42 U.S.C. § 287d — Office of Research on Women’s Health

(a) Establishment. There is an Office of Research on Women's Health (the Office) within NIH's Office of the Director, headed by a director whom NIH's Director appoints and to whom that director reports directly. (b) Purpose. The Office's Director must: (1) identify women's-health research projects NIH's research institutes should conduct or support; (2) identify multidisciplinary research on women's health to conduct or support; (3) do the same for research on aging in women, prioritizing menopause; (4) promote coordination and collaboration among groups doing this research; (5) encourage NIH-funded entities to do this research; (6) recommend an agenda for it; (7) push for enough NIH resources to support it; (8) help administer section 289a–2's rule on including women as subjects in clinical research; and (9) prepare the report required under section 287d–2. (c) Coordinating Committee. (1) To carry out subsection (b), the Office's Director must establish a Coordinating Committee on Research on Women's Health. (2) It's made up of the Directors of NIH's research institutes, or their senior-level staff designees. (3) The Office's Director chairs it. (4) On women's-health research, the Coordinating Committee helps the Office's Director: (A) identify the need for such research and estimate each fiscal year's needed funding; (B) identify needs for coordinating research activities, including intramural and extramural multidisciplinary work; (C) support developing methods for deciding when clinical trials should collect data specific to women, including their age and ethnic or racial group; (D) support developing and expanding clinical trials where collecting that data is appropriate; and (E) encourage NIH institutes to conduct and support such research, including such clinical trials. (d) Advisory Committee. (1) To carry out subsection (b), the Office's Director must also establish an Advisory Committee on Research on Women's Health. (2) It has 12 to 18 members who aren't federal officers or employees; NIH's Director appoints physicians, practitioners, scientists, and other health professionals with a real focus on women's-health research, and most members must be women. (3) The Office's Director chairs it as well. (4) The Advisory Committee must: (A) advise the Office's Director on research NIH institutes should undertake on women's health, gender differences in clinical drug trials, gender differences in disease and treatment, obstetrical and gynecological conditions (including preventable maternal mortality and severe maternal morbidity), and women's health conditions needing a multidisciplinary approach; (B) report to the Office's Director on that research; (C) recommend Office activities, including recommendations on the data-collection methods described in subsection (c)(4)(C) and priorities for the research described in subparagraph (A); and (D) help monitor compliance with section 289a–2's rule on including women in clinical research. (5)(A) The Advisory Committee must prepare a report every two years on its activities, including findings on compliance with section 289a–2, how much NIH's agencies spent on women's-health research, and the funding level still needed. (B) That report must go to NIH's Director for inclusion in the report required under section 283. (e) Representation of women among researchers. The Secretary, acting through the Assistant Secretary for Personnel and working with the Office's Director, must determine how well women are represented among senior physicians and scientists at NIH's research institutes and among researchers funded by them, and, as appropriate, take steps to increase that representation. (f) Definitions. For this part: (1) "Women's health conditions" means, across all age, ethnic, and racial groups of women, every disease, disorder, and condition (including mental health conditions) that is (A) unique to, more serious in, or more common in women; (B) different — or of unknown difference — in medical risk or type of medical treatment for women; or (C) understudied in clinical research or lacking sufficient clinical data on women. (2) "Research on women's health" means research on women's health conditions, including research on preventing them.