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 PUBLIC LAW 103-43—JUNE 10, 1993 107 STAT. 135 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.— The guidelines required in subsection Federal (d) shall be established and published in the Federal Register ^ubiication 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 msmner 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.". SEC. 132. PEER REVIEW. Section 492 of the Public Health Service Act (42 U.S.C. 289a) is amended by adding at the end the following subsection: "(c)(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with section 492B. "(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 492B, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.". SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS. 42 USC 289a-2 Section 492B of the Public Health Service Act, as added by section 131 of this Act, shall not apply with respect to projects of clinical research for which initial funding was provided prior to the date of the enactment of this Act. With respect to the inclusion of women and minorities as subjects in clinical research 69-194O-94-6:QL.3Part1

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