DOE Openness: Human Radiation Experiments: Roadmap to the Project
New Times, New Codes
Chapter 2: New Times, New CodesIn the spring of 1959 the National Society for Medical Research (NSMR), an organization that Andrew Ivy had helped to found in 1946, sponsored a "National Conference on the Legal Environment of Medicine" at the University of Chicago. Human experimentation was one of the major topics presented for discussion by the 148 conference participants, primarily medical researchers, from around the country. The published report of this conference reveals that the many researchers who gathered in Chicago understood the Nuremberg Code well enough to use it as a point of departure for discussion. As a group, the conferees acknowledged that "[t]he ten principles [of the Nuremberg Code] have become the principal guideposts to the ethics of clinical research in the western world." Not all those in attendance, however, seemed to have been entirely pleased with this state of affairs. A "Committee on the Re-Evaluation of the Nuremberg Experimental Principles" reported general agreement with "the spirit of these precautions" but discomfort with a number of "particulars." For example, they suggested that the absolute requirement for consent in the Code's first principle might be softened by inserting "either explicit or reasonably presumed" before the word "consent." They also added a clause that would allow for third-party permission for "those not capable of personal consent."
The 1959 NSMR conference strongly suggests that by the late 1950s many and perhaps even most American medical researchers had come to recognize the Nuremberg Code as the most authoritative single answer to an important question: What are the rules for human experimentation? The same conference also provides compelling evidence that many researchers who were giving the ethical issues surrounding human experimentation serious attention at this time were not entirely happy with the prospect of living by the letter of the Code. The sources of discomfort with the Nuremberg Code can be grouped, retrospectively, into three broad categories. First, some recognized the discrepancies between what they had come to know as real practices in research on patient-subjects and what they read in the lofty, idealized language of the Code. Others simply disagreed with some elements of the Code. Still others disliked the very idea of a single, concrete set of standards to guide behavior in such a complex matter as human experimentation.
Henry Beecher, the Harvard-based medical researcher who was Louis Lasagna's mentor in the early 1950s, published a paper, "Experimentation in Man," in the Journal of the American Medical Association only a few months before the NSMR conference in Chicago. In this lengthy piece, Beecher addressed a mixture of all three sources of discomfort with the Nuremberg Code. Beecher offered the assertion that "it is unethical and immoral to carry out potentially dangerous experiments without the subject's knowledge and consent" as the "central conclusion" of his paper. But, even with this strong statement, he was not entirely happy with the first clause of the Code; he viewed the Nuremberg consent clause as too extreme and not squaring with the realities of clinical research:
It is easy enough to say, as point one [of the Nuremberg Code] does, that the subject "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." Practically, this is often quite impossible . . . for the complexities of essential medical research have reached the point where the full implications and possible hazards cannot always be known to anyone and are often communicable only to a few informed investigators and sometimes not even to them. Certainly the full implications of work to be done are often not really communicable to lay subjects. . . . [P]oint one states a requirement very often impossible of fulfillment [emphasis added].
Beecher's second form of difficulty with the Code can be found in his opinion of another Nuremberg clause, which states, in part, that a human experiment should not be "random and unnecessary in nature." Beecher cited "anesthesia, x-rays, radium, and penicillin" as important medical breakthroughs that had resulted from "random" experimentation. He further stated that he "would not know how to define experiments 'unnecessary in nature.'" Finally, Beecher expressed skepticism in general that any code could provide effective moral guidance for researchers working with human subjects. Near the beginning of his paper he wrote that "the problems of human experimentation do not lend themselves to a series of rigid rules." Later in the piece, he expanded on this thought:
[I]t is not my view that many rules can be laid down to govern experimentation in man. In most cases, these are more likely to do harm than good. Rules are not going to curb the unscrupulous. Such abuses as have occurred are usually due to ignorance and inexperience. The most effective protection for all concerned depends upon a recognition and an understanding of the various aspects of the problem.
Another episode involving Henry Beecher further clarifies the medical profession's dissatisfaction with the construction of the Nuremberg Code. In the fall of 1961, Beecher and other members of the Harvard Medical School's Administrative Board, the school's governing body, were presented with a set of "rigid rules" that had begun to appear in Army medical research contracts. The members of the board quickly recognized the "Principles, Policies and Rules of the Surgeon General, Department of the Army, Relating to the Use of Human Volunteers in Medical Research" awarded by the Army as little more than a restatement of the Nuremberg Code. The Army Office of the Surgeon General's provisions, as we discussed in chapter 1, originally appeared in 1954. Given what we have just read of Beecher, it is not surprising that he was uncomfortable with the prospect of working in strict accordance with the Nuremberg Code if he were to receive funding from the Army, nor, as we see from the minutes of the Administrative Board meetings in which this matter came up for discussion, was Beecher alone in his opposition. At the October 6, 1961, meeting of the board, when the Army contract insertion was first mentioned, "some members . . . felt that with the minor changes the regulations were acceptable, while others described the regulations as vague, ambiguous and, in many instances, impossible to fulfill."
One of Beecher's fellow board members, Assistant Medical School Dean Joseph W. Gardella, M.D., produced a thoroughgoing written critique of the "Principles, Policies, and Rules of the Surgeon General" (and, thus, of the Nuremberg Code) following the October 1961 meeting for the consideration of the other board members. Gardella opened his analysis with some general comments on the intended meaning of the Nuremberg Code:
The Nuremberg Code was conceived in reference to Nazi atrocities and was written for the specific purpose of preventing brutal excesses from being committed or excused in the name of science. The code, however admirable in its intent, and however suitable for the purpose for which it was conceived, is in our opinion not necessarily pertinent to or adequate for the conduct of medical research in the United States.
