Der Nervenarzt
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The review deals with present problems of protecting mentally ill patients who are incompetent to give informed consent to participating in clinical research, and of assessment of the capacity to consent. 1. Clinical trials of drugs on efficacy and safety in incompetent patients are ethically justified and legally admissible if the investigational drug can be expected to exert a direct potential individual benefit and if such trials will be performed under defined criteria to protect these vulnerable patients. In Germany it is questionable how far these prescriptions of the German Drug Law (AMG) are transferable to other than drug research. 2. ⋯ However, the application of these criteria must be improved by practicable procedures. This is valid particularly for the assessment of the basic criterion whether a patient is capable of consenting or not. 5. Open Questions are formulated as need of research.