Some Christian contributions to the ethics of biomedical research. A historical perspective
Gonzalo Herranz, Departamento de Humanidades Biomédicas, Universidad de Navarra
Ponencia en la Novena Asamblea de la Academia Pontificia para la Vida
Ciudad del Vaticano, 24-26 de febrero de 2003.
Publicada en Vial Correa J, Sgreccia E., eds. Ethics of Biomedical Research in a Christian Vision. Proceedings of the Ninth Assembly of the Pontifical Academy for Life, Vatican City, 24-26 February 2003. Città del Vaticano: Libreria Editrice Vaticana; 2004:81-92
The dominant version of the history of ebmr
a. The Nuremberg Code, an epoch-making event
b. The time before Nuremberg, a dark age
d. The leading and exclusive part assigned to secularist ethics in the development of the ebmr
The genesis of the standard version
Some Christian ethics original contributions to the ebmr
a. An early claim for free and informed consent
b. Science, society and the individual: ethical relationship
Studies dealing with the short but eventful history of ethics of biomedical research (ebmr)1 are indeed not scarce. It is interesting to point out that, regardless obvious differences in outlook and approach, many of those studies show a marked leaning towards a convergent, if not uniform, interpretation of their subject matter. The coincidence is marked enough to make one suspect that an informal agreement had been attained among the authors not only on the main facts to be included and emphasized in their accounts, but also on the secularist and scientist outlook from which the history is interpreted and constructed. It appears as if a consensus has been reached on the place and time of birth of the ebmr, on the main milestones signaling its evolution, on its leading thematic issues, and, above all, in the internal forces that drive forward its progress2.
The result of this dominant interpretation is the widespread diffusion of what could be called the standard history of the ebmr, a history which tends to highlight some events as significant and momentous, and, at the same time, to eclipse some others as trivial and irrelevant.
Among the elements that appear diminished or absent in this standard history of ebmr are some pioneering contributions from Christian ethics. In consequence, they are never mentioned.
This article intends to be an initial effort to identify and collect the Christian contributions to the early development of ebmr, to redeem them from oblivion, and to offer them for discussion.
The dominant version of the history of ebmr
A brief characterization of the prevailing description of the history of ebmr is not out of place here. Only against that background, the significance and worth of the elements Christian ethics has brought to the building of the ebmr can be better understood and appraised.
Among the characteristic features of the dominant standard version of the history of ebmr, the following are of particular relevance to our context:
a. The attribution to the Nuremberg Code of the merit of being the starting point of the history of ebmr.
b. The labelling of the time prior to Nuremberg as a dark age.
c. The conviction that only after the publication of the Helsinki Declaration and the Belmont Report it was possible to recognize an autonomous ebmr, emancipated from the common ethics of medicine.
d. The leading and exclusive part assigned to secularist ethics in the development of the ebmr.
a. The Nuremberg Code, an epoch-making event
It is frequently affirmed that ebmr was born in Nuremberg on August 20th 1947, the day when the sentence was pronounced in the trial against the Nazi doctors guilty of performing inhuman experiments on war prisoners. As it is well known, the sentence of the American Military Tribunal contained a section, named afterwards as the Nuremberg Code, where ten clauses were enumerated as basic principles that must be observed in order to satisfy the generally accepted moral, ethical and legal requirements for the practice of experimentation on human subjects. The promulgation of the Ten Points of the Nuremberg Code is considered the germinal event, which marks the change from an old and dark prehistory to a new and enlightened time.
Such a glorification of Nuremberg is not fully justified. It is rather the result of an artificial and politically interested re-writing of history. The Code was plainly ignored or received with indifference. Actually, the legitimacy of the Code as a legal referent for the condemnation of the Nazi doctors in the Nuremberg medical trial, as well as the ethical contents of some of its articles, have been the object of well-founded criticisms3.
But far more important is another fact: the Nuremberg Code did not exert any immediate influence on the ethical conduct of medical research. The message of Nuremberg had no impact on the medical profession because it was held as specifically addressed to punish the perpetrators of war crimes, and thus without implications for the well-intentioned doctors working in democratic and free countries. Only two decades later, when the Code was rediscovered, the breadth of its ethical contents was openly acknowledged. In particular, its doctrine on voluntary and free consent achieved recognition when it was transferred to two influential later documents, the Declaration of Helsinki (1964) and the Belmont Report (1979).
The reception of Nuremberg principles into the Codes of Ethics of the national medical associations followed also a slow, haphazard and almost lethargic course. It acquired impulse only after 1975, when the World Medical Association published the second version of the Declaration of Helsinki4.
b. The time before Nuremberg, a dark age
It is not just to relegate the time prior to Nuremberg to the category of a dark age. It was a period contrasting substantially with ours in many aspects. No pressing need was felt then to regulate formally the ebmr, because, among other reasons, no clear separation was recognized then between ordinary practice and clinical experimentation, the greatest part of the research done was descriptive or observational in type, research did not perturb the common doctor-patient relationship and, therefore, ethical reflection could be set aside without remorse. It is true that prior to Nuremberg more consideration was devoted by scientists to the ethos of research (the calling and the specific virtues of the researcher, the selection and education of young researchers, methodological strictness, social responsibilities, counselling, role models) than to the ethics proper5. But it is also true, as it will shown further on, that a few doctors, from the circle of the French Morale Médicale, considered some of the basic questions of the ebmr and were able to forward some pioneering, and surprisingly modern, ethical concepts.
