U F L

C. N. Abromaitis, PhD Keith Cassidy, PhD Teresa Collett, JD Robert Crnkovich, LLD

Department of English Department of History South Texas School of Law Law Center

John F. Crosby, PhD Richard J. Fehring, DNSc Jorge Garcia, PhD Dianne Nutwell Irving, PhD

Department of Philosophy Department of Nursing Department of Philosophy Department of Philosophy

Franciscan U. of Steubenville Marquette University Rutgers University Dominican House of Studies

Thomas M. King, SJ, PhD Joseph Koterski, SJ, PhD Teresa Lamonica, MSN, PN Robert J. Spitzer, SJ, PhD

Department of Theology Department of Philosophy Department of Nursing Department of Philosophy

Georgetown University Fordham University Georgetown University Seattle University

As a member of the Board of Directors of an organization, i.e., the University Faculty For Life, I am contacting you on their behalf concerning your current request for responses to your "Human Stem Cell Research: Opportunities for Health and Ethical Perspectives" [hereafter referred to as "Recommendations"].

The University Faculty for Life was founded in 1989 to promote research, dialogue and publication among faculty members who respect the value of human life from its inception at fertilization or cloning to natural death. Abortion, infanticide and euthanasia, as well as human embryo and human fetal research, human embryonic stem cell research, and human cloning, are highly controversial topics, but we believe they should not be resolved by the shouting, newsbites and slogans that have dominated popular presentations. Because we believe the evidence is on our side, we would like to assure a hearing for our views in the academic community, as well as in the social and political communities -- hence our comments expressed to you here regarding certain concerns we have with the CIHR Recommendations.

The basic issues and concerns of the University Faculty For Life have many dimensions -- political, social, legal, medical, biological, psychological, ethical and religious. We do not have a detailed statement of orthodoxy; rather we have provided an interdisciplinary forum in which scholars can discuss these issues. Since 1990 the UFL has published a newsletter, Pro Vita; since 1991 it has held an annual conference at various university campuses; and since 1992 the Conference Proceedings have been published in book form and distributed to members and hundreds of university libraries. We have sent letters to public figures who misstate biological facts and submitted three amicus curiae briefs on the life issues to the U.S. Supreme Court (two of which I authored on "fetal personhood").

· To provide a forum to foster multidisciplinary dialogue and collaboration among professors concerned about human life.

· To educate the community, including politicians and the U.S. Congress, about life issues and the rational and factual reasons behind pro-life positions.

· To make available academic materials and resources for pro-life groups, including bibliographies and videotapes of conferences and lectures.

The University Faculty For Life is also communicating our concerns about similar legislation on these related important issues to groups and organizations both in the United States and abroad. The University Faculty For Life strongly supports good research, but also agrees that immediate legislative action must be taken to prevent harmful and unethical research using human beings in these areas.

As you well realize, the issues raised in your Recommendations are likewise relevant to other proposed legislation dealing with the integrally related issues of abortion, as well as all of the various forms of human embryo research -- including human embryonic stem cell research, human cloning, human chimera research, etc. It goes without saying that your Recommendations, if passed by the Canadian Parliament, will have an immediate impact on similar and related laws, guidelines and regulations passed in other countries around the world. Any legislation passed by Canadian Parliament on these several critically important issues will in effect act as a "role model" for similar legislation internationally. Such legislation impacts greatly on the health and well-being of the individual members of all of our societies. It is difficult to imagine many issues that would effect our societies' health and well-being more than the abuse of living human subjects in research, and the actual manipulation and permanent designing of the future members of the human species.

We have included in this submission a summary of our concerns, followed by a more detailed and extensively referenced scientific response. We hope that these comments may be helpful to your Working Group in reviewing your Recommendations, and we thank you very much in advance for allowing us to submit our concerns to you for your thoughtful consideration.

Part I: SUMMARY OF THE SCIENTIFIC AND ETHICAL CONCERNS OF THE UNIVERSITY FACULTY FOR LIFE:

Relevant to your Recommendations #1, #2, #3, and #5, the University Faculty For Life would respectfully submit the following scientific and ethical concerns:

The starting point for considering and determining public policy making in these

Many "views" are based simply on subjective personal opinions, religious beliefs, and even passe "scientific" myths. The position of the University Faculty For Life, and that of many other individuals and organizations, is based not on "opinion", or "beliefs", nor on discarded and long-rejected scientific "myths", but rather on the objective and accurate current facts of human embryology and human genetics -- i.e., that the immediate product of human fertilization or of human cloning is a new unique already existing human being, who's fundamental human rights -- among which is the inherent right to life -- should be equally afforded the full range of legal protections as all other living human beings. The scientific categorization of different human beings into increasing gradients of either "humanhood" or "personhood", and therefore different ethical, social and political rights and protections, has historically never had any scientific, social or political merit, and indeed, has led to disaster.

(a) fail to acknowledge the scientific fact that the immediate product of human fertilization and human cloning is a new unique living human being; (b) fail to acknowledge the scientific fact that individual cells and groups of cells from both totipotent and pluripotent "human embryonic stem cells" can "heal" themselves and exist as new individual human beings; (c) use such discarded "scientific" myths as the "biogenetic law", and (d) the "pre-embryo" theory, on which to ground public policy on stem cell research; (e) use a false scientific distinction between "therapeutic" and "reproductive" kinds of research using living human embryos; (f) ban only one scientific method of cloning, i.e., somatic cell nuclear transfer (SCNT), while allowing other direct and indirect methods of cloning human beings, e.g., (g) "embryo splitting", (h) human germ line cell cloning, (i) "sexual cloning", (j) non-chromosomal DNA cloning, and (k) the formation of human chimeras. Extensive current and accurate scientific references for our position may be found in more detail in Part II, below.

In sum: The University Faculty For Life would support only ethical medical research that is based on and that uses current and accurate science, and which does not involve the killing of innocent living human beings -- at any stage of development.

(a) the first ethical requirement of scientific research is not met; (b) the means used to reach good goals are not considered; (c) all human beings are human subjects; (d) a specific defunct, normative, and eugenic "ethics" is ambiguously employed; (e) neither mothers or fathers could give legally or ethically valid informed consent to donate their living human children for medical research; (f) other ethically acceptable means of achieving good goals are available, e.g., the use of adult human stem cells, and other ethical research avenues.

In sum: The University Faculty for Life would support only ethical medical research using adult human stem cells, or other ethical medical research which does not involve the killing of innocent living human begins -- at any stage of development.

PART II: DETAILED COMMENTS ON THE SCIENCE USED, OR IGNORED, IN THESE RECOMMENDATIONS: [Emphases used to aid those unfamiliar with the science]

(a) The immediate product of human sexual and asexual reproduction is a new, unique, living human being:

As we are certain you are aware, it is a long-established objective scientific fact that the immediate product of human fertilization -- in vivo or in vitro -- is a newly existing, genetically unique, individual living human being -- the single-cell human zygotic embryo.[1] This is also the beginning of the embryonic period[2] as well as the beginning of normal pregnancy in the fallopian tube of the woman.[3] These scientific facts are not new; indeed it has been established scientifically since 1880-1885, with publication of the three-volume tomb, Anatomie menschlicher Embryonen, (Vogel, Leipzig) by Wilhelm His, the founder of human embryology.[4] The immediate product of human cloning is likewise a newly existing, genetically unique, individual human being.

"Blastomere separation", "blastocyst splitting", or "fission", also referred to as "embryo multiplication", can result in these "totipotent" and "pluripotent" cells derived from whole human embryos to "heal" themselves, resulting in new human beings that are "copies" of the original embryo.[5] Therefore, these techniques are forms of cloning as well as forms of human embryo research . Since IVF-produced human embryos are usually implanted or frozen at the 2 to 16-cell stage of human embryonic development[6], they would be prime candidates for the multiplication of or for the cloning of new human beings.

It is an objective scientific fact that as long as the cells of the early human embryo are

still intact as parts of the whole embryo, these totipotent and "pluripotent" cells are correctly termed "stem cells". However, once these cells (or, "blastomeres") are separated from the whole embryo, each of these "totipotent or "pluripotent" cells are no longer "stem cells". Single "totipotent" cells, and even groups of "pluripotent" cells, are each capable of "healing" themselves (called "regulation"), and reverting back to being a whole human being. This is indeed what takes place naturally in human monozygotic twinning.[7] "Embryo splitting", therefore, is also a form of human cloning by which "identical copies" of human beings are produced.

In phrasing the issue in terms of "'a graduated approach' ... in which permitted interventions correlate with the developmental stage of the embryo", the Recommendations obfuscate the critical importance of grounding public policy on universally acknowledged and scientifically accurate facts. Such a "graduated approach" is grounded in the antiquated, long-rejected and scientifically discarded "biogenetic law", i.e., "ontogeny recapitulates philogeny", in the sense that this theory implies that the individual developing human embryo/fetus is not yet a full human being, but is only "gradually" becoming one. Today scientists understand that empirically this is not the case. As human embryologist Ronan O'Rahilly, who sits on the international board of the Nomina Embryologica, has succinctly put it (quoting de Beer), this discarded scientific theory has had a "regrettable influence in the progress of embryology".[8] The early human embryo and human fetus is an already existing whole human being immediately from fertilization or cloning on; it is not a frog or a fish "on its way to becoming" a human being. Scientifically, there is no scientific basis for any such "graduated approach" as used in the Recommendations. Ethically, it could be a form of "consensus ethics"; however, "consensus ethics" is a normative ethical theory, and therefore would be properly used to determine public policy in a democratic, pluralistic, multicultural society.

