SEC. 2. COLLABORATION TO ENHANCE DIVERSITY IN CLIN-
ICAL 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 fol-
lows: 
‘‘(4) shall assemble accurate data to be used to 
assess research priorities, including— 
‘‘(A) information to better evaluate sci-
entific 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 na-
tional 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 vari-
ables determined to be necessary by 
the Director of NIH; 
‘‘(ii) is disaggregated by research 
area, condition, and disease categories; and 
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‘‘(iii) is to be made publicly available 
on the Internet website of the National In-
stitutes 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 na-
tional 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 num-
ber of subjects studied; and 
‘‘(ii) utilize diverse study populations, 
with special consideration to biological, so-
cial, and other determinants of health that 
contribute to health disparities;’’. 
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SEC. 3. PROMOTING INCLUSION IN CLINICAL RESEARCH. 
(a) STRATEGIC PLAN.—Section 492B(a) of the Pub-
lic 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 regard-
ing objectives of the national institutes and na-
tional centers to ensure that future activities by 
such institutes and centers take into account 
women and minorities and are focused on re-
ducing health disparities. 
‘‘(B) STRATEGIC
PLANS.—Any strategic 
plan issued by a national institute or national 
center shall include details on the objectives de-
scribed 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 
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(2) by adding at the end the following: 
‘‘(2) REPORTING
REQUIREMENTS.—For any 
new and competing project of clinical research sub-
ject to the requirements under this section that re-
ceives a grant award 1 year after the date of enact-
ment of the Enhancing Minority and Women Rep-
resentation 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 con-
ducting 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 sub-
paragraph 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 anal-
ysis described in paragraph (1) through any ad-
ditional means determined appropriate by the 
Director.’’. 
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(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 in-
serting the following: 
‘‘(1) IN GENERAL.—The advisory council’’; and 
(3) by adding at the end the following: 
‘‘(2) CONTENTS.—Each triennial report pre-
pared by an advisory council of each national re-
search 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 con-
ducted 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 con-
ducted during the applicable reporting period, 
disaggregated by categories of research area, 
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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 com-
pleted. 
‘‘(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 des-
ignees’’. 
SEC. 4. IMPROVING COORDINATION RELATED TO MINOR-
ITY HEALTH AND HEALTH DISPARITIES. 
Section 464z–3 of the Public Health Service Act (42 
U.S.C. 285t) is amended— 
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(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 cen-
ters’’; and 
(E) by adding at the end the following: 
‘‘The Director of the Institute may foster part-
nerships between the national research insti-
tutes 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.— 
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(1) DEVELOPING POLICIES.—Not later than 2 
years after the date of enactment of this Act, the 
Director of the National Institutes of Health (re-
ferred 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 fe-
male 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 devel-
oping, 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 sci-
entific and academic communities; and 
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(B) shall conduct outreach to solicit feed-
back from members of the scientific and aca-
demic communities on the influence of sex as a 
variable in basic research, including feedback on 
when it is appropriate for projects of basic re-
search involving cells, tissues, or animals to in-
clude both male and female cells, tissues, or 
animals. 
(4) ADDITIONAL REQUIREMENTS.—The Direc-
tor of NIH shall— 
(A) ensure that projects of basic research 
funded by the National Institutes of Health are 
conducted in accordance with the policies devel-
oped, updated, or revised under this section, as 
applicable; and 
(B) encourage that the results of such re-
search, 
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 
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Health Disparities, shall update the guidelines estab-
lished 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 dif-
ferences; 
(B) improve adherence to the requirements 
under section 492B of the Public Health Serv-
ice Act (42 U.S.C. 289a–2), including the re-
porting requirements under subsection (f) of 
such section; and 
(C) clarify the circumstances under which 
studies should be designed to support the con-
duct 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. 
Æ 
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