Keywords

12.1 Introduction

The origins of modern ethics codes on clinical research and practice were long seen as an achievement of jurists responding to legally presented evidence of medical atrocities in the Holocaust. However, deeper probing of surviving victims and prisoner doctors presented evidence of medical atrocities in court as framing the need to prevent coerced experimentation.

Historical study of Nazi experiments on prisoners uncovers protest, sabotage and evasion both by victims and prisoner doctors against the experiments as illegitimate and unethical. This contradicts the assumption that prisoners were passive, silent victims and that it was only in the courtroom of the Nuremberg Palace of Justice that ethical principles were first debated and determined.

Prisoners had a strong sense that their rights were violated. For example, the self-styled Polish “Rabbits” (króliki) protested against experiments that deliberately made them disabled by deeply and painfully wounding their legs. Even some German doctors attempted to protest unethical experimentation, though many young researchers exploited prisoners in concentration camps justifying their actions on Germany’s highly scientized system of medical education. For example, the assistant surgeon Fritz Fischer initially carried out experiments, yet eventually extricated himself by transferring to military duties on the Eastern Front.

Auschwitz became in a short time the location with the highest number of experiment victims and the location where Nazi doctors selected groups for further experimentation elsewhere. A definitive database provides a means for comparative evaluations. The declaration, “The Prisoner Doctors of Auschwitz to the International Public,” issued on March 4, 1945, stated that prisoners had been treated as experimental animals, that the Allies and neutral states should bring to trial those responsible, and that prosecuting perpetrators would prevent coerced human experiments and medical atrocities in the future (The National Archives 1945). There were comparable efforts by liberated prisoner doctors to document Nazi medical experiments at the concentration camps of Buchenwald and Dachau. At the concentration camp of Bergen-Belsen, survivors of the death march from Auschwitz alerted British liberators to the widespread conduct of medical experiments. As a result efforts were made by scientific intelligence officers to collaborate with war crimes investigation teams to systematically document all experiments, not just those with surviving victims.

At a crucial meeting at the Pasteur institute in Paris from July 31 to August 1, 1946, the US physiologist Andrew Ivy formulated a code requiring participant consent in research. Telford Taylor decided that evidence for a medical trial was ready to go. Ivy was determined that any such trial should result in a regulative code fort human experiments.

The Nuremberg Medical Trial, held from December 5, 1946 until judgement on August 19, 1947, should be seen primarily as a trial revolving round the criminality of coerced experiments as well as an ethics tribunal. At times, the judges interrupted the criminal proceedings to ask for the ethical opinions of the defendants. Here, the judges appear to have been interested in the ethical mindset of defendants and not in proving their guilt. The trial differed from subsequent Nuremberg trials in that it concluded with a declaration of ethical principles by the judges. The trial included a large number of witnesses who were either subjects of Nazi research or witnesses to such experiments. This is unique in that other trials of Nazi criminals were primarily document based.

At the close of the Nuremberg Medical Trial (NMT) on August 19, 1947, the judges pronounced their guidelines on ethically permissible clinical experiments. From around 1963, these guidelines were called the “Nuremberg Code,” thereby investing them with status as a fundamental document on proper research procedure. The status as part of a judgement at an international court set a precedent in adjudicating landmark cases of murderous and maiming conduct arising from coercive research.

12.2 Misconceptions

The aim of this chapter is to correct certain misconceptions concerning the origins and implications of these guidelines. The first misconception is that the Guidelines/Code arose solely from courtroom proceedings. This overlooks a prior agenda set upon the liberation of concentration camps, which was to secure a set of regulations to protect research subjects. In short, victims of unethical experimentation actively protested against, resisted and sabotaged these coerced experiments. Moreover, they also spoke out as witnesses at the NMT. Victims of research and liberated prisoner doctors had made a profound impression on Allied scientific intelligence officers, who then laid the ethical foundations for the NMT. Secondly, although the judges stressed the autonomy of research subjects and the obligation to inform subjects about potential risks, the key term “informed consent” did not appear in the guidelines of 1947. Thirdly, it is a misapprehension that the principles promulgated by the judges received neither publicity nor recognition.