Furthermore, employing such a scientifically erroneous "anthropology" as the starting point, or major premise, of your considerations in these Recommendations unfortunately leads necessarily to the use of additional scientifically erroneous claims and concepts throughout your Recommendations. Such a "graduated approach" also leads to the ethically invalid claim that the early human embryo possesses simply a "reduced moral status" -- i.e., that there is some sort of a parallel "gradually acquired moral status" -- and therefore, supposedly, it would be "scientifically and morally justified" to use him/her in experimental and therapeutic research. However, this would not be a scientifically valid, and therefore not an ethically valid, claim.

Similar "scientific" efforts have been made to imply a "reduced moral status" for the early human embryo because it is simply a "pre-embryo", or by simply using the same scientifically erroneous "science" on which the "pre-embryo" myth was grounded without using the term itself. Scientifically there is no such thing as a "pre-embryo",[9] yet the term, or the same or similar false human embryology, has literally flooded the bioethics literature, and national and international documents,[10], for several years now. [See also Part III (c), below]. However, if scientifically there is no such thing as a "pre-embryo", and if the "science" on which the term is grounded is scientifically erroneous, then any ethical conclusions based on this erroneous "science" are thereby automatically likewise invalid. Therefore neither the false term "pre-embryo", nor the false "science" on which it is grounded, can be used to "scientifically justify" any "reduced moral status" for these early human beings.

(e) A scientifically false distinction between "therapeutic" and "reproductive" research with regard to using human embryos, and human embryonic and human fetal cells, is used:

Scientifically there is no real distinction between using human embryos, i.e., living human beings -- for "therapeutic" purposes or for "reproductive" purposes. Scientifically, once an innocent human being comes into full existence at fertilization, or at cloning, he/she remains an existing human being -- regardless of the scientific, social or political uses that other human beings might have for him/her. This false distinction is true for human stem cell research, as well as for human cloning.

(f) Only one form of cloning, i.e., somatic cell nuclear transfer (SCNT), is banned:

Although these Recommendations courageously do reject the cloning of human beings by means of somatic cell nuclear transfer (SCNT), they fail to properly and accurately address the scientific fact that SCNT is only one method of cloning human beings, and that other methods of cloning human beings would be possible if these Recommendations are "silent" about them. This includes the cloning of human beings by means of the method of parthenogenesis, as well as other methods of human cloning (discussed further below).

If "human cloning" is defined generally as "the direct or indirect production of 'identical copies' of human beings or human DNA materials", then there are several other types of direct and of indirect human cloning that would not be banned by these Recommendations.

These Recommendations fail to acknowledge scientifically that "embryo splitting", a procedure used by researchers, including for IVF research and for IVF "therapy", is both a form of human cloning as well as a form of human embryo research. [See Part II, (b), pp. 5-8 above].

(h) Direct cloning of human beings by the use of "human fetal stem cells", and their use in DNA-recombinant human gene germ line transfer, is not banned:

Although these Recommendations do accurately recognize that "human fetal stem cells" are actually "human embryonic germ line cells", they fail to specifically acknowledge that these human embryonic germ line cells are diploid [11] and therefore can also be cloned, or be used in human DNA-recombinant gene germ line transfer, thus permanently altering future generations of human beings.[12] In addition, it should be understood that these human germ line cells can also be retrieved from both living and dead cadavers, not just from embryos and fetuses post abortion.

By addressing only an "asexual" form of cloning (i.e., SCNT), these Regulations would not cover "sexual" human cloning, i.e., the duplication or "copying" of human DNA by means of DNA-recombinant human germ-line gene transfer to human gametes or human embryos in vitro, which genetic changes are then "copied" or cloned by means of normal sexual reproduction through the generations. DNA-recombinant human gene germ-line "therapy" is a form of "positive eugenics", as so defined by researchers themselves,[13] and essentially accomplishes the same thing eventually as normal a-sexual eugenic cloning, or as does the pre-selection of human embryos after sexual reproduction using IVF. It also involves the human germ-line cells, now referred to simply, and erroneously, in the stem cell debates as "fetal stem cells."

(j) Indirect cloning of human beings by the use of extra-chromosomal and extra-nuclear human

By restricting the ban to the cloning of chromosomal nuclear DNA only (i.e., by means of SCNT), the bill would not ban cloning or copying of extra-chromosomal and extra-nuclear human DNA, e.g., as found in several organelles inside and outside the cell nucleus (e.g., the cloning of mitochondrial DNA).[14]

(k) Indirect cloning of human beings by the use of human chimeras is not banned:

The very problematic issue of the cloning of human chimeras should be more clearly addressed in these Regulations. Chimera research would be an indirect form of human cloning. It would also be a form of human embryo research because: (a) theoretically, a human/animal chimera could be "back-bred"[15] to produce a new whole human embryo (human being); and, (b) the source of the human DNA used in such chimera research could be living human embryos or fetuses. Therefore, these Recommendations would not ban human cloning by means of the formation of human chimeras; additionally, these Recommendations would also sanction a form of human embryo research.

PART III: DETAILED COMMENTS ON THE ETHICS USED, OR ASSUMED, IN THESE RECOMMENDATIONS:

The first ethical requirement of any scientific research is that it be based on current, sound and accurate science -- as firmly and succinctly stated in international research guidelines using human subjects such as the Nuremberg Code[16], and the Declaration of Helsinki:

Basic Principles: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature."[17]

We would strongly encourage the CIHR Working Group to likewise consider this as the first ethical requirement of their Recommendations.

The means used to achieve the "therapeutic" and "scientific" goals of these Recommendations, even granted that these goals are important and worthy, must also be seriously considered as part of the equation. If the means used in such research are highly objectionable and unethical, then the research itself should be prohibited, regardless of how acceptable the goals may seem. To intentionally kill innocent living human beings as a means to cure diseases in others or to advance scientific knowledge per se is an inherently and highly objectionable unethical means to a goal, and therefore this research should not be permitted. To do otherwise would also violate international codes of research ethics, and clearly an unambiguously articulated in the 1998 Declaration of Helsinki:

I. Basic Principles: 5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interest of science and society.

II. Medical Research Combined with Professional Care
(Clinical Research) 6. The doctor can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

III. Non-therapeutic Biomedical Research Involving Human Subjects
(Non-clinical biomedical research) 4. In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.[18]

Of course, the issue is often raised within bioethics as to whether or not a human being is always simultaneously a human "person" -- and therefore a human subject to be ethically and legally respected and protected to the fullest extent. This issue is closely related to the use of the term "pre-embryo", the 14-day limit on research using living human embryos, and the "reduced moral status" terminology implied in these Recommendations to justify research using early human embryos -- a concept which can be traced back historically to the early bioethics writings of Richard McCormick, S.J. and Clifford Grobstein, e.g., their testimonies before the National Commission (1975), and their work on the DHEW Ethics Advisory Board (1978).[19]

Any competent and complete response to this divisive issue would be far too lengthy to include in this response; however, the issue should still be raised here. The massive bioethics literature in which "delayed personhood", on which, e.g., the CIHR 14-day limit on the use of living human embryos in research is based, has been extensively identified and analyzed by many critics around the world. It is sufficient to point out, however, just a few essential facts here.

The question of when a human being begins to exist is strictly a scientific question, and should be answered only by human embryologists -- i.e., those scientists who have the academically required training, advanced degrees, and professional experience to be considered "experts" in this field. Physicians, nurses, molecular biologists, geneticists, biochemists, engineers, X-ray technicians, politicians, public policy makers, theologians, philosophers, bioethicists, etc., do not have the necessary academic credentials to answer this strictly scientific question as "experts". Human embryologists internationally all agree, as referenced in Part II (above), that a new unique human being begins to exist immediately at fertilization or at cloning.[20]

The question of when a human "person" begins to exist is not a scientific question at all, but rather strictly a philosophical question -- and more recently, a "bioethics" question [see (d), below)]. It should be stressed that a "delay" in "personhood" is the major criteria for any conclusion of a "reduced moral status" for the early developing human being, and is the major basis for "biological markers" such as the 14-day marker incorporated by the CIHR Recommendations and other related Canadian (and some international guidelines). However, worldwide, extensive and highly critical analyses of these bioethics debates and conclusions on "delayed personhood" must not be ignored, and any efforts to utilize any of these "delayed personhood" claims as the basis for making public policy should be required to be defended in open public debates and before the full academy. Clearly, if the "science" used to ground any "delayed personhood" argument is false and erroneous "science", the ethical conclusion of "delayed personhood" is automatically likewise invalid.

Virtually all of these "delayed personhood" arguments are grounded in very specific scientific and philosophical claims, and all of these arguments are severely compromised. For example, this writer has written a 400-page doctoral dissertation on human embryo research (as well written as other extensive peer reviewed publications) in which these bioethics arguments for "delayed personhood" were analyzed in depth -- scientifically, philosophically, and logically.[21] The conclusions were frankly astounding. Of the 28 representative bioethics arguments analyzed, virtually all of them used extensive erroneous "science", and historically inaccurate or theoretically indefensible philosophical claims (e.g., a "mind/body split") to ground their conclusions on "delayed personhood". Further, virtually none of these conclusions followed logically from their major and minor premises. Such ridiculously erroneous "delayed personhood" arguments are precisely those which ground the Canadian, as well as several of the international documents as noted in the Recommendations -- of particular influence, the arguments incorporating the "pre-embryo" myth, and the "biogenetics" myth (as discussed in Part II above).

