临床数据获取广泛性知情同意在医疗机构实施中的模式探讨  

Exploration of the model of broad informed consent in clinical data acquisition in medical institutions

作　　者：杨照[1] 刘久秀 冯孟贤 于荣辉[1] 向宇[1] YANG Zhao;LIU Jiu-xiu;FENG Meng-xian;YU Rong-hui;XIANG Yu(Scientific Research Department,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院科研处,北京100034

出　　处：《中国临床药理学杂志》2023年第23期3491-3494,共4页The Chinese Journal of Clinical Pharmacology

基　　金：北京市卫生健康科技成果和适宜技术推广基金资助项目(BHTPP2022065)。

摘　　要：目的 研究通过建立泛知情同意制度规范及有效实施路径,推动临床数据的合理使用,有序开展健康医疗大数据研究。方法 主要采用文献检索和专家访谈的研究方法,制定了泛知情同意管理规章制度,明确了工作流程和部门职责,拟定了患者知情同意书。结果与结论北京大学第一医院基于国内医疗机构诊疗数据泛知情同意实施现状,明确了临床数据获取泛知情同意在医疗机构实施中的有效路径,为开展相关工作的试点奠定了前期基础;同时围绕临床数据泛知情同意制度实施后的患者权益保护、政策宣传解读、信息系统支撑能力及数据有效应用展开了讨论,有助于临床数据获取泛知情同意工作在国内的推广和应用。Objective To study how to promote the rational use of clinical data and orderly conduct health care Big data research by establishing a broad informed consent system and an effective implementation path.Methods The research methods of Document retrieval and expert interviews were mainly used to formulate management rules and regulations,clarify work processes and department responsibilities of the broad informed consent,and draw up patient informed consent forms.Results and Conclusion Based on the current implementation status of broad informed consent in domestic medical institutions,Peking University First Hospital has identified an effective path for obtaining clinical data in the implementation of broad informed consent in medical institutions,laying a preliminary foundation for the pilot implementation of related work.At the same time,discussions were conducted on the protection of patient rights,policy promotion and interpretation,information system support capabilities,and effective data application after the implementation of the broad informed consent system for clinical data,which will help promote and apply the work of broad informed consent for clinical data acquisition in China.

关 键 词：广泛性知情同意 医疗机构 临床数据 实施路径 

分 类 号：R97[医药卫生—药品]