material-normes-ethiques

Ethical standards after Nuremberg

Gonzalo Herranz, department de Bioética, University of Navarra.
Freiburg, 1996.

Index

Introduction

Material and Method

Results and Comments

A. Chronology of the reception of the Nuremberg Code into the professional codes

B. The Mediation of the Helsinki Declaration in the selective incorporation of the Nuremberg Code doctrine

a. Ce qui a été accepté à travers Helsinki

b. What has not been accepted from the Nuremberg Code

Résumé

Notes et bibliographie

Introduction 

I have been asked to provide you with a description of the way in which the Nuremberg Code influenced post-1947 ethical and professional standards in European countries, with the exception of the United Kingdom, and in Latin America. I have not been able to gather all the material that would have been necessary for a complete study. Also, the data and comments that follow, while representative, are only provisional. It seems to me, however, that it is not wrong to propose a conclusion: the influence of the Nuremberg Code on medical ethics codes has been late and partial.

Firstly, belatedly. From 1947 to 1975, the Nuremberg Code was practically ignored by national and international medical organisations, including the World Medical Association (WMA).

It was in fact through Helsinki II that the Nuremberg doctrine was incorporated into the medical ethics codes. It is only recently, in the course of the last two decades, that the Nuremberg Code has been rediscovered and that it begins to be considered as the polar ethos of the ethics of biomedical research2.

Secondly, the acceptance of the contents of the Nuremberg Code has never been complete: in the professional field, the rules of ethics and medical ethics guides have placed on their side, like an inaccessible ideal, certain components of the Nuremberg Code, components which, in my opinion, are among the noblest ethical elements: l'affirmation que l'investigator aussi bien que le sujet doivent agir comme des agents moraux sincères, incorruptibles, engagés.

Material and Method 

After postal contact, repeated if necessary, with 40 national medical associations in Europe (22 countries) and Latin America (18 countries), I was able to collect and review a total of 74 professional codes or regulations on medical ethics published after 1947, from 17 countries in Europe and 15 countries in Latin America. Table 1 shows the countries and the year of publication of the Codes examined.

In order to detect and characterise the effect that the Nuremberg Code has had on subsequent ethical standards, I used a very simple heuristic instrument: a schematic list of the ten provisions of the Nuremberg Code that have been taken as markers or examples of its influence. To facilitate the analysis, it seems advisable to divide these markers into two groups. The first group contains those that have been incorporated, to a greater or lesser extent, into successive versions of the Helsinki Declaration and which, in general and through it, have been incorporated into the codes of ethics of Medical Orders, Chambers, Associations or Colleges.3 The second group contains those that have been incorporated, to a greater or lesser extent, into successive versions of the Helsinki Declaration and which, in general and through it, have been incorporated into the codes of ethics of Medical Orders, Chambers, Associations or Colleges3. The second group comprises two ethical criteria that have not been taken up by Helsinki and have, in fact, been abandoned by the entire post-Helsinki ethical normative4 . These two types of "markers" are presented in Table 2 (a and b).

Results and Comments 

A. Chronology of the reception of the Nuremberg Code into the professional codes 

Contrary to what is usually claimed, the Nuremberg Code has been ignored by medical associations for two decades. And it was almost at the same time that the WMA published its Helsinki Declaration I, which takes up the main points of Nuremberg. Its impact on medical ethics codes was very limited, if not negligible. We had to wait until 1975 to see the Nuremberg doctrine fully re-examined.

