中国医学伦理学2025，Vol.38Issue(1)：15-22,8.DOI:10.12026/j.issn.1001-8565.2025.01.03
医疗技术临床应用伦理审查指引
Guidelines of ethics review for clinical application of medical technology
摘要
Abstract
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management,involving medical quality assurance,the achievement of patient safety goals,and medical service satisfaction.Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research,as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution.Based on the relevant laws,regulations,and ethical principles,combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions,a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references.These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions,the system of ethics committees and the requirements of review norms,technical plans and their review points,key points for the implementation of informed consent,technical teams and conditions,and other aspects.关键词
医疗技术临床应用/伦理审查/指引Key words
clinical application of medical technology/ethical review/guideline引用本文复制引用
周吉银,訾明杰,陆麒,蒋辉..医疗技术临床应用伦理审查指引[J].中国医学伦理学,2025,38(1):15-22,8.基金项目
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
北京市海淀区卫生健康发展科研培育计划"区域性医药科研项目管理的策略与方法探索"(HP2022-96-504005) （HP2022-96-504005）
