Legally Valid Informed Consent
Individual Testimony before the New Jersey State Senate Health and Human Services Committee on Human Embryonic Stem Cell Research, Ethical and Public Policy Considerations **

Dianne Irving’s Comments
Dianne N. Irving, M.A., Ph.D.
Professor of Philosophy, The Catholic University of America and,
former bench research biochemist (NIH/NCI)
copyright November 1, 2002

Monday, November 4, 2002
Committee Room #4, New Jersey State House Annex
Trenton, New Jersey
Reproduced with Permission

Also submitted for the official record: Three articles with extensive scientific, bioethical, and philosophical references to substantiate this testimony:

  1. D. N. Irving, "When does a human being begin? 'Scientific' myths and scientific facts", (International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47).
  2. D. N. Irving, "What is 'bioethics'?", UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.: University Faculty For Life, 2002), pp. 1-84.
  3. D. N. Irving, "Philosophical and scientific expertise: An evaluation of the arguments on 'personhood'" (Linacre Quarterly, Feb. 1993, 60:1:18-46).

** Please note: emphases are used throughout only to aid those unfamiliar with some of the issues.

Mr. Chairman and Members of this Senate Committee:

I am honored and very appreciative to be able to speak before the committee today on these important and controversial issues, and I thank the committee for giving me time to present some relevant information which I offer to you for your consideration.

Accurate and credible information about the ethics and public policy ramifications of the use of living human embryos -- whether produced sexually or a-sexually -- for deriving stem cells for important biomedical research and "therapies" for curing devastating diseases is critically important. One consideration that is often neglected in these discussions and debates is that such information is vital for the ethically and legally valid "informed consent" of the donors and the recipients involved, the legislators, and the citizen voters of the State of New Jersey as well.

Obviously, "informed consent" requires that full, accurate and truthful information be disseminated to all concerned decision makers. But valid "informed consent" must also include disseminating the correct and accurate scientific information about "what" these early human embryos are -- even before discussing the ethical and public policy issues surrounding their use as sources of stem cells. Are they prawns, cabbages, fish, frogs, chickens, monkeys, or human beings? Are they just "eggs" such as those used in fertilization, skin cells, "bunches of stem cells", "pre-embryos", or merely the earliest stages of "the evolving human species"? The ethical and public policy decisions themselves should be grounded in the answer to this scientific question -- the necessary and required starting point for all of the other discussions. Otherwise, public policy will continue to be irresponsibly based on mere fantasies and wishful thinking.

One thing I want to make perfectly clear today. What I will testify to is not just one subjective opinion to be considered among many others in a democratic, multicultural, pluralistic society. Rather, it is simply the reporting of irrefutable objective scientific facts -- critically relevant facts which must be used as the basis for all other ethical and public policy making decisions facing this committee. I will use absolutely no subjective "religious", "theological", "political", or "personal" opinions in this testimony. I will simply refer to the objective scientific facts documented by 100% of the experts in the field of human embryology -- the only scientists who are academically credentialed to answer the question, "When do human beings begin to fully exist?" These objective scientific facts are accessible to any one who wishes to locate them in human embryology text books in their local libraries.

It would seem that many people do not know that, unlike some other fields, in the field of human embryology these objective scientific facts are ultimately determined by the international Nomina Embryologica Committee,1 consisting of over 20 of the best and brightest human embryologist from around the world. After reviewing the latest research studies in human embryology, their deliberations are published in the Nomina Embryologica, part of the larger Nomina Anatomica, and are professionally required to be used, along with The Carnegie Stages of Early Human Development, by all human embryologists in their own work. Several of the human embryologist from whom I quote in my submissions are long-time members of this international Nomina Embryologica Committee. Indeed, one of them, i.e., the eminent Swiss researcher Dr. Ronan O'Rahilly, the "dean of human embryology", was also one of the originators of the famous Carnegie Stages.

Just as the appeals courts are reversing prior lower court decisions because of increased and advanced knowledge in the sciences, e.g., the advent and subsequent use of the new DNA profiling technology (nuclear DNA and/or mitochondrial DNA) in identifying crime suspects, I would respectfully suggest that legislators too consider the use of early human embryos in research and therapy in the light of the most internationally agreed upon, objective, current, and accurate scientific facts of human embryology. Nothing less than this can insure objective, sound, well-grounded, and credible public policies concerning human embryonic stem cell research. Nothing less than this can insure ethically and legally valid "informed consent".

