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3 Experimentation on Humans and Informed Consent: How We Arrived Where We Are Rolf Winau The practice of experimenting on humans dates back to antiquity, but we know few details from that time.The notion of experimental research came to fruition only once medicine had detached itself from the dogmatism of the ancient and medieval eras—that is, once the physician’s own eyes and what they observed, rather than the authority of the ancients, became the main point of reference for medical practice. In the course of the eighteenth century we observe sporadic individual experiments , some tending to be rather bizarre. But we also see a number of experimenters who did much to advance the theory and methodology of experimentation . Here I will discuss the experiments performed by only two of these, James Lind and Anton Störck. In 1747, Lind documented in a clinical test, aboard a sailboat, that citrus fruits were superior in combating scurvy. Lind, who can count as our representative of the establishment of the clinical experiment, otherwise still operates within the notions of the doctor-patient relation prevalent since antiquity. The doctor knows what is right for the patient and will not act to the patient’s detriment. Anton Störck’s position ends up looking similar. Störck set new standards in experimental medicine through his research on hemlock. His methodology was new and exemplary, but neither he nor his critics worried about the patient’s consent. This topic remained outside the categories of thought of the time (see Zumstein 1968). Similarly, in theoretical literature there are only occasional references to informing and consenting. Johann Friedrich Gmelin, for example, remarks in his Geschichte der Gifte (History of the poisons) of 1776 that experiments were limited to being performed on “wrongdoers and our own person” (Gmelin 1776– 77, 1:34). Georg Friedrich Hildebrandt argued similarly in his Versuch einer philosophischen Pharmakologie (Essay in philosophical pharmacology). He called for a multi-tier system of experimentation: in vitro testing—animal testing—human testing. It is in this context that the theoretical writing of the Enlightenment epoch on the subject touches on, though only implicitly, the question of consent (Hildebrandt 1786, 78). Hildebrandt similarly imposes detailed guidelines on the experimental healing of humans. In this context, however, the patient’s right to information and the question of consent did not arise for him. In another set of detailed directions , published by Johann Christian Reil and, independently, by Adolph Friedrich Nolde in 1799, the question is left similarly unmentioned (Reil 1799, 26–44; Nolde 1799, 1 St., 47–97, 2 St. 75–116). Summarizing this, we can say: the ¤rst phase of human testing leads to the development of a methodology of testing as well as to experimental healing, without leading to a notion of a patient’s rights (see Winau 1971). At ¤rst glance, informed consent appears to be a phenomenon of the most recent history of medicine, thematized at some point during the second half of the twentieth century. The date 1947 is often given as the origin of informed consent, when the notion arose in the context of the Nuremberg Codex. Another date often advanced is 1957, being the year of the ¤rst Supreme Court decision on the subject in the U.S.1 The question, whether there were indeed discussions about informed consent before these dates, and, if so, how far back these discussions go in history, has been subject to much debate and controversy (Katz 1984; Pernick 1982). But in researching this issue, I found little such discussion in the sources. Occasionally, formulations in eighteenth-century sources are open to rather easy misinterpretation. John Gregory is a good example; by and large, his arguments revolve around familiar notions of a paternalistic doctor-patient relationship . Single sentences picked out of context cannot really be adduced as documentation for a supposed call for patients’ rights. Rather, scanning the eighteenth-century literature on the topic, we ¤nd the same line of argumentation repeated: informing patients is linked to the philosophical Enlightenment, often with direct reference to Kant’s dictum of the “emergence of man from his self-caused immaturity.” Johann Karl Osterhausen, for example, in his book Über medicinische Aufklärung (On medical enlightenment) of 1798, demands the “emergence of man from his self-caused immaturity in matters of his physical health.” Scienti¤c Enlightenment and popular Enlightenment are the two main pillars of his project. He mentions the Universal Rights of Man as “the most...

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