I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Enhancing Minority 

5 and Women Representation in NIH Medical Research Act 

6 of 2016’’. 


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1 SEC. 2. COLLABORATION TO ENHANCE DIVERSITY IN CLIN2 ICAL RESEARCH. 

3 Section 402(b) of the Public Health Service Act (42 

4 U.S.C. 282(b)) is amended— 

5 (1) by amending paragraph (4) to read as fol6 lows: 

7 ‘‘(4) shall assemble accurate data to be used to 

8 assess research priorities, including— 

9 ‘‘(A) information to better evaluate sci10 entific opportunity, public health burdens, and 

11 progress in reducing health disparities; and 

12 ‘‘(B) data on study populations of clinical 

13 research, funded by or conducted at each na14 tional research institute and national center, 

15 which— 

16 ‘‘(i) specifies the inclusion of— 

17 ‘‘(I) women; 

18 ‘‘(II) members of minority 

19 groups; 

20 ‘‘(III) relevant age categories; 

21 and 

22 ‘‘(IV) other demographic vari23 ables determined to be necessary by 

24 the Director of NIH; 

25 ‘‘(ii) is disaggregated by research 

26 area, condition, and disease categories; and 


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1 ‘‘(iii) is to be made publicly available 

2 on the Internet website of the National In3 stitutes of Health;’’; and 

4 (2) in paragraph (8)— 

5 (A) in subparagraph (A), by striking 

6 ‘‘and’’ at the end; and 

7 (B) by adding at the end the following: 

8 ‘‘(C) foster collaboration between clinical 

9 research projects funded by the respective na10 tional research institutes and national centers 

11 that— 

12 ‘‘(i) conduct research involving human 

13 subjects; and 

14 ‘‘(ii) collect similar data; and 

15 ‘‘(D) encourage the collaboration described 

16 in subparagraph (C) to— 

17 ‘‘(i) allow for an increase in the num18 ber of subjects studied; and 

19 ‘‘(ii) utilize diverse study populations, 

20 with special consideration to biological, so21 cial, and other determinants of health that 

22 contribute to health disparities;’’. 


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1 SEC. 3. PROMOTING INCLUSION IN CLINICAL RESEARCH. 

2 (a) STRATEGIC PLAN.—Section 492B(a) of the Pub3 lic Health Service Act (42 U.S.C. 289a–2(a)) is amended 

4 by adding at the end the following: 

5 ‘‘(3) STRATEGIC PLANNING.— 

6 ‘‘(A) IN GENERAL.—The directors of the 

7 national institutes and national centers shall 

8 consult at least once annually with the Director 

9 of the National Institute on Minority Health 

10 and Health Disparities and the Director of the 

11 Office of Research on Women’s Health regard12 ing objectives of the national institutes and na13 tional centers to ensure that future activities by 

14 such institutes and centers take into account 

15 women and minorities and are focused on re16 ducing health disparities. 

17 ‘‘(B) STRATEGIC PLANS.—Any strategic 

18 plan issued by a national institute or national 

19 center shall include details on the objectives de20 scribed in subparagraph (A).’’. 

21 (b) CLARIFICATION OF REQUIREMENTS.—Section 

22 492B(c) of the Public Health Service Act (42 U.S.C. 

23 289a–2(c)) is amended— 

24 (1) by striking ‘‘In the case’’ and inserting the 

25 following: 

26 ‘‘(1) IN GENERAL.—In the case’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(2) REPORTING REQUIREMENTS.—For any 

3 new and competing project of clinical research sub4 ject to the requirements under this section that re5 ceives a grant award 1 year after the date of enact6 ment of the Enhancing Minority and Women Rep7 resentation in NIH Medical Research Act of 2016, 

8 or any date thereafter, for which a valid analysis is 

9 provided under paragraph (1)— 

10 ‘‘(A) and which is an applicable clinical 

11 trial as defined in section 402(j), the entity con12 ducting such clinical research shall submit the 

13 results of such valid analysis to the clinical trial 

14 registry data bank expanded under 402(j)(3), 

15 and the Director of NIH shall, as appropriate, 

16 consider whether such entity has complied with 

17 the reporting requirement described in this sub18 paragraph in awarding any future grant to such 

19 entity, including pursuant to section 

20 402(j)(5)(A)(ii) when applicable; and 

21 ‘‘(B) the Director of NIH shall encourage 

22 the reporting of the results of such valid anal23 ysis described in paragraph (1) through any ad24 ditional means determined appropriate by the 

25 Director.’’. 


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1 (c) REPORTING.—Section 492B(f) of the Public 

2 Health Service Act (42 U.S.C. 289a–2(f)) is amended— 

3 (1) by striking ‘‘biennial’’ each place such term 

4 appears and inserting ‘‘triennial’’ in each such place; 

5 (2) by striking ‘‘The advisory council’’ and in6 serting the following: 

7 ‘‘(1) IN GENERAL.—The advisory council’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(2) CONTENTS.—Each triennial report pre10 pared by an advisory council of each national re11 search institute as described in paragraph (1) shall 

12 include each of the following: 

13 ‘‘(A) The number of women included as 

14 subjects, and the proportion of subjects that are 

15 women, in any project of clinical research con16 ducted during the applicable reporting period, 

17 disaggregated by categories of research area, 

18 condition, or disease, and accounting for single19 sex studies. 