In fact, the pre-1975 codes concern the ethical treatment of human experimentation, to which they pay rudimentary attention. In the Codes of the time, it is not rare to find rules of the following tenor: "The doctor - as stated in the Code of Ethics published in 1950 by the Higher Council of the Belgian Order of Physicians - must avoid any unfounded treatment, as well as any fearful experimentation, and refrain from any medical act by which he could be harmed. Il lui est interdit de provoquer des maladies ou des états morbides sauf -dans le seul but d'observation scientifique- consentement formel du sujet dûment averti des risques auxquels il s'expose". On the other side of the Atlantic, the Code de Morale Médicale (1954) of the Fédération Médicale Colombienne prescribes: "The doctor must have great respect for the human person and, for this reason, he will prudently avoid [....] all irréfléchie experimentation, [...] and all acts that may affect the independence of the will or the freedom of a person of sound mind [...]. Il est défendu de favoriser, chez l'être humain, l'apparition de maladies ou de les prolonger, pas même à des fins de recherche scientifique".

However, it is very rare to find in the Latin American Codes the authorisation to apply, in circumstances of exceptional gravity, an experimental procedure that seems to be the only possibility of shortening the life of the patient, with the patient's prior consent and the favourable agreement of three confreres called in consultation.

Before 1975, only Switzerland, in Europe, and Brazil, Costa Rica, Peru and Venezuela, in Latin America, were close to Helsinki I. The first, using the Directives for Experimental Research on Human Beings, promulgated by the Swiss Academy of Medical Sciences on 1 December 1970, was the first to adopt Helsinki I. The first, using the Directives for Experimental Human Research, promulgated by the Swiss Academy of Medical Sciences on 1 December 1970, offers a regulation that not only transmits the contents of Helsinki I, but also enriches them with elements taken from the Nuremberg Code, which Helsinki had adopted on its side. The Directives have since been appended to the Codes of Ethics of the Swiss Medical Federation and the Cantonal Medical Societies: they all state that scientific research on the human person is regulated by the corresponding directives of the Swiss Academy of Medical Sciences.

On 30 January 1953, the Medical Association of Brazil adopted a Code of Ethics, officially recognised a few years later by Law No. 3268 of 30 September 1957. Its article 57 introduces in a professional code for the first time, albeit in a very simple way, the doctrine of free and informed consent to experimentation on man: "Even if they are consensual, experiments in anima nobili with speculative proposals are punishable. They may be tolerated for strictly therapeutic or diagnostic purposes, in the interest of the patient himself and if they do not imply for the subject the loss of his life or serious harm. Dans tel cas, on doit procéder à obtenir le consentement préalable, spontané et exprès du patient s'il jouit de l'usage des facultés mentales et est parfaitement informé des conséquences possibles de l'expérience".

On 12 March 1970, the Medical College of Peru inserted the full text of Helsinki I in Article 94 of its Code of Ethics and Deontology. On 18 August 1970, the National Medical Union of Costa Rica regulated experimentation on humans in three chapters of its Code of Medical Ethics entitled respectively: Experimentation involving a risk to the patient, Experimentation with new drugs, and Research on humans to solve problems of knowledge not relevant to therapeutics. On the other hand, the National Medical Union of Venezuela has enshrined in its Code of Medical Ethics of 23 January 1971 standards that are largely modelled on Helsinki I.

From 1975 onwards, the process of incorporating standards on human experimentation into the Codes has accelerated in Europe5. The Code of Medical Ethics, published the same year by the National Council of the Belgian Order of Physicians, contains a modern and fairly complete regulation of the subject, clearly inspired by Helsinki II. The Ordre des Médecins d'Italie regulated clinical experimentation in 1978, giving it a whole chapter of its New Code of Ethics, while in Spain it was not until 1979 that the same thing was found. In 1979, too, a new Code of Ethics was published in France and for the first time, but very briefly, the subject was mentioned.

In Ireland, codified ethical regulation is entrusted to the Medical Council by the Medical Practitioners Act 1978. In the first edition of its Guide to Ethical Conduct and Behaviour, published in 1981, there is no mention of the ethics of human experimentation. Pour qu'elle apparaisse, il faut attendre la seconde édition, celle de 1984, qui, de même que les deux suivantes, celles de 1989 et 1994, incloue un paragraphe sur l'Investigation sur l'homme, et insère comme appendice le texte de Helsinki II.

