Ries Nola M, Thompson Katie A, Lowe Michael
Faculty of Law, University of Technology Sydney, Broadway, NSW, 2007, Australia.
School of Law, University of Newcastle, Callaghan, NSW, 2308, Australia.
J Bioeth Inq. 2017 Sep;14(3):359-374. doi: 10.1007/s11673-017-9794-9. Epub 2017 Jun 20.
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.
研究对于增进对痴呆症的了解至关重要，但目前该疾病的负担超过了研究活动。研究往往将患有痴呆症和其他认知障碍的人排除在外，因为研究人员和伦理委员会担心与能力、同意和替代决策相关的问题。在澳大利亚，认知障碍者参与研究受一项国家伦理声明以及一系列各州和领地法律的约束，这些法律的规则差异很大。我们认为，这种立法差异排除了研究治理和参与的一致方法，并阻碍了旨在纳入能力受损者的研究。在本文中，我们提出关键的伦理原则，全面审查澳大利亚各州和领地适用的法律规则，并突出显著差异和模糊之处。我们的分析包括改革建议，以提高法律的清晰度和一致性，并减少可能将痴呆症患者排除在经伦理批准的研究之外的障碍。我们的建议旨在推进澳大利亚法律改革委员会推荐的国家决策原则，该原则强调所有成年人做出自己决定的权利，以及能力受损者获得适当支持以帮助他们做出影响其生活的决定的权利。
