What is "Bioethics"? pg.9

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Endnotes: (con't)

58  Jonsen, p. 100.[Back]

59  Ibid., pp. 102-103; for a more lengthy discussion, see pp. 325-351.[Back]

60  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research ; U.S. Department of Health, Education and Welfare (Washington, D.C.: Government Printing Office, 1978).[Back]

61  Title 45; Code of Federal Regulations; Part 46 [45 CFR 46]; Office for the Protection from Research Risks [OPRR]; U.S. Department of Health and Human Services, 1981 [revised 1983, 1991, 1993, and incorporated into the Federal Policy (or, Common Rule), 1991.][Back]

62  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975, p. 5.[Back]

63  Ibid., p. 5.[Back]

64  Title 45; Code of Federal Regulations; Part 46 [45 CFR 46]; Office for the Protection from Research Risks [OPRR]; U.S. Department of Health and Human Services, 1983, p. 12.[Back]

65  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975; "Dissenting Statement of Commissioner David W. Louisell" (p. 77-82). Because these materials are difficult for many to access, and because Dr. Louisell's comments are so relevant, I have excerpted the following:

"I am compelled to disagree with the Commission's Recommendations (and the reasoning and definitions on which they are based) insofar as they succumb to the error of sacrificing the interests of innocent human life to a postulated social need. ... Although the Commission uses adroit language to minimize the appearance of violating standard norms, no facile verbal formula can avoid the reality that under these Recommendations the fetus and nonviable infant will be subjected to nontherapeutic research from which other humans are protected. ... But the good in much of the Report cannot blind me to its departure from our society's most basic moral commitment: the essential equality of all human beings. For me the lessons of history are too poignant, and those of this century too fresh, to ignore another violation of human integrity and autonomy by subjecting unconsenting human beings, whether or not viable, to harmful research even for laudable scientific purposes. ... Admittedly, the Supreme Court's rationale in its abortion decisions of 1973 -- Roe v. Wade and Doe v. Bolton, 310 U.S. 113, 179 -- has given this Commission an all but impossible task. For many see in that rationale a total negation of fetal rights, absolutely so for the first two trimesters and substantially so for the third. The confusion is understandable, rooted as it is in the Court's invocation of the specially constructed legal fiction of "potential" human life, its acceptance of the notion that human life must be "meaningful" in order to be deserving of legal protection, and its resuscitation of the concept of partial human personhood, which had been thought dead in American society since the demise of the Dredd Scott decision.

... "It seems to me that there are at least two compelling answers to the notion that Roe and Doe have placed fetal experimentation, and experimentation on nonviable infants, altogether outside the established protections for human experimentation. First, while we must abide the Court's mandate in a particular case on the issues actually decided even though the decision is wrong and in fact only an exercise of 'raw judicial power' (White, J., dissenting in Roe and Doe), this does not mean we should extend an erroneous rationale to other situations. To the contrary, while seeking to have the wrong corrected by the Court itself, or by the public, the citizen should resist its extension to other contexts. ... Secondly, the Court in Roe and Doe did not have before it, and presumably did not intend to pass upon and did not in fact pass upon, the question of experimentation of the fetus or born infant. Certainly that question was not directly involved in those cases. ... [W]e should assume that the language was limited by the abortion context in which used and was not intended to effect a departure from the limits on human experimentation universally recognized at least in principle.

... "For me, the chief vice of Recommendation (5) is that it permits an escape hatch from human experimentation principles merely by decision of a national ethical review body. No principled basis for an exception has been, nor in my judgment can be, formulated. The argument that the fetus-to-be-aborted 'will die anyway' proves too much. All of us 'will die anyway.' A woman's decision to have an abortion, however protected by Roe and Doe in the interests of her privacy or freedom of her own body, does not change the nature or quality of fetal life.

