research on embryos and medical ethics
Gonzalo Herranz, department of Humanities Biomedical, University of Navarra.
lecture at seminar de Bioética "El destino de los embriones congelados".
Spanish University Foundation, School of Law of the Complutense University, Iber Foundation.
Madrid, April 1, 2003.
2. A bit of comparative deontology
Strong deontologies: Germany, Switzerland, Italy, Mexico
3. Ethics and information on embryo experimentation
4. What happens, and what can happen, with frozen embryos?
5. The deontology underlying the accumulation of frozen embryos.
How is this forgetfulness possible?
How does this apply to the problem at hand?
6. evaluation medical-ethical research with stem cells
7. Ethical and medical conclusions
Delimitation of the topic
Contrast between medical deontology - actually, professional ethics of medicine, the ethics developed by physicians to develop the social mandate of self-regulation - and bioethics, the multiform analyses and varied doctrines of philosophers on the ethical implications of biology.
What the professional ethics of medicine says about research on embryos can be assigned to many sub-sectors.
a. Medical ethics operates in the real world, not in philosophers' cabinets. It has very direct and immediate social responsibilities. The 1980 Royal Decree approving the Statutes assigns to the professional organization a legal mandate to contribute to the realization of the common good. A relevant aspect of that realization is related to information. The information that is provided to society about the research with embryos is a basic component of the matter under consideration.
b. It is important, not to say decisive, for a deontological approach to the problem of the research with embryos to have the most precise idea possible of how the norms on this research should be. For this, to know how to behave with the embryos as subjects of research, it is necessary to investigate some points: what are the deontological circumstances in which they originate, a fascinating and critical topic : that of the ethics of the accumulation of frozen embryos: how is it justified and what force do the arguments adduced have. And also what and how are the destinies, apart from that of the research, open or closed to the frozen embryos.
c. It is said, all over the world, that we must treat human embryos with respect, because they are human life, even human beings. Respect is, for me, the heart of medical ethics. We must therefore determine the intensity and extent of the respect due to embryos as subjects of experimentation, in order to know how to design and approve the projects of research.
2. A bit of comparative deontology 
Before moving on, a word of caution. My analysis is based on the medical deontology in force in Spain. Although, in deontology as in other aspects of culture, there are families of countries, it is superfluous to say that there is a great variety of attitudes towards frozen embryos among the different countries.
A diverse panorama that sample how strong the differences of opinion about the humanity of the embryo can be.
Some samples.
Strong deontologies: Germany, Switzerland, Italy, Mexico
Germany, Berufsordnung 1999. The production of human embryos for the purpose of research, the transfer of genes into embryos, and research on human embryos and totipotent cells are prohibited. Diagnostic interventions on embryos prior to their transfer into the uterus are also prohibited, except for the measures for the exclusion of serious sex-linked diseases as specified in paragraph 3 of the Embryo Protection Act.
Switzerland, Code de Déontologie, 1997. Art. 18 refers to the guidelines of the Académie suisse des sciences médicales (annexe 1) of which C) contains the Directives médico-éthiques pour la procréation médicalement assistée. In the section 10. Conservation of gametes and embryos, it says: 3. In general rule, the embryos must be kept alive only for the duration of the treatment in progress. On the common request of the two members of the couple, we can admit to keep them in the exclusive purpose of giving birth to another child of the couple. Adds: 11. Research. Human embryos must not be used as research objects.
Mexico, National Commission of Bioethics (competent organism to dictate the ethics of the health professions). In the Code-guide of Professional Conduct, of August 2001, it says article 38º The use and/or manipulation of surplus embryos from in vitro fertilization for any other purpose than to make them viable, violate Human Rights and are contrary to Bioethics.
Section I. The creation of zygotes for non-implantation purposes is considered an unethical attitude.
Soft deontology
Belgium. Code in force. Final part of Art. 88: Any experimentation in matters of procurement requires unfailing competence, extreme caution, the agreement of the interested parties and recourse to an ethics commission.
Canada, soft, awaiting legislation that has not yet arrived.
USA. The question arises as to who has authority over pre-embryos (sic) and what the appropriate uses of pre-embryos may be.
Cultural and legal traditions indicate that the persons who should logically exercise control over the frozen pre-embryos are the woman and the male who have provided the gametes. They are the most interested, the ones who can best protect the interests of the pre-embryos. They can use them for themselves, or donate them, but not sell them. If they are not to be transferred, they can be used at research. They can also be thawed and allowed to deteriorate.
The concorde consent of the two gamete providers, necessary for everything. The civil service examination of a progenitor, thwarts any project, reproductive or not, of the other. Recommended, but not obligatory, the anticipated decisions; for cases of divorce or other events.