20 ‘‘(B) The number of members of minority 

21 groups included as subjects, and the proportion 

22 of subjects that are members of minority 

23 groups, in any project of clinical research con24 ducted during the applicable reporting period, 

25 disaggregated by categories of research area, 


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1 condition, or disease and accounting for single2 race and single-ethnicity studies. 

3 ‘‘(C) For the applicable reporting period, 

4 the number of projects of clinical research that 

5 include women and members of minority groups 

6 and that— 

7 ‘‘(i) have been completed during such 

8 reporting period; and 

9 ‘‘(ii) are being carried out during such 

10 reporting period and have not been com11 pleted. 

12 ‘‘(D) The number of studies completed 

13 during the applicable reporting period for which 

14 reporting has been submitted in accordance 

15 with subsection (c)(2)(A).’’. 

16 (d) COORDINATION.—Section 486(c)(2) of the Public 

17 Health Service Act (42 U.S.C. 287d(c)(2)) is amended by 

18 striking ‘‘designees’’ and inserting ‘‘senior-level staff des19 ignees’’. 

20 SEC. 4. IMPROVING COORDINATION RELATED TO MINOR21 ITY HEALTH AND HEALTH DISPARITIES. 

22 Section 464z–3 of the Public Health Service Act (42 

23 U.S.C. 285t) is amended— 


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1 (1) by redesignating subsection (h), relating to 

2 interagency coordination, that follows subsection (j) 

3 as subsection (k); and 

4 (2) in subsection (k) (as so redesignated)— 

5 (A) in the subsection heading, by striking 

6 ‘‘INTERAGENCY’’ and inserting ‘‘INTRA-NIH’’; 

7 (B) by striking ‘‘as the primary Federal 

8 officials’’ and inserting ‘‘as the primary Federal 

9 official’’; 

10 (C) by inserting a comma after ‘‘review’’; 

11 (D) by striking ‘‘Institutes and Centers of 

12 the National Institutes of Health’’ and inserting 

13 ‘‘national research institutes and national cen14 ters’’; and 

15 (E) by adding at the end the following: 

16 ‘‘The Director of the Institute may foster part17 nerships between the national research insti18 tutes and national centers and may encourage 

19 the funding of collaborative research projects to 

20 achieve the goals of the National Institutes of 

21 Health that are related to minority health and 

22 health disparities.’’. 

23 SEC. 5. WOMEN AND MINORITIES IN RESEARCH. 

24 (a) BASIC RESEARCH.— 


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1 (1) DEVELOPING POLICIES.—Not later than 2 

2 years after the date of enactment of this Act, the 

3 Director of the National Institutes of Health (re4 ferred to in this section as the ‘‘Director of NIH’’) 

5 shall develop policies for projects of basic research 

6 funded by National Institutes of Health to assess— 

7 (A) relevant biological variables including 

8 sex, as appropriate; and 

9 (B) how differences between male and fe10 male cells, tissues, or animals may be examined 

11 and analyzed. 

12 (2) REVISING POLICIES.—The Director of NIH 

13 may update or revise the policies developed under 

14 paragraph (1) as appropriate. 

15 (3) CONSULTATION AND OUTREACH.—In devel16 oping, updating, or revising the policies under this 

17 section, the Director of NIH— 

18 (A) shall consult with— 

19 (i) the Office of Research on Women’s 

20 Health; 

21 (ii) the Office of Laboratory Animal 

22 Welfare; and 

23 (iii) appropriate members of the sci24 entific and academic communities; and 


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1 (B) shall conduct outreach to solicit feed2 back from members of the scientific and aca3 demic communities on the influence of sex as a 

4 variable in basic research, including feedback on 

5 when it is appropriate for projects of basic re6 search involving cells, tissues, or animals to in7 clude both male and female cells, tissues, or 

8 animals. 

9 (4) ADDITIONAL REQUIREMENTS.—The Direc10 tor of NIH shall— 

11 (A) ensure that projects of basic research 

12 funded by the National Institutes of Health are 

13 conducted in accordance with the policies devel14 oped, updated, or revised under this section, as 

15 applicable; and 

16 (B) encourage that the results of such re17 search, when published or reported, be 

18 disaggregated as appropriate with respect to 

19 the analysis of any sex differences. 

20 (b) CLINICAL RESEARCH.— 

21 (1) IN GENERAL.—Not later than 1 year after 

22 the date of enactment of this Act, the Director of 

23 NIH, in consultation with the Director of the Office 

24 of Research on Women’s Health and the Director of 

25 the National Institute on Minority Health and 


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1 Health Disparities, shall update the guidelines estab2 lished under section 492B(d) of the Public Health 

3 Service Act (42 U.S.C. 289a–2(d)) in accordance 

4 with paragraph (2). 

5 (2) REQUIREMENTS.—The updated guidelines 

6 described in paragraph (1) shall— 

7 (A) reflect the science regarding sex dif8 ferences; 

9 (B) improve adherence to the requirements 

10 under section 492B of the Public Health Serv11 ice Act (42 U.S.C. 289a–2), including the re12 porting requirements under subsection (f) of 

13 such section; and 

14 (C) clarify the circumstances under which 

15 studies should be designed to support the con16 duct of analyses to detect significant differences 

17 in the intervention effect due to demographic 

18 factors related to section 492B of the Public 

19 Health Service Act, including in the absence of 

20 prior studies that demonstrate a difference in 

21 study outcomes on the basis of such factors and 

22 considering the effects of the absence of such 

23 analyses on the availability of data related to 

24 demographic differences. 

Æ 


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