Page:United States Statutes at Large Volume 107 Part 1.djvu/160

 107 STAT. 134 PUBLIC LAW 103-43—JUNE 10, 1993 "(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 tmder 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

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