material-codigo-nuremberg

Was the Nuremberg Code too demanding? The history of a forgetfulness

Gonzalo Herranz, department of Bioethics, University of Navarra.
lecture Delivered at congress in Lecce, 1997.

Index

Introduction

1. Forgetting the Nuremberg Code

2. Selective Incorporation of the Nuremberg Doctrine

Epilogue

Bibliography

Introduction 

In bioethics, 1997 was the year of the fiftieth anniversary of the Nuremberg Code. The memory of the American Military Tribunal's judgement against Nazi doctors and medical doctors for their crimes against humanity and medicine has prompted many congresses and symposia, in which tribute has been paid to the profound ethical and human values of the Nuremberg Code and its role in inspiring the ethics of biomedical experimentation.

This year's celebrations have undoubtedly helped to consolidate as an indisputable fact that the Nuremberg Code possesses an incomparable historical greatness. It has received extraordinary praise: that it was the inaugural moment of contemporary medical ethics; that, thanks to it, society's awareness of the ethical problems of biomedical research was awakened; that it is the most important document in the history of the ethics of medical research 1; that it was the primum movens in the process that led to the protection of the rights of the person subjected to experimentation2. Finally, it has been said that Nuremberg is epoch-making: that, in Bioethics and Biolegal Ethics, there is a before and an after Nuremberg. And there is still a future, because there are, in Nuremberg, moral lessons that have not yet been learnt and will have to be learnt3.

There is, in all this, a profound truth, but also some laudatory exaggeration. The Nuremberg Code is a unique document, but its effect was delayed. It has only been openly accepted after many years. Its fate has been biphasic: for almost three decades, it remained in the obscurity of oblivion; in the last two, it has been recovered and placed in a place of honour.

Thus, it can only conditionally be said that, in medical ethics, there is a before and an after Nuremberg. But 1947 does not mark the dividing line between two epochs. A seed was sown then, but it took a long time for it to grow and become visible. It was only in the mid-1970s that the ethics derived from Nuremberg began to play an important role in the internship of biomedical experimentation. Even today, the Code is still partly ignored: its most demanding injunctions seem to fall into the blind spot in the retina of its exegetes: parts of the Code are still deliberately forgotten.

In this speech I will try to show two propositions. The first is this: between 1947 and 1975, the biomedical establishment chose to ignore, or forget, the Nuremberg Code: in those years, the Code was almost totally eclipsed. The second argues that, after 1975, the codes and declarations on the ethics of biomedical research only selectively incorporated the concepts of the Nuremberg Code: its most demanding imperatives were left aside. A part of the data used in this grade has been published recently4.

1. Forgetting the Nuremberg Code 

From the time of the verdict against the Nazi doctors and from the time of its promulgation in August 1948 onwards, there was almost total silence.

The immediate. In the medical field, the Nuremberg Code did not make the news. It went unnoticed. I have not researched the general press at the time, nor the minor medical journals. But a review of the major medical journals, the kind that tend to create the dominant opinion in medicine, suggests that Nuremberg did not arouse interest. The one exception is the Journal of the American Medical Association, the official journal of the American Medical Association association . At a time when war medicine continues to occupy a very important place in its pages, the judgement against the Nazi doctors does not appear until 29 November 1947 in the extremely humble form of a letter from the journal's Berlin correspondent on the Nuremberg Trial of German doctors, which includes a very abbreviated version of the ten clauses of the Code5.

How to explain this collective insensitivity to the Nuremberg standards? The topic has only recently been studied in preparation and celebration of the fiftieth anniversary of Nuremberg. The tone of the time was dominated by a general optimism in the beneficent power of science, by the conviction that research was the fairy godmother of well-being. Just as the war against the Axis powers had just been won thanks to science, so the war against disease and poverty would be won thanks to science. The scientist was regarded as a beneficent and benign magician. Nazi and Japanese atrocities were unthinkable in the clean atmosphere of democratic countries. Free citizens cannot be taken as human guinea pigs. And yet we are now beginning to gather evidence that those were times of harsh paternalism. As Levine has noted: "I am convinced that no researcher (myself included) who worked on human research before 1965 can recall anyone obtaining 'voluntary' informed consent under the Nuremberg rules "6. In the United States, research by committee advisor on Irradiation Experiments has shown that until well into the 1960s, the Nuremberg Code lacked influence among leading researchers in the United States7 .

History of a denied marginalisation. The Nuremberg Code did not therefore seem to be of much relevance to doctors in free countries. The association World Medical Association, created in 1947, has been made the great mediator of the implementation of Nuremberg in the world of medicine, but there is only very insufficient evidence to support this: unfortunately, the WMA has been terribly careless in the file of its documentation. In 1949, in the first issue of its official publication, it condemns the crimes of the Nazi physicians and applauds their judicial punishment, and recommends that physicians pledge the Declaration of Geneva to avoid falling into such deplorable situations8 . But that was all.

