ETHICS IN RESEARCH

Test-Tube Babies, Cloning, and TissueTransplants from Aborted and Anencephalic Children: Is There Anything Wrong With These?
Maria Fidelis C. Manalo, MD, MSc.

Consider the following scenario. A one-year-old baby dies in an accident.

The parents were really fond of him, and decide to have some of his cells frozen and eventually cloned. They say that this way they will have their baby boy back. Is there anything wrong with this? (1) Scientific Progress And Experimental Research A therapeutic action which is apt to be increasingly beneficial to health is for that very reason open to new investigative possibilities. These are the result of a progressive and ongoing activity of research and experimentation, which thus succeeds in arriving at new medical advances. To proceed by way of research and experimentation is a law of every applied science: scientific progress is structurally connected with it. Biomedical sciences and their development are subject to this law also. But they operate in a particular field of application and observation which is the life of the human person.

Department of Community and Family Medicine, Far Eastern University - Nicanor Reyes Medical Foundation, Fairview, Quezon City, 1118, Philippines. Email: mcmanalo@feu-nrmf.ph, lizamanalomd@gmail.com December 1998, Vol. 4. No. 2

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Care For The Dignity Of Human Life The human person, because of his unique dignity---that of bearing the image and likeness of the Creator and that of being destined to share in the divine life, --- can be the subject of research and clinical experimentation with the safeguards due to a being with the value of a subject and not an object. Mans dignity resides in the fact that he is a who and not a what, a unique being, irreplaceable, endowed with privacy, intelligence, will, freedom, and the ability to love and open himself to others. For this reason, biomedical sciences do not have the same freedom of investigation as those sciences which deal with things. (2) A unique responsibility belongs to health care personnel: doctors, pharmacists, nurses, chaplains, men and women religious, administrators and volunteers. Their profession calls for them to be guardians and servants of human life. In todays cultural and social context, in which science and the practice of medicine risk losing sight of their inherent ethical dimension, health care professionals can be strongly tempted at times to become manipulators of life, or even agents of death. (3) This happens when one does not know or when one forgets the ultimate basis of human dignity. A deep and thorough understanding of this will help one understand the reason behind the ethical norms guiding human experimentation and research especially those involving embryos and fetuses. Let us thus make certain definitions and answer some basic questions.

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What Do We Mean by Human? The adjective human is used to describe that which is characteristic of man as a species distinguished from other animals. Biologically there are two criteria of what is human, one intrinsic, one extrinsic. Extrinsically, that which is of human origin is human. By this criterion human applies to such things as sounds, footprints, excrement, etc., as well as human beings. The intrinsic criterion depends upon genetic constitution. Normally this constitution is contained in a set of 46 chromosomes which is present in almost all the cells of the human body.

When Does Life Become Human?

The answer is never. Like life, humanity is continuous. Intrinsically, the sperm, the ovum, the zygote, and all the cells, tissues, and stages that arise from the zygote are human. None of them can ever be characterized as belonging to any other species. Human life is not started---it is transmitted. There is no instant or interval of time between fertilization and birth when the unborn offspring is anything but human. But if life is continuous and humanity is continuous, what is the difference between the sperm and ovum before fertilization and the zygote after fertilization? They are all human life, are they not? Which brings us to our next question.

When Does Life Become a Human Being?

There are several differences between a zygote and either a sperm or an ovum. One is in information content. The haploid gametes have only half the genetic information that a zygote has. But that would not alone indicate a difference between the zygote and the gametes taken together.

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The destiny of the ovum is either to be fertilized or to die. In either case it ceases to exist as a gamete. The similar destiny of the sperm is to fertilize or to die. In fertilization the gametes lose their identity and individuality and fulfill their destiny. The result is a new individual, with a new life and a new unique identity and a new unique destiny. One way to illustrate the unique importance of this new individual is to look at the question

When Does Human Life Begin?

When did your life begin? The answer to this question can be phrased simply by going backward in time. Before you were an adult, you were an adolescent, and before that a child, and before that an infant. Before you were an infant---i.e., before you were born---you were a fetus, and before that an embryo. Before you were an embryo, around the time of your implantation, you were a blastocyst, and before that a morula, and before that a zygote or a fertilized ovum. Therefore while life is continuous, your life began when the nucleus of your fathers sperm fused with the nucleus of your mothers ovum, or at fertilization. So we see that there is something important, something special, that occurs at fertilization: A new life, a new human life, begins.

But Is It a Human Being?

