42 U.S. Code § 289a–2 - Inclusion of women and minorities in clinical research
The Director of NIH, in consultation with the Director of the Office of Research on Women’s Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.
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.
In the case of any clinical trial in which women or members of minority groups will under subsection (a) be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial.
The guidelines required in subsection (d) shall be established and published in the Federal Register not later than 180 days after June 10, 1993.
The advisory council of each national research institute shall prepare triennial reports describing the manner in which the institute has complied with this section. Each such report shall be submitted to the Director of the institute involved for inclusion in the triennial report under section 283 of this title.
2016—Subsec. (a)(3). Pub. L. 114–255, § 2031(c), added par. (3).
Subsec. (c). Pub. L. 114–255, § 2053, designated existing provisions as par. (1), inserted heading, and added par. (2).
Subsec. (f). Pub. L. 114–255, § 2038(b), designated existing provisions as par. (1), inserted heading, substituted “triennial” for “biennial” in two places, and added par. (2).
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