[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2745 Reported in Senate (RS)]
<DOC>
Calendar No. 430
114th CONGRESS
2d Session
S. 2745
To amend the Public Health Service Act to promote the inclusion of
minorities in clinical research, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 5, 2016
Ms. Collins (for herself, Ms. Warren, Mr. Kirk, Ms. Baldwin, Mr.
Alexander, and Mrs. Murray) introduced the following bill; which was
read twice and referred to the Committee on Health, Education, Labor,
and Pensions
April 18, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to promote the inclusion of
minorities in clinical research, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Advancing NIH Strategic
Planning and Representation in Medical Research Act''.</DELETED>
<DELETED>SEC. 2. NIH STRATEGIC PLAN.</DELETED>
<DELETED> (a) Strategic Plan.--Section 402 of the Public Health
Service Act (42 U.S.C. 282) is amended--</DELETED>
<DELETED> (1) in subsection (b)(5), by inserting before the
semicolon the following: ``, and through the development,
implementation, and updating of the strategic plan developed
under subsection (m)''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(m) NIH Strategic Plan.--</DELETED>
<DELETED> ``(1) In general.--Not later than 2 years after
the date of enactment of the Advancing NIH Strategic Planning
and Representation in Medical Research Act, and once every 6
years thereafter, the Director of NIH, in consultation with the
directors of the national research institutes and national
centers, shall develop and submit to the appropriate committees
of Congress and post on the Internet website of the National
Institutes of Health, a 6-year coordinated strategy (to be
known as the `NIH Strategic Plan') to provide direction to the
biomedical research investments made by the National Institutes
of Health, to facilitate collaboration across the institutes
and centers, to leverage scientific opportunity, and to advance
biomedicine.</DELETED>
<DELETED> ``(2) Requirements.--The strategy under paragraph
(1) shall--</DELETED>
<DELETED> ``(A) identify strategic research
priorities and objectives across biomedical research,
including--</DELETED>
<DELETED> ``(i) an assessment of the state
of biomedical and behavioral research,
including areas of opportunity with respect to
basic, clinical, and translational
research;</DELETED>
<DELETED> ``(ii) priorities and objectives
to advance the treatment, cure, and prevention
of health conditions;</DELETED>
<DELETED> ``(iii) emerging scientific
opportunities, rising public health challenges,
and scientific knowledge gaps; and</DELETED>
<DELETED> ``(iv) the identification of near-
,
mid-, and long-term scientific needs;</DELETED>
<DELETED> ``(B) consider, in carrying out
subparagraph (A)--</DELETED>
<DELETED> ``(i) disease burden in the United
States;</DELETED>
<DELETED> ``(ii) rare diseases and
conditions;</DELETED>
<DELETED> ``(iii) biological, social, and
other determinants of health that contribute to
health disparities; and</DELETED>
<DELETED> ``(iv) other factors the Director
of NIH determines appropriate;</DELETED>
<DELETED> ``(C) include multi-institute priorities,
including coordination of research among institutes and
centers;</DELETED>
<DELETED> ``(D) include strategic priorities for
funding research through the Common Fund, in accordance
with section 402A(c)(1)(C);</DELETED>
<DELETED> ``(E) address the agency's proposed and
ongoing activities related to training and the
biomedical workforce; and</DELETED>
<DELETED> ``(F) describe opportunities for
collaboration with other agencies and departments, as
appropriate.</DELETED>
<DELETED> ``(3) Use of plans.--Strategic plans developed and
updated by the national research institutes and national
centers of the National Institutes of Health shall be prepared
regularly and in such a manner that such plans will be informed
by the strategic plans developed and updated under this
subsection.''.</DELETED>
<DELETED> (b) Conforming Amendment.--Section 402A(c)(1)(C) of the
Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by
striking ``Not later than June 1, 2007, and every 2 years thereafter,''
and inserting ``As part of the NIH Strategic Plan required under
section 402(m),''.</DELETED>
<DELETED>SEC. 3. COLLABORATION TO ENHANCE DIVERSITY IN CLINICAL
RESEARCH.</DELETED>
<DELETED> Section 402(b) of the Public Health Service Act (42 U.S.C.