The point should be clear. To date there has been absolutely no claim for "delayed personhood" which can withstand any significant scientific or philosophical academic challenge. On the other hand there are significant realist philosophical arguments, using accurate, sound and current science as their starting points, which can and have argued for "immediate personhood", and this is the general position taken by the University Faculty for Life. Human beings are always simultaneously human persons -- and therefore human subjects -- regardless of their particular stage of growth, development, maturity, or state of dependency. The early human embryo and fetus are unquestionably living human beings, therefore human persons, therefore human subjects. Therefore the ethical and legal rights and protections of these young human subjects should be fully and equally respected as those of more mature human subjects.

Regardless of the bioethics or philosophy involved, public policy, we think, should not be based on such highly questionable and extensively refuted "theories" and claims for "delayed personhood" or "reduced moral status". Rather, it is more reasonable to based them on sound, current, and accurate science. We know objectively and empirically that new, unique, living human beings begin to exist immediately at fertilization or at cloning. This is not a "belief" or an "opinion" -- and efforts to attempt to falsely caste this debate in those terms should be ignored. We strongly urge that public policy should be based on the objective scientific facts, and that the life and personhood of these developing human beings be truly respected as equally as those of more mature human beings. The legacies of slavery and numerous holocausts -- currently and historically -- are there to remind us that any two-tiered classification of human beings eventually leads to disaster.

(d) A specific defunct, normative, and eugenic "ethics" is ambiguously employed:

Although the CIHR Working Group encouragingly registers serious concern for an "ethical" foundation for its Recommendations, the following questions should be immediately and directly addressed by the Working Group so that Canadian citizens can better understand the issues involved: (1) Which "ethics" should the Canadian government use on which to base its CIHR Recommendations?; (2) Who should determine which ethics the Canadian government should use?; (3) What does the CIHR consider constitutes "ethical expertise"?; (4) Can the Canadian government, which represents a democratic, pluralistic, multicultural society, legitimately base its public policies on any normative ethical theory -- i.e., a specific ethical theory that takes a stand on what is right and wrong, ethical and unethical?

"Bioethics", "utilitarianism", "consensus ethics", "deontology", "situation ethics", "ethical relativism", "cultural relativism", etc. -- in all their forms -- are all normative ethical theories. They all take a stand on what is right and wrong, ethical and unethical.

Therefore, especially in these scientific and medical public policies, which directly effect the very health and well-being of all members of society, how does the CIHR justify to the Canadian people the answers to these questions? Such major, fundamental and significant issues and questions appear to be ignored, or the answers simply posited and assumed, apparently without sufficient discussion, debate, or justifications in these Recommendations. It would appear, in fact, that these Recommendations, and related Canadian bills, ground "what is ethical" on a specific normative and defunct theory of "bioethics".

Contrary to popular opinion, bioethics, as predominantly practiced today -- is not the same thing as "ethics per se". Academically it is actually a sub-field of ethics, and stands alongside many other theories of ethics, e.g., Kantian deontology, Millsean utilitarianism, casuistry, natural law, egoism, situation ethics, relativism, and various forms of theological ethics, etc. And like all ethical theories, bioethics is by no means "neutral" -- there is no such thing as a "neutral ethics".[22] In fact, bioethics defines itself as a normative ethical theory -- i.e., it takes a stand on what is right or wrong.[23]

Nor is bioethics to be equated with "medical ethics", as that term is still generally understood.[24] Bioethics understood as "principlism" is an academic theory of ethics which was formally articulated for the first time in 1978 by the U. S. Congressionally-mandated 11-member National Commission in their Belmont Report.[25] That Report, as Congressionally mandated, identified three bioethics principles for the U.S. government to use in issues concerning the use of human subjects in research: respect for persons, justice and beneficence (defining these three bioethics principles in less-than-traditional terms). These ethical principles are now referred to as "principlism", the Belmont principles, or "bioethics". This Congressional mandate, indeed, ushered in what has been referred to as the formal "birth of bioethics".[26]

The Belmont principles were supposedly ultimately derived from the normative ethical systems of various moral philosophers -- e.g., Kant, John Stuart Mill, and John Rawls. In effect, they quite selectively took bits and pieces from different and contradictory ethical theories and rolled them up into one ball. Furthermore, each of these principles were referred to as prima facie [27] -- i.e., no one principle could over-rule any of the others. And the way we come to know these bioethics principles is by taking courses, attending conferences, and listening to bioethicists lecture at conferences.

However eventually, and inevitably, theoretical cracks began to form in the very foundation of this new "bioethics" theory -- eventually rendering the theory defunct. For example, because bioethics was derived from bits and pieces of fundamentally different and even often contradictory theoretical philosophical systems, the result was theoretical chaos, rendering it academically indefensible. More problematic, when people tried to apply the theory, it didn't work because practically speaking there was no way to resolve the inherent conflicts among these three prima facie principles. Paul Ramsey had complained about this specific problem early on, when such a suggestion was submitted at an early conference: "Within the amplitude ... of general ethics, our authors fail to address clearly and rigorously the issue: which of these moral principles has priority (e.g., in the case of conflict)?"[28] The inherent contradictions and conflicts between and among these prima facie bioethics principles would slowly erode the confidence of even those stalwarts within the field itself.

Even each of the bioethics principles individually is riddled with similar inherently contradictory conflicts and theoretical problems. For example, while the Commissioners of The Belmont Report gave a nod to the traditional Hippocratic understanding of "beneficence" in one definition as "doing good for the patient" (or at least, doing no "harm"), their "second" definition of "beneficence" is essentially utilitarian -- in terms of the good for society at large (or roughly, "the greatest good for the greatest number of people"). Obviously these two different and opposite definitions of "beneficence" could easily contradict each other. How can the "bene" refer to the good of an individual patient in the standard medical or the research settings, and at the same time in the same case refer to the good of society -- calculated in the crude terms of utilitarian "risks and benefits"? What physician, who has sworn the Hippocratic Oath, would even recognize the following definition of "doing good" that is found in the Belmont Report:

Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. The Hippocratic maxim "do not harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. ... In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.[29] [Emphases mine.]

It was The Belmont Report's utilitarian definition of "beneficence" which was to be quickly perpetuated throughout the emerging bioethics literature, e.g., as defended in the first bioethics textbooks by Beauchamp, Childress and Walters,[30] incorporated in the OPRR federal regulations, and assumed by bioethics conferences, committees, panels and commissions to come -- up to and including the current National Bioethics Advisory Commission appointed by President Clinton.[31] This "strong obligation" of the utilitarian-defined Belmont principle of "beneficence" blatantly contradicts the long-held international codes of research ethics, e.g., the Nuremberg Code and the Declarations of Helsinki, in which the protection of the individual patient always outweighs the needs or "good" of science or society (as already noted). Even The Belmont Report itself admits this inherent contradiction in its own definition of "beneficence": "Here, again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices."[32]

Utilitarianism has always had serious problems with defining in practice what "good" is,[33] but it is generally very roughly reduced to some sort of physical or mental pain or pleasure. One thing is clear, however. All utilitarian formulas, by definition, leave minorities and the vulnerable out in the cold. There are no moral absolutes here - only "rules" or mathematical risk/benefit ratios, which are by definition relative to "the greater good". As utilitarian, the general norm or standard against which one determines if an individual action is right or wrong is "utility"; i.e., if that action is useful to achieving good consequences, those also being defined in terms of "the greatest good for the greatest number". Even more problematical is the deconstruction of these classical forms of utilitarianism into what would be termed "preference" utilitarianism (as evidenced in these CIHR Recommendations), where what would be weighed and balanced would be "best interests" -- as developed in the works of British eugenicists such as Jonathan Glover and R.M. Hare, and Australian eugenicists Peter Singer, Helga Kuhse, etc.

The bioethics principle of "justice" in The Belmont Report is also ultimately defined along utilitarian lines, in terms of "fairness" -- i.e., fairness in the distribution of the benefits and burdens of research.[34] This is not your classic definition of "justice", e.g., in the Aristotelean sense of communitive or distributive justice, but rather in terms strongly influenced by Harvard Graduate School philosophy professor John Rawls, as articulated in his then-new book, A Theory of Justice.[35] Rawl's "theory" of justice also profoundly influenced the theory-makers of bioethics from several other different academic disciplines. For example, it would later be adapted by his student Norman Daniels and applied to health care; [36] it began to "creep into law", e.g., through lawyer/bioethicist John Robertson, who quoted from Rawls in influencing the justices' decision in the Saikewicz case -- resulting in the still controversial legal concept of "substituted judgement";[37] it has also been applied by Arthur Dyck in international population policy issues.[38] Recently international bioethicist Dan Wikler, as representative of the World Health Organization, appealed to this Rawlsian definition of "justice", declaring that, "The state of a nation's gene pool should be subject to government policies rather than left to the whim of individuals, ... The completion of the human genome project would also make it possible to promote some genetic qualities such as intelligence and lower the incidence of others. ... It may be conceivably required by justice itself,"[39](i.e., "justice" as defined by Rawls.).

