The relationship between an investigator and an experimental subject is different from that between a physician and a patient. While a doctor is supposed to put the welfare of the patient above all other considerations, investigators have an obligation primarily to the people who fund the research.
The line blurs even more when a patient has a life-threatening illness, and the only available treatment option is experimental. Should a doctor convince the patient to try an unproven drug, or should risky therapy be withheld as a safety precaution? Henry K. Beecher explored this troubling question in 1962.
Is Informed Consent a Fallacy?
In 1959, Beecher had published his first major article on human experimentation. “Experimentation in Man” did not receive the acclaim Beecher thought the topic deserved, so he kept returning to the subject over the course of the next three years.
In 1962, Beecher wrote an editorial in Clinical Pharmacology & Therapeutics entitled, “Some fallacies and errors in the application of the principle of consent in human experimentation.” Although some have suggested that this article demonstrated how Beecher's thinking had evolved, in reality it is less groundbreaking in a philosophical sense than many had imagined.
Once again, Beecher struggles with the implications of the Nuremberg Code and the principle of informed consent. Although Beecher (1962) acknowledged that informed consent was important in medical research, he also admitted that anyone “who believes that meaningful consent is always easily achieved has been guilty of . . . fallacious thinking.”
In his defense, Beecher cited three situations where obtaining informed consent was impossible:
- Where the investigator did not know the risks of the proposed experiment and thus could not communicate these risks to the subject.
- Where the risks were known for an average subject, but not for otherwise vulnerable populations (e.g., infants and children, the mentally ill, and the scientifically illiterate).
- Where there were conflicting opinions as to the safety or desirability of an experiment, as well as its impact on the public good.
The Concept of "Statistical Morality"
The Scottish writer, Andrew Lang, once mused that some people use “statistics as a drunken man uses lamp posts – for support rather than for illumination.” In Beecher's article, medical statistics is discussed in a different sense, within a concept known as "statistical morality."
In its simplest sense, statistical morality recognizes that a situation changes when viewed in human terms, instead of in the abstract. For example, does a risk become statistically insignificant simply because it occurs in only one case out of a million? Most researchers would tend to agree. But what happens if you are that one unlucky case? In that context, you would be just as dead as if the risk were extended to an entire population.
Beecher inverts the concept to bring it to an unpleasant conclusion: “Instead of a little risk for many... [we] have great risk (death) for a few.” The choice involves jeopardizing the life of a single individual in the hope that “more lives will be saved in the end.”
Beecher, however, goes on to argue that if the best research is inherently unpredictable and new, then its “risk cannot be known; therefore, valid consent can hardly be obtained” under any conditions. For Beecher, the "fallacy" of any discussion about informed consent is not that consent should not be sought, but rather that it can never be fully attained.
Ironically, the most interesting parts of this 1962 article are not Beecher's opinions on informed consent, but the thoughts expressed in the "comment" section at the end of the editorial.
True Ethicist, or Reluctant Moralist?
In the 1960s, it was common practice for journals to publish the correspondence between an editor and an author – especially if the communication shed light on the article. Beecher freely acknowledged editor Walter Modell's influence on the published editorial. But what was the nature of that influence?
In the "comment" section, the answer is clear. Modell (1962) claimed that, “Western civilization accepts medicine as an experimental discipline.” Thus, “when society confers the degree of physician on a man it instructs him to experiment on his fellow.”
Taking this to its logical conclusion, Modell advised Beecher that “when a patient goes to a modern physician for treatment...he is also unconsciously presenting himself for the purpose of experimentation.”
Even nearly a half century later, those words are chilling to many readers. In the eyes of the editor who Beecher praised, a physician did not need a patient's consent to experiment. The fact that Beecher not only endorsed this attitude, but also incorporated it in his editorial might be viewed as disturbing. It also raises questions about whether Beecher was a true moralist, or a reluctant ethicist.
References
Beecher HK. 1962. Some fallacies and errors in the application of the principle of consent in human experimentation. Clin Pharmacol Ther. 2:141–145.
Modell W. 1962. Comment. Clin Pharmacol Ther. 2:145–146.
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