Inclusion of Patients with Severe Mental Illness in Clinical TrialsIssues and Recommendations Surrounding Informed Consent

Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying.