摘要
近年来,随着可实现远程采集的数字健康技术逐步成熟,越来越多的临床研究应用这一技术提高了数据收集的质量并减轻研究参与者负担。但是,其脱离诊疗环境以及实时传输敏感信息的技术特点,也对受试者权益保障以及数据规范管理造成相应的风险,其中个人信息保护和数据控制权限是较为突出的问题。在风险分析和法规梳理的基础上,探讨申办方、研究者、临床试验机构及伦理委员会多方职责,并提出五项伦理审查特殊关注要素,以期为推动临床研究中数字健康技术部分的规范开展提供参考。
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.
作者
陈仲林
李星颐
冯钰
韩慧慧
姚瑶
杨梦婕
侯旭敏
CHEN Zhonglin;LI Xingyi;FENG Yu;HAN Huihui;YAO Yao;YANG Mengjie;HOU Xumin(Ethics Committee,Shanghai Chest Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200030,China;Medical Ethics Committee,Zhongshan Hospital,Fudan University,Shanghai 200032,China)
出处
《中国医学伦理学》
北大核心
2024年第6期693-698,共6页
Chinese Medical Ethics
基金
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)
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)。
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
digital health technology
electronic patient-reported outcome
clinical research
ethical management
