Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021 or the ENACT Act of 2021
This bill sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimer's disease and related dementias.
Specifically, the National Institute on Aging (NIA) must establish and provide technical assistance to Alzheimer's research centers located in areas with higher concentrations of minority groups. These centers must
Additionally, the NIA must disseminate information to members of minority populations about participating in clinical trials and take other actions to enhance diversity with respect to the Alzheimer's research that it conducts or supports.
The bill also directs the NIA to increase diversity among Alzheimer's researchers by encouraging the participation of individuals who are from groups that are underrepresented in clinical, behavioral, and social sciences.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3085 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 3085
To amend the Public Health Service Act to improve the diversity of
participants in research on Alzheimer's disease, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 11, 2021
Ms. Blunt Rochester (for herself, Ms. Herrera Beutler, Mr. Curtis, Mr.
Smith of New Jersey, and Ms. Waters) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to improve the diversity of
participants in research on Alzheimer's disease, 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 ``Equity in Neuroscience and
Alzheimer's Clinical Trials Act of 2021'' or the ``ENACT Act of 2021''.
SEC. 2. INCENTIVES, IMPROVEMENTS, AND OUTREACH TO INCREASE DIVERSITY IN
ALZHEIMER'S DISEASE RESEARCH.
(a) Improving Access for and Outreach to Underrepresented
Populations.--
(1) Expanding access to alzheimer's research centers.--
(A) In general.--Section 445(a)(1) of the Public
Health Service Act (42 U.S.C. 285e-2(a)(1)) is
amended--
(i) by striking ``(a)(1) The Director of
the Institute may'' and inserting the
following:
``(a)(1) The Director of the Institute--
``(A) may'';
(ii) by striking ``disease.'' and inserting
``disease; and''; and
(iii) by adding at the end the following:
``(B) beginning January 1, 2022, shall enter into
cooperative agreements and make grants to public or private
nonprofit entities under this subsection for the planning,
establishment, and operation of new such centers that are
located in areas with a higher concentration of minority groups
(as determined under section 444(d)(3)(D)), such as entities
that are historically Black colleges and universities,
Hispanic-serving institutions, Tribal colleges and
universities, or centers of excellence for other minority
populations.''.
(B) Use of funding for clinics to operate clinical
trials.--Section 445(b) of the Public Health Service
Act (42 U.S.C. 285e-2(b)) is amended by adding at the
end the following:
``(3) Federal payments made under a cooperative agreement or grant
under subsection (a) from funds made available under section 2(g) of
the ENACT Act of 2021 shall, with respect to Alzheimer's disease, be
used in part to establish and operate diagnostic and treatment clinics
designed--
``(A) to meet the special needs of minority and rural
populations and other underserved populations; and
``(B) to operate clinical trials''.
(2) Outreach.--
(A) Alzheimer's disease centers.--Section 445(b) of
the Public Health Service Act (42 U.S.C. 285e-2(b)), as
amended by paragraph (1)(B), is further amended by
adding at the end the following new paragraph:
``(4) Federal payments made under a cooperative agreement or grant
under subsection (a) shall be used to establish engagement centers to
carry out public outreach, education efforts, and dissemination of
information for members of minority groups about clinical trial
participation. Activities funded pursuant to the preceding sentence
shall include--
``(A) using established mechanisms to encourage members of
minority groups to participate in clinical trials on
Alzheimer's disease;
``(B) expanding education efforts to make members of
minority groups aware of ongoing clinical trials;
``(C) working with trial sponsors to increase the number of
recruitment events for members of minority groups;
``(D) conducting outreach to national, State, and local
physician professional organizations, especially for members of
such organizations who are primary care physicians or
physicians who specialize in dementia, to increase awareness of
clinical research opportunities for members of minority groups;
and
``(E) using community-based participatory research
methodologies to engage with minority populations.''.
(B) Resource centers for minority aging research.--
Section 444(c) of the Public Health Service Act (42
U.S.C. 285e-1(c)) is amended--
(i) by striking ``(c)'' and inserting
``(c)(1)'' ; and
(ii) by adding at the end the following new
paragraph:
``(2) The Director, acting through the Resource Centers for
Minority Aging Research of the Institute, shall carry out public
outreach, education efforts, and dissemination of information for
members of minority groups about participation in clinical research on
Alzheimer's disease carried out or supported under this subpart.''.
