In 1930, the large‐scale introduction of the BCG vaccination in the city of Lübeck in northern Germany led to a major scandal that focused public attention on medical experimentation with human beings as well as reviving criticism of the medical profession that had been voiced before. The trial following the catastrophe raised the first clearly identifiable public discussions on medical ethics in Europe, and led to the establishment of the first regulations for medical research on human beings in the western hemisphere; the German ‘Richtlinien’ of 1931. In 1935, Ludwik Fleck (1896–1961) published a now classic monograph entitled Genesis and Development of a Scientific Fact. The central hypothesis of this article is that, when Fleck published his book four years after the Lübeck trial, he was proposing answers to questions raised, at least partially, by the Lübeck case, although he never explicitly mentions it. Most interestingly, Fleck proposed a different approach to the fundamental dilemma of modern experimental medicine, the potential opposition between an individual's well‐being, and the production and application of scientific knowledge in medicine. Where the standard answer to these questions has, since the 1930s, become moral reasoning and ethical regulation, known today as bioethics, Fleck portrays a different approach that could be characterized as the attempt to foster a deeper and more democratic understanding of science through an examination of its intimate functioning.

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