The darkness unjustly attributed to the time preceding Nuremberg is more the consequence of a perhaps involuntary inattention to some historical sources than to the absence of authors and valuable contributions.
c. The conviction that only after the Helsinki Declaration or the Belmont Report a genuine ebmr was identifiable
It was not until recently that a specific and explicit regulation was established for the ebmr. Before 1947, only a few formal normative documents were published on the ebmr and they were practically ignored6.
The lack of normative ethics documents during this period is mainly due to the fact that until relatively recent times the separation between daily medical practice and experimentation was fuzzy or not recognised. Claude Bernard, the leading figure of experimental medicine, in his interest to give a moral justification to human experimentation, grants an experimental character to any medical or surgical intervention and blurs any clear separation between them. Summarising the general opinion of his time, Bernard wrote: “Physicians make therapeutic experiments daily on their patients, and surgeons practice everyday vivisections on their subjects. […] There is, therefore, a duty to submit oneself to experimentation, and a corresponding right to perform it whenever such a procedure can save someone’s life, cure his disease, or bring him a personal benefit”7.
This view appears to us as peculiar of long bygone days. But it is opportune to remember that, a century later, it was a common medical opinion that since anything the doctor decides to do on behalf of his patient is based on partial and unclear knowledge, every clinical act partakes many of the features of a clinical experiment8.
d. The leading and exclusive part assigned to secularist ethics in the development of the ebmr
Two factors can be invoked to explain the subordinate role of Christian contribution to the ebmr. On the one hand, in the time before 1950, the bibliographic sources of Christian origin pay an almost exclusive attention to issues connected with the moral problems and spiritual needs of sick people. More than on medical ethics, Catholic authors wrote on pastoral medicine. Their main interest was on the effects of medical care on the observance of God’s commandments and on the administration of the Sacraments of the Church, on questions such as the sacredness and transmission of human life, abortion and euthanasia, contraception and sterilization, the care of dying patients, professional secret, cooperation to evil, and marriage. The interest on ebmr was secondary, in such a way that in the majority of manuals it is not treated at all, or it is alluded to only in a cursory way9.
On the other hand, the deep changes operated in the field of contemporary bioethics have brought about, as a side effect, the progressive silencing and exclusion of Christian contributions to the ebmr. Along the 1950s and 1960s, Christian principles and standards were part and parcel of the articles and directives regarding ebmr10. In later decades, under the influence of a number of factors (the rebellion against authority, the open and public debate on some egregious examples of research abuses and misconduct, the intense judicialization of bioethical issues, the growing influence in theory and practice of situationist and utilitarian ethics, and the claiming of activist groups acutely critic of religion) gave bioethics a strong secularist character11.
Today, health care ethics is subjugated by the famous four principles of bioethics, which are a direct derivation of the three principles contained in the 1979 Belmont Report12. Many ethical and legal regulations of medical research have been built on the foundations of those principles, and consequently the deliberations of the institutional review boards turn around some fixed and recurrent topics, such as the protection of the subjects’ autonomy, the securing of their informed and free consent in accordance with law, the balancing of risks and benefits, the just distribution of the ethical burden of research among the members of society, and the protection of interests of research subjects, researchers, sponsors and society. In fact, the principles of bioethics monopolise in practice the activity of many Boards. No other alternative is at present deemed satisfactory13. So, the practical influence of Christian values in the ebmr has been weakened and forgotten its historical meaning.
The genesis of the standard version
As it will be shown in the next section, the Christian moral tradition held a clear and strong view on the participation of human beings in biomedical experimentation: because that participation is a human deed, it was required, on one side, that the experimenter had to request previously the indispensable consent of his subject; and, on the other, that the subject could enjoy both the information and freedom needed to consent in a truly human and morally responsible manner. This tradition, as noted above, is absent from the standard version on the history of ebmr.
Two factors have contributed to efface the memory of this tradition. First, the narrowing of the area and time of inquiry usual among Bioethics historians, who ordinarily restrict their studies to what happened in the United States after the World War II. So, frequently the history of the ebmr does not pay due attention to events that took place outside America in the time prior to Nuremberg14. And second, the application of specific markers to ascertain what is, and what is not, consent to research, following those provided exclusively by American court cases or American bioethicists. The expression “informed consent” becomes thus a sort of registered mark of which only a restricted and authorised use can be made. It is not a common descriptive term, but a qualified one, different in substance and superior in quality to similar things used in other times and places.