12.3 The Nuremberg Medical Trial Agenda to Create a Code of Ethics

Prisoner documentation came to the attention of Allied scientific intelligence officers, notably the neurophysiologists Leo Alexander, a US military officer, and John Thompson, head of the British branch of the FIAT scientific intelligence organization (Weindling 2010). In 1945 Thompson interrogated Belsen doctor Fritz Klein, who had conducted experiments with mescaline and on the drug Rutenol in Auschwitz (The National Archives 1945). Concerned about the criminality of German wartime research, Thompson first identified the experiments as “Medical War Crimes” in November 1945. This specific form of medical criminality required scientific intelligence and war crimes investigation teams to collaborate. To attract attention to the problem of coerced experimentation, Thompson stated that 90% of German wartime medical research by leading scientists and clinicians was criminal (Weindling 2010, 137–148). Thompson organized a meeting on medical war crimes at the Pasteur Institute in Paris from July 31 to August 1, 1946.

Another key expert drawn to the Nuremberg Medical Trial was Andrew Ivy (1893–1975), a Chicago-based physiologist who had conducted war-time research on water desalination for the US Navy. Some servicemen had opted out during these experiments, and Ivy recognized their full autonomy to do so. Ivy was nominated by the American Medical Association for an appointment as Special Consultant (on Nazi medical research) for the U.S. Secretary of War in 1946. During this time, Ivy outlined a set of principles on medical research. Ivy’s “OUTLINE OF PRINCIPLES AND RULES OF EXERIMENTATION ON HUMAN SUBJECTS” stated that:

  1. I.

    Consent of the subject is required; i.e. only volunteers should be used.

    1. (a)

      The volunteers, before giving their consent, should be told of the hazards, if any.

    2. (b)

      Insurance against an accident should be provided, if it is possible to secure it.

  2. II.

    The experiment to be performed should be so designed and based on the results of animal experimentation, that the anticipated results will justify the performance of the experiment; that is, the experiment must be useful and be as such to yield results for the good of society.

  3. III.

    The experiment should be conducted

    1. (a)

      so as to avoid unnecessary physical and mental suffering and injury, and

    2. (b)

      by scientifically qualified persons

    3. (c)

      The experiment should not be conducted if there is a prior reason to believe that death or disabling injury will occur (Weindling 2004, 261–265).

This long-overlooked draft code was drawn up a year before the Guidelines of August 1947. It was the basis for mounting the NMT as well as a series of revisions in the suggested code. Thompson’s investigations of medical crimes provided a basis for prosecution. The decision by Chief Prosecutor Telford Taylor to hold the NMT was made shortly after the Pasteur Institute meeting in August 1946 (Weindling 2004, 265).

The US Secretary of War then appointed Ivy to be an expert witness to the court at the NMT. Ivy had been nominated for this role by the American Medical Association. He had a strong sense of the need for medical research to be conducted on a Hippocratic basis in that the experimenter should do no harm and protect the welfare of the research subject. He was also in favor of prior animal experiments. He reflected, “I accepted the invitation to serve at the Nurenberg [sic] Trials only because I had in mind the objective of placing human beings in an international judicial decision the conditions under which human beings may serve as subjects in a medical experiment, so that these conditions would become the international common law on the subject” (Wellcome Library PP/MHP/C5 Ivy to Pappworth 6 April 1966; Gaw 2014). This confirms Ivy’s agenda for becoming expert witness to the court.

The relations with the 1931 Reich circular on human experiments was to be an issue for the NMT defense and prosecution because its existence implied a prior code of ethics regulating German medical experimentation. That the Reich guidelines of 1931 retained validity has been confirmed (Weindling 2004). However, that all German research abided by the Reich directive was a misleading claim by a defensive German medical establishment and defendants (Weindling 2004).

