Page:United States Statutes at Large Volume 107 Part 1.djvu/152

 107 STAT. 126 PUBLIC LAW 103-43—JUNE 10, 1993 TITLE I—GENERAL PROVISIONS RE- GARBING TITLE IV OF PUBLIC HEALTH SERVICE ACT Subtitle A—Research Freedom PART I—REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL RESEARCH SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS REGARDING RESEARCH CONDUCTED OR SUPPORTED BY NATIONAL INSTITUTES OF HEALTH. Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 492 the following section: "CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH 42 USC 289a-l. "SEC. 492A. (a) REVIEW AS PRECONDITION TO RESEARCH.— "(1) PROTECTION OF HUMAN RESEARCH SUBJECTS.— "(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under section 491(a) by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review. "(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval. "(2) PEER REVIEW.— In the case of any proposal for the National Institutes of Health to conduct or support research, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under section 492 unless the proposal has undergone such review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review. "(b) ETHICAL REVIEW OF RESEARCH.— "(1) PROCEDURES REGARDING WITHHOLDING OF FUNDS. —If research has been recommended for approval for purposes of subsection (a), the Secretary may not withhold funds for the research because of ethical considerations luiless— "(A) the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations; and "(B)(i) the majority of the advisory board recommends that, because of such considerations, the Secretary withhold funds for the research; or

