Ethical considerations implementing wearable sensors to record communication interactions by people with aphasia in the home and community

中风是一个重大的公共卫生问题，对数百万幸存者和 他们的照顾者。失语症是中风的常见后果，其影响范围超出了 由此导致的语言缺陷渗透到一个人生活的方方面面。康复的目标是 失语症患者改善沟通，并最终有意义地参与， 家庭和社区活动。母公司R01在以下方面衡量治疗结果 泛化，包括涉及使用多个可穿戴设备的探索性措施 监测设备：喉头传感器、长格式录音机和GPS。 这些可穿戴式监控设备的组合功能提供了一种创新的 有机会衡量参与者在家中的日常活动中的沟通行为 以及在他们的社区周围。然而，这些技术呈现了各种各样的生物伦理 对研究人员和参与者的挑战。对于失语症患者，有以下几种方法 由于语言障碍，增加了与知情同意程序相关的挑战 可能会影响决策的理解力或自主性。 本行政副刊对知情同意程序进行了调查，并重点介绍了 对失语症患者使用可穿戴监测设备的研究具有伦理重要性。我们 采取协作方式，从研究参与者、他们的家人以及 生物伦理学专家和其他研究人员。我们计划生成一系列建议 解决与这类研究相关的生物伦理挑战，以帮助该领域的其他人 并为未来的政策方向提供信息。具体而言，行政副刊旨在(1)开展 分析知情同意程序，以确定改进的机会和挑战 与人们将使用可穿戴监控设备时的知情同意过程相关 失语症；(2)对研究参与者和确定的家庭进行半结构化访谈 会员、照顾者和/或朋友描述他们在使用和 可穿戴式监控设备的影响；以及(3)生成一套建议，以促进 使用可穿戴监控设备进行研究的合乎道德的行为。

Stroke is a major public health issue with life-long consequences for millions of survivors and their caregivers. Aphasia is a common consequence of stroke whose impact reaches beyond the resulting language deficit into every aspect of a person’s life. The goal of rehabilitation for persons with aphasia is to improve communication, and ultimately meaningful participation, in home and community activities. The parent R01 measures treatment outcomes in terms of generalization and includes exploratory measures that involve the use of multiple wearable monitoring devices: laryngeal sensor, long-form audio recorder and GPS. The combined capabilities of these wearable monitoring devices present an innovative opportunity to measure communication behaviors in participants’ day-to-day activities at home and around their community. However, these technologies present a variety of bioethical challenges to researchers and participants. For persons with aphasia in particular, there are added challenges related to the informed consent process due to language impairments that may impact comprehension or autonomy in decision making. This administrative supplement investigates the informed consent process and highlights areas of ethical importance for research that uses wearable monitoring devices with people with aphasia. We take a collaborative approach to gather insight from research participants, their families as well as experts in bioethics and fellow researchers. We plan to generate a set of recommendations addressing the bioethical challenges associated with this type of research to assist others in the field and inform future policy directions. Specifically, the administrative supplement aims to (1) conduct an analysis of the informed consent process to identify opportunities for improvement and challenges related to the informed consent process when wearable monitoring devices will be used by people with aphasia; (2) conduct semi-structured interviews with study participants and identified family members, caregivers, and/or friends to describe their experience and attitudes regarding the use and implications of wearable monitoring devices; and (3) generate a set of recommendations to facilitate the ethical conduct of research that uses wearable monitoring devices.