Human experimentation in historical and ethical perspectives

Prepared as background material for a World Health Organization/Council for International Organizations of Medical Sciences document, Proposed International Guidelines for Biomedical Research Involving Human Subjects (1982), this article reviews historical aspects of human experimentation and considers several current issues. It refers to early experiments, including auto-experiments by physicians; traces the history of drug trials through the pharmacotherapeutic revolution and the thalidomide tragedy; and describes the formulation of ethical requirements during the Weimar Republic in Germany. Contemporary problems discussed are the use of controls and placebos, investigators as subjects, special categories of subjects, and informed and vicarious consent. The text of the proposed WHO/CIOMS Guidelines is appended.