Demented Subjects' Competence to Consent to Participate in Field Studies: The Berlin Ageing Study
Medicine and Law. 1994; 13(1-2): 177-184.
A violation of the right to self-determination appears to be the main individual risk for participants in the Berlin Ageing Study, which is a community based non-therapeutic study with minimal health risk. In order to minimize the risk, a procedure to test the competence to consent to participate had to be introduced. To protect the participants' right to self-determination, basic capabilities of judgment and reasoning appear to be sufficient to give informed consent in this study. As a result of testing competency, 76% of the severely demented persons had to be excluded from the study, whereas a majority of the persons with mild to moderate dementia could be included.
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