After questioning the pertinence of the Nuremberg Medical Trial to American medical science, Gardella went on to raise a general question about the scope of the Nuremberg Code; he strongly suggested that the code was not meant to cover what he perceived as the morally distinct enterprise of conducting potentially therapeutic research with sick patients:
Does it refer only to healthy volunteers who have nothing to gain in terms of their health by participating as research subjects? Or does it include the sick, whose physicians foresee for them the possibility of personal benefit through their participation? The distinction is important in that we believe that it would be difficult and might prove to be impossible to devise one set of guiding principles that would apply satisfactorily to both of these two different categories.
Gardella offered a variety of specific objections to the Army surgeon general's "Principles," but several of these points related directly to the general questions raised above. The first rule of the Army "Principles" stated (in a clear example of borrowing from the Nuremberg Code) that "the voluntary consent of the human subject is absolutely essential." Gardella, like Beecher, did not question the general spirit of this stricture; he worried about the practical application of this seemingly simple idea. Some of Gardella's worries arose specifically in the context of research with sick patients:
The concept of "voluntary consent" is of central importance in any code relating to experimentation on humans. . . . And yet the concept of "consent" is not satisfactorily defined [in the Army "Principles"]. . . . The quality of the subject's consent depends . . . upon an interpretation . . . of a factual situation which will frequently be complex. Could the subject comprehend what he was told? Did he in fact comprehend? How far was his consent influenced by his condition or by his trust in his physician? These questions may be easily answered in the case of the [healthy] volunteer. They may be more difficult for the sick [emphasis added].
Perhaps the most significant addition to the Nuremberg Code found in the Army "Principles" was the requirement for written consent from research subjects. Gardella objected to this requirement in research on patients in a firm, and revealing, fashion:
This condition is . . . inappropriate except in connection with healthy normal volunteers. The legal overtones and implications attendant to such a requirement have no place in [a] patient-physician relationship based on trust. Here such faith and trust serve as the primary basis of the subject's consent. Moreover being asked to sign a somewhat formal paper is likely to provoke anxiety in the subject [i.e., patient] who can but wonder at the need for so much protocol.
Dr. Gardella presented his analysis of the Army "Principles" to the other members of the Harvard Medical School Administrative Board on March 23, 1962. The minutes of that meeting document that Gardella's views were not extreme or exceptional among leading medical scientists in the early 1960s, at least at Harvard University: "The members of the Board were in general agreement with the objections and criticisms expressed in [Gardella's] critique." At this same meeting, Henry Beecher "agreed, in an expansive moment, to attempt to capture in a paragraph or so the broad philosophical and moral principles that underlie the conduct of research on human beings at the Harvard Medical School." The members of the board hoped that such a statement might satisfy the Army and that it would allow Harvard, as Gardella put it, "to avert the catastrophic impact of the Surgeon General's regulation."
A few months later, Beecher had completed a two-and-a-half-page "Statement Outlining the Philosophy and Ethical Principles Governing the Conduct of Research on Human Beings at Harvard Medical School." At the June 8, 1962, board meeting, Beecher's colleagues "commended" and "reaffirmed" the views expressed in Beecher's document. In this statement, as in his 1959 published paper, Beecher emphasized the significance of consent, but he also asserted that "it is folly to overlook the fact that valid, informed consent may be difficult to the point of impossible to obtain in some cases." More than consent, Beecher believed in the significance of "a special relationship of trust between subject or patient and the investigator." In the end, Beecher concluded that the only reliable foundation for this relationship was a virtuous medical researcher, with virtuous peers:
It is this writer's point of view that the best approach [to research with human subjects] concerns the character, wisdom, experience, honesty, imaginativeness and sense of responsibility of the investigator who in all cases of doubt or where serious consequences might remotely occur, will call in his peers and get the benefit of their counsel. Rigid rules will jeopardize the research establishments of this country where experimentation in man is essential.
Available evidence suggests that, by offering Henry Beecher's replacement for the Nuremberg Code, representatives of Harvard Medical School were able to extract a clarification during a meeting with Army Surgeon General Leonard D. Heaton, on July 12, 1962, that the "Principles" being inserted into Harvard's research contracts with the Army were "guidelines" rather than "rigid rules."
While the Harvard Medical School discussion of the Army's "Principles" took place behind closed doors and involved a policy of limited applicability, the leaders of the international medical community were simultaneously engaged in a far more visible and global attempt to bring the standards enunciated in the Nuremberg Code into line with the realities of medical research. The 1964 statement by the World Medical Association (WMA), commonly known as the Declaration of Helsinki, created two separate categories in laying out rules for human experimentation: "Clinical Research Combined with Professional Care" and "Non-therapeutic Clinical Research." In the former category, physicians were required to obtain consent from patient-subjects only when "consistent with patient psychology." In the latter type of research, the consent requirements were more absolute: "Clinical research on a human being cannot be undertaken without his free consent, after he has been fully informed." Another noteworthy deviation from the Nuremberg Code is Helsinki's allowance (in both therapeutic and nontherapeutic research) for third-party permission from a legal guardian.
As one might predict from the similarity between the changes introduced by the Declaration of Helsinki and the changes to the Nuremberg Code suggested by the American participants at the NSMR conference in 1959, the WMA document met with widespread approval among researchers in this country. Organizations including the American Society for Clinical Investigation, the American Federation for Clinical Research, and the American Medical Association offered their quick and enthusiastic endorsements. Compared with the lofty, idealized language of the Nuremberg Code, the Helsinki Declaration may have seemed more sensible to many researchers in the early 1960s because it offered rules that more closely resembled research practice in the clinical setting.