[Ethics and clinical drug trials].
During the last decade, biomedical ethics has known a rapid development. Research in man, including clinical drug trials, must now take into account ethical and legal requirements. The concept of the inviolability of the human person constitutes the basic tenet of biomedical ethics. Four main principles ensue: the principles of autonomy, of nonmaleficience, of beneficience and of justice. Some rules derive from them, for instance veracity, confidentiality, fidelity and respect of intimacy with regard to the subject of an experiment. From a practical standpoint, the design of a clinical trial must be scientifically sound, otherwise it cannot be ethical. An informed consent must be obtained, in written form, from the subject in a clinical trial and he must be aware of his right to withdraw from it at any moment. Moreover, the clinical trial must be monitored throughout its duration with respect to ethics. An ethics of the methodology of clinical trials must therefore exist. Ethics in research should be a way of thinking and behaving, inherent to the research training. The researcher should be keenly conscious of the ethical requirements involved in his work, if he wishes to avoid eventual external interventions.
Département de Psychiatrie, Faculté de Médecine, Université Laval, Sainte-Foy, Québec, Canada.
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Villeneuve
D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent
Ethique et essais médicamenteux.