The Ordre des Médecins du Portugal has dedicated a chapter of its 1985 Code of Ethics to human experimentation, which transmits a large part of the Helsinki II doctrine.

The case of Germany is striking. It is only since 1985 that the German Ärztekammer has made a clear and systematic reference in its Berufsordnung to human experimentation and imposes the obligation to consult an ethics commission and to follow the directives of the Helsinki Declaration I and II (Berufsordnung 1985), d'Helsinki I, II et III (Berufsordnung 1988) et d'Helsinki I, II, III et IV (Berufsordnung 1993). The introduction of this standard was prompted by the need to include ethical criteria in experimentation on the human embryo6.

The Codes of the medical associations of the Nordic countries are not very explicit on the ethics of biomedical research. I was told personally that since 1964 the Helsinki Declaration has been the commonly accepted ethical guide for Scandinavian medical associations, and that research ethics committees have been in operation since then. The Icelandic Code of Medical Ethics of 1992 states, for example, that "The doctor must always take into account, in his research on human beings, the well-being of each of his patients or volunteers. Il doit, dans tous les cas, appliquer la Déclaration d'Helsinki avec ses amendements postérieurs". The Code of Medical Ethics of the Finnish Medical Association (1988) and its Medical Ethics Manual (1994) are based on Helsinki III and IV, presented from the point of view of a strong and comprehensive development of patients' rights. In the Handbook, the Nuremberg Code takes pride of place between the Hippocratic Constitution and the United Nations Universal Declaration of Human Rights...

The Code of Medical Ethics of the Ordre National des Médecins de la Pologne (December 1991) devotes Chapter II to the treatment of scientific research and medical experimentation. The regulation is very broad and full of nuances (10 articles), and conforms to the standards of the Helsinki Declaration IV. It also includes rules on the ethics of biomedical publication. In contrast, the 1993 Code of Medical Ethics offers a comparatively simpler regulation.

The treatment of human experimentation standards in Latin American countries presents a very irregular set of rules. On the one hand, they have been ignored in some countries until today. C'est ainsi que, par exemple, jusqu'à présent, en Argentine, le Code d'Éthique de la Confédération Médicale de 1964, encore en vigueur, ne fait aucune mention à l'éthique de l'expérimentation médicale sur les êtres humains. Cuba's Principles of Medical Ethics, published in 1983, limit themselves to stating that doctors must avoid causing harm to healthy or sick people in the research work they carry out. The message of the Nuremberg Code has found little echo in the medical ethics codes of some countries, such as Bolivia (1986), Colombia (1981) and Guatemala (1984 and 1993). This video, if any, of professional deontological regulation is frequently referred to in the legislation on the subject.

The Nuremberg message has now met with early adherence in Latin America. Such is the case of Brazil, which overtook all other countries with its 1953 Code of Ethics of the Brazilian Medical Association, some five and a half years after the sentence of the American Military Tribunal. The Code of Ethics and Deontology of the Medical College of Peru, adopted in 1970, incorporated the full text of Helsinki I in its Article 94. Since the 1970 Code is still in force (the renewal of the Codes is generally very slow in Latin America), subsequent versions of the Declaration have not yet been able to enter into the Peruvian Code.

In Costa Rica, the 1970 Code of Medical Ethics of the Federation of Doctors is a surprise of modernity and an anticipation of the figure of the ethics committees of the Helsinki II Declaration: non seulement qu'il accueille pleinement Helsinki I, sinoon qu'il impose l'évaluation de la compétence de l'investigator par un organme jurisdictionnel indépendant et il exige que toute investigation sur les malades mentaux soit préalablement approuvée par une Commission Scientifique nommée à cet effet. Il établit, en outre, des garanties pour la protection de la santé et pour compenser les dommages éventuels causés sur les sujets. The 1981 Code establishes in Article 5 that "the physician shall observe the ethical principles of the Geneva and Helsinki Declarations adopted by the World Medical Association (...). The text of these Declarations is appended to the Code.

