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.
Mots-clés Pascal : Ethique, Consentement éclairé, Recherche scientifique, Démence Alzheimer, Traitement, Chimiothérapie, Aptitude, Vieillard, Homme, Système nerveux pathologie, Système nerveux central pathologie, Encéphale pathologie, Maladie dégénérative
Mots-clés Pascal anglais : Ethics, Informed consent, Scientific research, Alzheimer disease, Treatment, Chemotherapy, Ability, Elderly, Human, Nervous system diseases, Central nervous system disease, Cerebral disorder, Degenerative disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 96-0439824
Code Inist : 002B30A09. Création : 10/04/1997.