Statutory regimes relating to third party consent by patients with Alzheimer’s type dementia

Clinical trials on human subjects in Australia have to be conducted in accordance with written protocols which have been submitted for approval to a relevant Institutional Ethics Committee (IEQ whose main function is to act as a guardian of the interests of human subjects of research guided by the principle that the rights of the research subjects should take priority over the advancement of knowledge. The ethical and legal questions posed by clinical trials on patients suffering from Dementia include: 1. the ability of potential participants suffering from early stages of Dementia to grant valid consent; 2. the ability of the IECs to monitor the progress of cognitive impairment in those participants who have previously granted consent; 3. the ability of the IECs to scrutinise the validity of consent to participation in clinical trials granted by third parties on behalf of severely demented patients. The article discusses ethical concerns and legal problems associated with granting a “third party consent” on behalf of legally incompetent persons to experimental medical trials in Victoria, in particular, the agency provisions of the Medical Treatment Act 1994 (ACT) and the Medical Treatment Act 1988 (Vic).