282(b)) is amended--</DELETED>
<DELETED> (1) by amending paragraph (4) to read as
follows:</DELETED>
<DELETED> ``(4) shall assemble accurate data to be used to
assess research priorities, including--</DELETED>
<DELETED> ``(A) information to better evaluate
scientific opportunity, public health burdens, and
progress in reducing health disparities; and</DELETED>
<DELETED> ``(B) data on study populations of
clinical research, funded by or conducted at each
national research institute and national center,
which--</DELETED>
<DELETED> ``(i) specifies the inclusion of--
</DELETED>
<DELETED> ``(I) women;</DELETED>
<DELETED> ``(II) members of minority
groups;</DELETED>
<DELETED> ``(III) relevant age
categories; and</DELETED>
<DELETED> ``(IV) other demographic
variables determined to be necessary by
the Director of NIH;</DELETED>
<DELETED> ``(ii) is disaggregated by
research area, condition, and disease
categories; and</DELETED>
<DELETED> ``(iii) is to be made publicly
available on the Internet website of the
National Institutes of Health;''; and</DELETED>
<DELETED> (2) in paragraph (8)--</DELETED>
<DELETED> (A) in subparagraph (A), by striking
``and'' at the end; and</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(C) foster collaboration between
clinical research projects funded by the respective
national research institutes and national centers
that--</DELETED>
<DELETED> ``(i) conduct research involving
human subjects; and</DELETED>
<DELETED> ``(ii) collect similar data;
and</DELETED>
<DELETED> ``(D) encourage the collaboration
described in subparagraph (C) to--</DELETED>
<DELETED> ``(i) allow for an increase in the
number of subjects studied; and</DELETED>
<DELETED> ``(ii) utilize diverse study
populations, with special consideration to
biological, social, and other determinants of
health that contribute to health
disparities;''.</DELETED>
<DELETED>SEC. 4. PROMOTING INCLUSION IN CLINICAL RESEARCH.</DELETED>
<DELETED> (a) Strategic Plan.--Section 492B(a) of the Public Health
Service Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(3) Strategic planning.--</DELETED>
<DELETED> ``(A) In general.--The directors of the
national institutes and national centers shall consult
at least once annually with the Director of the
National Institute on Minority Health and Health
Disparities and the Director of the Office of Research
on Women's Health regarding objectives of the national
institutes and national centers to ensure that future
activities by such institutes and centers take into
account women and minorities and are focused on
reducing health disparities.</DELETED>
<DELETED> ``(B) Strategic plans.--Any strategic plan
issued by a national institute or national center shall
include details on the objectives described in
subparagraph (A).''.</DELETED>
<DELETED> (b) Clarification of Requirements.--Section 492B(c) of the
Public Health Service Act (42 U.S.C. 289a-2(c)) is amended--</DELETED>
<DELETED> (1) by striking ``In the case'' and inserting the
following:</DELETED>
<DELETED> ``(1) In general.--In the case''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(2) Reporting requirements.--For any new and
competing project of clinical research subject to the
requirements under this section that receives a grant award 1
year after the date of enactment of the Advancing NIH Strategic
Planning and Representation in Medical Research Act, or any
date thereafter, for which a valid analysis is provided under
paragraph (1)--</DELETED>
<DELETED> ``(A) and which is an applicable clinical
trial as defined in section 402(j), the entity
conducting such clinical research shall submit the
results of such valid analysis to the clinical trial
registry data bank expanded under section 402(j)(3),
and the Director of NIH shall, as appropriate, consider
whether such entity has complied with the reporting
requirement described in this subparagraph in awarding
any future grant to such entity, including pursuant to
section 402(j)(5)(A)(ii) when applicable; and</DELETED>
<DELETED> ``(B) the Director of NIH shall encourage
the reporting of the results of such valid analysis
described in paragraph (1) through any additional means
determined appropriate by the Director.''.</DELETED>
<DELETED> (c) Reporting.--Section 492B(f) of the Public Health
Service Act (42 U.S.C. 289a-2(f)) is amended--</DELETED>
<DELETED> (1) by striking ``biennial'' each place such term
appears and inserting ``triennial'' in each such
place;</DELETED>
<DELETED> (2) by striking ``The advisory council'' and
inserting the following:</DELETED>
<DELETED> ``(1) In general.--The advisory council'';
and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(2) Contents.--Each triennial report prepared by
an advisory council of each national research institute as
described in paragraph (1) shall include each of the
following:</DELETED>
<DELETED> ``(A) The number of women included as
subjects, and the proportion of subjects that are
women, in any project of clinical research conducted
during the applicable reporting period, disaggregated
by categories of research area, condition, or disease,
and accounting for single-sex studies.</DELETED>
<DELETED> ``(B) The number of members of minority
groups included as subjects, and the proportion of
subjects that are members of minority groups, in any
project of clinical research conducted during the
applicable reporting period, disaggregated by
categories of research area, condition, or disease and
accounting for single-race and single-ethnicity
studies.</DELETED>
<DELETED> ``(C) For the applicable reporting period,
the number of projects of clinical research that
include women and members of minority groups and that--
</DELETED>
<DELETED> ``(i) have been completed during
such reporting period; and</DELETED>
<DELETED> ``(ii) are being carried out
during such reporting period and have not been
completed.</DELETED>
<DELETED> ``(D) The number of studies completed
during the applicable reporting period for which
reporting has been submitted in accordance with
subsection (c)(2)(A).''.</DELETED>
<DELETED> (d) Coordination.--Section 486(c)(2) of the Public Health
Service Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees''
and inserting ``senior-level staff designees''.</DELETED>
<DELETED>SEC. 5. IMPROVING RESEARCH RELATED TO SEXUAL AND GENDER
MINORITY POPULATIONS.</DELETED>
<DELETED> (a) In General.--Part A of title IV of the Public Health
Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 404M. RESEARCH RELATED TO SEXUAL AND GENDER MINORITY
POPULATIONS.</DELETED>
<DELETED> ``The Director of NIH shall, as appropriate, encourage
efforts to improve research related to the health of sexual and gender
minority populations, including by--</DELETED>
<DELETED> ``(1) facilitating increased participation of
sexual and gender minority populations in clinical research
supported by the National Institutes of Health, and reporting
on such participation, as applicable;</DELETED>
<DELETED> ``(2) facilitating the development of valid and
reliable methods for research relevant to sexual and gender
minority populations; and</DELETED>
<DELETED> ``(3) addressing methodological
challenges.''.</DELETED>
<DELETED> (b) Reporting.--</DELETED>
<DELETED> (1) In general.--The Secretary, in collaboration
with the Director of the National Institutes of Health, shall
as appropriate--</DELETED>
<DELETED> (A) continue to support research for the
development of appropriate measures related to
reporting health information about sexual and gender
minority populations; and</DELETED>
<DELETED> (B) not later than 2 years after the date
of enactment of this Act, disseminate and make public
such measures.</DELETED>
<DELETED> (2) National academy of medicine
recommendations.--In developing the measures described in
paragraph (1)(A), the Secretary shall take into account
recommendations made by the National Academy of
Medicine.</DELETED>
<DELETED>SEC. 6. IMPROVING COORDINATION RELATED TO MINORITY HEALTH AND
HEALTH DISPARITIES.</DELETED>
<DELETED> Section 464z-3 of the Public Health Service Act (42 U.S.C.