Chile also includes in its Code of Ethics (1986) the essence of the Helsinki III conditions and includes, among the documents accompanying the Code, not only this Declaration, but also the full text of the Nuremberg Code.

B. The Mediation of the Helsinki Declaration in the selective incorporation of the Nuremberg Code doctrine 

Jay Katz is among the rare authors who claim that the doctrine of the Nuremberg Code had no chance of continuity, given the enormous difficulty of its practical application. For Katz, the high ethical requirement of the first clause implied the inevitable and immediate detriment of the Code from its prominent position. He affirms that the Nuremberg Code was handed down to history at the very moment of its birth7.

However, it is universally accepted, despite the considerable lack of documentation on the subject, that the Helsinki Declaration was the vehicle that transported the Nuremberg doctrine to the codes of national medical associations. There is no need for a detailed analysis to verify that the codes of the national medical associations are indeed inspired by, or are based on or transcribed, in whole or in part, from the different versions of Helsinki and that Helsinki has copied many points of the Nuremberg Code8.

a. Ce qui a été accepté à travers Helsinki 

If we use the above-mentioned heuristic instrument to compare the Codes which explicitly transcribe the ethical criteria of Nuremberg, we obtain the results shown in Table 3. These data show a very variable response, both in terms of the different countries and the contents of the Code.

The Swiss Academy of Medical Sciences has incorporated in its Directives all accepted criteria, while other countries (Ireland, Luxembourg, Brazil, Chile, Colombia or Guatemala) include only two or three.

The criterion of free consent of the subject has found universal acceptance. Other criteria are widely accepted: la condition de l'expérimentation préalable sur l'animal (critère c, 11 pays), l'obligation d'éviter ou de minimiser les dommages aux sujets (critères d et j, 9 et 10 pays, respectivement), le devoir d'atteindre un calcul favorable du quotient des bénéfices/risques (critère b, 9 pays) et, finalement, l'exigence de qualification scientifique des investigators (critère h, 10 pays). Other criteria have received only very limited support: this is the case of criterion g9.

However, many omissions are compensated by the fact that many codes (Germany, Denmark, Spain, Finland, Ireland, Iceland, Norway, Sweden, Switzerland, Chile, Colombia, Costa Rica, Peru, Uruguay) expressly establish that the successive versions of the Helsinki Declaration are the valid reference point for assessing the ethics of biomedical research in these countries. France, when it comes to it, establishes as an ethical guide to human experimentation what the law indicates in this respect. Il en est de même avec l'Autriche: la Chambre des Médecins Autrichiens n'a j'a jamais promulgué un Code d'Éthique médicale: en l'Autriche, l'expérimentation médicale est réglée par les dispositions de la loi des médecins, la loi du médicament, et la loi des établissements sanitaires. Nonetheless, the Austrian Chamber adheres to the doctrine of the Nuremberg Code and that of the Helsinki Declaration.

There are no ethical norms specifically designated for experimentation on human beings in the codes of Argentina, Bolivia, Cuba and Honduras.

b. What has not been accepted from the Nuremberg Code 

Two clauses of the Nuremberg Code, which place the investigators and the subjects on a plan of high moral exigency, have, in my opinion, been pénibly omitted.

L'une d'elles, contenue à la fin du point 1, fait retomber sur tous les membres, du plus haut au plus bas, de l'équipe des chercheurs (ceux qui initient, dirigent ou coopèrent à la réalisation de l'expérience) la responsabilité éthique - non juridique - non juridique, pénale ou civile - personnelle et indélégable, de s'asurer de la qualité éthique du consentement: le consentement du sujet n'est donc pas une simple formalité juridique ou administrative que l'investigur doit satisfaire par routine, mais une décision morale sérieuse dont il doit se faire garant de l'authenticité. To consent or not to consent is therefore not a decision that depends exclusively on the subject, but an ethical decision that seriously involves the investigator as a moral agent.

