Table 1

NATIONAL INSTITUTES OF HEALTH REVTTALIZATION ACT OF 1993 PUBLIC LAW 103–43

With reference to ‘INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

“Sec.492B.(a) Requirement of Inclusion.—

“(1) IN GENERAL—In conducting or supporting clinical research for purposes of this title, 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.—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 conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.

“(b) INAPPLICABILITY OF REQUIREMENT.—The 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.

“(c) DESIGN OF CLINICAL TRIALS.—In the case of any clinical trial in which women or members of minority groups will under subsection (a) be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial.

“(d) GUIDELINES.—

“(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



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Inclusion of Women in Clinical Trials: Policies for Population Subgroups Table 1 NATIONAL INSTITUTES OF HEALTH REVTTALIZATION ACT OF 1993 PUBLIC LAW 103–43 With reference to ‘INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH “Sec.492B.(a) Requirement of Inclusion.— “(1) IN GENERAL—In conducting or supporting clinical research for purposes of this title, 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.—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 conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research. “(b) INAPPLICABILITY OF REQUIREMENT.—The 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. “(c) DESIGN OF CLINICAL TRIALS.—In the case of any clinical trial in which women or members of minority groups will under subsection (a) be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial. “(d) GUIDELINES.— “(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

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Inclusion of Women in Clinical Trials: Policies for Population Subgroups 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.—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. “(f) REPORTS BY ADVISORY COUNCILS.—The advisory council of each national research institute shall prepare biennial reports describing the manner in which the institute has complied with this section. Each such report shall be submitted to the Director of the institute involved for inclusion in the biennial report under section 403. “(g) DEFINITIONS.—For 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.” Final action on this will be decided by the House/Senate Conference Committee Action.