title: Competence to give informed consent to clinical studies. Statement by the taskforce on "ethical and legal questions" of the Association for Neuropsychopharmacology and Pharmacopsychiatry ("Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie [AGNP]").
abstract: Over the last 50 years, patient autonomy has become an increasingly important part of the principles of medical ethics, or rather of the ethics of the doctor-patient relationship. While the principle of charity and the associated paternalism became less important, the patient's active consent became more and more relevant (Sass, 1989; Bayer, 1998; Nedopil, 1998). This development was inevitably also accompanied by a demand for more detailed information prior to medical interventions (Appelbaum and Grisso, 1988; Weisstub, 1990; Kreussler, 1997; Ulsenheimer, 1995; Laufs, 1997; Sommer, 1997) and for complete information on medical procedures subsequent to interventions (e. g. Bender, 1997). Determination of a person's competence to give informed consent is a central problem in the assessment of his expression of consent to a medical intervention. The capacity to adequately express consent can be impaired at certain stages of life and during some illnesses. Patients in borderline situations, children, mentally ill patients and old people with dementia may either be limited in their capacity to give informed consent, or be completely unable to do so. This results in special ethical problems when such groups are included in research projects.
authors.affiliation: Department of Forensic Psychiatry, Psychiatric Hospital, Munich, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Nedopil
authors.forename: J
authors.initials: J
authors.lastname: Aldenhoff
authors.forename: K
authors.initials: K
authors.lastname: Amelung
authors.forename: F X
authors.initials: FX
authors.lastname: Eich
authors.forename: J
authors.initials: J
authors.lastname: Fritze
authors.forename: M
authors.initials: M
authors.lastname: Gastpar
authors.forename: W
authors.initials: W
authors.lastname: Maier
authors.forename: H J
authors.initials: HJ
authors.lastname: Möller
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D011600:Psychopharmacology / Q000592:standards*; D012106:Research / Q000592:standards*