[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6224 Introduced in House (IH)]
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114th CONGRESS
2d Session
H. R. 6224
To amend the Public Health Service Act to promote the inclusion of
minorities and women in clinical research, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 28, 2016
Mrs. Beatty (for herself, Ms. Sewell of Alabama, and Mr. Young of Iowa)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to promote the inclusion of
minorities and women 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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Enhancing Minority and Women
Representation in NIH Medical Research Act of 2016''.
SEC. 2. 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. 3. 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 Enhancing Minority and Women Representation
in NIH Medical Research Act of 2016, 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. 4. 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. 5. 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'') 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 the 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.
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