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Guardianship and Administration Act – the law on medical research procedures involving adult patients under a legal incapacity

The Guardianship and Administration Act 1986 (the Act) sets out the law that governs when a medical research procedure can be performed on a person aged 18 years or older who has a disability (that is, an intellectual impairment, mental disorder, brain injury, or physical disability or dementia), where that person is incapable of deciding whether to consent to the procedure.

Prior to 15 July 2006, the Act required the approval of the Victorian Civil and Administrative Tribunal (VCAT) for the involvement of such a patient in a medical research procedure. On 15 July 2006 amendments to the Act came into effect which removed the requirement for VCAT consent. A different series of steps must now be complied with instead. This information paper provides an overview of these new provisions, together with a flow chart.

Guardianship and Administration Act – the law on medical research procedures involving adult patients under a legal incapacity - July 2006 (MS Word file 195KB)

Approval process for medical research procedures to be performed in Victoria on adults with a disability who lack capacity to consent - Flow Chart - June 2006 (PDF file 17KB)

A key change in the legislation is the requirement that where a medical research procedure is to be performed on a person with a disability who is unable to consent, it is legally required that the research project for the purposes of which the procedure is to be performed, must be approved by a Human Research Ethics Committee (HREC).

When such an approval is obtained, a registered medical or dental practitioner can only perform, or supervise the performance, of such a medical research procedure on a particular patient under the Act if satisfied that the statutory criteria are met, in the case of that patient.

The website of the Office of the Public Advocate contains information about the Act for patients and their families. This includes information about the laws regarding medical research procedures, and when a “person responsible” for a patient can consent to such a procedure. It is available at http://www.publicadvocate.vic.gov.au (go to “publications” and “medical consent”)

Contact

Policy Instruments Development and Review Unit
Metropolitan Health & Aged Care Services Division
Department of Human Services

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