42 U.S. Code § 284r - Basic research

(1) Developing policies

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,[1] 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 the National Institutes of Health 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 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) Additional requirements

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.

(Pub. L. 114–255, div. A, title II, § 2038(g), Dec. 13, 2016, 130 Stat. 1066.)

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[1]  See References in Text note below.

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.