摘要
医疗新技术临床应用伦理审查面临的主要问题是缺乏统一的指导原则和相关法规,参考药物临床试验伦理审查原则和操作规程的一般特点,初步建立医疗新技术临床应用伦理审查的基本流程,包括建立医疗技术临床应用管理委员会和伦理委员会、伦理送审清单、跟踪审查,重点探讨了技术方案和知情同意的伦理审查,最后展望职能部门关注该方面的伦理审查。
The main barrier facing ethical review on clinical application of new medical technology is focused on the lack of unified principle,appropriate regulations and guidelines.Based on the main principles and standard operation procedures regarding ethical review on medical drug clinical trial,a comprehensive procedure about ethical review on clinical application of new medical technology was established and discussed,including establishment of supervision committee for clinical application of medical technology and ethics committee,the list of materials for ethical review,tracking ethical review,and more emphasis was paid on the review of technical protocol and informed consent.And establishment of unified regulation and guideline concerning ethical review on clinical application of new medical technology was expected.
作者
张卫中
朱强
ZHANG Weizhong;ZHU Qiang(Hangzhou Wuyunshan Hospital,Hangzhou Institute of Health Promotion,Hangzhou 310000,China;Taizhou First People’s Hospital,Taizhou 318020,China)
出处
《现代医院》
2023年第6期863-866,共4页
Modern Hospitals
关键词
医疗新技术
临床应用
伦理审查
伦理委员会
知情同意
New medical technology
Clinical application
Ethical review
Ethics committee
Informed consent
