医疗新技术伦理审查经验探讨

Discussion on Ethical Censorship of New Medical Technology

目前国内医疗新技术的伦理审查还处在探索阶段,还缺乏比较权威的法律法规参考。自北京市卫计委颁布新的医疗技术管理制度以来,我院受理并审查了14项北京市重点医疗技术,积累了一定的认识和经验。本文从医疗新技术现行法律法规要求、伦理审查方式、提交材料的要求、伦理审查要点等方面进行总结分析,并结合我院在医疗技术审查中的经验,对医疗新技术伦理审查的相关内容进行陈述,旨在探索适合医疗技术的伦理审查规范。

Since the Beijing health and family planning commission promulgated the new medical technology management system, we have accepted and reviewed 14 key medical technologies in Beijing, such as resection of the skull base tumor （intracranial tumor outside communication）, resection of intracranial important functional areas and large vascular malformation, renal vascular reconstruction technique, the technique of artificial joint replacement, coronary interventional diagnosis and treatment technology, etc. Through the existing laws and regulations requirements from medical new technology, the ethical review way, submit materials requirements and ethical review focus is analyzed,and combining with the experiences of our hospital in the medical technical review, aims to explore suitable for medical technology ethical review specification.