... "Recommendation (6) concerns what is now called the 'nonviable fetus ex utero' but which up to now has been known by the law, and I think by society generally, as an infant, however premature. ... In my judgment all infants, however premature or inevitable their death, are within the norms governing human experimentation generally. [[ Stated before the formulation of the OPRR federal regulations on the use of human subjects in experimental research (see supra).]] We do not subject the aged dying to unconsented experimentation, nor should we the youthful dying. ... I would, therefore, turn aside any approval, even in science's name, that would by euphemism or other verbal device, subject any unconsenting human being, born or unborn, to harmful research, even that intended to be good for society. Scientific purposes might be served by nontherapeutic research on retarded children, or brain dissection of the old who have ceased to lead 'meaningful' lives, but such research is not proposed -- at least not yet. As George Bernard Shaw put it in The Doctor's Dilemma: 'No man is allowed to put his mother in the stove because he desires to know how long an adult woman will survive the temperature of 500 degrees Fahrenheit, no matter how important or interesting that particular addition to the store of human knowledge may be.'

... "An emotional plea was made at the Commission's hearings not to acknowledge limitations on experimentation that would inhibit the court-granted permissive abortion. However, until its last meeting, I think the Commission for the most part admirably resisted the temptation to distort its purpose by pro-abortion advocacy. But at the last meeting, without prior preparation or discussions, it adopted Recommendation (12) promotive of research on abortion techniques. This I feel is not germane to our task, is imprudent and certainly was not adequately considered.

... "That [the Commission] has not been more successful is in my judgment not due so much to the Commission's failings as to the harsh and pervasive reality that American society is itself at risk -- the risk of losing its dedication 'to the proposition that all men are created equal.' We may have to learn once again that when the bell tolls for the lost rights of any human being, even the politically weakest, it tolls for all." (emphases mine)[Back]

66  For early historical accounts see F. Keibel and F. Mall (eds.), Manual of Human Embryology, 2 vols. (Philadelphia: Lippincott, 1910-12); A. Meyer, The Rise of Embryology (Stanford, CA: Stanford University Press, 1939); J. Needham, A History of Embryology (Cambridge, MA: Cambridge University Press, 1959) (2nd ed.); J. Oppenheimer, Essays in the History of Embryology and Biology (Cambridge, MA: M.I.T. Press, 1967); Jan Langman, Medical Embryology (Baltimore: The Williams & Wilkins Company, 1969), p. 69. For the same information in current human embryology textbooks see: Bruce M. Carlson, Human Embryology and Developmental Biology (St. Louis, MO: Mosby, 1994), p. 407: "After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed and the fetal period begins." Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), p. 55: "The embryonic period proper ... occupies the first 8 postovulatory weeks ... The fetal period extends from 8 weeks to birth ... ."; Keith L. Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W.B. Saunders Company,1998), p. 6: "The embryonic period extends to the end of the eighth week ... After the embryonic period, the developing human is called a fetus. During the fetal period (ninth week to birth) ... ."; also, William J. Larsen, Human Embryology (New York: Churchill Livingstone, 1997).

For scientific clarification of these and numerous other scientific misdefinitions which have found their way into current debates on human embryo research, cloning research, stem cell research, chimera research, etc., see Dianne N. Irving, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Doctoral Dissertation; Department of Philosophy, Georgetown University, Washington, D.C.: University Microfilms, 1991); Irving, "Science, Philosophy and Expertise: An Evaluation of the Arguments on 'Personhood'", Linacre Quarterly (Feb.1993), 60(1):18-46; Irving, "When Do Human Beings Begin? 'Scientific' Myths and Scientific Facts", International Journal of Sociology and Social Policy (1999), 19:3/4:22-47; also, Ward C. Kischer and Dianne N. Irving, The Human Development Hoax: Time To Tell The Truth! (1997, distributed by American Life League).[Back]

67  E.g., Bruce M. Carlson, Human Embryology and Developmental Biology (St. Louis, MO: Mosby, 1994), p. 3: "Human pregnancy begins with the fusion of an egg and a sperm ... Finally, the fertilized egg, now properly called an embryo, must make its way into the uterus, ...".[Back]

