42 U.S.C. § 289a–2 — Inclusion of women and minorities in clinical research

(a) Requirement to include women and minorities. (1) General rule. When conducting or supporting clinical research under this subchapter, the Director of NIH must, subject to subsection (b), make sure that women are included as subjects in every such research project, and that members of minority groups are included as subjects too. (2) Outreach. The Director, working with the Directors of the Office of Research on Women's Health and the Office of Research on Minority Health, must run or support outreach programs to recruit women and minority group members as research subjects. (3) Strategic planning. The directors of the national institutes and centers must meet at least once a year 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, to make sure future activities account for women and minorities and focus on reducing health disparities; any strategic plan an institute or center issues must include details on this. (b) When the requirement doesn't apply. Subsection (a)'s inclusion requirement does not apply to a clinical research project if including women or minority group members, respectively, as subjects would be inappropriate for the subjects' health, inappropriate for the research's purpose, or inappropriate under other circumstances the Director of NIH sets. (c) Designing trials and reporting results. (1) Valid analysis required. For any clinical trial where women or minority group members are included as subjects under subsection (a), the Director must make sure the trial is designed and run so it can validly analyze whether the variables being studied affect women or minority group members differently than other subjects. (2) Reporting. For clinical research subject to this section that gets a new grant award one year or more after December 13, 2016, and for which such a valid analysis exists: if it is an "applicable clinical trial" under section 282(j) of this title, the entity running it must submit that analysis's results to the expanded clinical trial registry under section 282(j)(3), and the Director must, as appropriate, consider the entity's compliance with this reporting requirement when awarding it future grants; and the Director must also encourage reporting these results through any other appropriate means. (d) Guidelines. (1) General. Subject to paragraph (2), the Director, working with the Directors of the Office of Research on Women's Health and the Office of Research on Minority Health, must set guidelines covering: when excluding women and minorities under subsection (b) is appropriate; how trials must be designed and run under subsection (c); and how the outreach programs under subsection (a) work. (2) Cost rules. For clinical trials, the guidelines must say that the cost of including women or minorities is never a valid reason to exclude them. For other clinical research projects, cost also cannot justify exclusion, unless comparable-quality data about those groups is already being obtained some other way. For clinical trials, the guidelines may say that inclusion isn't required if solid scientific evidence shows no meaningful difference between how the studied variables affect women or minority group members versus other likely subjects. (e) Deadline and when this kicks in. The guidelines required under subsection (d) had to be published in the Federal Register within 180 days of June 10, 1993. Starting in fiscal year 1995, the Director cannot approve any NIH clinical research proposal unless it explains how the research will follow this section. (f) Reporting by advisory councils. Each national research institute's advisory council must write triennial (every-three-year) reports on how the institute has followed this section, and submit them to the institute's Director for inclusion in the triennial report under section 283 of this title. Each report must include: the number and proportion of women included as subjects, broken down by research area, condition, or disease, and accounting for single-sex studies; the same information for minority group members, accounting for single-race and single-ethnicity studies; the number of research projects, during the reporting period, that include women and minorities and that were either finished or still ongoing; and the number of studies finished in that period that reported results as required under subsection (c)(2)(A). (g) Definitions. "Project of clinical research" includes a clinical trial. "Minority group" includes subpopulations of minority groups, and the Director must define both "minority group" and "subpopulation," through the subsection (d) guidelines.