assistance, including interpreter services; food expenses; childcare expenses; lodging expenses; transportation expenses; or other expenses as identified by the participant, subject to review by the clinical trial sponsor, at its discretion, on a case-by-case basis. A sponsor of a clinical trial to which subsection (a)(1) applies, may require that, in order to receive reimbursement as described in paragraph (2), a participant complete an application and share with the sponsor such documentation of expenses described in such paragraph, as the sponsor may require. Not later than 30 days after the date on which a sponsor of a clinical trial receives an application under clause (i), the sponsor shall— review the application; and provide for reimbursement of eligible expenses documented in such application, as determined at the discretion of the clinical trial sponsor on a case-by-case basis. A sponsor of a clinical trial to which subsection (a)(1) applies, shall submit on an annual basis, as part of the progress reports submitted to the Secretary pursuant to section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ), during the data collection period of the clinical trial, to the Secretary an accounting of the reimbursements made to clinical trial participants under subparagraph (A). Such data shall— include relevant aggregate data with respect to each population group specified in subsection (a)(2)(A)(i) when such data will not compromise the identities of study participants and in a manner consistent with applicable privacy protections; and not later than 6 months after receipt by the Secretary, be published on a public website of the National Institutes of Health. 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 subsection as the Secretary ), in consultation with the stakeholders specified in paragraph (5), shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States with respect to the need for diverse clinical trials among the demographic groups identified pursuant to subsection (a)(1)(A). The national campaign conducted shall include— the development and distribution of written educational materials, and the development and placing of public service announcements, that are intended to encourage individuals who are members of the demographic groups identified pursuant to subsection (a)(2)(A)(i)(I) to seek to participate in clinical trials; such efforts as are reasonable and necessary to ensure meaningful access by consumers with limited English proficiency; 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 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. In developing the national campaign under paragraph (1), the Secretary shall recognize and address— health inequities among individuals who are members of the population groups specified in subsection (a)(2)(A)(i) with respect to access to care and participation in clinical trials; and any barriers in access to care and participation in clinical trials that are specific to individuals who are members of such groups. 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 ) and national organizations that serve underrepresented populations and community pharmacies to enable such entities— 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 gender or sex of patients with the disease or condition being investigated; and to cover administrative costs of such entities in assisting in diversifying clinical trials subject to subsection (a). The stakeholders specified in this paragraph are the following: Representatives of the Health Resources Services Administration, the Office of Minority Health of the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the National Institutes of Health. Community-based resources and advocates. There is authorized to be appropriated to carry out this subsection $10,000,000 for each of fiscal years 2023 through 2026. In this section: 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. The term sponsor has the meaning given such term in section 50.3 of title 21, Code of Federal Regulations (or successor regulations).

Connectionstraces to 7

Traces to 7 documents

U.S. Code