[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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