285t) is amended--</DELETED>
<DELETED> (1) by redesignating subsection (h), relating to
interagency coordination, that follows subsection (j) as
subsection (k); and</DELETED>
<DELETED> (2) in subsection (k) (as so redesignated)--
</DELETED>
<DELETED> (A) in the heading, by striking
``Interagency'' and inserting ``Intra-NIH'';</DELETED>
<DELETED> (B) by striking ``as the primary Federal
officials'' and inserting ``as the primary Federal
official'';</DELETED>
<DELETED> (C) by inserting a comma after
``review'';</DELETED>
<DELETED> (D) by striking ``Institutes and Centers
of the National Institutes of Health'' and inserting
``national research institutes and national centers'';
and</DELETED>
<DELETED> (E) by adding at the end the following:
``The Director of the Institute may foster partnerships
between the national research institutes and national
centers and may encourage the funding of collaborative
research projects to achieve the goals of the National
Institutes of Health that are related to minority
health and health disparities.''.</DELETED>
<DELETED>SEC. 7. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC
RESEARCH.</DELETED>
<DELETED> (a) Establishment.--Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human Services,
acting through the Director of the National Institutes of Health, shall
convene a working group under the Advisory Committee to the Director of
the National Institutes of Health, appointed under section 222 of the
Public Health Service Act (42 U.S.C. 217a), to develop and issue
recommendations for a formal policy, which may incorporate or be
informed by relevant existing and ongoing activities, to enhance rigor
and reproducibility of scientific research funded by the National
Institutes of Health.</DELETED>
<DELETED> (b) Considerations.--In developing and issuing the
recommendations under subsection (a), the working group established
under such subsection shall consider, as appropriate--</DELETED>
<DELETED> (1) preclinical experiment design, including
analysis of sex as a biological variable;</DELETED>
<DELETED> (2) clinical experiment design, including--
</DELETED>
<DELETED> (A) the diversity of populations studied
for clinical research, with respect to biological,
social, and other determinants of health that
contribute to health disparities;</DELETED>
<DELETED> (B) the circumstances under which summary
information regarding biological, social, and other
factors that contribute to health disparities should be
reported; and</DELETED>
<DELETED> (C) the circumstances under which clinical
studies, including clinical trials, should conduct an
analysis of the data collected during the study on the
basis of biological, social, and other factors that
contribute to health disparities;</DELETED>
<DELETED> (3) applicable levels of rigor in statistical
methods, methodology, and analysis;</DELETED>
<DELETED> (4) data and information sharing in accordance
with applicable privacy laws and regulations; and</DELETED>
<DELETED> (5) any other matter determined relevant by the
working group.</DELETED>
<DELETED> (c) Policies.--Not later than 18 months after the date of
enactment of this Act, the Director of the National Institutes of
Health shall consider the recommendations developed by the working
group under subsection (a) and develop or update policies as
appropriate.</DELETED>
<DELETED> (d) Report.--Not later than 2 years after the date of
enactment of this Act, the Director of the National Institutes of
Health, acting through the working group established under subsection
(a), shall issue a report to the Secretary of Health and Human
Services, the Committee on Health, Education, Labor, and Pensions of
the Senate, and the Committee on Energy and Commerce of the House of
Representatives regarding recommendations developed under such
subsection and any subsequent policy changes implemented, to enhance
rigor and reproducibility in scientific research funded by the National
Institutes of Health.</DELETED>
<DELETED> (e) Confidentiality.--Nothing in this section shall
authorize the Secretary of Health and Human Services to disclose any
information that is a trade secret, or other privileged or confidential
information, described in section 552(b)(4) of title 5, United States
Code, or section 1905 of title 18, United States Code.</DELETED>
<DELETED>SEC. 8. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND
LACTATING WOMEN.</DELETED>
<DELETED> (a) Task Force on Research Specific to Pregnant Women and
Lactating Women.--</DELETED>
<DELETED> (1) Establishment.--Not later than 90 days after
the date of enactment of this Act, the Secretary of Health and
Human Services (referred to in this section as the
``Secretary'') shall establish a task force, in accordance with
the Federal Advisory Committee Act (5 U.S.C. App.), to be known
as the ``Task Force on Research Specific to Pregnant Women and
Lactating Women'' (in this section referred to as the ``Task
Force'').</DELETED>
<DELETED> (2) Duties.--The Task Force shall provide advice
and guidance to the Secretary regarding Federal activities
related to identifying and addressing gaps in knowledge and
research regarding safe and effective therapies for pregnant
women and lactating women, including the development of such
therapies and the collaboration on and coordination of such
activities.</DELETED>
<DELETED> (3) Membership.--</DELETED>
<DELETED> (A) Federal members.--The Task Force shall
be composed of each of the following Federal members,
or the designee of such member:</DELETED>
<DELETED> (i) The Director of the Centers
for Disease Control and Prevention.</DELETED>
<DELETED> (ii) The Director of the National
Institutes of Health, the Director of the
Eunice Kennedy Shriver National Institute of
Child Health and Human Development, and the
directors of such other appropriate national
