Respect for the experimental subject as a person
Gonzalo Herranz, department of Bioethics, University of Navarra
Communication at the XVII International Symposium on Theology:
The primacy of the person in contemporary morality.
Session on Person, Corporeality and Human Life
School of Theology, University of Navarra, Thursday, April 18, 1996, 4 pm.
The Nuremberg Code and its ethical message
The consequences of forgetting
Introduction
It might seem out of place to bring to this Symposium a brief reflection on biomedical experimentation as area to study the primacy of the person in contemporary morality. Although only a tiny minority of human beings are called upon to participate as subjects in clinical experiments, the topic, I hope to show, does not lack relevance.
A couple of important testimonies will suffice to justify this affirmation. The first is the final paragraph of point 89 of the Encyclical Evangelium vitae, which reads as follows: "Even biomedical research , a fascinating and promising field of new and great benefits for humanity, must always reject experiments or applications which, by ignoring the inviolable dignity of the human being, cease to be at the service of mankind and are transformed into realities which, while appearing to help them, oppress them". The second is an important normative document of the United Nations: the International Convention on Civil and Political Rights, adopted in 1958 and ratified in 1966, whose article 7 reads. "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation". The biomedical research is thus placed on a plane of ethical responsibility from which it cannot escape without falling into oppression of man or moral abjection.
I would like to limit this communication to consider a point that has received curiously little, if any, attention: the oblivion into which the most ethically significant clauses of the Nuremberg Code fell into oblivion. This neglect is responsible for the stagnation that the ethical rules and regulations has experienced over the last 50 years, and from which it has not fully recovered, and in which a robust concept of respect for the dignity of man as a subject of experimentation should have taken shape. As the Pope points out, the risk that the inviolable dignity of the human being may be ignored or violated in some experiments is still present today.
The Nuremberg Code and its ethical message
It is now common opinion that the Nuremberg Code - a part of the judgment of the United States trial against Karl Brandt, the second Nuremberg Trial (1947), against Nazi doctors who had performed atrocious experiments on human beings - marks the origin of the contemporary concern for the ethical requirements of biomedical experimentation. It is considered, in retrospect, the birthplace of the ethical and legal doctrine of the voluntary consent of the experimental subject. This has not prevented the Code from being forgotten for the first 25 or 30 years of its existence and, unfortunately, the best of its doctrine continues to be ignored.
The main merit of the Code lies, in my opinion, in having defined physician-researchers and patient-subjects as moral human beings, primarily and unavoidably moral. In fact, the Code, apart from demanding scientific quality from the physician in the design of the experiment and professional skill in its realization, imposes as an absolute ethical condition, on researchers and experimental subjects alike, the obligation to apply for and to grant the voluntary consent of the subject. The person concerned must have the legal capacity to consent and be in a position to exercise full freedom of choice, unimpeded by force, fraud, deceit, intimidation, promise or any other form of coercion or threat; and must have sufficient information and knowledge of the significant elements of the corresponding experiment, so that he/she can understand what he/she is deciding.
The Code places this ethical, and not merely bureaucratic, responsibility on the shoulders of the researchers, i.e. each and every individual who initiates or directs the experiment or collaborates in it. If on the one hand they are obliged to sincerely inform their potential subjects of the morally significant data of the experiment (of its nature, duration and purpose; of its methods and means; of its drawbacks and risks; of its possible adverse effects and expected benefits), they assume, on the other hand, before accepting the affirmative response of each experimental subject, the responsibility of evaluating the human and ethical quality of that consent. In other words, they must verify that such consent is consonant with the full human dignity of the experimental subject.
The Code expects similar conduct from the latter: it asks that his or her consent be of the necessary high human quality. Voluntary participation in an experiment implies a commitment to participate seriously. And, although the subject enjoys the freedom to withdraw from it, he will only do so if he considers that he has reached a physical or mental state in which it seems impossible to continue the test.
Placing experimenters and experimental subjects on the same plane of common human dignity is, I insist, the main ethical message of the Nuremberg Code, its revolutionary novelty. A message so demanding at the time that it was immediately forgotten. The few times it was mentioned in those years, it was to criticize it harshly, accusing it of being legalistic and impossible to comply with.
The explanation for such a course of action is simple. Throughout the 1950s and 1960s, biomedical experimentation was intoxicated by its enormous success. According to the aggressively scientistic and paternalistic biomedical ethos of the time, the benefits of research could not depend on the limited understanding that potential test subjects might have of the complex problems of science; the pursuit of medical knowledge could not be hindered by remote criteria established by judges who condemned bizarre war crimes. The Nuremberg Code was considered to have nothing to do with the regulation of beneficial peacetime experimentation. It was unthinkable that medical scientists could be brought to the dock, for they proved to be kind and amazingly effective wizards. Nor should their work be hampered by the opinions of scrupulous theologians or philosophers. In those years of enthusiasm for science, only a few were aware that experimenting on human beings places biomedical science in an intense field of moral forces, and forces a very sensitive and delicate conscience. It had not yet been recognized that experimenting on man puts the physician in the dilemma of revering his dignity -his sacrosanctity, as Hans Jonas said best- or of reducing him to a mere object capable of providing verifiable data .
The consequences of forgetting
It was only when Beecher and Pappworth discussed human guinea pigs and published some inventories of recent ethical transgressions committed by researchers in more reputable hospitals that it became clear that the Nuremberg doctrine had never been taken seriously. As evidence and proof of abusive conduct by research physicians accumulated, it became necessary to promulgate new ethical standards on how to respect the dignity staff of man, the subject of experimentation. The World Medical Association ( association ) took the lead in the movement with the Declaration it adopted in Helsinki in 1964.
Between the Nuremberg Code and the Declaration of Helsinki there are broad coincidences, but also notable contrasts. These can be attributed to the different vision that both documents have of the capacity of men (researchers and subjects) to assume moral responsibilities.
Helsinki is markedly pessimistic: it does not believe in the ethical integrity of experimenters and subjects. In contrast to Nuremberg, he thinks that the physician-experimenter is incapable of leading a constant and demanding moral existence. He regards him as an ethically precarious being, who inevitably needs to be helped from outside. From Helsinki onwards, an independent committee will have to evaluate the ethical quality of the project of any research and monitor its development. This is not the time to criticize the performance of the Ethics Committees of research. Of course, there have been all kinds. But one thing is clear: many of them have authorized and continue to authorize abusive, disrespectful, inhumane research.
Nor does Helsinki believe that the subject can be a fully moral agent manager. If, according to agreement with the principle of autonomy that has taken root since the 1960s, the subject is considered to be entitled to honest information, by virtue of this same principle he is considered to be fickle, incapable of making a serious commitment: even if he has said yes to his participation in the experiment, he is free to abandon it without having or giving any reason whatsoever. This right creates an ethically weak status from which many research works suffer, because many of them can be ruined if the issue of the subjects who abandon them exceeds a certain proportion. Helsinki grants the subjects the curious privilege of not taking themselves seriously and the yes they have given, they are authorized to be ethically irresponsible.
The recovery of a robust concept of the dignity of man, of recognizing him as capable of a certain moral greatness, is a problem still pending today in the ethics of biomedical research . It is necessary to return to Nuremberg: the victims of the aberrant Nazi research continue to demand that researchers and experimental subjects be ethically vertebrate beings with respect for the dignity of man, that they learn to see the imago Dei that dwells in each other.