Sec. 9. Women and minorities in research

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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 ), taking into consideration the findings of the working group established under section 7, shall develop policies for projects of basic research funded by National Institutes of Health to assess— relevant biological variables including sex, as appropriate; and how differences between male and female cells, tissues, or animals may be examined and analyzed. The Director of NIH may update or revise the policies developed under paragraph

(1)as appropriate. In developing, updating, or revising the policies under this section, the Director of NIH— shall consult with— the Office of Research on Women’s Health; the Office of Laboratory Animal Welfare; and appropriate members of the scientific and academic communities; and 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. The Director of NIH shall— 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 encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences. 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 Public Health Service Act ( 42 U.S.C. 289a–2(d) ) in accordance with paragraph (2). The updated guidelines described in paragraph

(1)shall— reflect the science regarding sex differences; 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 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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42 USC 289a–2(d)
42 USC 289a–2

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Sec. 9

Women and minorities in research

Cite42 USC 289a–2(d)

Cite42 USC 289a–2

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