42 USC 289 - Inclusion of women and minorities in clinical research

View all text of Part H [§ 289 - § 290a]

§ 289a–2. Inclusion of women and minorities in clinical research

(a) Requirement of inclusion

(1) In generalIn conducting or supporting clinical research for purposes of this subchapter, the Director of NIH shall, subject to subsection (b), ensure that—

(A) women are included as subjects in each project of such research; and

(B) members of minority groups are included as subjects in such research.

(2) Outreach regarding participation as subjects

(3) Strategic planning

(A) In general

(B) Strategic plans

(b) Inapplicability of requirementThe requirement established in subsection (a) regarding women and members of minority groups shall not apply to a project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively—

(1) is inappropriate with respect to the health of the subjects;

(2) is inappropriate with respect to the purpose of the research; or

(3) is inappropriate under such other circumstances as the Director of NIH may designate.

(1) In general

(2) Reporting requirementsFor any new and competing project of clinical research subject to the requirements under this section that receives a grant award 1 year after December 13, 2016, or any date thereafter, for which a valid analysis is provided under paragraph (1)—

(A) and which is an applicable clinical trial as defined in section 282(j) of this title, the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section 282(j)(3) of this title, and the Director of the National Institutes of Health shall, as appropriate, consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity, including pursuant to section 282(j)(5)(A)(ii) of this title when applicable; and

(B) the Director of the National Institutes of Health shall encourage the reporting of the results of such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.

(d) Guidelines

(1) In generalSubject to paragraph (2), 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 establish guidelines regarding the requirements of this section. The guidelines shall include guidelines regarding—

(A) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate for purposes of subsection (b);

(B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c); and

(2) Certain provisionsWith respect to the circumstances under which the inclusion of women or members of minority groups (as the case may be) as subjects in a project of clinical research is inappropriate for purposes of subsection (b), the following applies to guidelines under paragraph (1):

(A)

(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is not a permissible consideration in determining whether such inclusion is inappropriate.

(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality.

(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between—

(i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and

(ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required.

(e) Date certain for guidelines; applicability

(1) Date certain

(2) Applicability

(f) Reports by advisory councils

(1) In general

(2) ContentsEach triennial report prepared by an advisory council of each national research institute as described in paragraph (1) shall include each of the following:

(A) The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies.

(B) The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies.

(C) For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that—

(i) have been completed during such reporting period; and

(ii) are being carried out during such reporting period and have not been completed.

(D) The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection (c)(2)(A).

(g) DefinitionsFor purposes of this section:

(1) The term “project of clinical research” includes a clinical trial.

(2) The term “minority group” includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established under subsection (d), define the terms “minority group” and “subpopulation” for purposes of the preceding sentence.

(July 1, 1944, ch. 373, title IV, § 492B, as added Pub. L. 103–43, title I, § 131, June 10, 1993, 107 Stat. 133; amended Pub. L. 114–255, div. A, title II, §§ 2031(c), 2038(b), 2053,