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.



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