Ethics of 'informed consent' in dementia research - The debate continues
M.R. Agarwal
Bok Engelsk 1996
| Utgitt | 1996
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| Omfang | Side 801- 806
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| Opplysninger | The Law Commission has recently proposed a legal test of capacity toconsent to treatment. Consent to treatment in phase three trials inAlzheimer's disease is usually obtained from both the subject and acarer or next of kin. This article examines the relevance of the LawCommission recommendations in accessing informed consent from earlydementia sufferers and their carers subjected to a double-blind,placebo-controlled trial of a potentially therapeutic agent. A totalof 15 subjects were administered questionnaires to determine whetherthey fulfilled the criteria (as laid down by the Law Commission) forcapacity to give informed consent. Carers were given a similarquestionnaire to assess their understanding of subjects' capacity toconsent and to assess whether consent was a 'true choice', None ofthe subjects fulfilled all the recommended criteria. Four of thesubjects probably did not exercise an 'independent will' to giveinformed consent and therefore failed the 'true choice' test. Is asingle 'test' for informed consent, with stringent criteria, likelyto impede future research activity in dementia patients? The role andinvolvement of carers in the decision-making process need to beconsidered so that subjects are not unnecessarily excluded.
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