Faculty of Law, University of Technology Sydney, PO Box 123, Broadway, NSW 2007, Australia.
Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.
Int J Law Psychiatry. 2020 Jan-Feb;68:101534. doi: 10.1016/j.ijlp.2019.101534. Epub 2019 Dec 11.
People with dementia are under-represented in clinical research, in part due to the ethical and legal complexities of involving people in studies who may lack capacity to consent. Excluding this population from research limits the evidence to inform care. The attitudes and practices of researchers are key to the inclusion of people with dementia in research, however, there are few empirical studies on researchers' perspectives in this area. A cross-sectional study involved researchers in Australia who had experience in the ethical aspects of conducting dementia-related studies with human participants (n = 70). Data were collected via an online survey from November 2017 to January 2018. Most respondents (97%) agreed with the importance of including people at all stages of dementia in research, yet around three-quarters of respondents perceived ethical and legal rules and processes as unduly restrictive or time-consuming. Researchers reported variable practices in assessing prospective participants' capacity to consent to their studies. Various tools are used for this purpose, ranging from tools designed for research (eg, MacArthur Competence Assessment Tool for Clinical Research) to more general cognitive function screens (eg, Mini Mental State Exam). Few respondents (14%) routinely exclude people from studies who are unable to give their own consent, but instead seek permission from proxy decision-makers, such as legally appointed guardians or family carers. Respondents reported positive and negative outcomes of ethics review processes. Positive outcomes included strengthening the protections for participants with cognitive impairment while negative outcomes included delays and inconsistent decisions from different ethics committees. The findings suggest a need for improved strategies in the research context to assess and enhance the decision-making capacity of people with dementia to support appropriate opportunities for inclusion. Education for ethics committees, proxy decision-makers and other gatekeepers is also needed to reduce barriers to participation in research.
痴呆症患者在临床研究中代表性不足，部分原因是在涉及可能缺乏同意能力的患者参与研究时存在伦理和法律方面的复杂性。将这部分人群排除在研究之外限制了为护理提供信息的证据。然而，研究人员的态度和做法是将痴呆症患者纳入研究的关键，但在这一领域，关于研究人员观点的实证研究很少。一项横断面研究涉及澳大利亚的研究人员，他们在涉及人类参与者的痴呆症相关研究的伦理方面具有经验（n=70）。数据通过 2017 年 11 月至 2018 年 1 月的在线调查收集。大多数受访者（97%）同意在研究中纳入所有痴呆症阶段的患者的重要性，但约四分之三的受访者认为伦理和法律规则和程序过于限制或耗时。研究人员报告了在评估潜在参与者同意参与其研究的能力方面存在不同的做法。为此目的使用了各种工具，范围从专为研究设计的工具（例如，麦克阿瑟临床研究能力评估工具）到更一般的认知功能屏幕（例如，简易精神状态检查）。很少有受访者（14%）例行将无法自行同意的人排除在研究之外，而是寻求代理人决策人的许可，例如法定指定的监护人或家庭照顾者。受访者报告了伦理审查过程的积极和消极结果。积极的结果包括加强对认知障碍参与者的保护，而消极的结果包括来自不同伦理委员会的延迟和不一致的决定。这些发现表明，需要在研究环境中制定更好的策略来评估和增强痴呆症患者的决策能力，以支持他们适当参与研究的机会。还需要对伦理委员会、代理人决策人和其他把关者进行教育，以减少参与研究的障碍。
