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CRS-6

Federal Policy Involving Human Embryo Research

At the present time, no U.S. laws or regulations would prohibit all cloning research. However, federal funding of any type of research involving human embryos, starting with in vitro fertilization (IVF) then later cloning and the creation of stem cell lines from embryos, had been blocked by various policy decisions dating back 25 years.

Ethics Advisory Board. Following the birth of the first IVF baby, Louise Brown, in July 1978, the federal Ethics Advisory Board (EAB) was tasked with considering the scientific, ethical, legal, and social issues surrounding human IVF.26 The EAB released its report on May 4, 1979, which found that IVF research was acceptable from an ethical standpoint and could be supported with federal funds. The EAB’s recommendations were never adopted by HHS, the EAB was dissolved in 1980, and no other EAB was ever chartered. Because federal regulations that govern human subject research (45 C.F.R. Part 46) stipulated that, at the time, federally supported research involving human IVF must be reviewed by an EAB, a so-called “de facto moratorium” on human IVF research resulted. Other types of embryo research ensuing from the development and use of IVF, such as cloning and stem cells, were therefore also blocked. The de facto moratorium was lifted with the enactment of the National Institutes of Health (NIH) Revitalization Act of 1993 (P.L. 103-43, Section 121(c)) which nullified the regulatory provision (45 C.F.R. § 46.204(d)) requiring EAB review of IVF proposals.

NIH Human Embryo Research Panel. In response, the NIH established the Human Embryo Research Panel to assess the moral and ethical issues raised by this research and to develop recommendations for NIH review and conduct of human embryo research. The NIH Panel released a report providing guidelines and recommendations on human embryo research in September 1994. The panel identified areas of human embryo research it considered to be unacceptable, or to warrant additional review. It determined that certain types of cloning27 without transfer to the uterus warranted additional review before the Panel could recommend whether the research should be federally funded. However, the Panel concluded that federal funding for such cloning techniques followed by transfer to the uterus should be unacceptable into the foreseeable future. The NIH Panel recommended that some areas of human embryo research should be considered for federal funding, including SCNT, stem cells and, under certain limited conditions, embryos created solely for

26 The EAB was created in 1978 by the Department of Health Education and Welfare (HEW), the forerunner of the Department of Health and Human Services (HHS). The EAB was formed at the recommendation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission operated from 1974 to 1978 and issued 10 reports, many of which formed the basis of federal regulations for research involving human subjects (45 C.F.R. Part 46).

27 These were blastomere separation, where a two- to eight-cell embryo is treated causing the cells (blastomeres) to separate; and, blastocyst division, in which an embryo at the more advanced blastocyst stage is split into two.

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