The second Nurembergian clause abandoned is the one formulated in point 9, which states that the commitment acquired by the subject is not something trivial that can be said for free. The subject, after Nuremberg, is a responsible moral being who, after having obtained sufficient understanding and knowledge of the full scope of the experience, and being able to measure the effect of his decision, gives his voluntary consent. It obviously retains, with its freedom, the right to end its participation in the experience. But, at the same time, he does not lose his responsibility, so that he only exercises this right, according to Nuremberg, "if he considers that he has reached the threshold of resistance, mental or physical, beyond which he cannot go".

The successive versions of Helsinki have not taken up these two ethical requirements, and they therefore no longer appear in the Codes.

La primera disparaît sans laisser de trace, s'étant transformée en avertissement occasionnel de ce que le consentement du sujet "donné de plein gré après tous les éclaircissements nécessaires, ne diminue en rien la responsabilité professionelle, civil ou pénale du directeur de la recherche "10.

The reality is that this aspect of the first Nuremberg clause was often abused. It goes without saying that Helsinki opted, in contrast to Nuremberg, for a minimalist conception of the moral size of the perpetrator. In Helsinki II, the WMA introduced the obligation to submit the human trials protocol to an independent committee specifically designed for this purpose, for advice and counselling, in order to provide a moral balance to the moral weaknesses of the perpetrators, if they were to be disregarded. Ainsi s'éteignit l'éteignit l'exigence de ce que l'investigator soit personnellement le garantant de l'authenticité éthique du consentement du sujet. Dès lors, ce sont les comités d'éthique d'investigation eux-mêmes qui se chargent de la surveillance du processus de consentement libre et bien renseigné du sujet. It could not be otherwise from the moment when the scandals denounced by Beecher11 and Pappworth12 had shown that it was not possible to rely on the moral integrity of the experimenters: these latter, after Helsinki, are inexcusably subject to external administrative and ethical controls.

En ce qui concerne la seconde, on y voit une trace à peine perceptible dans le Code de Déontologie Médicale du Vénézuéla, de 1971, quand il indique dans son article 115, alinéa b): Tout sujet doit avoir la faculté de pouvoir interrompre à un moment quelconque l'expérience en cours, lorsque la situation personnelle l'exige.

Helsinki opts for a minimalist conception of the moral size of the subject: in order to obtain his consent more easily, he has the door permanently left open so that he can leave the experience when he feels like it, without having to provide reasons or rationales. There is therefore a Nuremberg-type consent and a Helsinki-type consent. For Helsinki, in contrast to Nuremberg, the consent given by the subject does not in any way bind the subject to a serious commitment: it is always a provisional and fragile decision, not to say arbitrary and capricious. The subject's commitment can be released, withdrawn, at any time: he is free to return to his consent as he wishes. In my opinion, consent of the Nuremberg type implies the insertion of essential information on the consequences of the subject's abandonment of the experience. This information makes the consent more clear, free and rational than that of the Helsinki type. It favours a less responsible behaviour which is possibly at the origin of the abandonment of many subjects and which ends up invalidating or weakening the strength of a large number of clinical experiences.

Que je sache, personne n'a étudié récemment le contraste entre ces deux types de consentement. After Beecher's criticisms of the Nuremberg Code in affirming that the consent required by it is inaccessible13 , the question of this interesting point has not been raised to date14. Aussi, la tâche de concorder la liberté du sujet d'abandonner l'expérience avec la responsabilité qu'il acquiert, en tant que personne morale mûre, de poursuivre dans l'expérience, sauf en cas de situations qui justifient cet abandonment, reste-t-elle en suspens dans l'éthique de l'expérimentation humaine.

It seems to me that, on the occasion of the anniversary that we are celebrating, this problem deserves a thorough reconsideration. This proves that the ethical legacy of Nuremberg has not been forgotten. Thank you for your attention.

Résumé 

The study of 58 codes of medical ethics promulgated between 1950 and 1996, in 16 European countries and 13 Latin American countries, allows us to reach a provisional conclusion, given the incomplete nature of the research carried out: the acceptance of the Nuremberg Code's prescriptions by the codes of national medical associations has been a slow, delayed and partial process.