research institutes.</DELETED>
<DELETED> (iii) The Commissioner of Food and
Drugs.</DELETED>
<DELETED> (iv) The Director of the Office on
Women's Health.</DELETED>
<DELETED> (v) The Director of the National
Vaccine Program Office.</DELETED>
<DELETED> (vi) The head of any other
research-related agency or department not
described in clauses (i) through (v) that the
Secretary determines appropriate, which may
include the Department of Veterans Affairs and
the Department of Defense.</DELETED>
<DELETED> (B) Non-federal members.--The Task Force
shall be composed of each of the following non-Federal
members, including--</DELETED>
<DELETED> (i) representatives from relevant
medical societies with subject matter expertise
on pregnant women, lactating women, or
children;</DELETED>
<DELETED> (ii) nonprofit organizations with
expertise related to the health of women and
children;</DELETED>
<DELETED> (iii) relevant industry
representatives; and</DELETED>
<DELETED> (iv) other representatives, as
appropriate.</DELETED>
<DELETED> (C) Limitations.--The non-Federal members
described in subparagraph (B) shall--</DELETED>
<DELETED> (i) compose not more than one-
half, and not less than one-third, of the total
membership of the Task Force; and</DELETED>
<DELETED> (ii) be appointed by the
Secretary.</DELETED>
<DELETED> (4) Termination.--</DELETED>
<DELETED> (A) In general.--Subject to subparagraph
(B), the Task Force shall terminate on the date that is
2 years after the date on which the Task Force is
established under paragraph (1).</DELETED>
<DELETED> (B) Extension.--The Secretary may extend
the operation of the Task Force for one additional 2-
year period following the 2-year period described in
subparagraph (A), if the Secretary determines that the
extension is appropriate for carrying out the purpose
of this section.</DELETED>
<DELETED> (5) Meetings.--The Task Force shall meet not less
than 2 times each year and shall convene public meetings, as
appropriate, to fulfill its duties under paragraph
(2).</DELETED>
<DELETED> (6) Task force report to congress.--Not later than
18 months after the date on which the Task Force is established
under paragraph (1), the Task Force shall prepare and submit to
the Secretary, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives a report that includes
each of the following:</DELETED>
<DELETED> (A) A plan to identify and address gaps in
knowledge and research regarding safe and effective
therapies for pregnant women and lactating women,
including the development of such therapies.</DELETED>
<DELETED> (B) Ethical issues surrounding the
inclusion of pregnant women and lactating women in
clinical research.</DELETED>
<DELETED> (C) Effective communication strategies
with health care providers and the public on
information relevant to pregnant women and lactating
women.</DELETED>
<DELETED> (D) Identification of Federal activities,
including--</DELETED>
<DELETED> (i) the state of research on
pregnancy and lactation;</DELETED>
<DELETED> (ii) recommendations for the
coordination of, and collaboration on research
related to pregnant women and lactating
women;</DELETED>
<DELETED> (iii) dissemination of research
findings and information relevant to pregnant
women and lactating women to providers and the
public; and</DELETED>
<DELETED> (iv) existing Federal efforts and
programs to improve the scientific
understanding of the health impacts on pregnant
women, lactating women and, related birth and
pediatric outcomes, including with respect to
pharmacokinetics, pharmacodynamics, and
toxicities.</DELETED>
<DELETED> (E) Recommendations to improve the
development of safe and effective therapies for
pregnant women and lactating women.</DELETED>
<DELETED> (b) Confidentiality.--Nothing in this section shall
authorize the Secretary of Health and Human Services to disclose any
information that is a trade secret, or other privileged or confidential
information, described in section 552(b)(4) of title 5, United States
Code, or section 1905 of title 18, United States Code.</DELETED>
<DELETED> (c) Updating Protections for Pregnant Women and Lactating
Women in Research.--</DELETED>
<DELETED> (1) In general.--Not later than 2 years after the
date of enactment of this Act, the Secretary, considering any
recommendations of the Task Force available at such time and in
consultation with the heads of relevant agencies of the
Department of Health and Human Services, shall, as appropriate,
update regulations and guidance, as applicable, regarding the
inclusion of pregnant women and lactating women in clinical
research.</DELETED>
<DELETED> (2) Criteria for excluding pregnant or lactating
women.--In updating any regulations or guidance described in
paragraph (1), the Secretary shall consider any appropriate
criteria to be used by institutional review boards and
individuals reviewing grant proposals for excluding pregnant
women or lactating women as a study population requiring
additional protections from participating in human subject
research.</DELETED>
<DELETED>SEC. 9. WOMEN AND MINORITIES IN RESEARCH.</DELETED>
<DELETED> (a) Basic Research.--</DELETED>
<DELETED> (1) Developing policies.--Not later than 2 years
after the date of enactment of this Act, the Director of the
National Institutes of Health (referred to in this section as
the ``Director of NIH''), taking into consideration the
findings of the working group established under section 7,
shall develop policies for projects of basic research funded by
National Institutes of Health to assess--</DELETED>
<DELETED> (A) relevant biological variables
including sex, as appropriate; and</DELETED>
<DELETED> (B) how differences between male and
female cells, tissues, or animals may be examined and
analyzed.</DELETED>
<DELETED> (2) Revising policies.--The Director of NIH may