Ivy saw the matter of the doctors’ criminality in terms of their violation of the Hippocratic Oath. On December 28, 1946, the journal of the American Medical Association (JAMA) published recommendations for an abbreviated Code. Among the requirements: “The voluntary consent of the individual on whom the experiment must be performed must be obtained. The danger of each experiment must be previously investigated by animal experimentation. The experiment must be performed under proper medical protection and management” (AMA Judicial Council 1946, 35). During the NMT, Ivy assessed German/Austrian medical research. He astutely observed that the defendant Wilhelm Beiglböck altered records of the Dachau experiment on making seawater drinkable, so as to conceal the effects of the different types of desalinated seawater on victims. The judges consequently increased the sentence (Weindling 2017).

Ivy’s main achievement was to drive forward the agenda of creating an international code of ethics for medical experimentation. As Ivy reflected in 1964, “The judges and I were determined that something of a preventative nature had to come out of the “Trial of the Medical Atrocities” (Ivy in Ladimar I, Newman, R eds, Clinical Investigation in Medicine: Legal, Medical and Moral Aspects, Law-Medicine Research Institute Boston University, 1963, 116 “The Nuremberg Code”; University of Wyoming Ivy Papers, Ivy to Ladimar, 23 March 1964. His sense of mission is confirmed by a Special Press Release of January 22, 1947: “Dr Ivy … left Nuremberg with the recommendation that an international legalised code of ethics should be published on the use of human beings as experimental subjects.”(Archives de France, BB/33/260, folder 4c Special Release no. 104, 23 January 1947, OCCWC). Ivy shows a clear conviction that the NMT should conclude with a set of ethical principles, and he successfully persuaded the judges in making such a declaration as a preliminary finding to their judgement.

12.4 The Victim’s Voice

The Nuremberg Medical Trial was distinctive in that victims had a key role as witnesses. The NMT relied more on victim testimony than either the four-power International Military Tribunal or the later American military-administered trials. The prosecutors made radio appeals in German, Czech, and Polish for witnesses and victims of medical experiments. Letters from experiment and sterilization victims provided significant testimony. Victims’ organizations, such as Opfer des Faschismus (Victims of Fascism) and the Betreuungsstelle für Sonderfälle (Care Office for Special Cases) also sent evidence to the Nuremberg prosecution (Archives de France BB/35/268 documentation relative aux expériences médicales, no year). The victims’ voice was important in shaping views on the need for consent (Shuster 1997, 1998).

One victim of X-ray sterilization stated that he had come forward as a result of the radio call for witnesses. Leo Alexander, a US military physician with duties in aviation medicine and originally a graduate of Vienna University, was appointed expert witness for the prosecution. He wrote about the victim of X-ray sterilization experiments at Auschwitz:

When he heard over the radio that the people responsible for the German medical atrocities are going to be tried, he decided that it was his duty to come here and to testify although he is afraid that, especially if his name is printed in newspapers, his sisters might find out about his condition that way. However, he feels that it is his duty to be helpful in bringing those responsible for the atrocities, to which he and others have been subjected, to justice.

It appears that he is one of 100 young Jewish boys who were castrated for no reason other than to confirm the fact that they had been sterilised by sufficient Xray radiation as if Xray burns which resulted from a fifteen minute exposure were not enough to prove that point (Archives de France BB/35/260 Folder: Sterilisations. Interrogations et comptes-rendus d’interrogatoire: Alexander 22 November 1946).

Victims took the initiative in alerting the police about medical criminals. In February 1946, Dachau survivors alerted the Austrian state police that the Vienna specialist in internal medicine Wilhelm Beiglböck had conducted a painful experiment in Dachau by testing the salt water solutions derived from different methods of desalination of salt water on patients over a number of days. The investigations uncovered the involvement of the celebrated internist Hans Eppinger of the Vienna Medical Faculty, and led to the arrest of Beiglböck in Lienz in the British zone of occupation. Beiglböck was transferred to Nuremberg by the British in September 1946. He was the one Austrian defendant at the Medical Trial (Weindling 2017). Beiglböck was a member of the SA, and not one of the seven SS doctors on trial. Yet he was drafted in to Dachau concentration camp to direct these experiments.

There were three non-medical defendants, all SS members: Viktor Brack of the Chancellery of the Führer, responsible for euthanasia and Xray sterilization experiments, Rudolf Brandt, Himmler’s Secretary involved in arrangements for experiments on concentration camp prisoners, and Wolfram Sievers, manager of the SS Ahnenerbe research organization.

In the case against Beiglböck, the Sinto (“gypsy”) witness Karl Höllenrainer punched Beiglböck when asked to identify him in court. Höllenrainer’s testimony stressed mistreatment and coercion. Beiglböck was accused of drawing a pistol to force a Sinto, who had already survived the freezing water and malaria infection experiments at Dachau, to submit to the desalination experiment. However, the prosecution failed to prove any fatalities from the experiment. Although one research subject died before liberation, the connection with the experiment is unclear (Dörner et al. 1999; Spitz 2005, 151, 163).

On July 17, 1947, the defense lawyer Gustav Steinbauer gave an eloquent and revealing final plea for Beiglböck, imploring that deaths should be accepted as a necessary cost of medical progress:

Over the entrance gate of the General Hospital in Vienna we read the words “Saluti et solatio aegrorum-Dedicated to the health and consolation of the sick.” These words not only demand the highest accomplishment of the doctor’s duties but are the motive for the most successful work in the large field of medical research. Theory and practice joined together in order to become a piece of living humanity. I would go beyond the limits of my task if I mentioned all the names that spread the glory of Vienna University throughout the world. But their penetration into the world of the unknown was always a hazardous enterprise which demanded courage and sacrifice.

I want to quote the words of one of the great doctors, Professor Wagner-Jauregg, who says in his book “Fever and Infection Therapy,”, “The vaccination against malaria was certainly a risk, the outcome of which could not be foreseen. It was dangerous for the patient himself and this to a much higher degree than the treatment with tuberculin and other vaccines, and it also was a danger for the surroundings and even for the community.”

And, on page 136, it states “Three patients died after having been vaccinated with blood infected with malaria tropica and not with malaria tertian;” and “The tragic outcome of this experiment was discouraging, and only a year later could the author decide to proceed with the malaria vaccinations…” Nobody talks of these victims today, but Wagner-Jauregg's revolutionary discovery is known and adopted throughout the world and has become the common property of all peoples for the benefit of suffering mankind…. (Steinbauer 1947 Nuremberg Medical Trial, p. 6412)

The judges’ concluding principles sought to refute such dangerous arguments made by a series of defendants that injury and death of human subjects are necessary for medical progress.

With this aim in mind, US and British scientific intelligence officers Leo Alexander, Keith Mant, and John Thompson collected evidence from victims. The Court proceedings ran on two levels. It was an international trial to determine culpability for the consequences of aggressive war resulting in crimes against humanity, but it was also an ethics tribunal concerned with the medical validity of the research and consent of the research subject. The conduct of the trial involved periodic ethical discussions. The judges asked defendants for their opinions. Kurt Blome and Karl Brandt gave their opinions on clinical experiments. Blome’s statement that prisoners should always be volunteers and receive a reduction of sentence or an amnesty showed criticism of the concentration camp experiments. The defendants were permitted to cross-examine expert witnesses (Nuremberg Medical Trial Transcripts 1947, p 11,302 for 17 July 1947 http://Nuremberg.law.harvard.edu/transcripts/1-transcript-for-nmt-1-medical-case?seq=11450&q=+type:transcripts.). At one stage, Ivy was cross-examined by the defendants Ruff, Rose and Beiglböck. The Trial had a dual character as a criminal court and as an ethics debating chamber.