In fact, it was not until 1975, after the publication of the second Helsinki Declaration, that we saw a broad and frank acceptance of the Nuremberg standards in codes of ethics. The codes then either remained silent on the subject of the ethics of experimentation on man, or were content to affirm the platitudes in this regard. This general indolence excludes Switzerland, where the Swiss Academy of Medical Sciences published very modern and comprehensive Directives in 1971, as well as Brazil, which in 1957, and Peru, Costa Rica and Venezuela, in 1970 and 1971, followed the example of Helsinki in their Codes of Medical Ethics.

The ten Nuremberg criteria have been the subject of a selective acceptance, filtered through Helsinki II. For example, the indispensable requirement of the subject's consent was accepted by all. The need for pre-experimentation in animals, and the duty to minimise the risks or compensate for the damage linked to experimentation have been accepted by most codes.

However, more interesting than the study of acceptances is the consideration of refusals. Two Nuremberg rules have not found a place in any code of ethics: celle qui pose sur la conscience de tous ceux qu'initient, dirigent ou collaborent dans la recherche la grave responsabilité d'évaluer l'authenticité du consentement du sujet; et celle qui confère au sujet le droit de terminer sa participation à l'expériment "si on arrive à une situation, physique ou mental, dans laquelle il lui semble impossible de continuer dans la même". In the author's opinion, the general refusal of these two rules, which are very demanding of sincerity and rectitude in the experimenters as well as in the subjects, allows us to speak of two different types of consent: the Nuremberg type, generic and almost religious, and the Helsinki type, minimalist and almost libertarian.

Notes et bibliographie 

(1) The striking fact is that the Nuremberg doctrine remained practically in oblivion for a long period in Europe and Latin America, where it was only accepted after 1975 through the intermediary of the WMA's Helsinki II Declaration.

The Code only belatedly attracted the attention of the WMA. This Association, created in 1947 to be a free and open forum for ethical and medical education issues, decided, after much hesitation, to make recommendations to guide physicians in biomedical research by adopting its Helsinki Declaration (Helsinki I) in June 1964. This Declaration was substantially amended in October 1975 in Tokyo (Helsinki II). It was the subject of amendments in Venice in October 1983 and in Hong Kong in September 1989, but it is usually referred to as Helsinki III or IV.

Many authors are strongly advocating an early and continuing influence of the Nuremberg Code, which, in my opinion, has not been demonstrated. On a affirmé, sans fondement, que Nuremberg est présent à la Declaration de Genève et au Code International d'Ethique Médicale, les documents fondamentaux de l'AMM (Ainsi, par exemple, 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). Beecher a dit en 1959 que les dix points du Code de Nuremberg étaient devenus une sorte de Credo occidental (Beecher HK. Experimentation in Man. JAMA 1959;169:461-468), mais ceci est une affirmation volontariste, au moins en ce qui concerne l'Europe et l'Amérique Latine.

In truth, among the documents promulgated by the WMA, only one clause of the Rules for Times of Armed Conflict, adopted by the WMA in Havana in 1956, is in direct correlation with Nuremberg: paragraph 3 states, in the spirit of Nuremberg: "L'expérimentation sur l'être humain est soumise en temps de guerre au mêmes règles qu'en temps de paix; elle est formellement interdite sur toute personne ne disposant pas de sa liberté et notamment sur les prisonniers civils et militaires et sur les populations des pays occupés."

It would be interesting to investigate, beyond the institutional rules, the Code's immediate impact on actual practice. A glance at the major medical journals of the moment shows a general lack of interest in the Code. A striking example: the sentence against the Nazi doctors was published in JAMA (the official publication of the American Medical Association) in the extremely humble form of a letter from the Correspondent in Berlin containing a journalistic, non-technical version of the trial and the Code (Foreign Letters. Berlin. From our Regular Correspondent. The Nuremberg Trial Against German Physicians. JAMA 1947;135:867-868).