Even the bioethics principle of "respect for persons" eventually ends up serving "the greatest good". As noted above, it is The Belmont Report that explains that "respect for persons" includes the duty to participate in non-therapeutic research for the greater good of society. And the question arises: How could the principle that was supposed to ground an inviolable respect for each individual human being be defined in terms of a utilitarian respect for "society"? One explanation comes from Jonsen: "When Beauchamp and Childress formulated the principle of autonomy, they fused the Kantian deontological concept of respect for persons with John Stuart Mill's quite different notion of liberty ... Folding together the distinct views of Kant and Mill blurred the edges of both the Kantian and the Millsean notions."[40] It also, of course, blurred the edges of the metaphysical, epistemological, and anthropological presuppositions inherent in those diverse and contrary theories of ethics. Hence, Kant's "respect for persons" evolved rapidly into the Millsean utilitarian version of "respect for autonomy" (pace Tom Beauchamp) -- where "autonomy" referred only to "persons", and "persons" were defined only as "moral agents". Most unfortunately, what it also did therefore was turn non-autonomous human beings into non-persons (since they are not "autonomous moral agents"). We now have bioethicist Richard Fry, pushing Peter Singer's "logic", and publishing his own "theory": Since many adult human beings are not perfectly "autonomous" and therefore not "persons", and many of the higher primates are "persons", these adult human "non-persons" should be substituted in purely experimental research for these higher animal "persons".[41] This is surely "theory" run amok.

At any rate, after all is said and done, bioethics is ultimately reduced more or less to some form of utilitarianism or relativism -- both normative ethical theories -- where "the good of society" is the morally relevant principle, and the "good of the individual person" is clearly not top priority.

Eventually, practical cracks too began to form in the foundations of this brave new bioethics, cracks which seemed to widen deeper the more the "theory" was applied -- as admitted in publications by even many of the Founders themselves. For example, The Hastings Center's Daniel Callahan conceded in the 25th anniversary issue of The Hastings Center Report celebrating the "birth of bioethics", that the principles of bioethics simply had not worked. But not to worry, he said, we might try communitarianism now: "The range of questions that a communitarian bioethics would pose could keep the field of bioethics well and richly occupied for at least another 25 years".[42] Jonsen himself devotes considerable space to the critics of bioethics in his book, The Birth of Bioethics, and even courageously admitted years earlier, in his "Preface" to the first serious book confronting the myriad inadequacies of "bioethics principlism", that there were only two real ethicists on the National Commission, and that they had essentially made the principles up. Jonsen also agrees with the premise of that book that bioethics should now be regarded somewhat as "a sick patient in need of a thorough diagnosis and prognosis":

A fairly widespread perception exists, both within and without the bioethics community, that the prevailing U.S. approach to the ethical problems raised by modern medicine is ailing. Principlism is the patient. The diagnosis is complex, but many believe that the patient is seriously, if not terminally, ill. The prognosis is uncertain. Some observers have proposed a variety of therapies to restore it to health. Others expect its demise and propose ways to go on without it.[43]

Gilbert Meilaender's early and incisive suspicions about the consequences of the several philosophical "mind/body splits" inherent in bioethics theory emerged in yet another important book, Body, Soul and Bioethics, in which he explained "how easily the 'soul' - attention to the meaning of being human, a meaning often illuminated by religious and metaphysical insight - can be lost in bioethics."[44] Other controversies and battles over the validity of the bioethics principles on many levels are documented and collected in an already classic 1195-page tome edited by Rannan Gillon,[45] in which 99 scholars from around the world jump into the fray -- by far the majority of them arguing against bioethics "principlism".

One of the strongest critiques of "bioethics" came from another one of the early Founders, Renee Fox, a sociologist. Referring to "American bioethics" as isolated from the relationships, communities, and values of real life in sickness and health, she argued that the isolation produced an uneasy relationship between the social sciences and bioethics. Bioethics, she wrote, confined in its individualism and American chauvinism, rendered an "impoverished and skewed expression of our society's cultural tradition (which), in a highly intellectualized but essentially fundamentalistic way, thins out the fullness of that tradition and bends it away from some of the deepest sources of its meaning and vitality."[46] As Jonsen puts it, Fox perceived a genuine gap in the theory and method of bioethics. There is no easy and consistent flow of empirical data into ethics. Methods for gathering that sort of data, for interpreting it and fitting it into normative analysis are seldom familiar to ethicists. And the methods of ethicists are seldom known to behavioral scientists. Additionally, Fox argues that the data of the behavioral sciences often reveal situations as more complex than ethicists perceive them to be, rendering a straightforward ethical analysis more difficult.[47] In a scathing article against bioethics, "Leaving the Field", Fox and Swazey responded in depth and detail to the horrendous ethical dilemmas they considered posed by organ transplantation, especially on an international scale.[48]

Equally problematic is the fact that only a very tiny percentage of "professional bioethics experts" have any academic degrees in bioethics at all, and even for those few that do there is no uniform or standardized curriculum, most teachers don't really know the subject matter themselves, the courses vary from institution to institution, there are no local, state or national boards of examinations, and no standardized professional responsibilities are required. There is not even a code of ethics for bioethicists. Most "bioethicists" by far have never taken even one formal academic course in bioethics.[49] The question necessarily arises, then: What are bioethicists "experts" in? To whom are they accountable for their "expertise"?

Such pervasive concerns about "bioethics" were articulated even at the beginnings of the field, as in the following quote from founder Robert Morison (reiterated by Jonsen):

Professor Morison sketched his views on the relation between ethics, law, and religion and reviewed the brief history of 'the infelicitously named bioethics,' the results of which he 'was reasonably happy [with], but I fear for the future.' The future he feared was one in which ethics and religion were turned into law and regulation: 'What one fears is that the Commission may become the mechanism whereby the speculations of the ethicists become the law of the land. It is already far too easy for abstract notions of right and wrong to emerge as deontological rules which begin their public life as 'guidelines' but culminate in the force of law.' Morison's letter was a sobering reminder of the anomalous role of an 'ethics commission' in a pluralistic, secular society.[50]

We strongly urge the CIHR Working Group to consider these inherent problems with and concerns about "bioethics" before using it -- in whole or in part -- as the basis for "what is ethical" in its Recommendations.

Although the Recommendations allude several times to the critical importance of informed consent, especially for the women involved who are donating their living embryos, these Recommendations, if followed, would not accomplish this important legal and ethical requirement. Because of the general lack of current accurate scientific facts of human embryology and human genetics used, ignored, or assumed in the Recommendations, and because the specific actual kinds of research use to which their children would be put is unknown to them, these Recommendations and related bills would actually preclude legally or ethically valid informed consent from being obtained.

There are many other acceptable and ethical means by which to achieve the same therapeutic and scientific goals, e.g., the use of human adult stem cells and umbilical cord blood cells,[51] and there many other alternative avenues of research available which would not require the intentional killing of innocent living human beings.

[1] Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W.B. Saunders Company, 1998), p. 18: "Human development is a continuous process that begins when an oocyte (ovum) from a female is fertilized by a sperm (or spermatozoon) from a male. (p. 2); ibid.: ... but the embryo begins to develop as soon as the oocyte is fertilized. (p. 2); ibid.: Zygote: this cell results from the union of an oocyte and a sperm. A zygote is the beginning of a new human being (i.e., an embryo). (p. 2); ibid.: Human development begins at fertilization, the process during which a male gamete or sperm ... unites with a female gamete or oocyte ... to form a single cell called a zygote. This highly specialized, totipotent cell marks the beginning of each of us as a unique individual."

William J. Larsen, Essentials of Human Embryology (New York: Churchill Livingstone, 1998), p. 17: "Human embryos begin development following the fusion of definitive male and female gametes during fertilization" (p. 1); ibid.: ... "These pronuclei fuse with each other to produce the single, diploid, 2N nucleus of the fertilized zygote. This moment of zygote formation may be taken as the beginning or zero time point of embryonic development."

Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), pp. 5, 19, 55: "Fertilization is an important landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed. (p. 5); ibid.: Fertilization is the procession of events that begins when a spermatozoon makes contact with a secondary oocyte or its investments ... (p. 19); ibid.: The zygote ... is a unicellular embryo." (p. 19); ibid: "The ill-defined and inaccurate term pre-embryo, which includes the embryonic disc, is said either to end with the appearance of the primitive streak or ... to include neurulation. The term is not used in this book." (p. 55).

[2] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), p. 55: “Prenatal life is conveniently divided into two phases: the embryonic and the fetal. The embryonic period proper during which the vast majority of the named structures of the body appear, occupies the first 8 postovulatory weeks. ... [T]he fetal period extends from 8 weeks to birth ...

Bruce M. Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), p. 447: After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed, and the fetal period begins."

[3] Bruce M. Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), p. 2: "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 ...."

[4] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), p. 3.

[5] See, for example, Prof. Dr. Mithhat Erenus, "Embryo Multiplication" (<http://www.hekim.net/~erenus/20002001/asistedreproduction/micromanipulation/embryo_multiplication.htm>): "In such cases, patients may benefit from embryo multiplication, as discussed in the study by Massey and co-workers. ... Since each early embryonic cell is totipotent (i.e., has the ability to develop and produce a normal adult), embryo multiplication is technically possible. Experiments in this area began as early as 1894, when the totipotency of echinoderm embryonic cells was reported ... In humans, removal of less than half of the cells from an embryo have been documented. No adverse effects were reported when an eighth to a quarter of the blastomeres were removed from an embryo on day 3 after insemination. ... Further evidence supporting the viability and growth of partial human embryos is provided by cryopreservation. After thawing four-cell embryos, some cells may not survive, leaving one-, two-, or three-cell embryos. These partial embryos survive and go to term, but at a lower rate than whole embryos. ... Based on the results observed in lower order mammals, the critical period of development to ensure success in separating human blastomeres should be at the time of embryonic gene expression, which is reported in humans to be between the four- and eight-cell stages. .... The second potential method of embryo multiplication is blastocyst splitting. ... Embryo multiplication by nuclear transfer has been used in experimental cattle breeding programs. ... IVF clinics routinely replace multiple (three to four) embryos into the uterus to increase the chances of a successful pregnancy. For couples who have less than three quality embryos for transfer, blastomere separation could be of benefit."

