title: [Research on humans suffering from dementia].
abstract: The urgent necessity for dementia research is justified by the prevalence and increase in dementia associated with the demographic changes, for which no causal treatment is available; however, during the progressive course dementia destroys the capacity for self-determination of persons affected and thereby an essential prerequisite for participation in research, i.e. a valid consent to a research intervention. Accordingly, not only sufficient information about all issues which are relevant for decision making by potential participants but also a flawless assessment of the capacity to consent are important; however, currently this is not satisfactorily possible. This article attempts to answer questions associated with these problems, such as how consent can be established, including that of a surrogate for consent of potential research participants by whom consent is no longer possible. In a second section the benefit-risk evaluation, which is also underdeveloped, will be dealt with using two concrete research examples, a diagnostic and a therapeutic research intervention for patients with dementia.
authors.affiliation: Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200, Berlin, Deutschland, hanfried.helmchen@charite.de.
authors.forename: H
authors.initials: H
authors.lastname: Helmchen
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D003704:Dementia / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy*; D006302:Health Services Research / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D010358:Patient Participation / Q000379:methods*; D018579:Patient Selection; D010361:Patients