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ETHICS OF ‘INFORMED CONSENT’ IN DEMENTIA RESEARCH—THE DEBATE CONTINUES
Author(s) -
AGARWAL MANOJ R.,
FERRAN JOSE,
OST KATHERINE,
WILSON KENNETH C. M.
Publication year - 1996
Publication title -
international journal of geriatric psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.28
H-Index - 129
eISSN - 1099-1166
pISSN - 0885-6230
DOI - 10.1002/(sici)1099-1166(199609)11:9<801::aid-gps379>3.0.co;2-h
Subject(s) - informed consent , dementia , test (biology) , commission , psychology , clinical trial , relevance (law) , medicine , disease , family medicine , psychiatry , law , alternative medicine , political science , paleontology , pathology , biology
The Law Commission has recently proposed a legal test of capacity to consent to treatment. Consent to treatment in phase three trials in Alzheimer's disease is usually obtained from both the subject and a carer or next of kin. This article examines the relevance of the Law Commission recommendations in accessing informed consent from early dementia sufferers and their carers subjected to a double‐blind, placebo‐controlled trial of a potentially therapeutic agent. A total of 15 subjects were administered questionnaires to determine whether they fulfilled the criteria (as laid down by the Law Commission) for capacity to give informed consent. Carers were given a similar questionnaire to assess their understanding of subjects’ capacity to consent and to assess whether consent was a ‘true choice’. None of the subjects fulfilled all the recommended criteria. Four of the subjects probably did not exercise an ‘independent will’ to give informed consent and therefore failed the ‘true choice’ test. Is a single ‘test’ for informed consent, with stringent criteria, likely to impede future research activity in dementia patients? The role and involvement of carers in the decision‐making process need to be considered so that subjects are not unnecessarily excluded.