Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decision-making principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.
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Despite a process for National Mutual Acceptance of the scientific and ethical review of multisite human research in Australia (NSW Government 2017a), jurisdiction specific laws impose varying consent and substitute decision-making rules that must be followed.
The National Statement is produced by the National Health and Medical Research Council in accordance with its statutory obligations under s10 of the National Health and Medical Research Council Act 1992 (Cth) to issue guidelines for research involving humans.
The four national decision-making principles contained in the report (2014, 11) are:
The equal right to make decisions: All adults have an equal right to make decisions that affect their lives and to have those decisions respected.
Support: Persons who require support in decision-making must be provided with access to the support necessary for them to make, communicate, and participate in decisions that affect their lives.
Will, preferences, and rights: The will, preferences, and rights of persons who may require decision-making support must direct decisions that affect their lives.
Safeguards: Laws and legal frameworks must contain appropriate and effective safeguards in relation to interventions for persons who may require decision-making support, including to prevent abuse and undue influence.
In Schloendorff v Society of New York Hospital (1914) 211 NY 125, Cardozo J famously wrote that “[e]very human being of adult years and sound mind had has a right to determine what shall be done with his own body” (at 129). This principle has been adopted in Australian law: see for example, Rogers v Whitaker  HCA 58 and Hunter and New England Area Health Service (2009) 74 NSWLR 88.
At the time of writing, the NSW Guardianship Act 1987 is under review and the NSW Law Reform Commission has been charged, inter alia, with examining the statutory rules concerning clinical trials (NSW Government 2017b).
A submission to the NSW Government about the Guardianship Act 1987 (NSW) reform noted that it took eighteen months to obtain a tribunal decision on a research study that sought to include people with impaired capacity (South Eastern Sydney Local Health District Human Research Ethics Committee 2016).
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Ries, N.M., Thompson, K.A. & Lowe, M. Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform. Bioethical Inquiry 14, 359–374 (2017). https://doi.org/10.1007/s11673-017-9794-9
- Research ethics
- Substitute decision-making
- Advance directives