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

使用可穿戴传感器记录失语症患者在家庭和社区中的交流互动的伦理考虑

• 批准号: 10594286
• 负责人: Leora R Cherney
• 金额: $ 16.23万
• 依托单位: REHABILITATION INSTITUTE OF CHICAGO D/B/A SHIRLEY RYAN ABILITYLAB
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-09 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594286
• 关键词: Address; Administrative Supplement; Aphasia; Area; Attitude; Behavior monitoring; Bioethics; Bioethics Consultants; Biomedical Engineering; Caregivers; Clinic; Cognitive; Communication; Communication impairment; Communities; Comprehension; Consent; Data; Decision Making; Development; Devices; Diagnosis; Dose; Due Process; Ethics; Family; Family member; Foundations; Friends; Funding; Future; Goals; Home; Informed Consent; Interview; Language; Language Disorders; Larynx; Legal; Life; Linguistics; Measures; National Institute on Deafness and Other Communication Disorders; Outcome; Parents; Participant; Patient Self-Report; Persons; Policies; Prevalence; Prevention; Privacy; Process; Proxy; Public Health; Randomized Clinical Trials; Recommendation; Rehabilitation therapy; Research; Research Personnel; Research Priority; Self-Help Devices; Speech; Strategic Planning; Stroke; Structure; Survivors; Technology; Training; Treatment outcome; Video Recording; Voice; collaborative approach; communication behavior; efficacy evaluation; evidence base; experience; improved; innovation; insight; interest; language impairment; meetings; microphone; monitoring device; portable monitoring; primary outcome; remote monitoring; secondary outcome; sensor; skills; symposium; wearable device; wearable sensor technology; wireless

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.

中风是一个主要的公共卫生问题，对数百万存活和 他们的照顾者。失语症是中风的普遍结果，其影响超出了 由此产生的语言赤字进入了一个人生活的各个方面。康复的目标 失语症的人是改善沟通，最终有意义的参与， 家庭和社区活动。父r01根据 概括，包括涉及多个可穿戴的探索措施 监视设备：喉传感器，长形音频记录器和GPS。 这些可穿戴监控设备的组合功能呈现了创新的 衡量参与者在家日常活动中沟通行为的机会 以及他们的社区。但是，这些技术呈现出多种生物伦理 对研究人员和参与者面临的挑战。特别是患有失语症的人 由于语言障碍，与知情同意程序有关的挑战增加了 可能会影响决策的理解或自主权。 这种行政补充调查了知情同意程序，并强调了 对于使用失语症患者使用可穿戴监控设备的研究的道德重要性。我们 采用协作方法来收集研究参与者，家人以及 生物伦理学专家和研究人员。我们计划生成一组建议 解决与此类研究相关的生物伦理挑战，以帮助该领域的其他人 并告知未来的政策指示。具体而言，行政补充旨在（1）进行 分析知情同意程序，以确定改善和挑战的机会 当人们使用可穿戴监控设备时，与知情同意过程有关 失语症； （2）与研究参与者进行半结构化访谈并确定家庭 成员，看护人和/或朋友描述他们有关使用的经验和参加 可穿戴监控设备的含义； （3）生成一组建议以促进 使用可穿戴监控设备的研究的道德行为。