[6] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), p. 20: "In vitro fertilization involves the removal of an oocyte from an ovary under negative pressure, its culture and fertilization, and transfer of the embryo to the uterus. Successful IVF (Steptoe and Edwards) began with oocyte recovery, in vitro fertilization and culture, transfer of an 8-cell embryo to the uterus, and the birth of a girl in 1978. The various types of new reproductive technology, however, have important ethical, legal, and social implications that are under constant discussion.

"IVF involves the following steps. Ovarian hyper-stimulation is achieved by hormonal administration, usually hMG to induce follicular growth and hCG to encourage ovulation, so that a number of ovarian follicles develop for retrieval of pre-ovulatory oocytes. Follicular development is monitored by biochemical procedures (serum estradiol level) and ultrasound (to determine follicular size and position). Pre-ovulatory follicles are aspirated through the abdominal wall (laparoscopy) by direct visualization of the ovaries, or through the vagina (transvaginal) or through the bladder (transvesical ultrasound-directed oocyte recovery). The aspirated follicular fluid is then examined for the presence of oocytes, which are cultured. Insemination by the addition of numerous spermatozoa in vitro may result in fertilization and early development of embryos. The embryos are then cultured and transferred (ET). This involves the placement by catheter of several 1- to 16-cell embryos or (preferably) blastocysts in the fundus of the uterus, where implantation may occur in a relatively small number of instances. A higher rate is obtained by transferring an embryo to a uterine tube (zygote intratubal transfer) rather than to the uterus, or (as an alternative to IVF) by transferring gametes to a uterine tube (gamete intratubal transfer) and allowing intratubal fertilization to occur."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), 2nd ed., p. 35: "... The embryos are usually allowed to develop to the two- to eight-cell stage before they are considered ready to implant into the uterus."

Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (Philadelphia: W.B. Saunders, 1998), 6th ed. only, p. 39: "Successful transfer of four- to eight-cell embryos and blastocysts to the uterus after thawing is now a common practice (Fugger et al., 1991) ... Embryos and blastocysts resulting from in vitro fertilization can be preserved for long periods by freezing them with a cryoprotectant (e.g., glycerol)."

[7] Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994, p. 23: " ... The embryo enters the uterine cavity after half a week, when probably at least 8-12 cells are present and when the endometrium is early in its secretory phase (which corresponds to the luteal phase of the ovarian cycle). Each cell (blastomere) is considered to be still totipotent (capable, on isolation, of forming a complete embryo), and separations of these early cells is believed to account for one-third of cases of monozygotic twinning."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), 2nd ed., pp. 44-49: "Early mammalian embryogenesis is considered to be a highly regulative process. Regulation is the ability of an embryo or an organ primordium to produce a normal structure if parts have been removed or added. [Note at bottom of page: Opposed to regulative development is mosaic development, which is characterized by the inability to compensate for defects or to integrate extra cells into a unified whole. In a mosaic system, the fates of cells are rigidly determined, and removal of cells results in an embryo or a structure that is missing the components that the removed cells were destined to form. Most regulative systems have an increasing tendency to exhibit mosaic properties as development progresses]. At the cellular level, it means that the fates of cells in a regulative system are not irretrievably fixed and that the cells can still respond to environmental cues. Because the assignment of blastomeres into different cell lineages is one of the principal features of mammalian development, identifying the environmental factors that are involved is important.

"Of the experimental techniques used to demonstrate regulative properties of early embryos, the simplest is to separate the blastomeres of early cleavage-stage embryos and determine whether each one can give rise to an entire embryo. This method has been used to demonstrate that single blastomeres, from two- and sometimes four-cell embryos can form normal embryos, ....". (p. 44)

"Fate mapping experiments are important in embryology because they allow one to follow the pathways along which a particular cell can differentiate. Fate mapping experiments, which involve different isozymes of the enzyme glucose phosphate isomerase, have shown that all blastomeres of an eight-cell mouse embryo remain totipotent; that is, they retain the ability to form any cell type in the body. Even at the 16-cell stage of cleavage, some blastomeres are capable of producing progeny that are found in both the inner cell mass and the trophoblastic lineage. (p. 45)

" Another means of demonstrating the regulative properties of early mammalian embryos is to dissociate mouse embryos into separate blastomeres and then to combine the blastomeres of two or three embryos. The combined blastomeres soon aggregate and reorganize to become a single large embryo, which then goes on to become a normal-appearing tetraparental or hexaparental mouse. By various techniques of making chimeric embryos, it is even possible to combine blastomeres to produce interspecies chimeras (e.g., a sheep-goat). (p. 45)

... " The relationship between the position of the blastomeres and their ultimate developmental fate was incorporated into the inside-outside hypothesis. The outer blastomeres ultimately differentiate into the trophoblast, whereas the inner blastomeres form the inner cell mass, from which the body of the embryo arises. Although this hypothesis has been supported by a variety of experiments, the mechanisms by which the blastomeres recognize their positions and then differentiate accordingly have remained elusive and are still little understood. If marked blastomeres from disaggregated embryos are placed on the outside of another early embryo, they typically contribute to the formation of the trophoblast. Conversely, if the same marked cells are introduced into the interior of the host embryo, they participate in formation of the inner cell mass. Outer cells in the early mammalian embryo are linked by tight and gap junctions ... Experiments of this type demonstrate that the developmental potential or potency (the types of cells that a precursor cell can form) of many cells is greater than their normal developmental fate (the types of cells that a precursor cell normally forms)." (p. 45)

... " Classic strategies for investigating developmental properties of embryos are (1) removing a part and determining the way the remainder of the embryo compensates for the loss (such experiments are called deletion experiments) and (2) adding a part and determining the way the embryo integrates the added material into its overall body plan (such experiments are called addition experiments). Although

some deletion experiments have been done, the strategy of addition experiments has proved to be most fruitful in elucidating mechanisms controlling mammalian embryogenesis. (p. 46)

"Blastomere removal and addition experiments have convincingly demonstrated the regulative nature (i.e., the strong tendency for the system to be restored to wholeness) of early mammalian embryos. Such knowledge is important in understanding the reason exposure of early human embryos to unfavorable environmental influences typically results in either death or a normal embryo. (p. 46)

"One of the most powerful experimental techniques of the last two decades has been the injection of genetically or artificially labeled cells into the blastocyst cavity of a host embryo. This technique has been used to show that the added cells become normally integrated into the body of the host embryo, additional evidence of embryonic regulation. An equally powerful use of this technique has been in the study of cell lineages in the early embryo. By identifying the progeny of the injected marked cells, investigators have been able to determine the potency (the range of cell and tissue types that an embryonic cell or group of cells is capable of producing) of the donor cells." (p. 46)

"Some types of twinning represent a natural experiment that demonstrates the highly regulative nature of early human embryos, ...". (p. 48)

"Monozygotic twins and some triplets, on the other hand, are the product of one fertilized egg. They arise by the subdivision and splitting of a single embryo. Although monozygotic twins could ... arise by the splitting of a two-cell embryo, it is commonly accepted that most arise by the subdivision of the inner cell mass in a blastocyst. Because the majority of monozygotic twins are perfectly normal, the early human embryo can obviously be subdivided and each component regulated to form a normal embryo." (p. 49)

William J. Larsen, Essentials of Human Embryology (New York: Churchill Livingstone, 1998), p. 325: [Monozygotic twinning] "If the splitting occurred during cleavage -- for example, if the two blastomeres produced by the first cleavage division become separated -- the monozygotic twin blastomeres will implant separately, like dizygotic twin blastomeres, and will not share fetal membranes. Alternatively, if the twins are formed by splitting of the inner cell mass within the blastocyst, they will occupy the same chorion but will be enclosed by separate amnions and will use separate placentae, each placenta developing around the connecting stalk of its respective embryo. Finally, if the twins are formed by splitting of a bilaminar germ disc, they will occupy the same amnion." (p. 325)

Geoffrey Sher, Virginia Davis, and Jean Stoess, In Vitro Fertilization: The A.R.T. of Making Babies (copyright 1998 by authors; information by contacting Facts On File, Inc., 11 Penn Plaza, New York, NY 10001), pp. 20: "(2) the fertilized egg, which has not yet divided, is now known as a zygote; (3) the egg begins to divide and is now known as an embryo; at this point each blastomere, or cell, within the embryo, is capable of developing into an identical embryo."

[8] Ronan O’Rahilly and Fabiola Müller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), pp. 8-9: "“The theory that successive stages of individual development (ontogeny) correspond with (‘recapitulate’) successive adult ancestors in the line of evolutionary descent (phylogeny) became popular in the 19th century as the so-called biogenetic law. This theory of recapitulation, however, has had a ‘regrettable influence in the progress of embryology’ (citing de Beer). ... Furthermore, during its development an animal departs more and more from the form of other animals. Indeed, the early stages in the development of an animal are not like the adult stages of other forms, but resemble only the early stages of those animals.”

[9] O'Rahilly and Muller, p. 55: "The ill-defined and inaccurate term ‘pre-embryo,’ which includes the embryonic disk, is said either to end with the appearance of the primitive streak or to include neurulation. The term is not used in this book."

