Adult patients under a legal incapacity
Guidelines for medical research procedures
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.
Details of compliance with the Act must be included in your application.
Privacy legislation
Researchers must ensure that their proposal conforms to all relevant privacy legislation, including:
Information Privacy Act 2000 (Vic)
This Act regulates the responsible collection and handling of personal information (excluding health information) by organisations in the Victorian public sector.
Health Records Act 2001 (Vic)
This Act applies to all health information held in Victoria in the public or private sectors and includes the statutory guidelines for the purposes of Health Privacy Principles 1.1 (e) paragraph (iii) and 2.2 (g) paragraph (iii). The guidelines can be obtained from the Office of the Health Services Commissioner.
Privacy Act 1988 (Commonwealth)
Where researchers are seeking to obtain information in a Commonwealth setting, such as a nursing home, they should consult the guidelines under Section 95 and/or the guidelines approved under Section 95A of the Act.
The Common Application Form includes specific questions in relation to privacy issues, covering both Commonwealth and State legislation.
Researchers are responsible for providing sufficient information in their application to enable the HREC to determine whether the research represents any breach of the various Privacy legislation and, if so, whether the public interest in the research substantially outweighs the public interest in respecting privacy.
More information