DOE Openness: Human Radiation Experiments: Roadmap to the Project
Nuremburg and Research with Patients
Chapter 2: Nuremburg and Research with PatientsThe record of conducting nontherapeutic research with unconsenting sick patients during the postwar period discussed above seems to stand in particularly sharp contrast with the claims about the conduct of research involving human subjects in the United States that Andrew Ivy made during his testimony in Nuremberg. We have seen how some observers, even before Nuremberg, recognized that employing uninformed, vulnerable sick patients solely as a means to a scientific end was simply wrong. We must, however, also acknowledge that the particulars of the Nuremberg Medical Trial did not call for careful attention to the issues surrounding research with sick patients. None of the German physicians at Nuremberg stood accused of exploiting patients for experimental purposes.
Nonetheless, it is likely that Andrew Ivy would have argued that consent was appropriate in virtually all instances of medical research. Dr. Herman Wigodsky, who worked closely under Ivy at Northwestern in the late 1930s and early 1940s, explicitly commented during an Ethics Oral History Project interview that he did not believe that his mentor drew any sort of ethical line between various types of clinical research: "I don't think he made any distinction [between research with sick patients and research with healthy subjects]. Research was research. It didn't make any difference."
Additional evidence that Ivy would have supported standards of consent for research with ill as well as with healthy subjects comes from his response to a set of rules for human experimentation put forth by the German Ministry of Interior in 1931, presented to him after he had prepared his written report for the AMA in the fall of 1946. These rules appear to be considerably more comprehensive and sophisticated than the Nuremberg Code itself. Most significantly, the 1931 German standards cover both therapeutic and nontherapeutic research, calling for consent in both types of medical investigation. For reasons that are not clear, the prosecution team at Nuremberg did not choose to place much emphasis on these German standards in constructing the case. Ivy did, however, attempt (without much help from the prosecution) to initiate a discussion of the 1931 standards during his testimony. It is clear from the trial transcript that Ivy saw a rough equivalence between the more detailed and extensive German rules and those formulated by the AMA, with his assistance. Shortly after discussing the AMA principles on the witness stand, Ivy had the following exchange with prosecutor Alexander G. Hardy:
Q. Do you have any further statements to make concerning rules of medical ethics concerning experimentation in human beings?
Hardy did not take what now seems an obvious opportunity to allow Ivy to expand further on these rules. However, a few minutes later, Ivy brought up the German standards again on his own (and again Hardy did not pursue the topic further). At this point, Ivy stated his general agreement with the German standards of 1931 even more firmly:
I cited the principles . . . from the Reich Minister of the Interior dated February 28, 1931 to indicate that the ethical principles for the use of human beings as subjects in medical experiments in Germany in 1931 were similar to these which I have enunciated and which have been approved by the House of Delegates of the American Medical Association.
Ivy's assertion of "similarity" between the AMA principles and those in the 1931 German document may not meet with agreement among those who compare the two. Though they may be viewed as similar in philosophy and intent, the German interior ministry document is far more detailed and comprehensive than that of the AMA.
Contrary to Ivy's claims at Nuremberg, and the positioning of Ivy by the prosecution, he cannot in any full sense be taken as the embodiment of the entire American medical profession in the years immediately following World War II. Again, Dr. Wigodsky spoke to this point in his recent interview:
Well, I've always felt that that stuff that Ivy wrote up during the time of the trials was pretty much an expression of his personal philosophy about research. And . . . it was the kind of understanding that we had in working with him about how he felt. Voluntariness being number one--you had to volunteer and had to be in a situation where you could volunteer. And consent in the sense that you didn't do anything to anybody that they didn't know what you were doing. That you explained to people what it was you were going to do and why you were going to do it and that sort of thing [emphasis added].
Even if it is true that Andrew Ivy would have wholeheartedly endorsed the notion of obtaining consent from any research subject--whether an experiment held the possibility of personal benefit or not; whether the subjects were sick or healthy--it seems likely that the AMA House of Delegates would have been hesitant to endorse a condensation of Ivy's principles of research ethics if they had been explicitly extended to cover all categories of clinical investigation. Obtaining consent from patients within the normal clinical relationship was not a common practice in late 1946. At that time, and for many years to come, patient trust and medical beneficence were viewed as the unshakable moral foundations on which meaningful interactions between professional healers and the sick should be built. In fact, it was not until 1981 that the AMA's Judicial Council specifically endorsed "informed consent" as an appropriate part of the therapeutic doctor-patient relationship.
But, in the end, it must be acknowledged that the facts of the Nuremberg Medical Trial did not force Andrew Ivy, the AMA House of Delegates, the Nuremberg prosecutors, or the judges to grapple with the distinctions between research with sick patients and research with healthy subjects, or therapeutic and nontherapeutic research. The Nuremberg defendants stood accused of ghastly experimental acts that were absolutely without therapeutic intent, and their unfortunate subjects were never under any illusion that they were receiving medical treatment. To rebut the claims of some of the medical defendants that obtaining consent from research subjects was not a clearly established principle, Ivy could, and did, offer a variety of examples on the witness stand from a long tradition of human experimentation on consenting healthy subjects. Ivy and the members of the prosecution team were not faced with what might have been a more troubling process: finding examples of well-organized nontherapeutic experiments on sick patients in which the subjects had clearly offered consent. Simply put, the Nuremberg Medical Trial did not demand it.