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The Doctor Knows Best

Physicians in the United States gradually became willing to concede that the use of unconsenting subjects in experiments that could not benefit them was a dangerous encroachment of science on personal privacy. But therapeutic research-studies involving sick patients who might in some way benefit from experimental treatment-was a different story. Doctors jealously guarded the “therapeutic privilege,” the right to withhold information from patients.

Although the field of medicine was changing rapidly, the culture of medical practice still operated largely on an old- fashioned, paternalistic model. According to this view, the trusting, nearly sacred relationship between doctor and patient was based on the premise that the doctor knows best; a good patient was defined as a compliant one. Even if the physician’s care involved the use of experimental drugs or devices as part of a scientific study, doctors were reluctant to involve patients in making decisions about their own care.

Nothing symbolized doctors’ fears of intrusion into their relationships with patients more than consent forms. In the early 1950s consent forms were used in certain exceptional cases (such as invasive procedures that simply could not be performed without a patient’s knowledge and cooperation) but not in the vast bulk of therapeutic research. For the most part, the privacy of the doctor-patient relationship was accepted as serving the public interest.

The philosophy of medical paternalism was codified in the 1964 Helsinki Declaration. Partly in response to the consent problems posed by the Nuremberg Code, the World Medical Association had begun deliberations to formulate its own research code in 1953. The resulting document drew a sharp line between therapeutic and nontherapeutic research; doctors were not required to obtain consent for experimental procedures performed on their patients if this requirement was not “consistent with patient psychology.” This might apply, for instance, to terminally ill patients who could become depressed and unwilling to undergo further treatment if informed of their prognoses.

Few doctors involved in research in the 1950s paused to reflect on the contradictions between their own roles as caregivers and as researchers-the so-called double-agent problem. For example, from the 1940s through the early 1960s, scientists performed a series of secret, government-sponsored radiation experiments on patients who were hospitalized, institutionalized, or seeking treatment for other conditions (such as pregnancy), often without obtaining the patients’ consent. When records of these experiments recently became public, they provoked widespread outrage. At the time, however, there was no mechanism requiring scientists to obtain consent from their subjects. And even though the researchers must have been aware of the existence of the Nuremberg Code, it is doubtful that they felt its provisions applied to research conducted in the context of the doctor-patient relationship.

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