Original Paper

European Archives of Psychiatry and Clinical Neuroscience

, Volume 262, Issue 5, pp 441-452

First online:

Ethics of clinical research with mentally ill persons

  • Hanfried HelmchenAffiliated withDepartment of Psychiatry and Psychotherapy, Charité–University Medicine Berlin, CBF Email author 

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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.


Ethics of psychiatric research Mentally ill subjects Incapacity to consent Standards of benefits and risks Risk–benefit relationship