The notion, proposal by some9 , that the Nuremberg Code had a profound and precocious influence on the two great founding documents of the WMA, the Declaration of Geneva of 1948 and the International Code of Medical Ethics (London Code) of 1949, is, in my opinion, more a matter of wishful thinking than reality, the result of a biased interpretation. Only one clause of the latter ( procedure which may weaken the physical or mental resistance of a human being is prohibited, unless it must be employee for the benefit and in the interest of the individual) could be attributed a distant affinity with the Nuremberg Code. But this clause of the London Code refers exclusively to the ordinary therapeutic relationship of the physician with his patient. It was not until 1956, in its Rules for Time of Armed Conflict, that the WMA incorporated material from Nuremberg into one of its declarations for the first time. Paragraph 3 states: "Experimentation on human beings is subject in time of war to the same rules as in time of peace; it is formally forbidden to experiment on persons who do not have full freedom, in particular, on civilian or military prisoners and on the populations of occupied countries.

Schaupp11 has researched the history of the echo obtained by the Nuremberg Code on bibliography medical immediately afterwards. He claims, without offering evidence, that "of the papers published up to 1964 on human experimentation that he has been able to research, one third quotation to the Nuremberg Code". But in his study, Schaupp deals with only average dozen articles. He includes among them the known as report Green12, whose genesis is not free from ethical reproach13. The same can be deduced from a review of the bibliography appended to Ladimer and Newman's basic work14.

Beecher's15 assertion that the ten points of the Nuremberg Code had become a kind of credo of Western medicine as early as 1959 does not seem to have much foundation. This voluntarist assertion is contradicted by what was going on in hospitals at the time and which Beecher16 and Pappworth17 denounced years later: the widespread internship of experimentation disrespectful of human rights. And this despite the fact that in the United States there were already state and association American Medical subject18 regulations in place.

Even when, in 1964, the association World Medical Association published its first Declaration of Helsinki, a article publishing house of the BMJ commented: "During the last war, German doctors carried out experiments in concentration camps and on prisoners which shocked the conscience of the world when their nature and extent were revealed at the Nuremberg Trial. This led the Tribunal to draw up a ten-point code to serve as guide for those who carry out research on human beings. [...] There are many who doubt that it is necessary, or even desirable, to promulgate codes of ethics to regulate human experimentation, believing that the conscience of the physician or the maxims of subject do not do to others what you would not want done to you or members of your family, are far more effective [than codes of ethics]".

Codes of medical ethics and deontology. It is logical that, in this environment, medical corporations showed a passive or lazy attitude towards Nuremberg. Its standards made their way very slowly into professional codes of ethics. Some organisations at research were the first to accept them.

I have recently studied the chronology and intensity with which the ten clauses of the Nuremberg Code were received in the codes of medical ethics and deontology of Western European and Latin American medical orders and national medical associations. My conclusion is that it was only through the influential association World Medical Association and its second version of the Declaration of Helsinki, published in 1975, that the Nuremberg message entered the codes of medical ethics and deontology. In fact, the Nuremberg Code, in the decade following its promulgation, had no real influence on medical codes of ethics, both in the field of professional internship and in the field of research, is an interpretation based on a shaky foundation.

Before 1975, the codes followed one of two paths: either they remained silent on the ethics of human experimentation, or they limited themselves to saying a few unimportant words about it. From this general indolence, one must first of all exclude Brazil, whose association Médica included the doctrine of free and informed consent to experimentation in the Code of Ethics of January 1953, which became law in 1957. It was followed by the Swiss cantonal medical associations which, in December 1970, had adopted the modern and detailed guidelines of the Swiss Academy of Medical Sciences, and also in 1970, by the medical associations of Costa Rica and Peru, followed in 1971 by Venezuela.

It was not until 1975, and the second version of the Declaration of Helsinki, that the Nuremberg doctrine was widely and thoroughly implemented in the rules and regulations of medical corporations. The new codes of medical ethics and deontology devote more or less extensive chapters to topic and often refer reference letter to the Declaration of Helsinki: Belgium did so in 1975, as did the Nordic countries, which expressed their adherence to the Declaration of Helsinki II, drafted by Scandinavian doctors. Italy followed in 1978, Spain and France in 1979, Ireland in 1984, Portugal in 1985, as did Germany. The Eastern European countries have only been doing so since 1991. The Nuremberg message has hardly entered the professional ethics of some Latin American countries: the codes of ethics of Argentina, Bolivia, Colombia and Guatemala do not pay any attention to topic.