3. Ethics and information on embryo experimentation
A realm of exaggeration. What people know, what journalists say, what journalists are told by doctors and biologists.
Almost all information on human stem cells, embryonic or not, suffers from a lack of weight. It abounds in fanciful promises, without due critical counterbalance. As they flatter the ear, they are imposed on public opinion as worthy of credit , as incontrovertible facts.
The illusory has made its way into the political arena, and is the subject of parliamentary motions proposing legislative changes and promoting high-priority budget allocations.
No one risks deflating the balloon. One is not considered a scientist, but a defeatist or blinded by religion, who affirms that it is necessary to distinguish with precision between data verified and more or less plausible hypotheses, that science and its advances must be analyzed with ponderation and criticism. That, above all, they must be integrated with other individual and social values. It is unpopular to counteract the naive credulity and certainty of success that dominates today in the media, in politics and in science.
The drift towards ideological propagandism is to be regretted. This is a matter of little concern to the committee advisor of Ethics in Science and Technology research on its report.
No difficulties have been discussed, subject for a future article for Diario Medico.
requirements The Code of Medical Ethics and Deontology requires medical information to be "objective, prudent and truthful, so that it does not raise false hopes or propagate unfounded concepts" (Art. 38.1).
The truth in Law 41/2002, of November 14, 2002, basic law regulating patient autonomy and the rights and obligations in subject of clinical information and documentation. The article 4.2 states that "the clinical information that forms part of all healthcare actions will be true".
4. What happens, and what can happen, with frozen embryos?
We don't know too much. And that is a deontological responsibility. This ignorance tends to ignore embryos.
About the issue. We do not know how many. In the USA 600,000 or 800,000. The I Annual report of the National Commission of Assisted Human Reproduction estimated that in 1998, in Spain there were about 25,000 frozen embryos. Since then, it is said that this issue has doubled.
Nor does it seem that there is any serious interest in knowing, which is an omen that human embryos, as biological individuals, are of less concern than the embryos of panda bears or Iberian lynxes, of which there are guarantee controls.
There is talk that the issue is stabilizing or decreasing as a result of the legal authorization to freeze oocytes, the generalization of the internship of the long culture of in vitro embryos, or the application of preimplantation diagnosis.
But the impact of these innovations will take years. And, in any case, it will be minimal. It is questionable whether oocyte freezing, which has very restricted indications, can do much. Long culture and preimplantation diagnosis, although they try to detect and discard embryos of poor vital quality or Genetics, revolve around the selection mentality. And that mentality is, in a way, insatiable: to choose the optimum requires as much primary "material" as possible.
Moreover, the modest impact of these procedures may be counterbalanced by the trend to implant no more than two embryos per cycle, a timely measure to avoid the biological and economic problems caused by multiple pregnancies.
Loss of the sense of man, of the individual value of each human being: a serious deontological impoverishment.
On viability. Reliable estimates of viability after thawing cannot be made either, as it may depend on the technique used in the freezing/thawing procedures. There are no data of many, nor temperature control records.
Tendency to cumulative confounding factors: Survival is measured not on immediate post-thaw viability, but on the rate of infants born. There is insufficient data to evaluate fees for short-term survival deadline.
In addition, with some approximation it can be said that, in the clinical internship , embryos with a higher quality index are implanted fresh, so those destined for cryopreservation tend to be those of lower quality and, therefore, to show more precarious development possibilities.
On the low value of cryopreserved embryos. A tactic put into circulation to reduce the biological and ethical value of supernumerary embryos that have been in liquid nitrogen for years, is to insinuate that their vitality is deteriorated, that they have probably been result damaged by the long permanence in the cold. This is an unproven suspicion, which goes against many empirical observations on the survival of a multitude of cryopreserved biological objects. In fact, some legislations do not limit the deadline of cryopreservation. Others set long periods, 10 years, and others shorter ones. The HFEA had no objection to extending deadline from 5 to 10 years.
Curiously, the report of the committee advisor reads in its Recommendation 5 "Considering the presumed negative effect on them [human supernumerary embryos] of prolonged freezing [...]". But it does not bother to justify this presumption, on which so many lives depend.
5. The deontology underlying the accumulation of frozen embryos.
The accumulation of human embryos is, basically, a consequence of the climate of competitiveness, of the tone of efficiency, of the struggle for prestige and market, characteristic features of reproductive medicine.
degree programThe first step is to stimulate to the utmost, demonstrate how good you are in the oocyte retrieval phase, fertilize them all, develop them in prolonged culture, select, transfer the most promising ones to the uterus and cryopreserve the remaining ones. The reservation of frozen embryos will allow new attempts at embryo transfer to be made, without having to repeat the always tiresome process from the beginning.