Before proceeding, I want to make an important distinction which is often neglected in these debates. The question of when a human being begins to exist is strictly a scientific question -- and should be answered by the real experts, those academically credentialed in human embryology. The question of when a human person begins to exist is a philosophical -- or political -- decision,2 and must be able to withstand the rigors of scholarship and intense debates.

I will focus first on the scientific question, and make a further distinction between sexual human reproduction (e.g., the use of sperm and oocytes in the reproductive process of fertilization), and a-sexual human reproduction (e.g., in the several different reproductive processes of cloning). Time only permits me to basically list the most relevant scientific points. Further extensive details and references can be found in the additional scientific materials I am submitting to this committee for the record.

Sexual Human Reproduction

Speaking of scientifically grounded legally valid "informed consent":

  1. Did you know that it has been known for over a hundred years3 that the immediate product of human fertilization is an embryo, an individual, a single-cell organism, a zygote, a new unique fully existing living human being -- and that fertilization is the beginning of the embryonic period, and of normal pregnancy?4 And that early spontaneous abortions, or "pregnancy wastage" really occurs because of a seriously abnormal embryo, or an improperly prepared uterus?5
  2. Did you know that immediately at fertilization human species-specific proteins and enzymes are produced, and later human species-specific tissues and organs are produced?6 Indeed, this simple fact is the scientific basis for using human embryos in human experimental and therapeutic research.
  3. Did you know that the whole 5-7 day old human blastocyst is the embryo, not just the cells of the inner cell mass7 -- and that cells of the inner cell mass are totipotent (not pluripotent)?8
  4. Did you know that twinning can take place after 14-days?9
  5. Did you know that there is no such thing as a "fertilized egg"; no such thing as an "ovum"?10
  6. Did you know that there is no such thing as a "pre-embryo"? The term is a complete scientific myth. Indeed, the always dubious and arbitrary term "pre-embryo" has recently been formally rejected as scientifically ill-defined, inaccurate, unjustified, equivocal, and politically motivated by the international Nomina Embryologica Committee, along with the related and equally scientifically rejected term "individualization".11
  7. Did you know that there is also no such thing as a human embryo or fetus who is an evolving "human-being-on-the-way"? This is also a complete scientific myth, and based on the old "biogenetics law" (or "ontogeny recapitulates phylogeny") -- rejected by the scientific community many decades ago.12

Scientifically, then -- according to 100% of the expert specialists in the field of human embryology worldwide -- there is no question or confusion whatsoever that the immediate product, and all continuous, contiguous, growth and developmental stages thereafter through adulthood, involves an already fully existing unique living human being.

A-Sexual Human Production

Human beings can also be reproduced a-sexually, without the use of sperm or oocytes -- as we know empirically happens in human monozygotic twinning13 (a common, and the most exact form of, cloning14). Just as the single-cell organism produced sexually at fertilization is a human being, the single-cell organism produced a-sexually at cloning is also a human being. There are two biological processes that can help people understand this objective scientific fact: methylation, and regulation:

1. Methylation:15 Briefly, following sexual reproduction the early human embryo grows and develops by means of methylating and demethylating the DNA in each of the embryo's or fetus's cells. That is, the DNA in each cell is "allowed to speak", or is "silenced", by adding or removing these methylation bars -- depending on what products the embryo needs to grow and develop. These products then "cascade"16 down throughout growth and development. The more specialized, or differentiated, a cell, the more methylated its DNA becomes. I will refer to this process during growth and development following sexual human reproduction as a sort of "zipping up". By adulthood, the DNA in many of the cells of the human being has been almost completely "silenced" by the insertion of methylation bars -- such as in human skin cells.

By contrast, during human a-sexual reproduction (such as in twinning, or in somatic cell nuclear transfer) much of this methylation process is reversed, and the methylation bars are gradually almost all removed, resulting in the production of a new living human organism -- a single-cell human being, a zygote.17 I will refer to this process during a-sexual human reproduction as "zipping down". This at least partially explains how an adult cell can be transformed into a whole new single-cell organism.

