BACKGROUND Living labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far. OBJECTIVE Our aim was to determine a pragmatic, ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context. METHODS A narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed. RESULTS Individuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 'A's Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). CONCLUSIONS Including individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population.

中文翻译：

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如何处理参与欧洲老年生活实验室的认知障碍成年人的同意？

背景技术生活实验室是设计用于在技术开发人员和最终用户（即主要是老年人）之间建立联系的现实环境。LLH（健康生活实验室）的研究涵盖从非干预性研究到 CT（临床试验）的广泛研究，并且应涉及神经认知障碍患者。然而，迄今为止，LLH 研发项目的设计、开发和实施所引发的伦理问题很少引起人们的兴趣。目的 我们的目的是根据欧洲 LLH 进行的不同类型的研究，重点关注法国背景，确定一种务实、道德和监管的正确方法，以寻求神经认知障碍患者的知情同意。方法 对监管文本和临床文章进行叙述性审查，并提出了确定 LLH 老年人决策能力的务实程序。结果 个人必须充分知情并自由同意参与 CT。应通过 CT 评估同意能力，包括认知障碍的老年人。我们建议采取以下步骤：首先使用 4'A 测试 (4AT) 或 3 分钟混乱诊断访谈评估方法 (3D-CAM) 评估谵妄，其次寻找主要神经认知障碍的病史，第三使用加州大学圣地亚哥分校同意能力简要评估 (UBACC) 来评估决策能力。结论 将患有神经认知障碍的个体纳入研究意味着使用有效且务实的策略来告知参与者并获得他们的同意。我们在此提供的工具可能对 LLH 的常规操作有用，但也可以扩展到该人群的所有 CT。