Nothing reveals more the intent to transfer the ebmr to the American heritage than the distinction Faden and Beauchamp made between two different types of informed consent15. One, labelled as the effective type, refers itself to the mere formalistic procedures demanded by law or institutional policies to inform and document the patient’s permission to undertake research, by which the consent becomes formally valid. It is the mere filling of a form, by virtue of which the subject accepts the suggested research. This type of consent involves an effective, bureaucratic and formal procedure that materially fulfils the minimal requirements prescribed by law, the professional customs or institutional rules. The second form, named the autonomous authorisation type, defines informed consent as a subcategory of autonomous action by a subject to authorise a researcher to undertake a particular research intervention. It is precisely its quality of autonomous authorisation that makes such consent substantial and ethically genuine, because it manifests the nuclear core value of respect for persons. This type of consent reveres the sovereignty of subjects, their values and beliefs, and it is equivalent in point of fact to a transfer of authority and accountability actively performed by the subject into the researcher. These two types of consent correspond closely to the two models, of beneficence and autonomy, Beauchamp y McCullough have devised in their description of physician’s moral responsibility16.
In the review Caplan wrote on the book of Faden and Beauchamp17, he affirms that only the substantial type of informed consent is, in contrast to the effective one, true consent, and affirms also that it is a typical and necessarily American product. Caplan reproaches Faden and Beauchamp with a glaring flaw in the book: that despite their attentive historical analysis, they omit a very significant and decisive, fact: that the notion of autonomy-oriented informed consent is not only born and grown in the United States, but also it is rooted in the value of autonomy, a peculiarly American insight. By contrast, in other places and times, the practice and writings on informed consent concerned almost exclusively with the formal and procedural aspects of its effective variant. That genuine consent is a modern and radically American phenomenon is proved by the amazement non-Americans experience with the role autonomy plays in American medical practice18.
In this way, a new vision of informed consent is introduced, a view that breaks with the past. It is original and exclusive of the American mind, the resulting conceptual changes occurred during the past few decades in moral theory, law, and economics, and in cultural attitudes about individualism and personal choice that extend far beyond the realm of medical morality”19. In contrast to the moderate view of Faden and Beauchamp on the difficulties of valuing the consent practices of the past20, Caplan adopts the more radical one of measuring past and present consent procedures with the yardstick of the autonomous authorisation type, what implies a strong risk of axiological imperialism. The new concept of autonomous authorisation consent rests on judicial criteria born inside American law, and presupposes that the subject is regularly endowed with sound intellect and cultivated autonomy. And what is more: the new concept has been raised to the condition of a universal model. Such theoretical magnification brings discredit or belittlement on the pre-Nuremberg customs and uses related to consent.
Furthermore, the new paradigm severs all ties of the ebmr with Christian ethics. Whatever the medical and Christian tradition had affirmed on the moral rights of the research subject, on his responsibility and his freedom, on the power to administer his own life and his body, his capabilities and deeds, is brought into disrepute or diminished to the condition of a rudimentary or obsolete precedent. In front of such a bold self-attribution of historical importance and ideological superiority, it is a duty for all to wonder whether that version of the history of informed consent takes account of all the available data and analyzes them with fairness. I think that it is not the case, because such interpretation does not take into account an important part or the history of the ebmr21.
In what follows, I will present some data to show that the standard version of the history of the ebmr has neglected the exploration of authors and works that many years before Nuremberg proposed, with a surprising maturity and anticipation, very advanced ideas on the ethical criteria for informed consent and on the position biomedical research must occupy in our society.
Some Christian ethics original contributions to the ebmr
This is a not easy topic. There are very few publications on medical ethics from the time before Nuremberg. Besides, a number of those publications are not easy to find and, as noted previously, many of them do not deal with the ebmr.
Despite those difficulties, pre-Nuremberg time appears to be an interesting and peaceful period, when problems were relatively uncomplicated and medical ethics was cultivated principally by people with deep religious convictions. Many of them were Catholics. For moral theologians and doctors as well, the main topics of interest were in great measure the legacy of pastoral medicine, concretely those related either to the Sacraments of the Church, or to those Commandments of the Decalogue concerned with the preservation of life and body, and human sexuality. On the other hand, physicians, theologians and moralists, creatures of their own time, were imbued of the incertitude of the border separating medical practice and medical research.
Next, a presentation is made of two interesting findings, until now unknown to the bioethical literature. One is related to the respect for the person of the research subject in the specific situation of physiological (non-therapeutic) research, as the source of an energetic claim for the practice of informed consent. The other finding, dealing with the relationships tying science, society and the individual, is in the origin of a meaningful clauses present in many modern documents on the ebmr.
a. An early claim for free and informed consent
In the Catholic tradition, doctors and patients, researchers and subject must be guided by a spirit of moral rectitude, brotherly love, sincerity and freedom. All are equally human beings, in the image of God, installed in identical worth, done by divine grace capable of maintaining a direct, personal and filial relationship with God.
