Jefferson AL, Lambe S, Moser DJ, Byerly LK, Ozonoff A, Karlawish JH.
Decisional capacity for research participation in individuals with mild cognitive impairment.
J Am Geriatr Soc. 2008 Jul;56(7):1236-43.
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In our state (QLD, Australia) there is a guardianship tribunal that is able to provide approval for clinical trial participation by people with dementia who lack capacity. Depending upon the nature of the study, the tribunal might require submissions on a case by case basis or it might provide overall approval contingent upon the patient assenting and a substitute decision maker providing consent. Studies on marketed pharmaceuticals (e.g., donepezil) are more likely to be granted overall approval, whereas studies on novel agents (e.g., monoclonal antibodies) will require case by case submissions for approval.
The tribunal is required to ensure that the following conditions are met:
"(a) the special medical research or experimental health care is approved by an ethics committee;
(b) the risk and inconvenience to the adult and the adult’s quality of life is small;
(c) the special medical research or experimental health care may result in significant benefit to the adult or other persons with the condition;
(d) the special medical research or experimental health care cannot reasonably be carried out without a person who has or has had the condition taking part;
(e) the special medical research or experimental health care will not unduly interfere with the adult’s privacy." (1)
In Australia, human research ethics committees are increasingly interested in the methods employed to determine capacity and in whether a guardianship tribunal (or similar body) is involved in decision-making.
Guardianship and Administration Act 2000 (Queensland Government). Section 72.