Sec. 4. Research on sex differences
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Section 492B of the Public Health Service Act ( 42 U.S.C. 289a–2 ) is amended— by redesignating subsections
(b)through
(g)as subsections
(c)through (h), respectively; and by inserting after subsection
(a)the following: The Director of NIH shall determine when it is appropriate for projects of basic research involving cells, tissues or animals to include both male and female cells, tissues, or animals. The Director of NIH— shall make the initial determinations required by subparagraph
(A)not later than one year after the date of enactment of the Research for All Act of 2014 ; and may subsequently update or revise such determinations as the Director determines appropriate. In making the initial determinations required by subparagraph (A), the Director of NIH— shall consult with the Office of Research on Women's Health, the Institute of Medicine, the Office of Laboratory Animal Welfare, and appropriate members of the scientific and academic communities; and may conduct outreach and educational initiatives within the scientific and academic communities on the influence of sex as a variable in basic research in order to develop a consensus within such communities 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. Beginning on the date that is 1 year after the date of enactment of the Research for All Act of 2014 , in conducting or supporting basic research in accordance with paragraph (1), the Director of NIH shall, subject to paragraph (3), ensure that— in the case of research on cells or tissues— cells or tissues, as applicable, are derived from both male and female organisms in each project of such research; and the results are disaggregated according to whether the cells or tissues are derived from male or female organisms; and in the case of animal research— both male and female animals are included as subjects in each project of such research; and the results are disaggregated according to whether the subjects are male or female. Paragraph
(2)shall not apply to a project of basic research if the Director of NIH determines that the inclusion of cells or tissues derived from both male and female organisms, or the inclusion of both male and female animals as subjects, as applicable, is inappropriate in the case of such project. . Subsection
(d)of section 492B of the Public Health Service Act ( 42 U.S.C. 289a–2 ), as redesignated, is amended— by striking
(d)and all that follows through In the case and inserting the following: In the case ; and by adding at the end the following: In the case of basic research in which cells or tissues derived from both male and female organisms will be included in accordance with subsection (b)(2)(A) or both male and female animals will be included as subjects in accordance with subsection (b)(2)(B), the Director of NIH shall ensure that sex differences are examined and analyzed, as appropriate. . Section 492B(f)(1) of the Public Health Service Act ( 42 U.S.C. 289a–2 ), as redesignated, is amended to read as follows: The guidelines required in subsection
(e)regarding the requirements of this section for clinical and basic research shall— be updated and published in the Federal Register not later than 1 year after the date of enactment of the Research for All Act of 2014 ; reflect the growing understanding that sex differences matter; ensure better enforcement of the requirements of this section by the personnel of the agencies of the National Institutes of Health responsible for reviewing grant proposals; and include guidance on when research strongly supports or strongly negates the conclusion that there is a significant difference in how the variables being studied affect women or members of minority groups, as the case may be, relative to how such variables affect other subjects in the research. . Section 492B(f)(2) of the Public Health Service Act ( 42 U.S.C. 289a–2 ), as redesignated, is amended by adding at the end the following: For fiscal year 2016 and subsequent fiscal years, the Director of NIH may not approve any proposal of basic research to be conducted or supported by any agency of the National Institutes of Health unless the proposal specifies the manner in which the research will comply with this section. . Section 492B of the Public Health Service Act ( 42 U.S.C. 289a–2 ) is amended— in the heading of subsection (a), by striking and inserting Requirement of inclusion ; Inclusion in clinical research in subsection (a)(1), by striking subsection
(b)and inserting subsection
(c); in subsection (e)(1)(A), as redesignated, by striking subsection
(b)and inserting subsection
(c); in subsection (e)(1)(B), as redesignated, by striking subsection
(c)and inserting subsection
(d); and in subsection (e)(2), as redesignated, by striking subsection
(b)and inserting subsection
(c). Subparagraph
(C)of section 403(a)(4) of the Public Health Service Act ( 42 U.S.C. 283(a)(4) ) is amended— by redesignating clause
(vi)as clause (vii); and by inserting after clause
(v)the following: Basic research, including a breakdown of the sex of organisms from which cells and tissues are derived, a breakdown of the sex of animal subjects, and such other information as may be necessary to demonstrate compliance with section 492B (regarding sex differences in basic research). . Part H of title IV of the Public Health Service Act is amended by inserting after section 492B of such Act ( 42 U.S.C. 289a–2 ) the following: The Secretary may award grants or other support to entities for the continued operation and expansion of Special Centers of Research on Sex Differences. . Nothing in this Act or the amendments made by this Act shall be construed to lessen any standard or requirement set forth in part 1, 2, or 3 of subchapter A of chapter I of title 9, Code of Federal Regulations.
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- 42 USC 289a–2
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