(b) Incentives to Increase Diversity in Alzheimer's Disease
Research Through Principal Investigators and Researchers From
Underrepresented Populations.--
(1) Alzheimer's clinical research and training awards.--
Section 445I of the Public Health Service Act (42 U.S.C. 285e-
10a) is amended by adding at the end the following new
subsection:
``(d) Enhancing the Participation of Principal Investigators and
Researchers Who Are Members of Underrepresented Populations.--
``(1) In general.--The Director shall enhance diversity in
the conduct or support of clinical research on Alzheimer's
disease under this subpart by encouraging the participation of
individuals from groups that are underrepresented in the
biomedical, clinical, behavioral, and social sciences as
principal investigators of such clinical research, as
researchers for such clinical research, or both.
``(2) Training for principal investigators.--The Director
of the Institute shall provide training for principal
investigators who are members of a minority group with respect
to skills for--
``(A) the design and conduct of clinical research
and clinical protocols;
``(B) applying for grants for clinical research;
and
``(C) such other areas as the Director determines
to be appropriate.''.
(2) Senior researcher awards.--Section 445B(a) of the
Public Health Service Act (42 U.S.C. 285e-4(a)) is amended by
inserting ``, including senior researchers who are members of a
minority group'' before the period at the end of the first
sentence.
(c) Incentives to Increase Diversity in Alzheimer's Disease
Research Through Trial Sites.--Section 444(d) of the Public Health
Service Act (42 U.S.C. 285e-1(d)) is amended--
(1) by striking ``(d)'' and inserting ``(d)(1)'' ; and
(2) by adding at the end the following new paragraphs:
``(2) In conducting or supporting clinical research on Alzheimer's
disease for purposes of this subpart, in addition to requirements
otherwise imposed under this title, including under section 492B, the
Director of the Institute shall increase the participation of members
of minority groups in such clinical research through one or more of the
activities described in paragraph (3).
``(3)(A) The Director of the Institute shall provide incentives for
the support of clinical research on Alzheimer's disease with clinical
trial sites established in areas with a higher concentration of
minority groups, including rural areas if practicable.
``(B) In determining whether to conduct or support clinical
research on Alzheimer's disease, the Director of the Institute shall
encourage the conduct of clinical research with clinical trial sites in
areas described in subparagraph (A) as a higher-level priority
criterion among the criteria established to evaluate whether to conduct
or support clinical research.
``(C) In determining the amount of funding to be provided for the
conduct or support of such clinical research, the Director of the
Institute shall provide additional funding for the conduct of such
clinical research with clinical trial sites in areas described in
subparagraph (A).
``(D) In determining whether an area is an area with a higher
concentration of minority groups, the Director of the Institute--
``(i) shall consider the most recent data collected by the
Bureau of the Census; and
``(ii) may also consider--
``(I) data from the Centers for Medicare & Medicaid
Services on the incidence of Alzheimer's disease in the
United States by region; and
``(II) such other data as the Director determines
appropriate.
``(4) In order to facilitate the participation of members of
minority groups in clinical research supported under this subpart, in
addition to activities described in paragraph (3), the Director of the
Institute shall--
``(A) ensure that such clinical research uses community-
based participatory research methodologies; and
``(B) encourage the use of remote health technologies,
including telehealth, remote patient monitoring, and mobile
technologies, that reduce or eliminate barriers to
participation of members of minority groups in such clinical
research.
``(5)(A) Clinical research on Alzheimer's disease conducted or
supported under this subpart shall ensure that such research includes
outreach activities designed to increase the participation of members
of minority groups in such research.
``(B)(i) Each applicant for a grant under this subpart for clinical
research on Alzheimer's disease shall submit to the Director of the
Institute in the application for such grant--
``(I) a budget for outreach activities to members of
minority populations with respect to participation in such
clinical research; and
``(II) a description of the plan to conduct such outreach.
``(ii) The Director of the Institute shall encourage applicants
for, and recipients of, grants under this subpart to conduct clinical
research on Alzheimer's disease to engage with community-based
organizations to increase participation of minority populations in such
research.
``(6) For purposes of this subpart:
``(A) The term `clinical research' includes a clinical
trial.
