《生命科学》 2025, 37(11): 1380-1384

科技伦理治理背景下医疗新技术临床应用的伦理审查

唐　燕¹ , 郭丽莉¹ , 奚益群^2,*

¹上海市儿童医院/上海交通大学医学院附属儿童医院，上海 200062 ²上海交通大学医学院附属第六人民医院，上海 200233

摘　要：

医疗新技术的快速发展在提升医疗服务质量与效率的同时，也对传统伦理审查机制提出了挑战。本文从医疗新技术的特性入手，分析传统伦理审查机制在医疗新技术伦理审查中面临的困境，结合科技伦理治理的新要求，提出了包括设立医疗新技术伦理委员会，建立技术准入分类伦理审查机制、技术应用分类跟踪审查机制、医疗技术临床应用管理委员会与伦理委员会协同机制等在内的医疗新技术临床应用伦理审查实践建议。

通讯作者：奚益群 , Email:yiqun-xi@126.com

Ethical review of clinical applications of new medical technologies under the background of science and technology ethics governance

TANG Yan¹ , GUO Li-Li¹ , XI Yi-Qun^2,*

¹Shanghai Children’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200062, China ²Shanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China

Abstract:

The rapid development of new medical technologies has not only improved the quality and efficiency of healthcare services, but also posed challenges to conventional ethical review mechanisms. This article starts with the  characteristics of new medical technologies and analyzes the dilemmas faced by conventional ethical review mechanisms. In light of the new requirements of science and technology ethics governance, this article proposes practical recommendations for the ethical review of clinical applications of new medical technologies, including setup of a medical new technology ethics committee, and establishment of a technology access classification ethical review mechanism, a technology application classification tracking review mechanism, and a collaborative mechanism between the medical technology clinical application management committee and the ethics committee.

Communication Author：XI Yi-Qun , Email:yiqun-xi@126.com