Therefore it can be deduced that, in the peculiar circumstances of biomedical experimentation, there are some specific relationships of researchers and subjects with God, relationship that are shaped by the respect for the dignity and freedom of persons who are simultaneously brethren and creatures of God. To rob the human being of his responsible freedom to decide about his health and body, or to grant or decline his consent to research, is not only a distasteful abuse, but a sin, because it enslaves one’s neighbour and deprives him of the moral merit to consciously help science and humankind. Free and informed consent are part and parcel of the researcher-subject relationship in the Catholic tradition22. It emerges, as a radical and obligated requirement, clearly articulated by authors belonging to the practically ignored school of the French 19th century Morale médicale23. Such is the case of Georges Surbled.
When Surbled discusses physiological experimentation, protests with energy against the insensitivity of certain colleagues who do not acknowledge the limits imposed on research by sane morals. For Surbled, “charitable love is the first and last word of science”. He regrets that many scientists who do not believe in God and are therefore unable to love their neighbor in God, cannot forget that they are compelled by the imperatives of justice enforced to all. Surbled is convinced that there is a way to abjure from inmoral or abusive experimentations: the unmistakable affirmation of “the rights of man, and, therefore, of the rights of the patient. […] Every man has the right to be respected in his body […], has the absolute right of not being offended or tortured. So, it is not permitted to the doctor to experiment on man without his formal consent. And never was it known that patients have authorized the practice of the dangerous and risky experiments recorded by history and condemned by the right conscience. Such experiments have been performed surreptitiously, in unacquainted subjects, with the perverse pretext of a medical treatment. Let us hurry to affirm, to make things clear, that neither the patient himself is endowed with the absolute right to dispose of his […] The patient never can be used as a cheap object for experimentation”24.
When dealing with the consent for the ordinary clinical encounter, Surbled does not show so much energy, but he has also very important ideas on the matter. Adopting an attitude which deviates in some points from the beneficent and paternalistic approach of his contemporaries. Certainly, he follows in first place “the ancient and supreme rule enfonced on the conscience of the doctor and governing all his practice: primum non nocere”, a rule in force the same in experimentation as in clinical treatment. But, in both circumstances, Surbled affirms that the patient has the right to refuse whatever treatment or experiment, “since it is enough for him to barricade himself behind his will, without any obligation to explain the reasons of his decision […]. He is the only master of his body to use it in freedom. He only must submit himself to God’s will”. Surbled does not doubt in labelling as criminal and monstrous the behavior of those researchers who deceive their subjects, healthy or ill, when they inject in their unknowing victims pathogenic microorganisms.
Surbled’s concept of informed consent does not yield in ethical depth to the notion of consent enshrined in the more advanced documents of today. It includes those requirements of respect for the autonomy of the subject Faden and Beauchamp consider indispensable for an ethically flawless informed consent: the assent to participate in the research based on the full understanding of the relevant information; the deliberate and conscious authorization granted for the research intervention; the absence of duress or external incentives that could vitiate or predetermine the subject’s choice25. There is, however, a meaningful difference between both concepts, a difference that reveals the long distance intervening between the Christian and the secularist interpretation of man. In effect, instead of the absolute autonomy of the subject of the secularist ethics leading him to an isolated, immanent and individualistic decision, the autonomy of the Christian subject, a man who lives in the presence of God and enjoys the help of His grace, realizes lucidly that he is not the absolute master of himself, bur a prudent and responsible administrator of his life and his body, gifts borrowed and that must be traded with wisdom and responsibility. Exactly the same can be said of the gifts received by, and the duties imposed to, the researcher, who maintains an lively and active relationship with God and his subjects26.
Man’s mastership on himself is a dominion of use, not of self-property, a stewardship subordinated to God, that everyone must exercise with freedom and in the service of others27. Christian humanism professes a strong belief in the man’s worth and freedom, in human rights, and in the task, assigned by God to man in the Garden of Eden, of governing and improving this world28.
The idea of free and informed consent coined by Surbled appear in posterior writings belonging to the French tradition of the Morale médicale under different appearances, frequently, and curiously, subsumed under the dominant principle of doing no harm29. In other occasion appears clearly stated: Bon30, for example, states among the requirements for legitimate research that “The subject, after being fully informed of the incurred risks, must lend himself to the research absolutely free and of his own will”.
b. Science, society and the individual: ethical relationship
The Declaration of Helsinki, not in its 1962 original wording, but in subsequent versions from 1975 on, includes a clause of deep moral meaning: that that affirms the ethical superiority of the interests of the individual over the interests of science and society. During 25 years, from 1975 to 2000, this lofty concept was reiterated: “Concern for the interests of the subject must always prevail over the interests of science and society” read clause I, 5, echoed by clause III, 4. In the current version, up-dated in Edinburgh in 2000, the clause 5 of the Introduction insists on saying: “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society”.