update or revise the policies developed under paragraph (1) as
appropriate.</DELETED>
<DELETED> (3) Consultation and outreach.--In developing,
updating, or revising the policies under this section, the
Director of NIH--</DELETED>
<DELETED> (A) shall consult with--</DELETED>
<DELETED> (i) the Office of Research on
Women's Health;</DELETED>
<DELETED> (ii) the Office of Laboratory
Animal Welfare; and</DELETED>
<DELETED> (iii) appropriate members of the
scientific and academic communities;
and</DELETED>
<DELETED> (B) shall conduct outreach to solicit
feedback from members of the scientific and academic
communities on the influence of sex as a variable in
basic research, including feedback on when it is
appropriate for projects of basic research involving
cells, tissues, or animals to include both male and
female cells, tissues, or animals.</DELETED>
<DELETED> (4) Additional requirements.--The Director of NIH
shall--</DELETED>
<DELETED> (A) ensure that projects of basic research
funded by the National Institutes of Health are
conducted in accordance with the policies developed,
updated, or revised under this section, as applicable;
and</DELETED>
<DELETED> (B) encourage that the results of such
research, when published or reported, be disaggregated
as appropriate with respect to the analysis of any sex
differences.</DELETED>
<DELETED> (b) Clinical Research.--</DELETED>
<DELETED> (1) In general.--Not later than 1 year after the
date of enactment of this Act, the Director of NIH, in
consultation with the Director of the Office of Research on
Women's Health and the Director of the National Institute on
Minority Health and Health Disparities, shall update the
guidelines established under section 492B(d) of Public Health
Service Act (42 U.S.C. 289a-2(d)) in accordance with paragraph
(2).</DELETED>
<DELETED> (2) Requirements.--The updated guidelines
described in paragraph (1) shall--</DELETED>
<DELETED> (A) reflect the science regarding sex
differences;</DELETED>
<DELETED> (B) improve adherence to the requirements
under section 492B of the Public Health Service Act (42
U.S.C. 289a-2), including the reporting requirements
under subsection (f) of such section; and</DELETED>
<DELETED> (C) clarify the circumstances under which
studies should be designed to support the conduct of
analyses to detect significant differences in the
intervention effect due to demographic factors related
to section 492B of the Public Health Service Act,
including in the absence of prior studies that
demonstrate a difference in study outcomes on the basis
of such factors and considering the effects of the
absence of such analyses on the availability of data
related to demographic differences.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advancing NIH Strategic Planning and
Representation in Medical Research Act''.
SEC. 2. NIH STRATEGIC PLAN.
(a) Strategic Plan.--Section 402 of the Public Health Service Act
(42 U.S.C. 282) is amended--
(1) in subsection (b)(5), by inserting before the semicolon
the following: ``, and through the development, implementation,
and updating of the strategic plan developed under subsection
(m)''; and
(2) by adding at the end the following:
``(m) NIH Strategic Plan.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Advancing NIH Strategic Planning and
Representation in Medical Research Act, and once every 6 years
thereafter, the Director of NIH, in consultation with the
directors of the national research institutes and national
centers, shall develop and submit to the appropriate committees
of Congress and post on the Internet website of the National
Institutes of Health, a 6-year coordinated strategy (to be
known as the `NIH Strategic Plan') to provide direction to the
biomedical research investments made by the National Institutes
of Health, to facilitate collaboration across the institutes
and centers, to leverage scientific opportunity, and to advance
biomedicine.
``(2) Requirements.--The strategy under paragraph (1)
shall--
``(A) identify strategic research priorities and
objectives across biomedical research, including--
``(i) an assessment of the state of
biomedical and behavioral research, including
areas of opportunity with respect to basic,
clinical, and translational research;
``(ii) priorities and objectives to advance
the treatment, cure, and prevention of health
conditions;
``(iii) emerging scientific opportunities,
rising public health challenges, and scientific
knowledge gaps; and
``(iv) the identification of near-, mid-,
and long-term scientific needs;
``(B) consider, in carrying out subparagraph (A)--
``(i) disease burden in the United States;
``(ii) rare diseases and conditions;
``(iii) biological, social, and other
determinants of health that contribute to
health disparities; and
``(iv) other factors the Director of NIH
determines appropriate;
``(C) include multi-institute priorities, including
coordination of research among institutes and centers;
``(D) include strategic priorities for funding
research through the Common Fund, in accordance with
section 402A(c)(1)(C));
``(E) address the agency's proposed and ongoing
activities related to training and the biomedical
workforce; and
``(F) describe opportunities for collaboration with
other agencies and departments, as appropriate.
``(3) Use of plans.--Strategic plans developed and updated
by the national research institutes and national centers of the
National Institutes of Health shall be prepared regularly and
in such a manner that such plans will be informed by the
strategic plans developed and updated under this subsection.''.
(b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public
Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking
``Not later than June 1, 2007, and every 2 years thereafter,'' and
inserting ``As part of the NIH Strategic Plan required under section
402(m),''.