[10] The term "pre-embryo", or "pre-implantation embryo" (as used with the same "moral" meaning), roughly goes back to at least 1979 in the bioethics writings of Jesuit theologian Richard McCormick and amphibian embryologist Clifford Grobstein in their work with the Ethics Advisory Board to the United States Department of Health, Education and Welfare (see, e.g., Ethics Advisory Board, 1979, Report and Conclusions: HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer, Washington, D.C.: United States Department of Health, Education and Welfare, p. 101), and in the debates, testimonies and final report of the British Warnock Committee, 1984 (see, Dame Mary Warnock, Report of the Committee of Inquiry into Human Fertilization and Embryology (London: Her Majesty’s Stationary Office, 1984), pp. 27, 63). The scientifically erroneous term "pre-embryo" was then picked up by literally hundreds of bioethics writers internationally, including, e.g., Australian writers Michael Lockwood, Michael Tooley, Alan Trounson—and especially by Peter Singer (a philosopher), Pascal Kasimba (a lawyer), Helga Kuhse (an ethicist), Stephen Buckle (a philosopher) and Karen Dawson (a geneticist, not a human embryologist). For a more in-depth discussion of the historical roots of and the erroneous science used to ground the "pre-embryo", and its illegitimate use to ground the philosophical construct of "delayed personhood", see: doctoral dissertation of Dianne N. Irving, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Washington, D.C.: Georgetown University Graduate School, Doctoral Dissertation, Department of Philosophy, 1991); C. Ward Kischer and Dianne N. Irving (eds.), The Human Development Hoax: Time To Tell The Truth! (distributed by the American Life League, Stafford, VA, 1997) [this book is a collection of previously peer reviewed and published articles in academic journals written independently by both Dr. Kischer and by Dr. Irving]; D.N. Irving, "When do human beings begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy 1999, 19:3/4:22-47; D.N. Irving, "The woman and the physician facing abortion: The role of correct science in the formation of conscience and the moral decision making process", Linacre Quarterly (Nov.-Dec. 2000).

[11] William J. Larsen, Essentials of Human Embryology (New York: Churchill Livingstone, 1998), p. 4: "like all normal somatic (non-germ- cells), the primordial germ cells contain 23 pairs of chromosomes, or a total of 46."

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), p.2: "In a mitotic division, each germ cell produces two diploid progeny that are genetically equal."

Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York: Wiley-Liss, 1999), p. 28"A subset of the diploid body cells constitute the germ line. These give rise to specialized diploid cells in the ovary and testis that can divide by meiosis to produce haploid gametes (sperm and egg). ... The other cells of the body, apart form the germline, are known as somatic cells ... most somatic cells are diploid ...".

Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994), pp. 13-14: "Gametogenesis is the production of germ cells (gametes), i.e., spermatozoa and oocytes. These cells are produced in the gonads, i.e., the testes and ovaries respectively. The gametes are believed to arise by successive divisions from a distinct line of cells (the germ plasm), and the cells that are not directly concerned with gametogenesis are termed somatic. ... The reduction of chromosomal number from 46 (the diploid number) to 23 (the haploid number) is accomplished by a cellular division termed meiosis. ... Primordial germ cells ... are difficult to recognize in very young human embryos. Claims for them have been made as early as in the blastocyst, and they are believed to be segregated at latest by 2 weeks and possibly much earlier."

Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology, (Philadelphia, PA: W.B. Saunders Company, 1998), 6th ed. only, p. 18: "Meiosis is a special type of cell division that involves two meiotic cell divisions; it takes place in germ cells only. Diploid germ cells give rise to haploid gametes (sperms and oocytes).

[12] Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999), pp. 46-47; William J. Larsen, Human Embryology (New York: Churchill Livingstone, 1997), pp. 22-28; Benjamin Lewin (ed.), Genes III (New York: John Wiley & Sons, 1987), pp. 353-354. The use of germ-line gene "therapy" by U.S. scientists has recently been published, producing genetically altered human infants. See, Dr. David Whitehouse, "Genetically altered babies born: Mitochondria contain genes outside the

cell's nucleus", BBC News Online, <http://news.bbc.co.uk/hi/english/sci/tech/newsid_1312000/1312708.stm>).

See also, Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York: Wiley-Liss, 1999), pp. 539-541], "The ethics of human germ line therapy":

"All current gene therapy trials involve treatment for somatic tissues (somatic gene therapy). somatic gene therapy, in principle, has not raised many ethical concerns. Clearly, every effort must be made to ensure the safety of the patients, especially since the technologies being used for somatic gene therapy are still at an underdeveloped stage. However, confining the treatment to somatic cells means that the consequences of the treatment are restricted to the individual patient who has consented to this procedure. ... The same technology has the potential, of course, to alter phenotypic characters that are not associated with disease, such as height for instance. Such genetic enhancement, although not currently considered, can be expected to pose greater ethical problems; attempts to produce genetically enhanced animals have not been a success and in some cases have been spectacular failures (Gordon, 1999).

Germline gene therapy, involving the genetic modification of germline cells (e.g., in the early zygote), is considered to be entirely different. It has been successfully practiced on animals (e.g., to correct beta-thalassemia in mice). However, thus far, it has not been sanctioned for the treatment of human disorders, and approval is unlikely to be given in the near future, if ever.

Human germline gene therapy has not been practiced because of ethical concerns and limitations of the technology for germline manipulation. The lack of enthusiasm for the practice of germline gene therapy can be ascribed to three major reasons:

[a] The imperfect technology for genetic modification of the germline

Germline gene therapy requires modification of the genetic material of chromosomes, but vector systems for accomplishing this do not allow accurate control over the integration site or event. In somatic gene therapy, the only major concern about lack of control over the fate of the transferred genes is the prospect that one or more cells undergoes neoplastic transformation. However, in germline gene therapy, genetic modification has implications not just for a single cell: accidental insertion of an introduced gene or DNA fragment could result in a novel inherited pathogenic mutation.

[b] The questionable ethics of germline modification

Genetic modification of human germline cells may have consequences not just for the individual whose cells were originally altered, but also for all individuals who inherit the genetic modification in subsequent generations. Germline gene therapy would inevitably mean denial of the rights of these individuals to any choice about whether their genetic constitution should have been modified in the first place (Wivel and Walters, 1993). Some ethicists, however, have considered that the technology of germline modification will inevitably improve in the future to an acceptably high level and, provided there are adequate regulations and safeguards, there should then be no ethical objections (see, for example, Zimmerman, 1991). At a recent scientific research meeting in the USA some scientists have also come out in support of such a development (Wadman, 1998).

From the ethical point of view, an important consideration is to what extent technologies developed in an attempt to engineer the human germline could subsequently be used not to treat disease but in genetic enhancement. There are powerful arguments as to why germline gene therapy is pointless. There are serious concerns, therefore, that a hidden motive for germline gene therapy is to enable research to be done on germline manipulation with the ultimate aim of germline-based genetic enhancement. The latter could result in positive eugenics programs, whereby planned genetic modification of the germline could involve artificial selection for genes that are thought to confer advantageous traits.

The implications of human genetic enhancement are enormous. Future technological developments may make it possible to make very large alterations to the human germline by, for example, adding many novel genes using human artificial chromosomes (Grimes and Cooke, 1998). Some people consider that this could advance human evolution, possibly paving the way for a new species, homo sapientissimus. To have any impact on evolution, however, genetic enhancement would need to be operated on an unfeasibly large scale (Gordon, 1999).

Even if positive eugenics programs were judged to be acceptable in principle and genetic enhancement were to be practiced on a small scale, there are extremely serious ethical concerns. Who decides what traits are advantageous? Who decides how such programs will be carried out? Will the people selected to have their germlines altered be chosen on their ability to pay? How can we ensure that it will not lead to discrimination against individuals? Previous negative eugenics programs serve as a cautionary reminder. In the recent past, for example, there have been horrifying eugenics programs in Nazi Germany, and also in many states of the USA where compulsory sterilization of individuals adjudged to be feeble-minded was practiced well into the present century.

[c] The questionable need for germline gene therapy

Germline genetic modification may be considered as a possible way of avoiding what would otherwise be the certain inheritance of a known harmful mutation. However, how often does this situation arise and how easy would it be to intervene? A 100% chance of inheriting a harmful mutation could most likely occur in two ways. One is when an affected woman is homoplasmic for a harmful mutation in the mitochondrial genome and wished to have a child. The trouble here is that, because of the multiple mitochondrial DNA molecules involved, gene therapy for such disorders is difficult to devise.

A second situation concerns inheritance of mutations in the nuclear genome. To have a 100% risk of inheriting a harmful mutation would require mating between a man and a woman both of whom have the same recessively inherited disease, an extremely rare occurrence. Instead, the vast majority of mutations in the nuclear genome are inherited with at most a 50% risk (for dominantly inherited disorders) or a 25% risk (for recessively inherited disorders). In vitro fertilization provides the most accessible way of modifying the germline. However, if the chance that any one zygote is normal is as high as 50 or 75%, gene transfer into an unscreened fertilized egg which may well be normal would be unacceptable: the procedure would inevitably carry some risk, even if the safety of the techniques for germline gene transfer improves markedly in the future. Thus, screening using sensitive PCR-based techniques would be required to identify a fertilized egg with the harmful mutation. Inevitably, the same procedure can be used to identify fertilized eggs that lack the harmful mutation. Since in vitro fertilization generally involves the production of several fertilized eggs, it would be much simpler to screen for normal eggs and select these for implantation, rather than to attempt genetic modification of fertilized eggs identified as carrying the harmful mutation."

