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<p>After 1945 the West German society underwent profound social and cultural changes, which also affected the field of medicine. This development also applied to the legal and ethical standards of drug research. Since the late nineteenth&#xa0;century, any medical intervention had been considered an infringement of bodily integrity, the legality of which depended on an effective consent. Even though there were initially no specific legal regulations governing this, the requirements for consent and information were steadily increased from the middle of the twentieth&#xa0;century onwards. When testing new drugs, the experimental nature of the trial had to be pointed out. For minors, the decision-making authority fundamentally lay with the parents; non-therapeutic experiments on children and adolescents were assessed particularly restrictively from an early stage and were in some cases expressly prohibited. In addition to the law, medical ethics guidelines gained importance after 1945. The experiences of Nazi medical crimes led to the Nuremberg Code and later the Declaration of Helsinki, which clearly emphasized voluntary, informed consent as an indispensable prerequisite for any research involving human subjects. Nevertheless, the clinical practice remained ambivalent. Written consent was by no means a&#xa0;matter of course and particularly when testing drugs on children, there was often a&#xa0;gray area between therapeutic necessity and experimental risk. The history of drug research thus appears less as a&#xa0;legal vacuum and more as an area of tension between normative guidelines, the medical profession’s self-image, and changing ideas about patient autonomy.</p>

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Arzneimittelforschung an Kindern und Jugendlichen in Westdeutschland 1945–1975

  • 期刊论文

  • 发表日期：

    2026年5月15日

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  • Niklas Lenhard-Schramm

摘要

After 1945 the West German society underwent profound social and cultural changes, which also affected the field of medicine. This development also applied to the legal and ethical standards of drug research. Since the late nineteenth century, any medical intervention had been considered an infringement of bodily integrity, the legality of which depended on an effective consent. Even though there were initially no specific legal regulations governing this, the requirements for consent and information were steadily increased from the middle of the twentieth century onwards. When testing new drugs, the experimental nature of the trial had to be pointed out. For minors, the decision-making authority fundamentally lay with the parents; non-therapeutic experiments on children and adolescents were assessed particularly restrictively from an early stage and were in some cases expressly prohibited. In addition to the law, medical ethics guidelines gained importance after 1945. The experiences of Nazi medical crimes led to the Nuremberg Code and later the Declaration of Helsinki, which clearly emphasized voluntary, informed consent as an indispensable prerequisite for any research involving human subjects. Nevertheless, the clinical practice remained ambivalent. Written consent was by no means a matter of course and particularly when testing drugs on children, there was often a gray area between therapeutic necessity and experimental risk. The history of drug research thus appears less as a legal vacuum and more as an area of tension between normative guidelines, the medical profession’s self-image, and changing ideas about patient autonomy.