Ethics of clinical research with mentally ill persons

Original Paper

DOI: 10.1007/s00406-011-0287-2

Cite this article as:
Helmchen, H. Eur Arch Psychiatry Clin Neurosci (2012) 262: 441. doi:10.1007/s00406-011-0287-2


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 researchMentally ill subjectsIncapacity to consentStandards of benefits and risksRisk–benefit relationship

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  1. 1.Department of Psychiatry and PsychotherapyCharité–University Medicine Berlin, CBFBerlinGermany