[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2706 Introduced in Senate (IS)]
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117th CONGRESS
1st Session
S. 2706
To improve diversity in clinical trials and data collection for COVID-
19 and future public health threats to address social determinants of
health.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 10, 2021
Mr. Menendez (for himself and Mr. Scott of South Carolina) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve diversity in clinical trials and data collection for COVID-
19 and future public health threats to address social determinants of
health.
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 ``Diversifying Investigations Via
Equitable Research Studies for Everyone Trials Act'' or the ``DIVERSE
Trials Act''.
SEC. 2. GUIDANCE ON DECENTRALIZED CLINICAL TRIALS.
(a) Definitions.--In this section, 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.
(b) Guidance.--Not later than 6 months after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this Act as the ``Secretary''), acting through the Commissioner of Food
and Drugs (referred to in this Act 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issue a draft guidance that addresses how to conduct decentralized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draft guidance ends, the Secretary shall issue a final guidance.
(c) Content of Guidance.--The guidance under subsection (b) shall
address the following:
(1) 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.
(2) Recommendations for--
(A) protocol design approaches;
(B) appropriate clinical endpoints;
(C) institutional review board composition and
ensuring that such boards include members with
expertise in decentralized clinical trials;
(D) delegation of clinical research organization
responsibilities and suitable proxies for clinical
research organizations; and
(E) simplifying informed consent.
(3) 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.
(4) 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.
(5) Information regarding when and how a study sponsor may
solicit a meeting with the Secretary regarding the issues
described in paragraphs (1) through (4).
(d) International Harmonization.--After issuing the final guidance
under subsection (b), 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.
SEC. 3. ENCOURAGEMENT OF CLINICAL TRIAL ENROLLMENT BY RACIALLY AND
ETHNICALLY DIVERSE POPULATIONS.
(a) No Cost Provision of Digital Health Technologies.--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--
(1) 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;
(2) the digital health technologies will facilitate
individuals participation, or are necessary to such
participation;
(3) 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
(4) the clinical trial sponsor requires participants to
return, purchase, or disable the digital health technologies by
the conclusion of the trial.
(b) Grants and Contracts.--
(1) In general.--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--
(A) working with community clinical trial sites,
including community health centers, academic health
centers, and other facilities;
(B) training health care personnel including
potential clinical trial investigators, with a focus on
significantly increasing the number of underrepresented
racial and ethnic minority healthcare personnel who are
clinical trial investigators at the community sites for
ongoing clinical trials;
(C) engaging community stakeholders to encourage
participation in clinical trials, especially in
underrepresented racial and ethnic minority
communities; and
(D) fostering partnerships with community-based
organizations serving underrepresented racial and
ethnical minority populations, including employee
unions and frontline health care workers.
(2) Priority for grant and contract awards.--In awarding
grants and contracts under this subsection, the Secretary shall
prioritize entities that--
(A) develop educational, recruitment, and training
materials in multiple languages; or
(B) undertake clinical trial outreach efforts in
more diverse racial and ethnic communities that are
traditionally underrepresented in clinical trials, such
as tribal areas.
(3) Authorization of appropriations.--There is authorized
to be appropriated for fiscal years 2020 and 2021 such sums as
may be necessary to carry out this subsection.
SEC. 4. ENHANCEMENT OF COVID-19 DATA COLLECTION TO ADDRESS DEMOGRAPHIC
DATA GAPS AND SOCIAL DETERMINANTS OF HEALTH.
(a) Data Collection To Address Demographic Data Gaps.--
(1) In general.--The Secretary shall require laboratories
that are subject to the reporting requirements under section
18115(a) of the Coronavirus Aid, Relief, and Economic Security
Act (Public Law 116-136), to include with reports made under
such section 18115(a) information to enhance such existing
COVID-19 data collection activities and to advance policies to
address social determinants of health, including additional
identifiers, such as those identified by the Commissioner,
including building on guidance existing on the date of
enactment of this Act, for the collection of race and ethnicity
data in clinical trials, as determined appropriate by the
Secretary.
(2) Additional use of data.--The data collected under
paragraph (1) may be used to inform--
(A) clinical trial recruitment;
(B) resource allocations;
(C) treatment strategies; and
(D) other public health activities.
(3) Collection via grants or contracts.--
(A) In general.--The Secretary may issue grants to,
and enter into contracts with, States, local public
health departments, or other entities supplying data to
the Secretary as required under this subsection, to
support the activities under this subsection.
(B) Guidance for use of funds.--In issuing grants
or contracts under subparagraph (A), the Secretary may
issue guidance regarding best practices for collecting
data pursuant to paragraph (1) and track the
performance of entities receiving grants or contracts.
(4) Use and disclosure for public health activities.--The
submission and use of data collected pursuant to this
subsection shall be considered a permitted disclosure and use
for public health activities as set forth in section
164.512(b)(1)(i) of 45, Code of Federal Regulations (or any
successor regulations).
(b) Data Collection Regarding Enhanced Risk for COVID-19.--The
Secretary shall--
(1) conduct a study on best practices for laboratories that
are subject to the reporting requirements under section
18115(a) of the Coronavirus Aid, Relief, and Economic Security
Act (Public Law 116-136) to aid such laboratories in collecting
data elements related to enhanced risk for COVID-19, such as
data, with respect to a patient, regarding income, education,
employment, disability, community resources, and social
support;
(2) consider which governmental entities (including
Federal, State, and local governmental entities) would be best
suited to aiding in collecting such data elements in
coordination with such laboratories; and
(3) issue guidance on such best practices.
SEC. 5. CLARIFICATION THAT CERTAIN REMUNERATION RELATED TO
PARTICIPATION IN CLINICAL TRIALS DOES NOT CONSTITUTE
REMUNERATION UNDER THE FEDERAL CIVIL MONEY PENALTIES LAW.
(a) In General.--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, 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''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to remuneration provided on or after the date of the enactment of
this Act.
SEC. 6. NATIONAL ACADEMY OF MEDICINE STUDY.
(a) In General.--The Secretary shall 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.
(b) Report.--The arrangement under subsection (a) 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 subsection (a) and
the design proposed based on such study.
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