The term human being is used interchangeably with human individual, which is frequently shortened to just individual. It signifies a complete, though not completed, living, organized, unique, individual human organism, always more or less dependent on other human beings, but always with a certain amount of autonomy and charge over its own destiny. The zygote fits all of these criteria. The informationally complete cell has an information content equivalent to 1000 volumes of the Encyclopedia Britannica and unlike that of another human being. If it does not twin, it will retain this uniqueness. The new cell is programmed to divide, differentiate, form hormones and enzymes, implant,
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develop organs, brain, nerve and bone, eventually becoming an adult and repeating the cycle. (4)

Immorality of Research Contrary to the True Good of the Person

In the research stage, the ethical norm requires that its aim be to promote human wellbeing. Any research contrary to the true good of the person is immoral. To invest energies and resources in it contradicts the human finality of science and its progress. In the experimental stage, that is, testing the findings of research on a person, the good of the person, protected by the ethical norm, demands the respect for previous conditions which are essentially linked with consent and risk. (2) Let us now elaborate on specific aspects of research and experimentation on embryos, human fetuses and anencephalic infants:

In Vitro Fertilization In vitro fertilization consists in putting spermatocytes in contact with oocytes inside a test tube. It is an attempt to simulate in a culture medium what occurs naturally in the fallopian tube. The oocytes are obtained from the mother or a donor by puncture of the ovary; the sperms, ordinarily, by masturbation. Once fertilization takes place inside the test tube with consequent fusion of the pronuclei, division begins. The fertilized ova (zygotes) already in the

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embryonic stage are then transferred to the uterus; there they continue their normal development. Well-known and heralded by the press at that time, the first case of IVF was performed by Drs. Edward and Steptoe in England in 1978, with the birth of the first test tube baby, Louise Brown. Thereafter, IVF has been employed in many parts of the world. The first thing that comes to mind when one talks of IVF is homologous artificial insemination. This utilizes the husbands semen and the wifes ovum. The zygote produced is implanted in the uterus of the wife. Other methods of artificial insemination are:

fertilization of the ova of the wife with the sperm of an anonymous donor

fertilization of the ova of the wife with the sperm of the husband but the embryo produced is transferred to the uterus of another woman (surrogate mother or mother for hire)

fertilization of the ovum of a donor by the sperm of the husband and the embryo is transferred to the uterus of the wife

fertilization of the ovum of a female donor with the sperm of a male donor and the embryo is transferred into the uterus of the wife

The possibilities and interchanges may be multiplied leading to varied situations including aberrant ones: post-mortem insemination of a single woman who wants a child without father, etc. It can be said in jest that a test tube baby can have up to 5 parents: the mother and the father who paid the donors; the donors of the gametes (who are the genital parents), and the surrogate mother who received the embryo and incubated it until it is delivered.

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One to 4 embryos are transferred to the uterus because the probability of pregnancy is 7%, 21%, and 28% when 1, 2, or 3 embryos are transferred, respectively. The transfer of more than 4 embryos increases the risk of multiple pregnancy; therefore, it is not advised. A large number of embryos must be produced in order to proceed with IVF. What happens to the embryos that are not transferred to the uterus? Some embryos are discarded, others conserved, frozen to be transferred to the same patient in another session or to another patient with the consent of the donor couple. The embryos are also utilized in scientific research. In any case IVF involves manipulation of human beings. (5)

Cloning Advances in knowledge and related developments in the procedures of molecular biology, genetics and artificial fertilization have long made it possible to experiment with and successfully achieve the cloning of plants and animals. Since the 30s experiments have been made in producing identical individuals by artificial twin splitting, a procedure, which can be improperly called cloning. The practice of twin splitting in the zootechnical field has been spreading in experimental barns as an incentive to the multiple production of select exemplars. In 1993 Jerry Hall and Robert Stilman of George Washington University published data concerning the twin splitting they performed on human embryos of two, four and eight embryoblasts. These experiments were conducted without the prior consent of the appropriate Ethics Committee and were published, according to the authors, in order to stimulate the ethical debate.