The prevailing background of the person over other human values is a constant in the Catholic ethics of medicine. Surbled stated unambiguously that patient’s best interest imposes itself with such strength on the physician’s conscience that it determines his behaviour. “The love of science, so deep and energetic it can be, never can prevail in our heart over the love to our suffering brethren in need of our help”. But, many years before Surbled, Max Simon affirmed with determination and clarity this same principle of superiority of persons over the more valued interests of science. As early as 1845, he wrote: “Neither the concern for science, nor the decision to solve an important theoretical problem or the craving for adding a new agent to the medical armamentarium, can lead experimenters to lose the touch with the immediate interest of the individual who is the subject of their studies. Nothing can release doctors from their humanitarian duty to assure the suffering patient the whole benefits of their art”31. And some lines further, Simon adds: “But, at last, it is not possible to over-emphasize this principle: the most indigent and worthless patient, the more useless to society, cannot be subjected to risky or dangerous experiments. Perish rather science than this principle!”32
Simon argues in favor of concentrating medical research in the larger hospitals and under the leadership of highly capable and eminent academics, since only in this way it becomes possible to perform numerous enough series of observations and, above all, to ensure that those doctors will never use their privileges to sacrifice the interest of the individual to the interests of society and still less to personal enhancement33.
It would be of great interest a search for the path linking Simon to Helsinki, to see how a French book, written in mid-19th century France in the circle of the Morale médicale, made its way to the 1975 Declaration of Helsinki, a product of the secular post World War II medical ethics. Some intermediate points can be identified. One is the well-known discourse Pius XII delivered the 14 September 1952. In it, the Pope analysed the ethics of biomedical research around three principles: the interests of medical science, the interests of the individual subject, and the interests of the community. He expressed, among other important ideas, that science is not the highest value to which all other values are to be subordinated; that the human person cannot be used as an object by the community; and, finally, that the patient is not the absolute master of himself: he cannot, therefore, freely dispose of himself as he pleases34.
These ideas were probably carried to the Declaration of Helsinki by the intermediate of a Symposium on religious views on medical experimentation, organized by the World Medical Association in its protracted incubation of the Declaration of Helsinki, published in 1960. The representative of the Protestant confessions, Jacques de Senarclens, after affirming that neither the interest of science nor the interest of society is sufficient to justify any experiment on man that contradicts the principles of medical ethics, wounds the dignity of human beings or breaks the most elementary precepts of the Christian faith, adduces the moral authority of the Pope as expressed in his 1952 discourse: that man “in his personal being must not be subordinated to the community; on the contrary, the community exists for the man”35.
It is evident that the current Declaration of Helsinki retains in its integrity, although certainly with less emphasis than in previous versions, the precious legacy of Simon. The commitment to give precedence in any circumstance to the well-being of the human subject over the interests of science and society is worth the place of honor the injunction occupies in the Declaration. Its meaning, not easy to define with precision, is open to diverging interpretations36. In its vagueness, it can be understood as a valuable tool to ascertain the limits of acceptable risk in very particular research situations or as a preventive disapproval of perilous experiments. But it can be also apprehended as a parenetic exhortation to sharpen our ethical sensitivity for the protection of the research subject or as a basic moral attitude that gives wholehearted preference to the integrity of the human being over any other consequentialist consideration. This topic has been developed with profundity by Jonas in a study that has become a classic37.
[1] The bibliography on this topic is copious. Here are offered only a few references presenting a panoramic view on the history of the ebmr: Beecher H.K., Research and the individual. Human Studies, Boston: Little, Brown, 1970:5-15. Brieger G., History of human experimentation, in Reich W.T. (ed.), Encyclopedia of Bioethics, New York: The Free Press, 1978:684-92. Bynum W., Reflections on the history of the use of human subjects in research, in Spicker S.F., Alon I., de Vries A., Engelhardt H.T. Jr, (eds.), The use of human beings in research. Dordrecht: Kluwer; 1988:29-46. Howard-Jones N., Human experimentation in historical and ethical perspectives, in Bankowski Z., Howard-Jones N, (eds.), Human experimentation and medical ethics. Geneva: C.I.O.M.S.; 1982:453-95. Ivy A.C., The history and ethics of the use of human subjects in medical experiments, Science 1948;108:1-5. Jonsen A.R., The Birth of Bioethics. New York: Oxford University Press; 1998:125-165. Katz J., Experimentation with Human Beings, New York: Russell Sage Foundation;1972. Ladimer I., Newman R.W. (eds.), Clinical Investigation in Medicine: Legal, Ethical and Moral Aspects. An Anthology and Bibliography, Boston: Law-Medicine Research Institute, Boston University; 1963. Lock S., Research Ethics – a Brief Historical Review to 1965. J Intern Med 1995;238:513-520. Rothman D.J., Strangers at the Bedside. A History of how Law and Bioethics Transformed Medical Decision Making, New York: Basic Books; 1991:15-100. Rothman D.J., Research, Human: Historical Aspects, in Reich W.T. (ed.), Encyclopedia of Bioethics. Revised edition. New York: MacMillan; 1995: 2248-2258. Vaux K., Schade S.G., The Search for Universality in the Ethics of Human Research: Andrew C. Ivy, Henry K. Beecher, and the Legacy of Nuremberg, in Spicker S.F., Alon I., de Vries A., Engelhardt H.T. jr (eds.), The Use of Human Beings in Research, Dordrecht: Kluwer; 1988:3-16.
