中国医学伦理学2024，Vol.37Issue(6)：693-698,6.DOI:10.12026/j.issn.1001-8565.2024.06.11
远程采集数字健康技术赋能临床研究的伦理探讨
Ethical exploration of clinical research empowered by remote collection of digital health technology
摘要
Abstract
In recent years,with the gradual maturity of achievable remote collection of digital health technology,more and more clinical research have applied this technology to improve the quality of data collection and reduce the burden on subjects.However,its technological characteristics of detachment from the diagnostic and treatment environment and real-time transmission of sensitive information also pose corresponding risks to the protection of subjects'rights and interests and data standardization management,among which personal information protection and data control permissions are more prominent issues.Based on risk analysis and regulatory review,this paper explored the responsibilities of multiple parties,including the sponsors,researchers,clinical trial institutions,and ethics committee,as well as proposed five elements of special concern for ethical review,with a view to providing a reference for promoting the standardized development of digital health technology in clinical research.关键词
数字健康技术/电子化患者报告结局/临床研究/伦理管理Key words
digital health technology/electronic patient-reported outcome/clinical research/ethical management分类
医药卫生引用本文复制引用
陈仲林,李星颐,冯钰,韩慧慧,姚瑶,杨梦婕,侯旭敏..远程采集数字健康技术赋能临床研究的伦理探讨[J].中国医学伦理学,2024,37(6):693-698,6.基金项目
上海申康医院发展中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目"生物医药创新背景下医院临床研究的伦理审查体系建设"(SHDC2023CRS046) （SHDC2023CRS046）
上海申康医院发展中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目"医疗机构实施远程智能化临床研究的监管模式对策研究"(SHDC2023CRS047) （SHDC2023CRS047）