SEC. 3. COLLABORATION TO ENHANCE DIVERSITY IN CLINICAL RESEARCH.
Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b))
is amended--
(1) by amending paragraph (4) to read as follows:
``(4) shall assemble accurate data to be used to assess
research priorities, including--
``(A) information to better evaluate scientific
opportunity, public health burdens, and progress in
reducing health disparities; and
``(B) data on study populations of clinical
research, funded by or conducted at each national
research institute and national center, which--
``(i) specifies the inclusion of--
``(I) women;
``(II) members of minority groups;
``(III) relevant age categories;
and
``(IV) other demographic variables
determined to be necessary by the
Director of NIH;
``(ii) is disaggregated by research area,
condition, and disease categories; and
``(iii) is to be made publicly available on
the Internet website of the National Institutes
of Health;''; and
(2) in paragraph (8)--
(A) in subparagraph (A), by striking ``and'' at the
end; and
(B) by adding at the end the following:
``(C) foster collaboration between clinical
research projects funded by the respective national
research institutes and national centers that--
``(i) conduct research involving human
subjects; and
``(ii) collect similar data; and
``(D) encourage the collaboration described in
subparagraph (C) to--
``(i) allow for an increase in the number
of subjects studied; and
``(ii) utilize diverse study populations,
with special consideration to biological,
social, and other determinants of health that
contribute to health disparities;''.
SEC. 4. PROMOTING INCLUSION IN CLINICAL RESEARCH.
(a) Strategic Plan.--Section 492B(a) of the Public Health Service
Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the
following:
``(3) Strategic planning.--
``(A) In general.--The directors of the national
institutes and national centers shall consult at least
once annually with the Director of the National
Institute on Minority Health and Health Disparities and
the Director of the Office of Research on Women's
Health regarding objectives of the national institutes
and national centers to ensure that future activities
by such institutes and centers take into account women
and minorities and are focused on reducing health
disparities.
``(B) Strategic plans.--Any strategic plan issued
by a national institute or national center shall
include details on the objectives described in
subparagraph (A).''.
(b) Clarification of Requirements.--Section 492B(c) of the Public
Health Service Act (42 U.S.C. 289a-2(c)) is amended--
(1) by striking ``In the case'' and inserting the
following:
``(1) In general.--In the case''; and
(2) by adding at the end the following:
``(2) Reporting requirements.--For any new and competing
project of clinical research subject to the requirements under
this section that receives a grant award 1 year after the date
of enactment of the Advancing NIH Strategic Planning and
Representation in Medical Research Act, or any date thereafter,
for which a valid analysis is provided under paragraph (1)--
``(A) and which is an applicable clinical trial as
defined in section 402(j), the entity conducting such
clinical research shall submit the results of such
valid analysis to the clinical trial registry data bank
expanded under 402(j)(3), and the Director of NIH
shall, as appropriate, consider whether such entity has
complied with the reporting requirement described in
this subparagraph in awarding any future grant to such
entity, including pursuant to section 402(j)(5)(A)(ii)
when applicable; and
``(B) the Director of NIH shall encourage the
reporting of the results of such valid analysis
described in paragraph (1) through any additional means
determined appropriate by the Director.''.
(c) Reporting.--Section 492B(f) of the Public Health Service Act
(42 U.S.C. 289a-2(f)) is amended--
(1) by striking ``biennial'' each place such term appears
and inserting ``triennial'' in each such place;
(2) by striking ``The advisory council'' and inserting the
following:
``(1) In general.--The advisory council''; and
(3) by adding at the end the following:
``(2) Contents.--Each triennial report prepared by an
advisory council of each national research institute as
described in paragraph (1) shall include each of the following:
``(A) The number of women included as subjects, and
the proportion of subjects that are women, in any
project of clinical research conducted during the
applicable reporting period, disaggregated by
categories of research area, condition, or disease, and
accounting for single-sex studies.
``(B) The number of members of minority groups
included as subjects, and the proportion of subjects
that are members of minority groups, in any project of
clinical research conducted during the applicable
reporting period, disaggregated by categories of
research area, condition, or disease and accounting for
single-race and single-ethnicity studies.
``(C) For the applicable reporting period, the
number of projects of clinical research that include
women and members of minority groups and that--
``(i) have been completed during such
reporting period; and
``(ii) are being carried out during such
reporting period and have not been completed.
``(D) The number of studies completed during the
applicable reporting period for which reporting has
been submitted in accordance with subsection
(c)(2)(A).''.
(d) Coordination.--Section 486(c)(2) of the Public Health Service
Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and
inserting ``senior-level staff designees''.
SEC. 5. IMPROVING RESEARCH RELATED TO SEXUAL AND GENDER MINORITY
POPULATIONS.
(a) In General.--Part A of title IV of the Public Health Service
Act (42 U.S.C. 281 et seq.) is amended by adding at the end the
following:
``SEC. 404M. RESEARCH RELATED TO SEXUAL AND GENDER MINORITY
POPULATIONS.
``The Director of NIH shall, as appropriate, encourage efforts to
improve research related to the health of sexual and gender minority
populations, including by--
``(1) facilitating increased participation of sexual and
gender minority populations in clinical research supported by
the National Institutes of Health, and reporting on such
participation, as applicable;
``(2) facilitating the development of valid and reliable
methods for research relevant to sexual and gender minority
populations; and
``(3) addressing methodological challenges.''.