The embryos resulting from a stimulation cycle can never seem to be too many. The consequence is that the issue of the surplus embryos grows: the parents, satisfied with the child or twins born in the first cycle, no longer wish to increase their offspring; other times, because the trauma of the failed experience leads them to postpone new attempts to a future that does not come.
With the passage of time, abandoned human embryos appeared.
The frozen embryo is a living human being, not a glass bubble in nitrogen. A living being whose metabolism has been suspended, but whose relations with God the Creator and with parents, doctors, society have not been annulled. Our obligations towards him, intact. Relationship staff. Created as a son, as a patient.
How is this forgetfulness possible?
An explanation. The main contribution that modern medical ethics has made is to have awakened its ethical responsibility. Until not so long ago, medical paternalism prevailed. Patients played a passive role: they willingly placed their health and their destiny in the hands of the physician. Today this is no longer the case: the patient is invited to understand the status in which he or she is involved and to authorize the physician's interventions with his or her consent. This places the doctor-patient relationship in an intense field of ethical forces.
How does this apply to the problem at hand?
Those who seek assisted reproduction often find themselves in a special status . They are anxiously looking for a child. They do so with a strong emotional burden, in a struggle against time, with the threat that sterility poses in certain environments to the stability of marriage.
Does the information to be given by the physician to these persons include information on the issue of embryos to be created? Should the physician provide information on the problems that may arise in connection with the EHS? Is the decision on the issue of embryos to be created a strictly technical matter, such as adding such a factor to the culture medium used, or is it, on the other hand, a fundamental ethical question, which no one can take in place of the parents? Is there, in assisted reproduction, something that could be called paternity manager? Or does the old paternalism persist intact?
Modern medical ethics and now, among us, the Law, oblige physicians to provide their patients with all ethically significant information, including the risks and consequences of the decisions they may make. Couples need this information, objective and complete, because they cannot disengage themselves from the decisions that concern them and that they have to take in full lucidity. The physician must provide this information with the aim of placing the couples in front of their duties, purpose . Patients sometimes tend to close their eyes to reality, but physicians must help them to act responsibly, even if this means that they decide not to go ahead.
I have tried to search, at bibliography and in the few informed consent forms for embryo freezing that have been published, whether there is information and consent requested on the specific point of the issue of embryos that the parents authorize the parents to create with their gametes. The search has been in vain, with the exception of a reference letter to a law in effect in the State of Louisiana.
I do not deny that in the legal rules and regulations and in the daily reality of assisted reproduction centers, full information is provided, authorization is requested for many aspects of the medical interventions, and rights are also granted to the parents on many things that have to do with the embryos already created. It is claimed that the right to decide on the fate of the embryos belongs to the parents and that this is a fundamental right, based both on the special link between the "genetic material" and the identity of the person, and on the importance and centrality that reproduction occupies in the life plan of individuals or couples and on the non-transferable interest of individuals in controlling their own reproductive capacity.
But, curiously, nobody makes accredited specialization of the right of the progenitors to determine the issue of created embryos. Typical in this sense is the I Annual report of the National Commission of Assisted Human Reproduction of Spain. In its analytical section there are some general proposals to reduce the issue of cryopreserved embryos. And, although it states that the main thing is that couples take joint responsibility for the destiny of frozen embryos, it does not make any accredited specialization that couples have any say in the issue of embryos that are produced. It advises report that Centers should limit the issue of embryos they freeze to that rationally necessary to achieve procreation for the couple in question. But, at the moment of truth, the report neither considered it appropriate to recommend a limit on the issue of oocytes to be retrieved and fertilized, nor does it reference letter that the parents have the capacity to determine it. Accordingly, the model of form of informed consent C by the Commission does not ask for the couple's opinion on this decisive point.
Many supernumerary embryos are result of a fraud.
The house of the father of the prodigal son. God's infinite love for man and his freedom. God's love is reciprocated with an extreme lack of love. The FIVET summum of selfishness, of domination. Of disrespect
6. evaluation medical-ethical research with stem cells
Among the basic commitments of medical ethics is the utmost respect for human life.
There is also an imperative to know, to do research to improve the science and skills of the physician.
The Declaration of Geneva, the founding document of contemporary medical ethics, imposes on physicians, among others, two strong obligations: to respect human life from its beginning, and to treat all human beings equally, without allowing any discrimination to come between them and their patients. This is the hard core of medical ethics.
The current Code of Medical Ethics and Deontology states that the physician is a servant of human life (Art. 23) and that, since the medical profession is at the service of man and society, respecting human life is one of the physician's primary duties (Art. 4).
