I 114th CONGRESS 2d Session H. R. 6224 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. Short title This Act may be cited as the Enhancing Minority and Women Representation in NIH Medical Research Act of 2016 . 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; . 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 . 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. . 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.