12.5 From Ethical Debate to the Final Declaration

On December 7, 1946, just after commencement of the NMT, Alexander noted that he had finished his own written guidelines for ethical and unethical human experimentation. This text outlined the conditions for “permissible experimentation by a doctor” (Alexander 1976). As in Ivy’s draft guidelines of August 1, 1946, Alexander required consent—meaning the full understanding of the issues being investigated, and voluntary participation of the experimental subject. While Ivy required the experiment to be useful, Alexander preferred a more generalized viewpoint, requiring only that the experiment should not be unnecessary. Both, however, concurred that results should be for the good of society. This overlap suggests that Alexander took Ivy’s report as a basis for his views. Alexander nevertheless amplified the concept of consent, such that it would be based on a proven understanding of the exact nature and consequences of the experiment. He considered that a doctor or medical student was most likely to have the knowledge base and capability for full understanding. The degree of risk was justified by the importance of the experiment and the readiness of the experimenter to risk his own life. Overall, Alexander produced a more rigorous set of requirements than either Ivy or the minimalist AMA code.

Rather than informed consent, the expression of choice at the trial was of a “Voluntary Consent,” which includes disclosure of risks. Alexander also noted the intention of the judges to rule on issues of experimentation at the end of the NMT: “As we have anticipated all along the defense is making a concerted effort to introduce a great deal of literature on human experimentation in other countries. So far we have been successful in keeping out most of the proof, but the Tribunal has stated that it will rule on this question at the conclusion of the case” (Archives de France 1947, BB/35/260 Folder 4c, 4 May 1947). The judges provided a distillation of the Alexander and Ivy drafts along with stress on the autonomy of the research subject. Voluntary consent meant that “the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision…” (Trials of War Criminals before the Nuremberg Military Tribunals, vol. 2. Washington DC: US Government Printing Office 1949, 181–183).

12.6 Publicizing the Guidelines

The declaration on permissible experiments provided criteria for judgment of the 23 defendants. Yet, it was also intended to have wider circulation, thereby fulfilling Ivy’s hope of entering the international common law on medical experiments. Telford Taylor had been meticulous in allowing press access and inviting international jurists to be present at the trial as observers. The presence of the German medical delegation throughout the trial was remarkable, because Taylor wished to show impartiality of the court to the German medical profession. The judgement was publicized in German by Alexander Mitscherlich and Fred Mielke in their NMT overview Wissenschaft ohne Menschlichkeit (Mitscherlich and Mielke 1949a), and in French by François Bayle, the French military observer in his study of the Trial (Bayle 1950, 1493, 1495). Importantly, in 1949 Telford Taylor published the guidelines on “Permissible Medical Experiments” in his contribution to Doctors of Infamy, which was based on the interim publication by Mitscherlich and Mielke, with additional contributions by Taylor, Ivy and Alexander (Mitscherlich and Mielke 1949b). The volume included a draft apology, which the German delegation declined to make at the first World Medical Association (WMA) meeting, and a concise version of the WMA’s revised version of the Hippocratic oath, which was oriented to apply to practitioners. Commentators have suggested the impact of the Nuremberg Medical Trial on various international conventions and agencies, notably the WMA and ultimately the Helsinki Declaration for medical research involving human subjects. The WMA and WHO closely engaged with each other on the issue of war crimes committed by the medical profession and issued a preliminary report on “War Crimes and Medicine. The German Betrayal and a Restatement of the Ethics of Medicine” in 1948 (World Medical Association 1947). US military and official agencies took note of the NMT judicial guidelines (Advisory Committee on Human Radiation Experiments 1995).

The judges’ guidelines on permissible experiments were a distillation of a wider post-WW II discourse in which victims played a crucial role. Each version of the guidelines needs to be contextualized so as to understand the agendas of the various participants. For example, the expert witness Ivy had a firm agenda, which he impressed on the judges, prompting their guidelines on permissible experiments. Ivy’s original principles of August 1946 served as a starting point, which was then elaborated on by Alexander before the NMT judges finally added the additional principle of the autonomy of the research subject. The guidelines were accepted and publicized and made readily available as a reference document in English, French and German in the period after the NMT. This explains the widespread acceptance of these guidelines in medical jurisprudence in the early 1960s as the definitive “Nuremberg Code”.