[13] Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York: Wiley-Liss, 1999), p. 541: " There are powerful arguments as to why germline gene therapy is pointless. There are serious concerns, therefore, that a hidden motive for germline gene therapy is to enable research to be done on germline manipulation with the ultimate aim of germline-based genetic enhancement. The latter could result in positive eugenics programs, whereby planned genetic modification of the germline could involve artificial selection for genes that are thought to confer advantageous traits."

[14] Benjamin Lewin (ed.), Genes VII (New York: Oxford University Press, pp. 81-86, 174-175, 546; Tom Strachan and Andrew Read, Human Molecular Genetics: Second Edition (New York: Wiley-Liss, 1999), pp. 60, 140-141.

[15] Back-breeding has been done "naturally" for centuries by farmers using plants and animals. See discussions of back-breeding in, e.g.: <http://www.aces.edu/department/extcomm/publications/he/he-728/he-728.htm>, HE-728, New June 1996. Jean Olds Weese, Extension Food Science Specialist, Associate Professor, Nutrition and Foods, Auburn University: "Farmers have been trying for years to improve crop yields from both plants and animals. This has been accomplished through cross-breeding in animals and grafting in plants. Through this selective mating the plant or animal receives the genes from another plant or animal that will improve a trait in that species. The problem with this is that along with this one good trait comes several traits that may not be so positive. This is because plants have more than 100,000 genes and with each gene comes a character trait. After cross-breeding two plants, the farmer must then go through back-breeding to keep the good traits and breed out the bad traits."

<http://www.cmf.gc.ca/en/cf/1998/vol3/html/1998fca22348.p.en.html>, president and Fellows of Harvard College v. Canada (Commissioner of Patents): "What is involved here is the insertion of the myc gene and the subsequent breeding, cross-breeding and back-breeding of a mouse. ... The inventors were able to "backcross" and in-breed in order to obtain offspring with more widely varying sites of the new myc gene. ... As described by the Commissioner, 'analysis of the DNA of the resulting transgenic offspring indicated that the injected oncogene was transmitted through the germline in a ratio consistent with Mendelian inheritance of single loci.' In other words, the transgene will be passed on to the offspring in accordance with the ordinary principles of inheritance. "

<http://www.biology.iupui.edu/biocourses/K338/338_14.html>, Cogenic MHC Mouse Strains:
" Syngenic (mice with all identical locus) Cogenic (mice with all identical locus, except a single genetic locus) Cogenic mice are isolated by inter-breeding, selection, back-breeding for at least 12 generations."

[16] The Nuremberg Code was part of the Judgement against Karl Brandt during the Nuremberg trials; see the full judgement, and the Nuremberg Code, in Jay Katz, Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process (New York: Russell Sage Foundation, 1972), pp. 305-307. See also in United States Department of Health and Human Services, Office for the Protection of Research Risks: Protecting Human Research Subjects: Institutional Review Board Guidebook (1993), at A6-3 to A6-6.

[17] The 1998 Declaration of Helsinki can be found at Codes of Ethics Online: <http://csep.iit.edu/Codes/coe/World_Medical_Association_Declaration_of_Helsinki_1975.html>; see also in United States Department of Health and Human Services, Office for the Protection of Research Risks: Protecting Human Research Subjects: Institutional Review Board Guidebook (1993), at A6-3 to A6-6.

[18] Declaration of Helsinki (1998), see Codes of Ethics Online: <http://csep.iit.edu/Codes/coe/World_Medical_Association_Declaration_of_Helsinki_1975.html>.

[19] See Richard McCormick's testimony in 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, pp. 34-35; McCormick, How Brave a New World? (Washington, D.C.: Georgetown University Press), p. 76; McCormick, "Proxy Consent in the Experimentation Situation", Perspectives in Biology and Medicine (1974), 18:2-20; McCormick, "Who or What is the Preembryo?", Kennedy Institute of Ethics Journal 1:1 (1991).. McCormick was following similar earlier work by Andre Helegers, founder of the Kennedy Institute of Ethics at Georgetown University: see, Andre E. Hellegers, "Fetal Development", Theological Studies (1970), 31:3-9; Hellegers,

"Fetal Development", in Thomas A. Mappes and Jane S. Zembatty (eds.), Biomedical Ethics (New York: Macmillan, 1981). See also, Clifford Grobstein, "The Early Development of Human Embryos", Journal of Medicine and Philosophy (1985), 10:213-236; also, Science and the Unborn (New York: Basic Books, 1988), p. 61; See also, Clifford Grobstein, "The Early Development of Human Embryos", Journal of Medicine and Philosophy (1985), 10:213-236; also, Science and the Unborn (New York: Basic Books, 1988), p. 6. For a brief historical account of bioethics, containing extensive references from the bioethics and government literatures, see Dianne N. Irving, "What is 'bioethics'?", in Joseph Koterski (ed.), University Faculty for Life: Proceedings of the Conference 2000 (in press).

[20] See D. N. Irving, "When do human beings begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy 1999, 19:3/4:22-47)

[21] See D. N. Irving, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (doctoral dissertation) (Washington, D.C.: Georgetown University, Department of Philosophy, 1991); see also similar analyses in peer-reviewed published articles, listing the pros and cons in the bioethics literature, e.g., Irving: "Science, philosophy and expertise: An evaluation of the arguments on 'personhood'", Linacre Quarterly Feb. 1993, 60(1):18-46; ibid., "Politicization of science and philosophy: The 'delayed personhood' debates and conceptual transfer", C.E.R.P.H. Newsletter 1995, no. 2, p. 4 (Centre d'Etudes sur la Reconnaissance de la Personne Humaine [CERPH]), CHU La Miletrie, B.P. 577, 86021 Poitiers, France);

[22] Claims abound that such fields as "logic" or "meta-ethics" are inherently "neutral"; however further research demonstrates the fallacies in such claims. There are many different schools of "logic", each school using terms and definitions peculiar to very specific metaphysical and epistemological schools of philosophy, or cosmology (which determine the different terms and their definitions). That is, these different schools of "logic" drag with them very specific metaphysical and epistemological presuppositions. That is why the dozens of very different schools of "logic" come to different "logical" conclusions. See, e.g., the sections on "logic" in Paul Edwards (ed.), The Encyclopedia of Philosophy (New York: Macmillan Publishing Co., Inc. and The Free Press, 1967), Vols. 3/4 pp. 504-571; and Vols. 5/6 pp. 1-83.

Thus there is no such thing as a "neutral logic".

Similarly, if "meta-ethics" is defined as the "merely logical" analysis of ethical propositions, then by necessity "meta-ethics" too is not "neutral", but carries with its use and the selection of its terms, definitions and analyses very specific metaphysical and epistemological presuppositions. See any basic ethics textbook; see especially the most widely used text, Frederick Copleston, A History of Philosophy (New York: Image Books/Doubleday, 1993). Specifically addressing the possibility of a "neutral ethics" in bioethics see Irving, "Quality Assurance Auditors: Between a Rock and a Hard Place", Quality Assurance: Good Practice, Regulation, and Law (March 1994), 3(1):33-52; Irving, "Which Ethics for Science and Public Policy?", Accountability in Research (1993), 3(2-3):77-99; Irving, "Maryland State Proposed Statute for Research Using 'Decisionally Incapacitated' Human Subjects: The Legalization of Normative Bioethics Theory", Accountability in Research (in press).

[23] See, e.g., Tom Beauchamp and James Childress, Principles of Biomedical Ethics (New York: Oxford University Press, 1979), pp. 7-9; also, Tom Beauchamp and LeRoy Walters (eds.), Contemporary Issues in Bioethics (Belmont, CA: Wadsworth Publishing Company, Inc., 1982), pp. 1-3.

[24] See e.g., Wesley J. Smith, Culture of Death: The Assault on Medical Ethics in America (San Francisco, CA: Encounter Books, 2000); Smith, "Is Bioethics Ethical?" Weekly Standard (April 3, 2000), pp. 26-30; Smith, "The Deadly Ethics of Futile Care Theory," Weekly Standard (November 30/December 7, 1998), pp. 32-35; Ruth Shalit, "When We Were Philosopher Kings", The New Republic (April 28, 1997); Eugene Russo, "'Bioethicists' Proliferate Despite Undefined Career Track", The Scientist (Apr. 12, 1999), 13:8:16 [http://www.the-scientist.com/yr1999/apr/prof_990412.html]. See also Dianne N. Irving, "The Bioethics Mess", Crisis Magazine, May, 2001; Irving, "The Woman and the Physician Facing Abortion: The Role of Correct Science in the Formation of Conscience and the Moral Decision Making Process", Linacre Quarterly November 2000); Irving, "NIH Human Embryo Research Panel Revisited: What is Wrong With This Picture?", Linacre Quarterly (May 2000); 67:2:8-22; 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.

[25] 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).

[26] See the recent book by one of the National Commissioners, founding bioethicist Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), p. 295; also, David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: BasicBooks/Perseus Books, L.L.C., 1991).