(b) Reporting.--
(1) In general.--The Secretary, in collaboration with the
Director of the National Institutes of Health, shall as
appropriate--
(A) continue to support research for the
development of appropriate measures related to
reporting health information about sexual and gender
minority populations; and
(B) not later than 2 years after the date of
enactment of this Act, disseminate and make public such
measures.
(2) National academy of medicine recommendations.--In
developing the measures described in paragraph (1)(A), the
Secretary shall take into account recommendations made by the
National Academy of Medicine.
SEC. 6. IMPROVING COORDINATION RELATED TO MINORITY HEALTH AND HEALTH
DISPARITIES.
Section 464z-3 of the Public Health Service Act (42 U.S.C. 285t) is
amended--
(1) by redesignating subsection (h), relating to
interagency coordination, that follows subsection (j) as
subsection (k); and
(2) in subsection (k) (as so redesignated)--
(A) in the subsection heading, by striking
``Interagency'' and inserting ``Intra-NIH'';
(B) by striking ``as the primary Federal
officials'' and inserting ``as the primary Federal
official'';
(C) by inserting a comma after ``review'';
(D) by striking ``Institutes and Centers of the
National Institutes of Health'' and inserting
``national research institutes and national centers'';
and
(E) by adding at the end the following: ``The
Director of the Institute may foster partnerships
between the national research institutes and national
centers and may encourage the funding of collaborative
research projects to achieve the goals of the National
Institutes of Health that are related to minority
health and health disparities.''.
SEC. 7. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH.
(a) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Director of the National Institutes of Health, shall
convene a working group under the Advisory Committee to the Director of
the National Institutes of Health, appointed under section 222 of the
Public Health Service Act (42 U.S.C. 217a), to develop and issue
recommendations for a formal policy, which may incorporate or be
informed by relevant existing and ongoing activities, to enhance rigor
and reproducibility of scientific research funded by the National
Institutes of Health.
(b) Considerations.--In developing and issuing the recommendations
under subsection (a), the working group established under such
subsection shall consider, as appropriate--
(1) preclinical experiment design, including analysis of
sex as a biological variable;
(2) clinical experiment design, including--
(A) the diversity of populations studied for
clinical research, with respect to biological, social,
and other determinants of health that contribute to
health disparities;
(B) the circumstances under which summary
information regarding biological, social, and other
factors that contribute to health disparities should be
reported; and
(C) the circumstances under which clinical studies,
including clinical trials, should conduct an analysis
of the data collected during the study on the basis of
biological, social, and other factors that contribute
to health disparities;
(3) applicable levels of rigor in statistical methods,
methodology, and analysis;
(4) data and information sharing in accordance with
applicable privacy laws and regulations; and
(5) any other matter determined relevant by the working
group.
(c) Policies.--Not later than 18 months after the date of enactment
of this Act, the Director of the National Institutes of Health shall
consider the recommendations developed by the working group under
subsection (a) and develop or update policies as appropriate.
(d) Report.--Not later than 2 years after the date of enactment of
this Act, the Director of the National Institutes of Health, acting
through the working group established under subsection (a), shall issue
a report to the Secretary of Health and Human Services, the Committee
on Health, Education, Labor, and Pensions of the Senate, and the
Committee on Energy and Commerce of the House of Representatives
regarding recommendations developed under such subsection and any
subsequent policy changes implemented, to enhance rigor and
reproducibility in scientific research funded by the National
Institutes of Health.
(e) Confidentiality.--Nothing in this section shall authorize the
Secretary of Health and Human Services to disclose any information that
is a trade secret, or other privileged or confidential information,
described in section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
SEC. 8. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND LACTATING
WOMEN.
(a) Task Force on Research Specific to Pregnant Women and Lactating
Women.--
(1) Establishment.--Not later than 90 days after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall establish a task force, in accordance with the Federal
Advisory Committee Act (5 U.S.C. App.), to be known as the
``Task Force on Research Specific to Pregnant Women and
Lactating Women'' (in this section referred to as the ``Task
Force'').
(2) Duties.--The Task Force shall provide advice and
guidance to the Secretary regarding Federal activities related
to identifying and addressing gaps in knowledge and research
regarding safe and effective therapies for pregnant women and
lactating women, including the development of such therapies
and the collaboration on and coordination of such activities.
(3) Membership.--
(A) Federal members.--The Task Force shall be
composed of each of the following Federal members, or
the designees of such members:
(i) The Director of the Centers for Disease
Control and Prevention.
(ii) The Director of the National
Institutes of Health, the Director of the
Eunice Kennedy Shriver National Institute of
Child Health and Human Development, and the
directors of such other appropriate national
research institutes.
(iii) The Commissioner of Food and Drugs.
(iv) The Director of the Office on Women's
Health.
(v) The Director of the National Vaccine
Program Office.
(vi) The head of any other research-related
agency or department not described in clauses
(i) through (v) that the Secretary determines
appropriate, which may include the Department
of Veterans Affairs and the Department of
Defense.
(B) Non-federal members.--The Task Force shall be
composed of each of the following non-Federal members,
including--
(i) representatives from relevant medical
societies with subject matter expertise on
pregnant women, lactating women, or children;
(ii) nonprofit organizations with expertise
related to the health of women and children;
(iii) relevant industry representatives;
and
(iv) other representatives, as appropriate.
