Ethical guidelines in psychiatric research.

Capacity to consent is a basic prerequisite for participation of patients as probands in research. However, mental illness often impairs this competence. Therefore, in psychiatric research, the first obligation is to assess a mentally ill patient's competence to consent. This is not a simple task. Informed consent should be viewed not only as a legal must, but also as a chance to build up a trusting patient-psychiatrist relationship. This is called for by respect for the autonomy and dignity of the patient. Specifically, competence to consent is related to the specific intervention; the validity of a consent requires that the patient understands the intervention-related medical information, comprehends its significance and consequences, and can appreciate its meaning for himself. Research with patients who lack this competence to consent validly meets a major problem: an uncovered need for research in frequent major psychiatric disorders exists, but a substantial number of patients with these illnesses cannot consent validly. Several guidelines for dealing with this problem will be discussed. Mentally ill patients who are willing to participate in needed research are a rare resource. This must be protected by the virtue of the clinical researcher who has to take great pains over the strict adherence to ethical guidelines.