2. Regulation:18 Regulation is operative in both "zipping up" and "zipping down". In "zipping up", as in sexual reproduction (fertilization), regulation concerns various processes of differentiation; but it also becomes involved when an injury has occurred to the organism. Here, regulation is the ability of an embryo or an organ primordium to "heal" a normal structure if parts have been removed or added. In "zipping down", as in a-sexual reproduction such as twinning, regulation could possibly revert separated totipotent embryonic cells back to new living human embryos, i.e., new living human beings. Indeed, this is precisely what happens with human monozygotic twinning in vivo, and in somatic cell nuclear transfer.

Finally, there are many different kinds of human cloning techniques possible, including twinning (blastomere separation and blastocyst splitting),19 somatic cell nuclear transfer (SCNT), germ line cell nuclear transfer (GLCNT),20 etc. In all such cloning techniques, the immediate product would be a new living human being.

Note, however, for legislative purposes: in somatic cell nuclear transfer or in germ line cell nuclear transfer, the human being produced would not be "an exact genetic copy of the donor cell" -- because the mitochondrial DNA of the donor cell is not transferred, and the mitochondrial DNA of the recipient oocyte cell is retained in the newly produced human being.21 Thus to scientifically misdefine the product of SCNT or GCNT in legislation would be to preclude that legislation from actually applying to these real cloning techniques. And many have grave concerns about the use of germ line cells in sexual or a-sexual human reproduction for eugenic purposes.22

These objective scientific facts about sexual and a-sexual human reproduction must be the starting point for any legislation on the use and destruction of these early innocent living human beings in stem cell research or cloning, and part and parcel of any ethically and legally valid process of "informed consent."


To claim that these innocent and vulnerable living human beings can be used and destroyed in order to help other human beings -- especially when there are viable alternatives, such as the use of umbilical cord and adult stem cells -- is to legislatively create a subcategory of human beings who may be exploited as a mere commodity for the use of other human beings -- and we've been there before. The argument is that some human beings are not "persons", and other human beings are "persons", and is based on a theory about active "functionality", rather than on the empirical facts about a thing's nature.

Such is the position of many of those in bioethics, e.g., Peter Singer, Director of Human Values at Princeton University (Princeton, New Jersey). Singer opines that "personhood" is defined only by the active exercising of "rational attributes" (e.g., willing, choosing, knowing, relating to the world around one, etc.) or "sentience" (e.g., the feeling of pain and pleasure)23 -- a philosophical claim inherently based on passé 17th and 18th century Cartesian, rationalist, and empiricist philosophical systems.24 Time does not permit a further philosophical analysis (and I refer you to extensive philosophical refutations of these theories in my submitted materials), but suffice it to say here that these philosophical systems are fraught with inherent contradictions, are academically and realistically indefensible, and were literally laughed out of the academy by the late 1800's. They were recently revived, however, by contemporary bioethics. One reason for their indefensibility is simply that if there are two separate and different things, such as a "mind" or "soul" thing, and a "body" thing, there is no possible way to explain any interaction between these two different and separated things. In philosophical parlance, this is known as the myth of the "mind/body" split -- or chorismos.

Further, virtually all of the contemporary bioethics arguments for "delayed personhood" are based on and grounded in very erroneous "science" -- hence their philosophical "personhood" conclusions are automatically invalid.25

Finally, "pushing the logic" of those bioethics definitions of "person" leads to extraordinarily bizarre conclusions -- and it would be wise, I respectfully suggest, not to cement them into legislation. Peter Singer, for example, opines that some human beings are not "persons", and some animals are "persons". Indeed, this is the basis for Singer's recent defense of "bestiality".26 But think about it: if only those who are actively exercising "rational attributes" and "sentience" are "persons", then the following list of adult human beings are not "persons", and thus not ethically or legally protected as real "persons": Alzheimer's and Parkinson's patients, the mentally ill and mentally retarded, the frail elderly, the emotionally ill, drug addicts and alcoholics, literally all mentally and physically disabled, -- even all of us when we are sleeping! Richard Frey, a senior bioethics scholar at the Hastings Center, agrees -- arguing that the adult human beings I have just listed be substituted for animal "persons" in destructive experimental research!27 Abstract concepts can lead to concrete, and devastating, consequences in the real world.