No one, including embryos, can be denied this maximum respect and this non-discriminatory attention . This is confirmed by the current Code of Ethics and Deontology: "The sick embryofetal human being must be treated at agreement with the same ethical guidelines [...] that apply to other patients" (Art. 24.1).
Physicians are obliged to maintain an affirmative attitude towards biomedical research , the decisive driving force behind the progress of their science and their internship. The Code also establishes that the research on human beings shall comply with the guarantees required in this respect by the Declarations of the World Medical association (Art. 29.2).
In total congruence with the Declaration of Helsinki, the Code states that the risks involved in experimentation may never be disproportionate to the expected benefits, nor may they be detrimental to the conscience or dignity of the experimental subjects. It adds that the physician shall interrupt the experimentation if he/she detects a possible danger to the life or integrity of the subjects under investigation.
It has been affirmed, both in scientific circles and in the media, that the use of human embryos left over or abandoned in experimental projects, particularly those that seek the production of embryonic stem cells, is ethically acceptable because these embryos, left over or abandoned, have no other destiny than to be abandoned to death or to be destroyed. This affirmation, which presupposes an undoubted good will to promote the health of other human beings, could only be ethically sustained through the reduction of the human embryo to the condition of a thing available, of an animal for experimentation.
The medical ethical mandate to respect human life from its beginning has always been interpreted as an obligation to respect the embryo from the first day of its existence, that is, from fertilization. In this respect, professional medicine follows its own deep-rooted tradition, which is recorded in all, without exception, the treatises on Human Embryology written by physicians.
[It should be noted in passing, because it is a highly significant fact both from a cultural and professional point of view, the surprising fact that no medical embryologist has been invited to be part of any of the ethics committees that, in Spain or abroad, have been commissioned to make recommendations on embryonic experimentation or stem cell technology].
The existence of tens of thousands of supernumerary or abandoned embryos constitutes, from the deontological point of view, a regrettable error that must necessarily appeal to the social conscience and, particularly, to the professional responsibility of physicians working in assisted human reproduction.
It is obvious that this should be replaced by an ethos of profound and effective respect for the embryo produced in vitro, the ethos of efficiency and mastery that presides over the internship of assisted reproduction. To produce, in the course of assisted human reproduction interventions, embryos in issue superior to the one to be implanted in the woman's uterus is a grave irresponsibility.
The recent report of the committee advisor of Ethics in Scientific and Technological research (The research on Stem Cells) includes in its Recommendation 7 a lukewarm call to cushion the problem, when what seems necessary is to transfer to our legislation the German rule on the subject, as I do in my particular vote to the II report of the CNRHA.
7. Ethical and medical conclusions
7.1. The serious question of what destination to give to the massive issue of surplus human embryos does not have, in the opinion of the Central Commission of Deontology, answers that are both ethical and practicable. The alternatives proposed since years ago, of indefinite cryopreservation, adoption by other couples, donation for the destructive research , or allowing their death, are not, separately or jointly.
7.2. Indefinite cryopreservation is not a solution: it does not seem feasible or reasonable to expand year after year the issue of liquid nitrogen tanks to store tens of thousands, hundreds of thousands of frozen embryos, petrified in time.
7.3. Nor is the solution of donation to other couples feasible: as pointed out by a recent work , embryo donation is much talked about and well, but it is rarely practiced. There are enormously complex legal regulations, the French, for example, which make embryo adoption very difficult. The psychosocial and ethical implications create confusion and uncertainty for potential donors and recipients, since the recipients want to know a lot about the psychological and genetic background of the donors, and the donors, for their part, have to overcome their emotional attachment to the embryos in order to place their children in the hands of strangers.
7.4. Simple destruction, abandoning to death, is not acceptable either. No words (letting die, not allowing growth, destroying) can disguise the hard fact that a human creature was created to live and is left to perish. This is a reaction of moral revulsion that reached massive proportions in 1996 in the United Kingdom, when public outcry forced the relevant Authority to extend the deadline conservation legislation.
7.5. Neither, finally, is the destructive research , which reduces human embryos to the condition of consumable things, which is incompatible, if the words are taken for what they mean, with the minimum respect required for the human subject in biomedical experimentation. There are no goals of research so valuable that they can legitimately be achieved at the cost of human lives. This was stated in the Nuremberg Code, affirmed in the Helsinki Declaration and imposed on us by the agreement on Human Rights and Biomedicine, of the committee of Europe, ratified by Spain, which, in its article 2, proclaims the primacy of the human being when it tells us that "the interest and welfare of the human being shall prevail over the exclusive interest of society and science".