(2) The silence or ignorance of the Nuremberg Code is dissipated at a time when interest in medical ethics has been growing strongly since the 1970s. The articles commenting on the Code are, from 1947 to 1963, practically inexistent, as can be seen in the bibliography annexed to the work of Ladimer and Newman (Ladimer I, Newman RW, eds. Clinical Investigation in Medicine: Legal. Ethical, and Moral Aspects. An Anthology and Bibliography. Boston: Boston University Law-Medecine Research Institute, 1963: 493-516).

(3) On doit excéptuer la seconde partie de la clause 5, autorisant la pratique d'expériences peuvant entraîner la mort ou l'invalidité du sujet à condition que les médecins qui font les recherches servent eux-mêmes de sujets à l'expérience.

(4) The significance of this abandonment, which is dealt with briefly at the end of this paper, merits in-depth study. It is strange that many authors, when they transcribe the text of the Code, include the text of, or comments on, the "engaging" parts of these two clauses, which are those that focus precisely on the ethical quality of consent, its granting and its withdrawal. See, for example, Fargot-Largeault A. L'Homme bio-éthique. Pour une déontologie de la recherche sur le vivant. Paris; Maloine, 1985:154; and Schaupp W. Der ethische Gehalt der Helsinki Deklaration. Frankfurt am Main; Peter Lang, 1994: 58.

(5) It is astonishing to note that, contrary to what happened in the immediate preceding and subsequent periods, the productive activity of professional codes in Europe between 1957 and 1977 remained practically paralysed. The phenomenon had no parallel in Latin America.

(6) Communication personelle, Dr. Otmar Kloiber, (Bundesärztekam-mer, Cologne, Allemagne).

(7) 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 Rioghts and Human Experimentation. New York; Oxford University Press. 1992:227-228.

(8) Voir à ce propos, sur les relations réciproques entre Nuremberg et Helsinki: 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 Rioghts and Human Experimentation. New York; Oxford University Press. 1992: 157-160.

(9) Nombreux sont les Codes interdisant les expériences qui a priori peuvent entraîner la mort ou l'invalidité du sujet. Mais on en compute ici que les Codes qui réflètent la partie finale de la clause 5 du Code. Avec une touche d'humour plein de malignité, le Code accepte la possibilité d'une exception: le cas, peut-être, où les médecins qui font ces recherches si dangereuses servent eux-mêmes de sujets à l'expérience. This criterion, which is not without its ordinariness, was included only in the 1971 Guidelines for Experimental Research on Human Beings of the Swiss Academy of Medical Sciences, which state: "Il n'est pas permis de procéder à une recherche expérimentale lorsque le projet fait apparaître un risque prévisible de lésion grave ou irréversible ou un danger mortel, à moins que l'investigur en chef ne s'y soumette lui-même. L'essai sur soi-même avec risque élevé ne devrait dans la règle être entrepis qu'en équipe". This ethic for science kamikazes could not last: its permanence in the Directives was short-lived: it had been dropped in the new version of 1981.

(10) Swiss Academy of Medical Sciences. Directives pour la recherche expérimentale sur l'homme. Basle; Schwabe & Cie, 1971.

(11) More interesting than reading the original article (Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-1360) is undoubtedly to read Rothman's article evaluating it from a long-term perspective (Rothman DJ. Ethics and Human Experimentation. Henry Beecher Revisited. N Engl J Med 1987;317: 1195-1199).

(12) D'un point de vue de l'intérêt historique, il peut résulter aussi gratifiant que lire l'œuvre originale (Pappworth MH. Human guinea pigs: experimentation in man. London: Routledge, 1967) read an article in which Pappworth himself comments on the history of the book's genesis and the reactions to its publication: Pappworth MH. "Human guinea pigs - a history. BMJ 1990;301:1456-1460.

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

(14) 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 (in press).

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