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  • Title: [Ethical and legal problems in first clinical trials of psychotropic drugs (author's transl)].
    Author: Helmchen H.
    Journal: Arzneimittelforschung; 1978; 28(8):1253-6. PubMed ID: 380572.
    Abstract:
    Starting with the relevant national and international guidelines and legal regulations for clinical trials and with the distinction of therapeutical experimentation, therapeutical trial ("Heilversuch") and standard therapy the following points are discussed: a) informed consent in psychically ill patients with restricted capacity for stress and for insight and consent, b) consequences for insurances, c) advice and control for the researcher regarding the design, the performance and the judgment of the results of clinical trials of psychotropic drugs.
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