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Policy Derivation: When Should A Human Embryo Be Afforded Human Research Protection?

July 17, 2004
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The birth of the reprogenetic field, a blending genetics, reproductive biology and developmental biology plus the availability of animal and human gametes, embryos, and embryonic stem cells, have provided means to explore heretofore unimaginable scenarios.  This session will examine implications of policies to afford human research protection to human embryos.  Currently, humans are afforded research protection at the point of implantation.  This authority comes from the Public Health Service Act (42 U.S.C. 289g(b)) and 45 CFR 46, which explicitly apply to research, funded by federal monies.  However, if research applications ultimately desire FDA approval, there is impetus to comply.  The Annual Labor, Health and Human Service, Education Appropriations Act Section 511 Public Law 105-277, extends jurisdiction so human embryos can not be knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under CFR 46.208(a) (2) and section 498 (b) and prohibits federal monies to be used to create human embryos.  While federally funded research is restricted to embryonic stem cell lines created by the deadline of August 2001, private research continues to expand research techniques for the human embryo.  Guidance must be provided for ethical research on human embryos.  This session will explore the caveats with creating policy in this area.  This session will also examine several of the recommendations of the President’s Bioethics Council report entitled “Reproduction and Responsibility: The Regulation of New Biotechnologies.”  We must be ahead of the technology and proactively outlaw all human procreation except the combining of gametes between one male and one female.

Keywords:
"the human embryo, embryonic stem cell research, law, public policy, legal protection"