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001     202284
005     20210129220112.0
024 7 _ |a 10.1007/s00481-015-0359-3
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024 7 _ |a 0935-7335
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024 7 _ |a 1437-1618
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024 7 _ |a WOS:000377439800002
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037 _ _ |a FZJ-2015-04555
041 _ _ |a German
082 _ _ |a 100
100 1 _ |a Schütz, Holger
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245 _ _ |a Informierte Einwilligung in der Demenzforschung. Eine qualitative Studie zum Informationsverständnis von Probanden.
260 _ _ |a Berlin
|c 2016
|b Springer
336 7 _ |a article
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336 7 _ |a ARTICLE
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520 _ _ |a BackgroundInformed consent is a legal as well as ethical prerequisite in clinical research. For dementia research, informed consent can be a problem if subjects with dementia, whose capacity for understanding and thus also decision making might be limited, are to be examined. This might result in exclusion of dementia patients from research, as capacity for understanding and decision making are often equated with the ability for rational decision making. However, this valuation has been criticized at times for attaching too much importance to the cognitive aspect of decision making.MethodsThis qualitative study investigates the actual consent procedure of a clinical research study in Germany with regard to dementia patients’ subjective and objective understanding of informed consent information. Research participants were ten dementia patients, who volunteered in two clinical research studies, as well as their caregivers. Data were collected by use of semi-structured interviews.ResultsIt was determined that the patients’ comprehension of informed consent information was rather limited. However, a number of patients were quite aware of this. In contrast, all caregivers claimed to have fully understood the provided information, while their objective comprehension was also incomplete. Several participants indicated that they did not attach much importance to the information given in the consent procedure and that their consent did not primarily depend on this information. Rather, participation in the research study for them seemed to be more of a problem-focused coping strategy for dealing with their diagnosis of dementia.ConclusionFor research ethics these results raise the question whether the currently prevailing emphasis on the cognitive aspect of autonomous decision making, i.e., comprehension, may be too one-sided, and to what extent the “volitional” aspect in giving consent should be given greater consideration.
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700 1 _ |a Heinrichs, Bert
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700 1 _ |a Fuchs, M.
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700 1 _ |a Bauer, Andreas
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