[2] With variations, this standard version of the history of ebmr is found not in academic research papers or the chapters of monographs or books, but in short editorials, encyclopedias and publications for the general public. A typical example is: Booth C.C., Clinical Research. In: Bynum W.F., Porter R., eds. Companion Encyclopedia of the History of Medicine. Vol. 1. London: Routledge, 1993:205-229. It is also present in many influential tutorials used in the Internet for the initial education of future members of Institutional Review Boards. In thus way, the persistence and dissemination of the message are perpetuated.
[3] On the artificial origin of the Nuremberg and on its improvised nature as a legal referent, see: Grodin M. E., Historical Origins of the Nuremberg Code. In Annas G. J., Grodin M. E., The Nazi Doctors and the Nuremberg Code. Human Rights and Human Experimentation. New York: Oxford University Press, 1992:121-144. On the internal inconsistencies of the Code, see: Deutsch E., Der Nürnberger Kodex. Das Strafverfahren gegen Mediziner, die zehn Principien von Nürnberg un die bleibende Bedeutung der Nürnberger Kodex, in Tröhler U., Reiter-Theil S., Ethik und Medizin 1947- 1997. Was leistet die Kodifizierung von Ethik, Göttingen: Wallstein, 1997:103-114.
[4] Herranz G., The Inclusion of the Ten Principles of Nuremberg in Professional Codes of Ethics: An International Comparison, in Tröhler U., Reiter-Theil S., Ethics Codes in Medicine. Foundations and Achievements of Codification since 1947. Aldershot: Ashgate, 1998: 127-139.
[5] As examples of the old literature on the ethos of biomedical research, see: Cannon W. B., The Way of an Investigator, A Scientist’s Experiences in Medical Research. New York: W.W. Norton & Co, 1945: Gregg A. The Furtherance of Medical Research, New Haven: Yale University Press, 1941; Albareda J.M., Consideraciones sobre la Investigación Científica, Madrid: C.S.I.C., 1951; Ramón y Cajal S., Reglas y Consejos sobre Investigación Biológica (Los Tónicos de la Voluntad), 6th ed. Madrid: Imprenta Pueyo, 1923.
[6] For example, in the United States (Cannon W.B., The Right and Wrong of Making Experiments on Human Beings, Journal of the American Medical Association 1916;67:1372;1373) or in Germany (Volmann J., Winau R., The Prussian Regulation of 1900: Early Human Experimentation in Germany. IRB: a Review of Human Subjects Research, 1996;18(4):9;11; Reich Minister of the Interior, Regulation on the New Therapy and Human Experimentation, February 28, 1931. In: Annas G.J., Grodin M.A., The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992:129-132.) The most flagrant case was probably the 1946 Resolution of the American Medical Association, which after an accelerated approval to serve as an ethical referent during the Nuremberg Trial, fall on deaf ears and slipped into oblivion (American Medical Association, Requirements for Experiments on Human Beings, Journal of the American Medical Association 1946;132:1090).
[7] Bernard C., Introduction à l’étude de la médecine expérimentale, Paris: Garnier-Flammarion, 1966: 151-152.
[8] Before the introduction of the controlled clinical trial and the acceptance of the evidence based medicine mentality, it was held as common wisdom that practically all medical interventions were in a certain sense experimental. Ivy, for example, affirmed that “even after the therapy of a disease is discovered, its application to the patient remains in part experimental. Because of the physiological variations in the response of different patients to the same treatment, the therapy of disease is, and will always be, an experimental aspect of medicine”. (Ivy A. C., The History and Ethics of the Use of Human Subjects in Medical Experiments, Science 1948;108:1-5). And Shimkin, a few years later, considered that “medical experimentation on human beings, in its broadest meaning and for the good of the individual patient, takes place continually in every doctor’s office” (Shimkin M.B., The Problem of Experimentation on Human Beings, Science 1953;117:205-207).
[9] A substantial number of the most used manuals do not include the ebmr among the matter treated, for example: Bonnar A., The Catholic Doctor, 4th ed., London: Burns Oates & Washburne, 1944; Marshall J., The Ethics of Medical Practice, Darton, Longman & Todd, London, 1960; Peyró F.J., Deontología médica, 5a edición, Madrid: Marbán editor, 1954. Pazzini A., Il Medico di Fronte alla Morale, Brescia: Editoriale Morcelliana, 1950.
