Sec. 7552. Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act

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In this subsection, the term decentralized clinical trials includes clinical trials that are executed through a broad spectrum of options, such as telemedicine or other mobile or digital technologies, to allow for the remote collection and assessment of clinical trial data from participants, including in the home or office setting. Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs (referred to in this section as the Commissioner ), shall issue a draft guidance that addresses how to conduct decentralized clinical trials with meaningful demographic diversity, including racial, ethnic, age, gender, and geographic diversity in patient engagement, enrollment, and participation, including how to appropriately use digital health technologies or other remote assessment options, such as telemedicine, to support such trials.

Not later than 6 months after the date the public comment period for the draft guidance ends, the Secretary shall issue a final guidance. The guidance under paragraph

(2)shall address the following: Strategies to engage with prospective clinical trial participants and community partners, such as patient advocacy groups with diverse representation, to incorporate input of such patients and partners into the design of decentralized clinical trials. Recommendations for— protocol design approaches; appropriate clinical endpoints; institutional review board composition and ensuring that such boards include members with expertise in decentralized clinical trials; delegation of clinical research organization responsibilities and suitable proxies for clinical research organizations; and simplifying informed consent. Recommendations for how digital health technology or other remote assessment options, such as telemedicine, could support decentralized clinical trials, including guidance on appropriate technological platforms and mediums, data collection and use, data integrity, and communication to study participants through digital technology. Recommendations for appropriate methods of patient recruitment and retention, including institutional review board oversight, patient communication, and the role of study participants and community partners as advocates to facilitate clinical trial recruitment, particularly with respect to underrepresented populations. Information regarding when and how a study sponsor may solicit a meeting with the Secretary regarding the issues described in subparagraphs

(A)through (D). After issuing the final guidance under paragraph (2), the Secretary, acting through the Commissioner, may work with foreign regulators pursuant to existing memoranda of understanding governing exchange of information to facilitate international harmonization of the regulation of decentralized clinical trials and use of digital health technology or other remote assessment options. The free provision of digital health technologies by drug or device manufacturers to their clinical trial participants shall not be considered a violation of section 1128A of the Social Security Act (commonly known as the Civil Monetary Penalties Law ) ( 42 U.S.C. 1320a–7a ), section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ), or sections 3729 through 3733 of title 31, United States Code (commonly known as the False Claims Act ), provided that— the use of digital health technologies will facilitate in any phase of clinical development the inclusion of diversity of patient populations, such as underrepresented racial and ethnic minorities, low-income populations, and the elderly; the digital health technologies will facilitate individuals’ participation, or are necessary to such participation; all features of the digital health technologies that are unrelated to use in the clinical trial are disabled or only allowed to remain activated to model real-world usage of the digital technology; and the clinical trial sponsor requires participants to return, purchase, or disable the digital health technologies by the conclusion of the trial. The Secretary may issue grants to, and enter into contracts with, entities to support community education, outreach, and recruitment activities for clinical trials with respect to drugs, including vaccines for diseases or conditions which have a disproportionate impact on underrepresented populations (including on racial and ethnic minority populations), including for the diagnosis, prevention, or treatment of COVID–19. Such activities may include— working with community clinical trial sites, including community health centers, academic health centers, and other facilities; training health care personnel including potential clinical trial investigators, with a focus on significantly increasing the number of underrepresented racial and ethnic minority health care personnel who are clinical trial investigators at the community sites for ongoing clinical trials; engaging community stakeholders to encourage participation in clinical trials, especially in underrepresented racial and ethnic minority communities; and fostering partnerships with community-based organizations serving underrepresented racial and ethnical minority populations, including labor organizations and frontline health care workers. In awarding grants and contracts under this paragraph, the Secretary shall prioritize entities that— develop educational, recruitment, and training materials in multiple languages; or undertake clinical trial outreach efforts in more diverse racial and ethnic communities that are traditionally underrepresented in clinical trials, such as Tribal areas. There is authorized to be appropriated for fiscal years 2023 and 2024 such sums as may be necessary to carry out this paragraph. Section 1128A(i)(6)(F) of the Social Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amended by inserting (including remuneration offered or transferred to an individual to promote the participation in an approved clinical trial, as defined in subsection

(d)of the first section 2709 of the Public Health Service Act (relating to coverage for individuals participating in approved clinical trials), as so designated by section 1563(c)(10)(C) of the Patient Protection and Affordable Care Act, that is registered with the database of clinical trials maintained by the National Library of Medicine (or any successor database), so long as such remuneration facilitates equitable inclusion of patients from all relevant demographic and socioeconomic populations and is related to patient participation in the approved clinical trial) after promotes access to care . The amendment made by paragraph

(1)shall apply to remuneration provided on or after the date of the enactment of this Act. The Secretary shall seek to enter into an arrangement with the National Academy of Medicine under which the National Academy agrees to study and propose a design for a national interoperable data platform to improve access to health data, and other relevant data needs, during public health emergencies. The arrangement under paragraph

(1)shall provide for submission by the National Academy of Medicine to the Secretary and Congress, not later than 120 days after the date of enactment of this Act, of a report on the results of the study under paragraph

(1)and the design proposed based on such study.

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42 USC 1320a–7a
42 USC 1320a–7b
42 USC 1320a–7a(i)(6)(F)

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Sec. 7552

Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act

Cite42 USC 1320a–7a

Cite42 USC 1320a–7b

Cite42 USC 1320a–7a(i)(6)(F)

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