<p>In the 1950s the pediatrician Helmut Ries wanted to impel a&#xa0;discussion about ethics in human subject research by criticizing various medical experiments on patients that he deemed ethically questionable. He referred in this argumentation to the German guidelines for human subject research from 1931 (“Reichsrichtlinien”). His manuscript “Nil nocere!” caused several years of correspondence with different journals and the German Society for Pediatrics (Deutsche Gesellschaft für Kinderheilkunde, DGfK, now DGKJ), who refused to publish Ries’ work. Instead, the DGfK organized an internal survey. The correspondence and responses from this survey are preserved in the “Ries file” in the DGKJ archives.</p><p>A&#xa0;qualitative content analysis was conducted to examine the 32&#xa0;responses received, enabling analysis and historical reconstruction of the central statements. The results indicate that most respondents regarded research ethics as important but were opposed to a&#xa0;public debate on the subject. Only a&#xa0;minority advocated a&#xa0;public discussion or expressed positive views on the “Reichsrichtlinien” of 1931. Many were particularly concerned about the potential for sensation reporting and the risk that regulatory measures might impose restrictions on medical research.</p><p>In the early post-war period, leading pediatricians in Germany believed that self-regulation and personal responsibility were sufficient, viewing state regulation as a&#xa0;hindrance to research. It was not until the 1978 version of the German “Arzneimittelgesetz” (German Drug Act) that mandatory ethical regulations for patient protection were incorporated into medical practice.</p>

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Nil nocere! Experiment und Forschung am Krankenbett

  • Klaus Schepker,
  • Chinyere Jennifer Igwe,
  • Matthias Schwab,
  • Thomas Beddies,
  • Andreas Artlich

摘要

In the 1950s the pediatrician Helmut Ries wanted to impel a discussion about ethics in human subject research by criticizing various medical experiments on patients that he deemed ethically questionable. He referred in this argumentation to the German guidelines for human subject research from 1931 (“Reichsrichtlinien”). His manuscript “Nil nocere!” caused several years of correspondence with different journals and the German Society for Pediatrics (Deutsche Gesellschaft für Kinderheilkunde, DGfK, now DGKJ), who refused to publish Ries’ work. Instead, the DGfK organized an internal survey. The correspondence and responses from this survey are preserved in the “Ries file” in the DGKJ archives.

A qualitative content analysis was conducted to examine the 32 responses received, enabling analysis and historical reconstruction of the central statements. The results indicate that most respondents regarded research ethics as important but were opposed to a public debate on the subject. Only a minority advocated a public discussion or expressed positive views on the “Reichsrichtlinien” of 1931. Many were particularly concerned about the potential for sensation reporting and the risk that regulatory measures might impose restrictions on medical research.

In the early post-war period, leading pediatricians in Germany believed that self-regulation and personal responsibility were sufficient, viewing state regulation as a hindrance to research. It was not until the 1978 version of the German “Arzneimittelgesetz” (German Drug Act) that mandatory ethical regulations for patient protection were incorporated into medical practice.