``(B) The term `minority group' has the meaning given such
term by reason of section 492B(g).''.
(d) Participant Eligibility Criteria.--Section 445I of the Public
Health Service Act (42 U.S.C. 285e-10a), as amended by subsection
(b)(1), is further amended by adding at the end the following new
subsection:
``(e) Participant Eligibility Criteria.--The Director of the
Institute shall take such actions as are necessary to ensure that
clinical research on Alzheimer's disease conducted or supported under
this subpart is designed with eligibility criteria that ensure the
clinical trial population reflects the diversity of the prospective
patient population. Such actions may include the following:
``(1) Examination of criteria.--
``(A) In general.--An examination of each exclusion
criterion to determine if the criterion is necessary to
ensure the safety of trial participants or to achieve
the study objectives.
``(B) Modification of criteria.--In the case of an
exclusion criterion that is not necessary to ensure the
safety of trial participants or to achieve the study
objectives--
``(i) encouraging the modification or
elimination of the criterion; or
``(ii) encouraging tailoring the criterion
as narrowly as possible to avoid unnecessary
limits to the population of the clinical study.
``(2) Requirement for strong justification for exclusion.--
A review of each exclusion criterion to ensure that populations
are included in clinical trials, such as older adults,
individuals with a mild form of disease, individuals at the
extremes of the weight range, or children, unless there is a
strong clinical or scientific justification to exclude them.
``(3) Use of adaptive design.--Encouraging the use of an
adaptive clinical trial design that--
``(A) starts with a defined population where there
are concerns about safety; and
``(B) may expand to a broader population based on
initial data from the trial and external data.''.
(e) Resource Center for Successful Strategies to Increase
Participation of Underrepresented Populations in Alzheimer's Disease
Clinical Research.--Section 444 of the Public Health Service Act (42
U.S.C. 285e-1) is amended by adding at the end the following new
subsection:
``(e)(1) Acting through the Office of Special Populations and in
consultation with the Division of Extramural Activities, the Director
of the Institute shall support resource information and technical
assistance to grantees under section 445 (relating to Alzheimer's
disease centers), other grantees, and prospective grantees, designed to
increase the participation of minority populations in clinical research
on Alzheimer's disease conducted or supported under this subpart.
``(2) The resource information and technical assistance provided
under paragraph (1) shall include the maintenance of a central resource
library in order to collect, prepare, analyze, and disseminate
information relating to strategies and best practices used by
recipients of grants under this subpart and other researchers in the
development of the clinical research designed to increase the
participation of minority populations in such clinical research.''.
(f) Annual Reports.--Section 444 of the Public Health Service Act
(42 U.S.C. 285e-1), as amended by subsection (e), is further amended by
adding at the end the following new subsection:
``(f)(1)(A) The Director of the Institute shall submit annual
reports to the Congress on the impact of the amendments made to this
subpart by the ENACT Act of 2021.
``(B) The Secretary shall transmit a copy of each such report to
the Advisory Council on Alzheimer's Research, Care, and Services
established under section 2(e) of the National Alzheimer's Project Act
(Public Law 111-375).
``(2) In each report under paragraph (1), the Director of the
Institute shall include information and data on the following matters
with respect to clinical trials on Alzheimer's disease conducted during
the preceding year:
``(A) The number of participants who are members of a
minority group in such clinical trials.
``(B) The number of such clinical trials for which
incentives under subsection (d)(3) were made available, the
nature of such incentives, the amount of increased funding (if
any) made available for research on Alzheimer's disease, and
the training provided to principal investigators who are
members of a minority group and the amount of funding (if any)
for such training.
``(C) The number of such clinical trials for which the
principal investigator is a member of a minority group.
``(D) The number of such clinical trials for which a
significant percentage of researchers are members of a minority
group.
``(E) Modifications to patient eligibility criteria in
clinical trial designs under section 445I(e).
``(F) Outreach and education efforts conducted under
section 445(b)(3).
``(3) The Director of the Institute shall make each report under
paragraph (1) available to the public, including through posting on the
appropriate website of the Department of Health and Human Services.''.
(g) Authorization of Appropriations.--For each of fiscal years 2022
through 2026, there is authorized to be appropriated to the Secretary
of Health and Human Services $60,000,000 to carry out the amendments
made by this section, to remain available until expended.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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