"Personhood", then, must be based on the kind of nature a thing possess, not on its active "functionality" -- unless you would agree with the conclusions that necessarily follow from the theories of the likes of Singer, Frey, and most bioethicists. The human being and the human person are inseparable -- from the very beginning of his or her existence.

So we need to consider where we are going with this legislation. It is worth noting briefing that such bioethics concepts of "personhood" can, and already have been, transferred from these debates on human embryo research to adult human beings in most bioethics debates on euthanasia, physician-assisted suicide, organ transplantation, removal of food and water, the use of human subjects in research, etc. Is this the kind of society the good citizens of New Jersey want? Do they fully know and fully understand the massive theoretical defects of this bioethics "personhood" information, and the bizarre and devastating conclusions that must necessarily follow from it? I don't think so.


There is one further bit of "ethical" information that I suggest most people are also basically uninformed about -- the dubious validity of bioethics as the basis for any legislative decision making. Bioethics was formally "born" in the 1978 Belmont Report of the National Commission -- mandated by the U.S. Congress in its 1974 National Research Act.28 This commission identified and (oddly) defined the three bioethical principles of "autonomy", "justice", and "beneficence", referred to as "principlism", or "the Georgetown mantra". But bioethics is not "ethics-per-se"; it is only one of a dozen different ethical theories developed through the centuries -- and a very recent one at that. Nor is bioethics "neutral"; it defines itself as "normative"29 -- i.e., it takes a stand on what is right or wrong. Thus how can any one justify forcing that normative ethical theory on the rest of us through legislation in this democratic, multicultural, pluralistic society?

Furthermore, bioethics is fraught with so many theoretical and practical problems that even many of the Founders of bioethics themselves have admitted that it can't and doesn't work.30 The bioethics literature is full of hot and turbulent on-going debates on whether or not bioethics is a valid ethical theory at all.31 And as one of the original scholars of the Hastings Center wisely expressed when observing the creation of bioethics by the National Commission, "What one fears", he said, "is that the [National] 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."32 Thus "informed consent" also requires that decision makers on all levels understand at least that to base any "ethical" decisions on bioethics theory or bioethics definitions of terms is dubious at best, and basically indefensible.


I have indicated that "personhood" arguments often appealed to in these debates are essentially a political gambit which cannot be academically, theoretically, or practically defended, and that to use current non-neutral normative bioethics theories and definitions in legislation is likewise indefensible in this democratic, multicultural, pluralistic society. I have attempted to briefly present the well-established objective scientific facts which establish beyond any shadow of a doubt that the immediate products of both sexual and a-sexual human reproduction are innocent living human beings. Responsible and credible legislation concerning human stem cell research, as well as valid "informed consent", must be grounded first and foremost in these objective scientific facts.

We do know scientifically "what" these early human embryos are -- they are innocent living human beings -- and we have known this for over a century. To try to legislate false and erroneous science is a dangerous enterprise, unbecoming of this great legislature. And to attempt to claim that these human beings are "less than" other human beings is to legislate a sub-category of human beings as mere commodities. It is also to legislate the basis for future "conceptual transfer" -- i.e., the transfer of indefensible and irresponsible bioethics definitions of "personhood" to even adult human beings -- most of them very vulnerable. Is this what the good citizens of New Jersey would want -- if they knew and fully understood the whole truth?

For the above reasons, and many others stated elsewhere in my submitted work, I would conclude that it is unethical and irresponsible to use and destroy, or to pass legislation permitting the use and destruction of, living human embryos -- produced sexually or a-sexually -- in destructive biomedical research and/or "therapy". The end, even a worthy one, does not justify the use of any and all means. Ethical, and safer, alternative means are now available.

Thank you, again, for the opportunity to provide testimony concerning human embryonic stem cell research, and its ethical and public policy implications before the New Jersey Senate Health and Human Services Committee.

Respectfully submitted,
Dr. Dianne N. Irving, M.A., Ph.D.

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