Demented subjects' competence to consent to participate in field studies: the Berlin Ageing Study.
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.
Geiselmann
B
B
Academy of Sciences and Technology Berlin, Department of Psychiatry, Freie Universität Berlin, Germany.
Helmchen
H
H
D000368:Aged; D000375:Aging; D035841:Behavioral Research; D001604:Berlin; D003430:Cross-Sectional Studies; D003704:Dementia / Q000523:psychology*; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D026684:Personal Autonomy; D012106:Research; D035842:Research Subjects; D018570:Risk Assessment; D012720:Severity of Illness Index