[10] In those years, it was customary to invite Christian theologians to take part in debates or collective works on the ebmr. In 1960, the World Medical Association sponsored a symposium of representatives of the main religions as a necessary step to the development of the future Declaration of Helsinki (Human Experimentation. A World Problem from the Standpoint of Spiritual Leaders, World Medical Journal 1960;7:80-83, 86). In the monographs and anthologies then published (Beecher H.K., Research and the Individual. Human Studies, Boston: Little, Brown and Co, 1970; LadimerI., Newman R.W., eds., Clinical Investigation in Medicine: Legal, Ethical, and Moral Aspects. An Anthology and Bibliography, Boston: Law-Medicine Research Institute, 1963; Katz J. Experimentation with Human Beings. The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process, New York: Russell Sage Foundation, 1972) are regularly included articles by moral theologians, as well directives on research from Catholic health care institutions and also magisterial pronouncements, particularly of the Pope Pius XII.
[11] Callahan D., Religion and the Secularization of Bioethics, Hastings Center Report 1990;20(4 Suppl):2;4.
[12] National Commission for the Protection of Research Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Washington, D.C.: Government Printing Office, 1979
[13] As Veatch affirms, “autonomy stands between us and a moral abyss”. Veatch R. M., From Nuremberg through the 1990s: The Priority of Autonomy. In: Vanderpool H. Y., The Ethics of Research Involving Human Subjects. Facing the 21th Century. Frederick, MD: University Publishing Group, 1996: 44-58.
[14] Faden y Beauchamp, in dealing with the historical evolution of the requirements of consent in the field of biomedical research, declared that their main purpose is to show how consent emerges and matures in the United States. They affirm furthermore that, in contrast with what happened in the richer field of common clinical care, in the research ethics context and before the World War II very few interesting facts occurred moral. Scientific rigorous research on humans took place in the States only after the War, and moral criticism on biomedical research began to arise there in the mid-1960s: Faden R.R., Beauchamp T.L., A History and Theory of Informed Consent. New York: Oxford University Press, 1986:150-151.
[15] Faden R.R., Beauchamp T.L., o. c.: 274-297.
[16] Beauchamp T.L., McCullough L.B. Medical Ethics: The Moral Responsibilities of Physicians. Englewood Cliffs, N.J.: Prentice Hall, 1984.
[17] Caplan A. L., A History and Theory of Informed Consent, by Ruth R. Faden and Tom L. Beauchamp. Book Review. JAMA 1987;257:386-387.
[18] Caplan’s reaffirmation of the American exclussive citizienship of the substantive -and nor merely formalistic- understanding of the rationale for informed consent reaches a exultant tone when he speaks of the “total befuddlement exuded by Europeans, Asians, Middle Easteners, and South Americans at our seeming obsession with autonomy”, a feature unnoticed and unremarked by Faden and Beauchamp. Caplan A.L., A History and Theory of Informed Consent, by Ruth R. Faden and Tom L. Beauchamp (Book review). Journal of the American Medical Association 1987;257:386-387.
[19] Caplan, o. c.: 387.
[20] Faden R.R., Beauchamp T.L., A History and Theory …: 55.
[21] It has been a frequent object of complaint the attitude of some American bioethicists, who for justify their claim to the title of founders of modern medical ethics tend to ignore the contributions, old and new, of authors belonging to other areas and times. The annoyance some Europeans feel is sincere and, in my view, partly justified. Serres wrote rhetorically some years ago: “Novelties are frequently made of things we have forgotten. We import, at great expense in translations, books on ethics made of crumbled plastic, and, at the same time, we fail to remember that our European tradition has been carving ethics along two millennia on granite and gold”. Serres M., Préface, in Testard J., L’Œuf Transparent, Paris: Flammarion, 1986:11-12.
[22] Soane B., Consent and Practice in the Catholic Tradition, in Dunstan G.R., Seller M.J., Consent in Medicine. Convergence and Divergence in Tradition, London: King Edward’s Hospital Fund, 1983:37- 44.
[23] It is surprising to check that neither in France nor in other countries has no investigation been made on the 19th century French authors of books on medical morals and deontology. None reference has been found in the articles and books devoted to the history of the ebmr in France to the contributions of Surbled and Simon, the two authors who are studied next. See, for example: Ambroselli, C. L’Éthique Médicale, 2nd ed, Paris: Presses Universitaires de France, 1988. Fagot Largeault A., L’Homme Bio-éthique. Pour une Déontologie de la Recherche sur le Vivant, Paris: Maloine, 1985. Hoerni, B. L’Autonomie en Médecine. Nouvelles Relations entre les Personnes Malades et les Personnes Soignantes. Paris: Payot, 1991. Moulin, A.-M., Medical Science and Ethics before 1947, in Tröhler U., Reiter-Theil, S., Herych, E. eds. Ethics Codes in Medicine. Foundations and Achievements of Codification since 1947. Aldershot: Ashgate, 1998. Moulin, A.-M., Medical Ethics in France, Theoret Med1989,9:271-285.