2. Selective Incorporation of the Nuremberg Doctrine 

Although belatedly, most of the Nuremberg doctrine was transferred into professional standards. And, although the relevant documentation has not been published, it seems clear that such a transfer was mediated by the second version of the Declaration of Helsinki.

The basic criterion of free consent of the subject has found universal acceptance. Other standards, such as prior experimentation on animals, the duty to avoid or reduce risks or harm to subjects, the appropriate and favourable ratio of calculated benefits and risks, and the requirement of scientific skill of researchers, have been very widely accepted. The other points of Nuremberg have gained more limited acceptance, especially the strange final part of clause 5, which prohibits the internship of experiments suspected of causing the death or disability of the experimental subject, unless the experimenting physicians also serve as experimental subjects.

But there are two clauses that have received little attention: not only do they not appear in any of the national medical associations' codes of ethics, but they have not received the attention of the Code's commentators. I think the reason for this is that these are two mandates that require a very high level of integrity and understanding of free and informed consent Degree . Katz has argued that the Code's doctrine would not prosper, given the enormous difficulty of its application internship, given the lofty ethical ideals of the Code19.

It has even happened that, in many quotations or transcriptions, more or less complete, of the Nuremberg Code, these two clauses have been omitted.20 21 They are the second paragraph of point 1 and the final sentence of point 9.

With regard to the first. The first states: "The duty and responsibility to assess the quality of consent rests with each individual who initiates, conducts or participates in the experiment. It is a duty staff and a responsibility that cannot be delegated to another with impunity". The message is clear: each and every member of the researcher team is said to be indivisibly manager responsible for the most fundamental aspect of the ethics of the experiment, that the quality of consent cannot be left to the judgement of any one individual, but is equally and non-delegatably the responsibility of all others. All must be unbribable evaluators of the quality of consent. None of those who experience, whatever their position in the whole, can abdicate this responsibility. Just as the Nuremberg Trial rejected as an ethical or legal justification the claim that the accused was merely carrying out orders from his superior, so there are no beings without conscience or responsibility in the team researcher . Obtaining consent is not a routine, but a moral decision shared between subject and experimenter, whose authenticity the experimenter guarantees.

As we all know, the Declaration of Helsinki opted, in contrast to Nuremberg, for a minimalist concept of the ethical stature of the experimenter. None of them can be trusted any more, as abuses have continued to occur, and very few meet the high standards of rule of Nuremberg. To remedy this, an independent committee has been mandatory since 1975, not only to assess the ethics of the experimental protocol but also to supervise its implementation.

Undoubtedly, the rigid hierarchical structure of many research teams, then and now, is incompatible with this equal participation of all in the ethical responsibility of the common work . There are still many reforms to be made in the structure and functioning of research groups in order to achieve the coexistence of the scientific leadership of some and the essential equality of all as moral agents.

With regard to the second. It reads: "During the course of the experiment, the human subject shall be free to terminate the experiment and has reached such a point status, physical or mental, that the continuation of the experiment seems to him impossible". The human subject is told that his or her consent is not a triviality, but a serious commitment that cannot be freely withheld. The Code takes the subject and his commitment seriously. It logically retains his freedom: he can leave the experiment, but his freedom is manager. He cannot end his participation if there is no serious reason to do so. When he reaches a status, physical or mental, where he judges that he should not continue, he must leave.

Helsinki also opted for a minimalist concept of the ethical quality of the subject: he made of him a being with little manager, who can abandon the experiment, and for that matter fulfil the protocol, according to his whim.

I have written elsewhere that there are two types of consent. The subject Nuremberg and the subject Helsinki. Nuremberg consent is serious, committed, binding subject and experimenter in a common business bond of loyalty. It is revocable for just cause, assessed by the subject's own conscience. On the other hand, the Helsinki consent lacks binding force: it is always a decision provisional, fragile, which can be retracted at any time.

Undoubtedly, Nuremberg presupposes in the subject a robust capacity to understand and cooperate. Beecher was of the opinion that there are no subjects of this ethical quality in the real world22. Perhaps the freedom and responsibility of the subjects could be enhanced if they were adequately informed of the consequences of their conduct for the scientific quality and the economic cost of the experiment they are invited to perform23 . Probably, this information could serve for a better selection of subjects and to decrease the rate of withdrawal or non-compliance. I have recently proposed to the Secretary of the World Medical Association association that the information to be provided to potential subjects of medical experiments should include information on the consequences that unjustified withdrawal or inadequate compliance with the experimental protocol would have for the scientific value and economic cost of the research. In this way, the decision to accept or refuse the invitation would become much more manager because it would be freer and more conscious.

Epilogue 

I would like, in conclusion, to add two very brief thoughts. The first is this: the ethical heritage of the Nuremberg Code is still not exhausted, the ethical doctrine of the code can enrich the souls of researchers and subjects alike. For this it is necessary to consider it primarily as an ethical document, and not as a mere legal document, of dubious legitimacy and "plastic" content, susceptible to minimalist interpretation.