[27] E.g., Tom Beauchamp and James Childress, Principles of Biomedical Ethics (1st ed.) (New York: Oxford University Press, 1979), pp. 45-47; Tom Beauchamp and LeRoy Walters (eds.), Contemporary Issues in Bioethics (2nd ed.) (Belmont, CA: Wadsworth Publishing Company, Inc., 1982), p.26; Tom Beauchamp, Philosophical Ethics (New York: McGraw-Hill Book Company, 1982, pp. 124-128, 141, 188-190; Tom Beauchamp; and Laurence B. McCullough, Medical Ethics: The Moral Responsibilities of Physicians (New Jersey: Prentice-Hall, Inc., 1984), pp. 13-16, 21-22, 39-40, 46, 48, 133-35, 162-64.

[28] Jonsen, p. 328.

[29] The Belmont Report, supra, pp. 6-7.

[30] Tom Beauchamp and James Childress, Principles of Biomedical Ethics (1st ed.) (New York: Oxford University Press, 1979), pp. 135-167; Tom Beauchamp and LeRoy Walters, Contemporary Issues in Bioethics (eds.) (2nd ed.) (Belmont, California: Wadsworth Publishing Company, 1982), pp. 28-43.

[31] [National Bioethics Advisory Commission] Federal Register: October 5, 1995 (Volume 60, Number 193), pp. 52063-52065; Presidential Documents, Executive Order 12975 of October 3, 1995: Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission. [http://www.bioethics.gov/nbac.html]. See, e.g., the commissioned paper by John C. Fletcher, "Deliberating Incrementally on Human Pluripotential Stem Cell Research", especially pp. E-25-E33, and note 75, p. E-40. [http://bioethics.gov/stemcell2.pdf].

[32] The Belmont Report, supra, p. 8.

[33] The literature on this is legion, but see several excellent recent books by: David S. Oderberg and Jacqueline A. Laing (eds.), Human Lives: Critical Essays on Consequentialist Bioethics (New York: St. Martin's Press, 1997); David S. Oderberg, Moral Theory: A Non-Consequentialist Approach (Malden, MA: Blackwell Publishers Inc., 2000); Oderberg, Applied Ethics: A Non-Consequentialist Approach (Malden, MA: Blackwell Publishers, Inc., 2000). See also Charles Harris, Michael Pritchard and Michael Rabins, Engineering Ethics: Concepts and Cases (New York: Wadsworth Publishing Company, 1995), esp. pp. 156-165; J.J.C. Smart and Bernard Williams, Utilitarianism: For and Against (New York: Cambridge University Press, 1973); Samuel Scheffler, The Rejection of Consequentialism: A Philosophical Investigation of the Considerations Underlying Rival Moral Conceptions (New York: Oxford University Press, 1982); Scheffler (ed.), Consequentialism and Its Critics (New York: Oxford University Press, 1988).

[34] The Belmont Report, supra, p.8.

[35] John Rawls, A Theory of Justice (Cambridge: Belknap Press of Harvard University Press, 1971); Rawls, "Justice as Fairness", in Tom Beauchamp and LeRoy Walters (eds.), Contemporary Issues in Bioethics (2nd ed.) (Belmont, CA: Wadsworth Publishing Company, Inc., 1982), pp. 44-46, and pp. 23-24.

[36] Norman Daniels, Just Health Care (New York: Cambridge University Press, 1985); Jonsen, p. 222.

[37] See, e.g.: Superintendent of Belchertown State School v. Saikewicz, Mass Supreme Court, 1977. 373 Mass. 728, 736 (p. 7); Jonsen, p. 267. The legal concept of "substituted judgment" has been specifically rejected by many writers and courts, e.g.: Mathy Mezey et al., "Life-Sustaining Treatment Decisions by Spouses of Patients with Alzheimer's Disease," Journal of the American Geriatrics Society (Feb. 1996), pp. 144-150; David C. Thomasma, "A Communal Model for Presumed Consent for Research on the Neurologically Vulnerable," Accountability in Research (1996), 4:227-239; Ralph Baergen, "Revisiting the Substituted Judgment Standard," Journal of Clinical Ethics (Spring 1995), pp. 30-38; Rosalind E. Ladd and Edwin N. Forman, "Adolescent Decision-Making: Giving Weight to Age-Specific Values," Theoretical Medicine (Dec. 1995), pp. 333-345; Jeremiah Suhl et al., "Myth of Substituted Judgment: Surrogate Decision-Making Regarding Life Support is Unreliable," Archives of Internal Medicine (1994), 154:90-96; John Hardwig, "The Problem of Proxies With Interests of Their Own: Toward a Better Theory of Proxy Decisions," Journal of Clinical Ethics (Spring 1993), pp. 20-27; James Coyne King, "The Search for Objectivity in Applying the Substituted Judgment Rule in Medical Care Cases," Boston Bar Journal (1993), 37:10-12, 14; Robert A. Perlman et al., "Contributions of Empirical Research to Medical Ethics," Theoretical Medicine (Sept. 1993), pp. 197-210; Lynne E. Lebit, "Compelled Medical Procedures Involving Minors and Incompetents and Misapplication of the Substituted Judgment Doctrine," Journal of Law and Health (1992-1993), pp. 107-130; Alexander M. Capron, "Substituting Our Judgment," Hastings Center Report (March-April 1992), pp. 58-59; Ezekiel J. Emanuel and Linda L. E. Emanuel, "Proxy Decision-Making for Incompetent Patients: An Ethical and Empirical Analysis," Journal of the American Medical Association (1992), 267:2067-2071; Jan Hare et al, "Agreement Between Patients and Their Self-Selected Surrogates on Difficult Medical Decisions," Archives of Internal Medicine (1992), 152:1049-1054; Thomas G. Gulkeil and Paul S. Appelbaum, "Substituted Judgment: Best Interests in Disguise," Hastings Center Report (June 1983), pp. 8-11; George J. Annas, "Precatory and Mindless Mimicry: The Case of Mary O'Connor," Hastings Center Report (Dec. 1988), pp. 31-33. For recent court decisions, see Illinois. Appellate Court, First District, Fourth Division. In re C.A. North Eastern Reporter, 2nd series. 1992 Oct 15 (date of decision). 603:1171-1194; Illinois. Supreme Court. Curran v. Bosze. North Eastern Reporter, 2nd series. 1990 Dec. 20 (date of decision). 566:1319-1345; Florida. District Court of Appeal, Second District. In re Guardianship of Browning. Southern Reporter, 2nd series. 1989 Apr. 10 (date of decision). 543:258-276; Missouri. Supreme Court, en banc. Cruzan by Cruzan v. Harmon. South Western Reporter, 2nd Series. 1988 Nov 16 (date of decision). 760:408-445.

[38] Arthur Dyck, "Assessing the Population Debate," The Monist 61 (Jan. 1977); Jonsen, p. 302.

[39] Quoted in, Victoria Button, "Control Gene Pool, Says Ethicist", The Age [theage.com.au], October 13, 2000. For lengthy and articulate writings linking eugenics and international bioethics with the United Nations, the Humane Genome Project, genetic pre-selection of embryos, abortion, the use of abortifacients, human embryo research, stem cell research, fetal research, cloning, formation of chimeras, euthanasia, physician-assisted suicide, research with the mentally ill, etc., see bioethicist/biologist and U.N. consultant Daryl Macer 's published books and articles posted on his web site: <http://www.biol.tsukuba.ac.jp/~macer/index.html>.

[40] Jonsen, p. 335.

[41] R.G. Frey, "The Ethics of the Search For Benefits: Animal Experimentation in Medicine", in Raanan Gillon (ed.), Principles of Health Care Ethics (New York: John Wiley & Sons, 1994), pp. 1067-1075.

[42] Daniel Callahan, "Bioethics: Private Choice and Common Good", Hastings Center Report (May-June 1994), 24:3:31.

[43] See Jonsen's "Preface", in Edwin DuBose, Ronald Hamel and Laurence O'Connell (eds.), A Matter of Principles?: Ferment in U.S. Bioethics (Valley Forge, PA: Trinity Press International, 1994), p.1.

[44] Gilbert C. Meilaender, Body Soul, and Bioethics (Notre Dame, IN: University of Notre Dame Press, 1995), p. x.

[45] Raanan Gillon (ed.), Principles of Health Care Ethics (New York: John Wiley & Sons, 1994).

[46] Renee Fox, "The Evolution of American Bioethics: A Sociological Perspective," in George Weisz (ed.), Social Sciences Perspective on Medical Ethics (Philadelphia: University of Pennsylvania Press, 1990), pp. 201-220. Renee Fox and Judith Swazey, "Medical Morality is Not Bioethics -- Medical Ethics in China and the United States," Perspectives in Biology and Medicine 27 (1984):336-360, in Jonsen p. 358.

[47] Jonsen, p. 344.

[48] Renee C. Fox and Judith P. Swazey, "Leaving the Field", Hastings Center Report (September-October 1992), 22:5:9-15.

[49] See, e.g., Eugene Russo, "'Bioethicists' Proliferate Despite Undefined Career Track", The Scientist (Apr. 12, 1999), 13:8:16 [http://www.the-scientist.com/yr1999/apr/prof_990412.html]; Dianne N. Irving, "What is 'bioethics'?", in Joseph Koterski (ed.), University Faculty for Life: Proceedings of the Conference 2000 (in press); Irving, "Scientific and Philosophical Expertise: An Evaluation of the Arguments on 'Personhood'", Linacre Quarterly (1993), 60:1:18-47; Irving, "The bioethics mess", Crisis Magazine, May 2001.

[50] Jonsen, pp. 109-110.

[51] See extensive listing of successful scientific studies using adult stem cells on web site by David Prentice: < http://biology.indstate.edu/prentice/stemcell/>.