Inclusion of Women in Clinical Trials: Policies for Population Subgroups (1993)

“(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.

“(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.—Subject 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

“(C)” the operation of outreach programs under subsection (a).

“(2) CERTAIN PROVISIONS.—With 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

“(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.

“(1) DATE CERTAIN.—The guidelines required in subsection (d) shall be established and published in the Federal Register not later than 180 days after the date of the enactment of the National Institutes of Health Revitalization Act of 1993.

“(2) APPLICABILITY.—For fiscal year 1995 and subsequent fiscal years, the Director of NIH may not approve any proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health unless the proposal specifies the manner in which the research will comply with 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.”