The second idea is this: moral progress in medicine is necessarily linked to the humility of recognising that there is no place for ethical exemption . Nazi doctors were convicted by an American military tribunal; but it was American military personnel, who believed themselves to be unaffected by the Nuremberg rules, who most recalcitrantly broke the rules they themselves had promulgated. It was precisely doctors appointed by the national medical associations who acted as experts and advisors to the Nuremberg Tribunal; but it was the national medical associations who incredibly delayed the implementation of the Code's standards. The point is relevant. This year 1997 saw the promulgation of bioethical documents which, although imperfect, are destined to achieve great resonance: the Bioethics Convention of committee of Europe and the UNESCO Universal Declaration on the Human Genome and Human Rights. What fate awaits them: cautious but immediate implementation at internship or withdrawal and procrastination?

For this too, the Nuremberg Code is a lesson.

Bibliography 

(1) Shuster E. Fifty years later: The significance of the Nuremberg Code. N Engl J Med 1997;337:1436-1440.

(2) Grodin MA, Annas GJ. Legacies of Nuremberg. Medical Ethics and Human Rights. JAMA 1996;276:1682-1683.

(3) Pellegrino DE. The Nazi doctors and Nuremberg: Some moral lessons revisited. Ann Intern Med 1997;127:307-308.

(4) Herranz G. Der Eingang der zehn Nürnberger Postulate in berufsständische Ethik-Kodices. Ein internationaler Vergleich. In: Tröhler U, Reiter-Thiel S. Ethik und Nedizin 1947-1997. Was leistet die Kodifizierung von Ethik? Göttingen: Wallstein. 1997:171-187.

(5) Anonymous. The Nuremberg Trial Against German Physicians. JAMA 1947;135:866-867. Foreign Letters, From our Regular Correspondent, Berlin.

(6) Levine RJ. International codes and guidelines for research ethics: a critical appraisal. In: Vanderpool HY, ed. The ethics of research with human subjects: Facing the 21st century. Frederick, Md: University Publishing Group, 1996:235-59.

(7) Advisory Committee on Human Radiation Experiments. Research ethics and the medical profession: Report of the Advisory Committee on Human Radiation Experiments. New York: Oxford University Press; 1996.

(8) Anonymous. The dedication of the physician. World Med Ass Bull 1949;1:4-13.

(9) Perley S, Fluss SS, Bankowsky Z, Simon F. The Nuremberg Code: An international overview. In: Annas GJ, Grodin MA. The Nazi doctors and the Nuremberg Code. Human rights and human experimentation. New York; Oxford University Press. 1992: 149-173.

(10) World Medical Association. Handbook of Declarations. Ferney-Voltaire, The Association. 1995.

(11) Schaupp A. Der ethische Gehalt der Helsinki Deklaration. Eine historisch-systematische Untersuchung der Richtlinien des Weltärztebunds über biomedizinische Forschung am Menschen. Frank-furt a.M.; Peter Lang. 1994:58-60.

(12) Anonymous. Ethics governing the service of prisoners as subjects in medical experiments: report of a committee appointed by Governor Dwight H. Green of Illinois. JAMA 1948;135:457-458.

(13) Harkness JM. Nuremberg and the issue of wartime experiments on US prisoners. JAMA 1996;276:1672-1675.

(14) Ladimer I, Newman RW, eds. Clinical investigation in medicine: Legal, ethical and moral aspects. An anthology and bibliography. Boston: Boston University Law-Medicine Research Institute, 1963: 493-516.

(15) Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-1360.

(16) Beecher HK. Research and the Individual. Human Studies. Boston; Little, Brown and Co., 1970: 227-234 and 278-279.

(17) Pappworth MH. Human guinea pigs: experimentation in man. London: Routledge, 1967.

(18) Levine RJ. Ethics and Regulation of Clinical Research. New Haven: Yale University Press, 1988:480.

(19) Katz J. The consent principle of the Nuremberg Code: Its significance then and now. In: Annas GJ, Grodin MA. The Nazi Doctors and the Nuremberg Code. Human rights and human experimentation. New York; Oxford University Press. 1992:227-228.

(20) Fargot-Largeault A. L'Homme bio-éthique. Pour une déontologie de la recherche sur le vivant. Paris; Maloine, 1985:154.

(21) J. The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA 1996;276:1662-1666.

(22) Beecher HK. Experimentation in Man. JAMA 1959;169:461-468.

(23) Herranz G. The retraction by the research subject of his or her free and informed consent: an historical-ethical explanation. International Bioethics Committee of UNESCO Proceedings, 1996.

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