Problems of informed consent for clinical trials in psychiatry

Abstract

The author begins by considering what kinds of questions should be used to establish informed consent, and particularly seeks to establish criteria for a valid consent; both for the person who asks the patient for consent, and for the person who judges the consent as a valid one. Then some variables—duration, severity and kind of illness, and type of personality—are considered that may influence consent. With regard to the discrepancy between the law and reality, it is proposed not to interpret the requirements of the law in a sense of all-or-none but as a demand that must be adapted adequately in content and in time to the individual patient and that they should be embedded in the therapeutic process that is an expression of the so-called “therapeutic privilege.” Finally, it is asked, what are the consequences of information and consent on the results of therapy as well as of research? The necessity of empirically based research to answer these unsolved questions is emphasized.