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.

中风是一个重大的公共卫生问题，对数百万幸存者造成终身影响， 他们的照顾者。失语症是中风的一种常见后果， 语言缺陷渗透到人们生活的方方面面。康复的目标是 失语症患者是为了改善沟通，并最终有意义的参与， 家庭和社群活动。父R 01根据以下方面测量治疗结局： 一般化，包括涉及使用多个可穿戴设备的探索性措施 监测设备：喉部传感器、长形录音机和GPS。 这些可穿戴监测设备的组合功能呈现出创新的 有机会测量参与者在家中的日常活动中的沟通行为 和周围的社区。然而，这些技术提出了各种生物伦理问题， 对研究人员和参与者的挑战。特别是对于失语症患者， 由于语言障碍， 可能会影响决策的理解或自主性。 本行政补充调查了知情同意过程，并强调了 对失语症患者使用可穿戴监测设备的研究的伦理重要性。我们 采取合作方式，从研究参与者、他们的家人以及 生物伦理学专家和研究人员。我们计划提出一系列建议 解决与这类研究相关的生物伦理挑战，以协助该领域的其他人 并为未来的政策方向提供信息。具体而言，行政补充的目的是（1）进行 分析知情同意过程，以确定改进的机会和挑战 当人们使用可穿戴监测设备时， （2）对研究参与者和确定的家庭进行半结构化访谈 成员，护理人员和/或朋友描述他们的经验和对使用的态度， 可穿戴监测设备的影响;以及（3）生成一组建议，以促进 使用可穿戴监测设备的研究的道德行为。