[24] This proclamation of the human rights of the patient in the special circumstances of being the subject of an experiment, is taken from the 1905 edition of: Surbled G., La Morale dans ses Rapports Avec la Médecine et l’ Hygiène, Paris: V. Retaux et fils, 1905, Vol. 3 : 216-217. It has not been possible at this time to obtain the previous editions of this work, particularly the first of 1981. The transcribed Surbled’s words precede in almost a decade the so frequently quoted of Judge B. Cardozo, where the famous clause is contained: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable to damages”. Schloendorf v. Society of New York Hospitals (1914), as appears in Katz J., ed., Experimentation…: 526.
[25] Faden R. R., Beauchamp T. L., o. c.: 241-262.
[26] Full of wittiness and religious belief is the advice of Witts to the researcher: “[…] there is no stock formula which the physician engaged in therapeutic trials can use to guide his actions. Instead, he must have a tender conscience and be prepared to justify all his actions before his Maker. He should also be ready to defend them at an earlier date in the law courts”. Witts L.J., The Ethics of Controlled Clinical Trials, in Hill A.B., ed., Controlled Clinical Trials, Oxford: Blackwell Scientific Publications, 1960:13.
[27] On the Christian view on the mastering of man of his life and his body, from a personalist standpoint, see: Sgreccia E., Manuale di Bioetica. I. Fondamenti ed Etica Biomedica, 2ª ed, Roma: Vita e Pensiero, 1994:153-199. Of much interest are also the ideas on prudential personalism in: Ashley B.M., O’Rourke K.D., Health Care Ethics. A Theological Analysis, 4th ed., Washington, D.C.: Georgetown University Press, 1997:166-169.
[28] On the deep human and Christian value of the attitude of intelligent and faithful acceptance of God’s will, as manifested by divine revelation and specified by the Church Magisterium, see: Smith J.E., The Introduction to the Vatican Instruction, en McCarthy D.G., ed., Reproductive Technologies, Marriage and the Church, Braintree, Mass: The Pope John Center, 1988:13-28.
[29] Payen G., Deontología médica según el Derecho Natural, Deberes de Estado y Derechos Profesionales, Barcelona: Sucesores de Juan Gili, 1944:164-183.
[30] Bon H., Compendio de Medicina Católica, Madrid: Ediciones Fax, 1942: 480. (French original: Bon H., Précis de Médecine Catholique, Paris: Félix Alcan, 1936).
[31] Simon M., Déontologie Médicale ou des Devoirs et des Droits des Médecins dans l’Etat Actuel de la Civilisation, Paris: J.B. Baillière, 1845:335.
[32] Simon M., o. c., 337.
[33] Simon M., o. c., 334.
[34] The discourse to the First International Congress on the Histopathology of the Nervous System, September 14, 1952, on the ethical limits of human experiments and medical interventions was published in the Acta Apostolicae Sedis (AAS 1952;44:779;789). It was also reproduced and commented upon by many medical journals. An English translation can be found in Linacre Quart 1952;19:98-107, and also, an almost complete version, in Ladimer I., Newman RW., o. c.: 276-286. Some select fragments appear in Katz J. Experimentation with Human Beings: 731-733 y 549-551. The discourse is object of a detailed review in Beecher H.K., o. c.: 189-200. More or less extensive comments are included in the President’s Advisory Committee, Final Report, The Human Radiation Experiments, New York: Oxford University Press, 1996: 88; Ford J., Human Experimentation in Medicine: Moral Aspects. Clin Pharmacol Therap 1960;1:396-400; Jonsen A.R., O. c.: 149; O’Donnell T.J., Medicine and Christian Morality, New York: Alba House, 1976:91-93. And in: Vallery-Radot, j., Lenègre, J., Milliez, P., Étude des conditions Morales d’Exploration Clinique en Médecine. I Congrès International de Moral Médicale, Vol. 1, Rapports. Paris: Ordre National des Médecins, 1955: 123.
[35] Giuseppe B.M., De Senarclens, J., Groen J. J., Human Experimentation. A World Problem from the Standpoint of Spiritual Leaders. World Med J 1960; 7:80-83, 96. The three contributions are reproduced in Ladimer I., Newman R.W., O. c. : 267-270.
[36] Schaupp W., Der etische Gehalt der Helsinki Deklaration. Eine historisch-systematische Untersuchung der Richtlinien des Weltärztebunds über biomedizinische Forschung am Menschen. Frankfurt am Main: Peter Lang, 1993:243-245.
[37] Jonas H., Philosophical Reflections on Experimenting with Human Subjects, en Shannon T.A., ed., Bioethics, 3rd ed, Mahwah, New Jersey: Paulist Press, 1987:253-279. Of particular interest in this connection are the sections examining the polarity of individual versus society, between private and public welfare, on one side, and, on the other, the suggestive analysis of the contrasting components of sacrifice and social contract implied in human experimentation.