PRIA, Government Policy, Made Personal

Summary

Creates an Office of Research on Women’s Health inside the NIH Director’s office. The Office must be run by a director chosen by the NIH Director who reports directly to that Director. The director must find and recommend research projects on women’s health, including team-based studies and work on aging in women with priority on menopause. The director must help get researchers to work together, push for enough funding, suggest a research agenda, help enforce rules about including women in clinical studies, and prepare required reports. The director must set up two groups to help. A Coordinating Committee made up of the heads (or top designees) of the national research institutes must help spot research needs, estimate funds needed each fiscal year, improve coordination of studies, and support methods and clinical trials that collect data specific to women (including age and race or ethnicity). An Advisory Committee of 12 to 18 nonfederal experts (mostly women) must advise the director on research priorities like gender differences in drugs and disease, obstetric and gynecologic issues (including preventable maternal death and severe maternal illness), and studies needing many types of experts. The Advisory Committee must write a report every two years about its work, funding levels, and compliance with rules on including women in research. The Secretary and the Office must also check how many women are senior researchers and take steps to increase their representation when needed. Definitions: “women’s health conditions” = diseases or conditions that are unique to, more serious in, more common in, treat differently for, or lack enough study in women; “research on women’s health” = research about those conditions, including prevention.

Title 42, §287d

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

(a)Establishment

There is established within the Office of the Director of NIH an office to be known as the Office of Research on Women’s Health (in this part referred to as the “Office”). The Office shall be headed by a director, who shall be appointed by the Director of NIH and who shall report directly to the Director.

(b)Purpose

The Director of the Office shall—

(1)identify projects of research on women’s health that should be conducted or supported by the national research institutes;

(2)identify multidisciplinary research relating to research on women’s health that should be so conducted or supported;

(3)carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause;

(4)promote coordination and collaboration among entities conducting research identified under any of paragraphs (1) through (3);

(5)encourage the conduct of such research by entities receiving funds from the national research institutes;

(6)recommend an agenda for conducting and supporting such research;

(7)promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research;

(8)assist in the administration of section 289a–2 of this title with respect to the inclusion of women as subjects in clinical research; and

(9)prepare the report required in section 287d–2 of this title.

(c)Coordinating Committee

(1)In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Research on Women’s Health (in this subsection referred to as the “Coordinating Committee”).

(2)The Coordinating Committee shall be composed of the Directors of the national research institutes (or the senior-level staff designees of the Directors).

(3)The Director of the Office shall serve as the chair of the Coordinating Committee.

(4)With respect to research on women’s health, the Coordinating Committee shall assist the Director of the Office in—

(A)identifying the need for such research, and making an estimate each fiscal year of the funds needed to adequately support the research;

(B)identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities;

(C)supporting the development of methodologies to determine the circumstances in which obtaining data specific to women (including data relating to the age of women and the membership of women in ethnic or racial groups) is an appropriate function of clinical trials of treatments and therapies;

(D)supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been determined to be an appropriate function; and

(E)encouraging the national research institutes to conduct and support such research, including such clinical trials.

(d)Advisory Committee

(1)In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the Advisory Committee on Research on Women’s Health (in this subsection referred to as the “Advisory Committee”).

(2)The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not officers or employees of the Federal Government. The Director of NIH shall make appointments to the Advisory Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on research on women’s health. A majority of the members of the Advisory Committee shall be women.

(3)The Director of the Office shall serve as the chair of the Advisory Committee.

(4)The Advisory Committee shall—

(A)advise the Director of the Office on appropriate research activities to be undertaken by the national research institutes with respect to—

(i)research on women’s health;

(ii)research on gender differences in clinical drug trials, including responses to pharmacological drugs;

(iii)research on gender differences in disease etiology, course, and treatment;

(iv)research on obstetrical and gynecological health conditions, diseases, and treatments, including preventable maternal mortality and severe maternal morbidity; and

(v)research on women’s health conditions which require a multidisciplinary approach;

(B)report to the Director of the Office on such research;

(C)provide recommendations to such Director regarding activities of the Office (including recommendations on the development of the methodologies described in subsection (c)(4)(C) and recommendations on priorities in carrying out research described in subparagraph (A)); and

(D)assist in monitoring compliance with section 289a–2 of this title regarding the inclusion of women in clinical research.

(5)(A)The Advisory Committee shall prepare a biennial report describing the activities of the Committee, including findings made by the Committee regarding—

(i)compliance with section 289a–2 of this title;

(ii)the extent of expenditures made for research on women’s health by the agencies of the National Institutes of Health; and

(iii)the level of funding needed for such research.

(B)The report required in subparagraph (A) shall be submitted to the Director of NIH for inclusion in the report required in section 283 of this title.

(e)Representation of women among researchers

The Secretary, acting through the Assistant Secretary for Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are represented among senior physicians and scientists of the national research institutes and among physicians and scientists conducting research with funds provided by such institutes, and as appropriate, carry out activities to increase the extent of such representation.

(f)Definitions

For purposes of this part:

(1)The term “women’s health conditions”, with respect to women of all age, ethnic, and racial groups, means all diseases, disorders, and conditions (including with respect to mental health)—

(A)unique to, more serious, or more prevalent in women;

(B)for which the factors of medical risk or types of medical intervention are different for women, or for which it is unknown whether such factors or types are different for women; or

(C)with respect to which there has been insufficient clinical research involving women as subjects or insufficient clinical data on women.

(2)The term “research on women’s health” means research on women’s health conditions, including research on preventing such conditions.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (d)(4)(A)(iv). Pub. L. 117–103 inserted “, including preventable maternal mortality and severe maternal morbidity” before “; and”. 2016—Subsec. (c)(2). Pub. L. 114–255 substituted “senior-level staff designees” for “designees”. 2010—Subsec. (a). Pub. L. 111–148 inserted “and who shall report directly to the Director” before period at end. 1998—Subsec. (d)(2). Pub. L. 105–340 substituted “NIH” for “the Office”.

Statutory Notes and Related Subsidiaries

Termination of Advisory CommitteesAdvisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 1013 of Title 5, Government Organization and Employees. Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.

§287d Office of Research on Women’s Health