Date: 03 Jan 2012

Ethics of clinical research with mentally ill persons

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This article describes ethical, legal and professional components of the two core requirements of clinical research: informed consent and risk–benefit relationships. It deals particularly with the ethically relevant reasons, criteria, procedures and validity of (1) the informed consent process, (2) the relationship between benefits and risks, and as a requirement of its assessment: (3) standards and (quasi quantitative) criteria of benefits and risks and/or burdens of a research intervention. These requirements will be discussed with specific reference to research interventions in mentally ill patients, and particularly in those who are incompetent to consent. (4) The analysis concludes by demanding a strong adherence to the ethical rules of clinical research in order to protect participants and preserve the trust of both the patients and the public and (5) yields in a set of recommendations.

The text is related to discussions in the Interdisciplinary Working Group “Clinical research in vulnerable populations” of the Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen, Bad Neuenahr and the Berlin-Brandenburgische Akademie der Wissenschaften, Berlin. However, the responsibility for the text and the conclusions is only with the author.