68  In addition to references in notes 2 and 4 supra, see also: Irving, "Cloning: When Word Games Kill", (May 1998), commissioned by the Free Congress Foundation but never published by them); Irving, "NIH Human Embryo Research Panel Revisited: What is Wrong With This Picture?", Linacre Quarterly (May 2000), 67:2:8-22; Irving, "Stem Cell Research: Some Pros and Cons", UFL PRO VITA: Newsletter of the University Faculty for Life (October 1999), Vol. X, No. 1, pp. 1-2; Irving, "Testimony Before the U.S. House of Representatives' Hearing on Cloning: Legal, Medical, Ethical and Social Issues", Linacre Quarterly (May 1999), 66:2:26-40; Irving, "Testimony Against the Use of Human Biological Materials in Experimental Research", in National Bioethics Advisory Commission Report [NBAC], The Use of Human Biological Materials in Research: Ethical Issues and Policy Guidance, Appendix (Government Printing Office, 1999), submitted February 1999; Irving, "Commentary", in Frank J. Ayd, Jr., M.D., The Medical-Moral Newsletter, 35 (3-4): pp. 15-16 (Baltimore, MD: Ayd Medical Communications, 1998); Irving, "Affidavit on 'Personhood': Submission to the Constitutional Court of South Africa", 25-page notarized affidavit submitted to the Constitutional Court of South Africa, June 24, 1996; Irving, "Politicization of Science and Philosophy: The 'Delayed Personhood' Debates and Conceptual Transfer", C.E.R.P.H. Newsletter (1995), 2:4 (Centre d'Etudes sur la Reconnaissance de la Personne Humaine [CERPH]), CHU La Miletrie, B.P. 577, 86021 Poitiers, France); Irving, "Academic Fraud and Conceptual Transfer in Bioethics: Abortion, Human Embryo Research and Psychiatric Research", in Joseph W. Koterski (ed.), Life And Learning IV (Washington, D.C.: University Faculty for Life, (1995), pp. 193-215; Irving, "Individual Testimony Before the NIH Human Embryo Research Panel - March 14, 1994", reprinted in Linacre Quarterly (Nov. 1994), 61(4):82-89; Irving, "Embryo Research: A Call For Closer Scrutiny", Linacre Quarterly (July 17, 1994); Irving, "'New Age' Embryology Text Books: 'Pre-Embryo', 'Pregnancy' and Abortion Counseling: Implications for Fetal Research", Linacre Quarterly (May 1994), 61(2):42-62; Irving, "Can Either Scientific Facts or 'Personhood' be Mediated?", Pontis (March 1994) (The Center for Medical Ethics and Mediation, San Diego, CA), 2(1):3-5; Irving, "Post-Abortion Trauma Syndrome: Getting the Facts Straight", ("Letter to the Editor"), Linacre Quarterly (1994), 61(1): 3-6; Irving, Amicus curiae brief, Scientific and Philosophical Inaccuracies in Fetal Personhood Arguments, prepared for Gil Messina, Esq., Red Bank, NJ, and submitted by Daniel Gray, Esq., to the United States Supreme Court, February 17, 1994, in support of Alexander Loce v. The State of New Jersey, and Krail v. The State of New Jersey; ibid., in support of J.M. v. V.C., July 3, 1993; Irving, "The Impact of Scientific 'Misinformation' on Other Fields: Philosophy, Theology, Biomedical Ethics and Public Policy", Accountability in Research (April 1993), 2(4):243-272.[Back]