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The news published in the journal Nature , 27 February 1997, about the birth of the sheep Dolly through the efforts of the Scottish scientists Jan Vilmut and K.H.S. Campbell and their team at Edinburghs Roslin Institute, however, is troubling on two aspects: The first is that it is not a question of splitting but of a radical innovation defined as cloning meant to produce individuals biologically identical to the adult which provided the nuclear genetic inheritance. The second is that until now this type of true and proper cloning was considered impossible. It was thought that the DNA in the somatic cells of the higher forms of animal life, having already undergone the imprinting of differentiation, could no longer recover their original totipotentiality and consequently, their ability to direct the development of a new individual. In its biological aspects as a form of artificial reproduction, cloning is achieved without the contribution of two gametes; therefore it is an asexual and agametic reproduction. Fertilization properly so-called is replaced by the fusion of a nucleus taken from a somatic cell of the individual one wishes to clone, or of the somatic cell itself, with an oocyte from which the nucleus has been removed, that is, an oocyte lacking the maternal genome. Since the nucleus of the somatic cell contains the whole genetic inheritance, the individual obtained possesses--except for the possible alterations---the genetic identity of the nucleus donor. It is this essential genetic correspondence with the donor that produces in the new individual the somatic replica or copy of the donor itself. The Edinburgh event occurred after 277 oocyte-donor nucleus fusions: only eight were successful, that is, only eight of the 277 started to develop as embryos and only one of these eight embryos reached birth: the lamb called Dolly. (6) Let us now go back to the hypothetical situation we proposed at the beginning of this article. From the ethical point of view, this case of cloning can be considered wrong, just like any other act of cloning a human being. But there
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is still another reason why this is wrong, this time from the point of view of the cloned persons identity. The cloned baby boy will not be the same as the original one. Cloning cannot offer that, as what the parents will get will merely be a copy, not the first baby boy himself. In the first place, their bodies will not be the same: the originals will be buried (or frozen), while the clones will be composed of other molecules. Their souls will also be different, as each person receives a different soul. Finally, their upbringing will greatly vary, as even the upbringing between twins cannot be identical. We must also consider how a cloned person might feel about himself or herself. The best way to do this is to imagine how we would feel if we were the clone of somebody else. People will surely refer to us not as "John" or "Maria", but as "Johns clone or Marias clone. The constant point of reference will be the original, and we will tend to lose our identity. For example, right after his death, your mother decides to clone him, so that she could be with him again. In this case you will still be your fathers son. But your mother will still want to consider you her husband. She will later find out that this is impossible, given the difference in age. But above all, no matter what she does, you will always remain a different person and never become your father. Or how would you feel to be Hitlers clone? People will look at you as when they look at an object in a museum. Some of your neighbors will be afraid of you and stories about Hitler (I mean you) will circulate all over the country. And what if you were Albert Einsteins clone? The time will come when you go to school, and everyone will expect you to be a genius. Good if you will be, but what if not? You will be the laughing stock of the classa defective Albert Einstein. People will pressure you to imitate him. Whether you give in to this

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pressure or not will depend on you. But in any case, you will surely rather have none of this at all. So far we have been talking about successful clones. But at least for the near future, the cloning will involve producing many candidate clones, from whom one (or any number needed) will be selected and brought to maturity. What will be done with the other copies that are not lucky enough to be considered fit or needed? They may either be simply killed and thrown away, used in experiments (human experiments, that is) or maybe frozen until somebody else wants to use them. Clones can also be used for other purposes. Some say that clones might be made to order to provide us with needed replacement parts. Why take a kidney from a donor relative to have transplant, when you can simply bring one of your cells to a laboratory, order a clone, and harvest the clones kidney? However, you will still probably have to wait long before your clone grows up and reaches your age (but since meanwhile you too will grow older, the clone will never reach your age), or at least reach an age wherein the clones organ could already be used. To solve this problem, clones can also be farmed or massproduced. Then, depending on what kind of antibodies you have, you can choose the organ you need from a wide range of clones, to ensure no rejection after the transplant. Meanwhile, some of these clones will be frozen, while others will still be alive. Another very important issue in transplant of clones will be consent. In the same way that you have to obtain a donors consent before taking out his kidney (as you also have to give your consent before giving your kidney to anyone), you will also have to get the clones consent before harvesting his kidney. Most likely, the clone will not be happy about your having cloned him or her in the first place to obtain your needed spare parts, much less allow himself to lose a kidney. Who wants to be a clone, anyway?!? (1)
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Cells From Aborted Children Said To Stop Parkinsons Disease The results of a new study said most Parkinsons disease patients, but especially younger ones, stand to benefit from a transplant of brain cells from aborted children. The University of Colorado Health Sciences Center said the

comprehensive study showed that the cells flourished in all the patients, but did best in younger patients. Tremors, rigidity, and the inability to control movements characterize Parkinsons disease. The illness is linked to the death of brain cells that produce a chemical called dopamine. The procedure in the study used tissues from unborn children aborted at the 7 or 8th week of pregnancy, and each patient in the study required brain cells from about 4 children. Researchers said the cells were only harvested from previously scheduled abortions not taken specifically for the study. (7) Organ Donation from Children with Anencephaly The remarkable technique of organ transplantation has raised a question about the child with anencephaly as an organ donor. Organs from fetuses and infants may be especially helpful for transplantation because at early stages of life the physiological factors that may cause a transplant to be rejected by its recipient are not yet fully present. In addition, organs can also be subject to rapid deterioration after death. Anencephaly is a congenital anomaly characterized by failure of development of the cerebral hemispheres and overlying skull and scalp, exposing the brain stem. This condition exists in varying degrees of severity.
th

