Page:United States Statutes at Large Volume 110 Part 2.djvu/567

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PUBLIC LAW 104-146—MAY 20, 1996 110 STAT. 1359 "(1) IN GENERAL. —With respect to the projects of research with which an applicant under subsection (a) is concerned, the Secretary may make a grant under such subsection to the applicant only if the following conditions are met: " (A) The applicant agrees to make reasonable efforts— "(i) to identify which of the patients of the applicant are women, infants, children, and youth who would be appropriate participants in the projects; "(ii) to carry out clause (i) through the use of criteria provided for such purpose by the entities that will be conducting the projects of research; and "(iii) to offer women, infants, children, and youth the opportunity to participate in the projects (as appropriate), including the provision of services under subsection (d)(3). "(B) The applicant agrees that, in the case of the research-related ranctions to be carried out by the applicant pursuant to subsection (a)(1), the applicant will comply with accepted standards that are applicable to such functions (including accepted standards regarding informed consent and other protections for human subjects). "(C) For the first and second fiscal years for which grants under subsection (a) are to be made to the applicant, the applicant agrees that, not later than the end of the second fiscal year of receiving such a grant, a significant number of women, infants, children, and youth who are patients of the applicant will be participating in the projects of research. "(D) Except as provided in paragraph (3) (and paragraph (4), as applicable), for the third and subsequent fiscal years for which such grants are to be made to the applicant, the Secretary has determined that a significant number of such individuals are participating in the projects. "(2) PROHIBITION. —Receipt of services by a patient shall not be conditioned upon the consent of the patient to participate in research. "(3) SIGNIFICANT PARTICIPATION; CONSIDERATION BY SEC- RETARY OF CERTAIN CIRCUMSTANCES. —In administering the requirement of paragraph (1)(D), the Secretary shall take into account circumstances in which a grantee under subsection (a) is temporarily unable to comply with the requirement for reasons beyond the control of the grantee, and shall in such circumstances provide to the grantee a reasonable period of opportunity in which to reestablish compliance with the requirement. " (4) SIGNIFICANT PARTICIPATION; TEMPORARY WAIVER FOR ORIGINAL GRANTEES. — "(A) IN GENERAL. —In the case of an applicant under subsection (a) who received a grant under such subsection for fiscal year 1995, the Secretary may, subject to subparagraph (B), provide to the applicant a waiver of the requirement of paragraph (1)(D) if the Secretary determines that the applicant is making reasonable progress toward meeting the requirement. " (B) TERMINATION OF AUTHORITY FOR WAIVERS.—The Secretary may not provide any waiver under subparagraph (A) on or after October 1, 1998. Any such waiver provided