摘要
医学科学数据共享是伦理基本原则应用实践的新领域。伦理审核是机构数据伦理管理的重要内容和难点。但是,目前缺乏实践经验和指南。本指南根据中国法律法规和医学伦理审查规范草拟,并结合考虑了数据共享的国际原则和规则。指南共识是由来自法学、医学伦理学、管理学、医学、生物技术等领域的专家,在充分讨论和持续修订的基础上达成。我们认为其可以指导相关机构的伦理审核实践。
Scientific data sharing in healthcare and medicine is a new field in the application of basic principles of medical ethics.Ethical review is an important content with difficulties of data ethical management of the institutes.However,there is lack of experience and guidance.The guideline was drafted according to China’s laws,regulations and ethical review norms.The international principles and rules for data sharing were also considered.This consensus was obtained from experts of law,medical ethics,management,medicine,biotechnology and other fields after full discussion and Continuous revision.We believed that it could be used to guide the ethical review practice of the related institutes.
作者
关健
GUAN Jian(The National Population and Health Scientific Data Centre,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China)
出处
《中国医学伦理学》
2020年第10期1159-1166,共8页
Chinese Medical Ethics
基金
国家科技基础条件平台中心委托课题“科学数据管理计划等重点领域标准预研”(2020WT04)
科技部重大专项课题“中国遗传资源基础数据库建设”(2019FY100103)。
关键词
医学科学数据
数据共享
数据再利用
伦理审核
指南
专家共识
Scientific Data in Healthcare and Medicine
Data Sharing
Data Re-use
Ethical Review
Guideline
Expert Consensus