(C) Limitations.--The non-Federal members described
in subparagraph (B) shall--
(i) compose not more than one-half, and not
less than one-third, of the total membership of
the Task Force; and
(ii) be appointed by the Secretary.
(4) Termination.--
(A) In general.--Subject to subparagraph (B), the
Task Force shall terminate on the date that is 2 years
after the date on which the Task Force is established
under paragraph (1).
(B) Extension.--The Secretary may extend the
operation of the Task Force for one additional 2-year
period following the 2-year period described in
subparagraph (A), if the Secretary determines that the
extension is appropriate for carrying out the purpose
of this section.
(5) Meetings.--The Task Force shall meet not less than 2
times each year and shall convene public meetings, as
appropriate, to fulfill its duties under paragraph (2).
(6) Task force report to congress.--Not later than 18
months after the date on which the Task Force is established
under paragraph (1), the Task Force shall prepare and submit to
the Secretary, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives a report that includes
each of the following:
(A) A plan to identify and address gaps in
knowledge and research regarding safe and effective
therapies for pregnant women and lactating women,
including the development of such therapies.
(B) Ethical issues surrounding the inclusion of
pregnant women and lactating women in clinical
research.
(C) Effective communication strategies with health
care providers and the public on information relevant
to pregnant women and lactating women.
(D) Identification of Federal activities,
including--
(i) the state of research on pregnancy and
lactation;
(ii) recommendations for the coordination
of, and collaboration on research related to
pregnant women and lactating women;
(iii) dissemination of research findings
and information relevant to pregnant women and
lactating women to providers and the public;
and
(iv) existing Federal efforts and programs
to improve the scientific understanding of the
health impacts on pregnant women, lactating
women, and related birth and pediatric
outcomes, including with respect to
pharmacokinetics, pharmacodynamics, and
toxicities.
(E) Recommendations to improve the development of
safe and effective therapies for pregnant women and
lactating women.
(b) Confidentiality.--Nothing in this section shall authorize the
Secretary of Health and Human Services to disclose any information that
is a trade secret, or other privileged or confidential information,
described in section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
(c) Updating Protections for Pregnant Women and Lactating Women in
Research.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary, considering any
recommendations of the Task Force available at such time and in
consultation with the heads of relevant agencies of the
Department of Health and Human Services, shall, as appropriate,
update regulations and guidance, as applicable, regarding the
inclusion of pregnant women and lactating women in clinical
research.
(2) Criteria for excluding pregnant or lactating women.--In
updating any regulations or guidance described in paragraph
(1), the Secretary shall consider any appropriate criteria to
be used by institutional review boards and individuals
reviewing grant proposals for excluding pregnant women or
lactating women as a study population requiring additional
protections from participating in human subject research.
SEC. 9. WOMEN AND MINORITIES IN RESEARCH.
(a) Basic Research.--
(1) Developing policies.--Not later than 2 years after the
date of enactment of this Act, the Director of the National
Institutes of Health (referred to in this section as the
``Director of NIH''), taking into consideration the findings of
the working group established under section 7, shall develop
policies for projects of basic research funded by National
Institutes of Health to assess--
(A) relevant biological variables including sex, as
appropriate; and
(B) how differences between male and female cells,
tissues, or animals may be examined and analyzed.
(2) Revising policies.--The Director of NIH may update or
revise the policies developed under paragraph (1) as
appropriate.
(3) Consultation and outreach.--In developing, updating, or
revising the policies under this section, the Director of NIH--
(A) shall consult with--
(i) the Office of Research on Women's
Health;
(ii) the Office of Laboratory Animal
Welfare; and
(iii) appropriate members of the scientific
and academic communities; and
(B) shall conduct outreach to solicit feedback from
members of the scientific and academic communities on
the influence of sex as a variable in basic research,
including feedback on when it is appropriate for
projects of basic research involving cells, tissues, or
animals to include both male and female cells, tissues,
or animals.
(4) Additional requirements.--The Director of NIH shall--
(A) ensure that projects of basic research funded
by the National Institutes of Health are conducted in
accordance with the policies developed, updated, or
revised under this section, as applicable; and
(B) encourage that the results of such research,
when published or reported, be disaggregated as
appropriate with respect to the analysis of any sex
differences.
(b) Clinical Research.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Director of NIH, in consultation
with the Director of the Office of Research on Women's Health
and the Director of the National Institute on Minority Health
and Health Disparities, shall update the guidelines established
under section 492B(d) of Public Health Service Act (42 U.S.C.
289a-2(d)) in accordance with paragraph (2).
(2) Requirements.--The updated guidelines described in
paragraph (1) shall--
(A) reflect the science regarding sex differences;
(B) improve adherence to the requirements under
section 492B of the Public Health Service Act (42
U.S.C. 289a-2), including the reporting requirements
under subsection (f) of such section; and
(C) clarify the circumstances under which studies
should be designed to support the conduct of analyses
to detect significant differences in the intervention
effect due to demographic factors related to section
492B of the Public Health Service Act, including in the
absence of prior studies that demonstrate a difference
in study outcomes on the basis of such factors and
considering the effects of the absence of such analyses
on the availability of data related to demographic
differences.
Calendar No. 430
114th CONGRESS
2d Session
S. 2745
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to promote the inclusion of
minorities in clinical research, and for other purposes.
_______________________________________________________________________
April 18, 2016
Reported with an amendment