伦理审查信息化建设的实践与思考

Practice and reflection on the informatization of ethics review

我国生物医学研究的高速发展对伦理审查的效率和质量提出更高要求,伦理审查信息化建设成为行业热点和未来趋势。中国医学科学院肿瘤医院伦理委员会2018年1月启用电子系统进行伦理审查,并在2020年8月突破传统的伦理文件管理方式,在临床研究项目层面实行送审文件全面电子化。该措施使得伦理审查和沟通交流过程清晰透明,伦理申请人送审文件、伦理办公室人员管理文件更加便捷高效,缩短伦理审查时间,是一种值得推广的伦理审查信息化模式。与此同时,国内伦理审查信息化建设在未来应重点关注伦理委员会管理系统的用户权限设置,加强数据安全和标准化治理,进行伦理审查信息化建设的整体调研和统筹,进一步提升伦理审查的信息化水平和整体质量。

The rapid development of biomedical research in China puts forward higher requirements for the efficiency and quality of ethics review. The informatization of ethics review has become a hot spot and future trend. The Ethics Committee of the Cancer Hospital, Chinese Academy of Medical Sciences launched the electronic system for ethics review in January 2018, and implemented comprehensive electronization of the submitted files of clinical studies in August 2020, which broke through the traditional document management method. The measure has made the ethics review and communication process clear and transparent, improved convenience and efficiency of the document management for both applicants and the ethics office staff, and shortened the time of ethics review. Therefore, this informatization mode of ethics review is worthy of promotion. In the future, the informatization of ethics review should focus on the user authority setting of the Ethics Committee Management System, strengthen data security and standardization, conduct overall research and planning, to further improve the informatization level and quality of ethics review in China.