HHS HUMAN RESEARCH SUBJECT PROTECTION REGULATIONS PERTAINING TO INVITRO FERTILIZATION (IVF) OF HUMAN OVA MODIFIED BY THE NIH REVITALIZATION ACT NIH GUIDE, Volume 22, Number 32, September 3, 1993 P.T. 34 Keywords: Human Subjects Policy Abortion (Induced) Biological Resources National Institutes of Health The National Institutes of Health Revitalization Act of 1993 (P.L. 103- 43) nullified the provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)). The provisions- -which are now void--read: "No application or proposal involving human in vitro fertilization may be funded by the Department until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint." The practical effect of this nullification is that research applications and proposals involving in vitro fertilization (IVF) of human ova may be conducted or funded by HHS and its components without the prior review and advice of a national advisory body. IRB (Institutional Review Board) review and approval continues to be required in accord with 45 CFR 46.205. It is anticipated that applications and proposals involving certain types of human IVF research will still be subject to special review on a case-by-case basis, at the discretion of the Department and its components. INQUIRIES For further information, contact F. William Dommel, Jr., J.D. Senior Policy Advisor Office for Protection from Research Risks Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-7005 .
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