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Most infants who have anencephaly do not survive for more than a few days after birth. The fact that the life of a child suffering from anencephaly will probably be brief cannot excuse directly causing death before viability or gravely endangering the childs life after viability as a result of complications of prematurity. In both cases of stem-cell transplants from aborted children and organ donation from children with anencephaly, we have to consider that while the donation of organs to another is an act of true charity which has the full support of the Church, certain criteria must be observed: (a) Persons may not be killed as a means to obtain organs, either before the removal of the organs, or when its removal kills the donor. (b) Living donors must give free and informed consent, but must refuse this consent if the donation would put their own life or health to grave risk. In the case of anencephalic children and still-living aborted fetuses, it is obvious that their consent cannot be obtained and the proxy consent from the parents or other legal guardians must take into consideration that it is always and gravely wrong to use an evil means even to a good end, in this case to kill a child by removing his or her tissues or organs for transplantation. (c) Organs may be taken from the dead, provided due respect is shown the corpse and if their families give consent, or if this is required by law for the common good. (8)

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Norms on Experimentation On Embryos And Human Fetuses Going back to the question raised by the title of this article on whether anything is wrong with test-tube babies, cloning, tissue transplants from aborted or anencephalic infants, the answer is: definitely. Since the human individual, in the prenatal stage, must be given the dignity of a human person, research and experimentation on human embryos and fetuses is subject to the ethical norms valid for the child already born and for every human subject. Research in particular, that is the observation of a given phenomenon during pregnancy, can be allowed only when there is moral certainty that there will be no harm either to the life or the integrity of the expected child and the mother, and on the condition that the parents have given their consent. Experimentation, on the other hand, is possible only for clearly therapeutic purposes, when no other possible remedy is available. No finality, even if itself noble, such as the foreseeing of a usefulness for science, for other human beings or for society, can in any way justify experimentation on live human embryos and fetuses, whether viable or not, in the maternal womb or outside of it. The informed consent, normally required for clinical experimentation on an adult, cannot be given by the parents, who may not dispose of the physical integrity or the life of the expected child. On the other hand, experimentation of embryos or fetuses has the risk, indeed in most cases the certain foreknowledge, of damaging their physical integrity or even causing their death. To use a human embryo or the fetus as an object or instrument of experimentation is a crime against their dignity as human beings. The practice of keeping human embryos
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alive, actually or in vitro, for experimental or commercial reasons, is especially and altogether contrary to human dignity. (2) Conclusion The most urgent need now seems to be that of re-establishing the harmony between the demands of scientific research and indispensable human values. The scientist cannot regard the moral rejection of in vitro fertilization, human cloning, and organ donation from still living aborted fetuses and anencephalic infants for example as a humiliation; on the contrary, this prohibition eliminates the demiurgic degeneration of research by restoring its dignity. The dignity of scientific research consists in the fact that it is one of the richest resources for humanitys welfare. Moreover, there is a place for research, including cloning, in the vegetable and animal kingdoms, wherever it answers a need or provides a significant benefit for man or for other living beings, provided that the rules for protecting the animal itself and the obligation to respect the biodiversity of species are observed. When scientific research in mans interest aims to cure diseases, to relieve suffering, to solve problems due to malnutrition, to make better use of the earths resources, it represents a hope for humanity, entrusted to the talent and efforts of scientists. To enable biomedical science to maintain and strengthen its relationship with the true welfare of man and society, it is necessary to foster, as the pope, John Paul II, recalls in the Encyclical Evangelium vitae, a contemplative outlook on man himself and the world, with a vision of reality as Gods creation and in the context of solidarity between science, the good of the person and of society.

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It is the outlook of those who see life in its deeper meaning, who grasp its utter gratuitousness, its beauty and its invitation to freedom and responsibility. It is the outlook of those who do not presume to take possession of reality but instead accept it as a gift, discovering in all things the reflection of the Creator and seeing in every person his living image. (6) References: 1. Gaston, Gregory, Who Wants To Be A Clone? Documentation Service, 1998 January XI: 1, 10-13. 2. Pontifical Council for Pastoral Assistance to Health Care Workers, Charter for Health Care Workers 1996, 72-79.

3. Pope John Paul II, Evangelium Vitae (The Gospel of Life) 1995, 158-159. 4. Freiling, Edward, When Does Human Life Begin? Documentation Service, 1991 July IV: 7, 19-27. 5. Monge, Michael. Ethical Practices in Health & Disease Sinag-tala Publishers, Inc. Manila, 1994, 147-153. 6. Pontifical Academy for Life, Reflections on Cloning Documentation Service, 1998 January XI: 1, 2-8. 7. Achacoso, Jaime, ed., Theological Centrum Newsletter 1999 May XIV: 5, 5. 8. Committee on Doctrine of the U.S National Conference of Catholic Bishops, Moral Principles Concerning Infants With Anencephaly LOsservatore Romano, 1998 September, 6-10.

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