§284r — Title 42 The Public Health and Welfare | U.S. Code

Summary

Not later than 2 years after December 13, 2016, the NIH Director must write rules for NIH-funded basic research to check important biological factors, including sex, and to say how to study and compare male and female cells, tissues, or animals. The Director can update those rules later. When making or changing the rules, the Director must talk with the Office of Research on Women’s Health, the Office of Laboratory Animal Welfare, and relevant scientists and academics, and ask the research community for feedback on how sex should be considered and when studies should include both male and female cells, tissues, or animals. The Director must ensure NIH-funded basic research follows the rules and should encourage that results be reported separately by sex when appropriate.

Title 42, §284r

The Public Health and Welfare — Source: USLM XML via OLRC

(1)Not later than 2 years after December 13, 2016, the Director of the National Institutes of Health (referred to in this section as the “Director of the National Institutes of Health”), taking into consideration the recommendations developed under section 2039,11 See References in Text note below. 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)The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.

(3)In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—

(A)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)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)The Director of the National Institutes of Health 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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 2039, referred to in par. (1), is section 2039 of Pub. L. 114–255, which is set out as a note under section 282 of this title. Codification Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.

§284r Basic research

Summary

Title 42, §284r

Notes & Related Subsidiaries

Editorial Notes

References in Text

Citations & Metadata