69  Richard A. McCormick, S.J., "To Save or Let Die," Journal of the American Medical Association (1974), 229:172-176. See also, John C. Fletcher, "Abortion, Euthanasia and Care of the Defective Newborn", New England Journal of Medicine (1975); 292:75-79; H. Tristram Engelhardt, Jr., "Ethical Issues in Aiding the Death of Young Children," in Martin Kohl (ed.), Beneficent Euthanasia (Buffalo, N.Y.: Prometheus Books, 1975), pp. 180-192; John Robertson and Norman Fost, "Passive Euthanasia of Defective Newborn Infants," Journal of Pediatrics 88 (1976), 88:883-192; John Robertson, "Involuntary Euthanasia of Defective Newborns: A Legal Analysis," Stanford Law Review (1975), 27:213-269; Albert R. Jonsen and Michael J. Garland (eds.), Ethics of Newborn Intensive Care (Berkeley: Institute for Government Studies, 1976), pp. 33 and 190; Albert Jonsen, William Tooley, Roderick Phibbs, and Michael Garland, "Critical Issues in Newborn Intensive Care: A Conference Report and Policy Proposal," Pediatrics (1975), 55:756-768; Barbara Culliton, "Intensive Care for Newborns: Are There Times to Pull the Plug?", Science (1975), 188:133-134; Paul Ramsey, "An Ingathering of Other Reasons for Neonatal Infanticide," in Ethics at the Edges of Life: Medical and Legal Intersections (New Haven: Yale University Press, 1978), pp., 228-267, 250; Darrel W. Amundsen, "Medicine and the Birth of Defective Children: Approaches of the Ancient World," in Richard M. McMillan, H. Tristram Engelhardt, Jr., and Stuart F. Spicker (eds.), Euthanasia and the Newborn: Conflicts Regarding Saving Lives (Dordrecht/Boston: D. Reidel Publishing Company, 1987), pp. 3-22; Maria W. Piers, Infanticide (New York: Norton, 1978); Clement A. Smith, "Neonatal Medicine and Quality of Life: An Historical Perspective", in Jonsen and Garland (eds.), Ethics of Newborn Intensive Care, p. 33; Alexander Schaffere, Diseases of the Newborn (Philadelphia: Saunders, 1960); William Silverman, "The Lesson of Retrolental Fibroplasia," Scientific American (1977), 236:100-107; Paul A. Freund, "Mongoloids and 'Mercy Killing'" in Reiser et al, Ethics in Medicine, pp. 536-538; James M. Gustafson, "Mongolism, Parental Desires and the Right to Live," Perspectives in Biology and Medicine (1973), 16:4:529-557; Raymond S. Duff and A.G.M. Campbell "Moral and Ethical Dilemmas in the Special-Care Nursery," New England Journal of Medicine (1973), 289:890-984; President's Commission on Ethical Problems in Medicine and Biomedical and Behavioral Research, Deciding to "Forego Life-Sustaining Treatment: A Report on the Ethical and Legal Issues in Treatment Decisions (Washington, D.C.: U.S. Government Printing Office, 1982), Chapter 6; Cindy Bouillon-Jensen, "Infanticide," in Warren T. Reich (ed.), Encyclopedia of Bioethics (2nd ed.) (New York: Simon and Schuster Macmillan, 1995), pp. 1200-1205; Martin S. Pernick, The Black Stork: Eugenics and the Death of "Defective" Babies in American Medicine and Motion Pictures (New York: Oxford University Press, 1996)[Back]

70  See discussions on the impact of the work of Richard McCormick on the development of bioethics in the NBAC commissioned paper by John C. Fletcher, "Deliberating Incrementally on Human Pluripotential Stem Cell Research", [http://bioethics.gov/stemcell2.pdf], Sept. 1999, p. E-11 and several others; also in Jonsen, pp. 52-56, 100, 106, 154-155, 247, 259, 291, 293, 310-311.[Back]

71  Andre E. Hellegers, "Fetal Development," in Thomas A. Mappes and Jane S. Zembatty (eds.), Biomedical Ethics, (New York: Macmillan, 1981); Hellegers, "Fetal Development", Theological Studies (1970), 31:3-9.[Back]

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