医院伦理委员会审查权的程序规制  

Procedural regulation of the review authority of hospital ethics committees

作　　者：任静[1] 赵依凡 李筱永[1] 郭昂扬 REN Jing;ZHAO Yifan;LI Xiaoyong;GUO Angyang(School of Medical Humanities,Capital Medical University,Beijing,100069,PRC)

机构地区：[1]首都医科大学医学人文学院,北京市100069 [2]中国政法大学法学院,北京市100088

出　　处：《中国医院》2024年第10期87-92,共6页Chinese Hospitals

摘　　要：医院伦理委员会的审查权是基于共同体自治而产生的社会公权力,由此产生的伦理审查决定具有区别于一般民事行为或行政决定的特殊性。审查权的行使不可因医学自治“庇佑”而脱离法制轨道,成为“法治真空”。检视现行相关规定,在不干预伦理审查独立性的同时,需要通过重构程序要件为其提质增效:应该明确会议审查、简易和免除伦理审查的界限和适用条件,确立专家复核程序的方式及多元评价体系;扩大利益冲突回避主体范围、丰富利益冲突回避内涵、完善回避程序;强化事前信息披露、事中听证等程序保障申请人和研究参与者的合法利益;确立区域伦理委员会评价职能的救济渠道。审查权的程序规制,以期使医院伦理委员会审查权行使更符合程序正义和法治要求。The review authority of hospital ethics committees is a form of social public power derived from community autonomy,and the ethical review decisions made by these committees have a distinct nature compared to general civil or administrative decisions.The exercise of this review authority must not deviate from the legal framework under the protection of medical autonomy,thus avoiding a"legal vacuum."Upon examining current regulations,while not interfering with the independence of ethical reviews,it is necessary to enhance the quality and efficiency of the review process by restructuring procedural requirements:clearly defining the boundaries and applicable conditions for full review,expedited review,and exempted review;establishing methods for expert re-evaluation and a diversified assessment system;expanding the scope of conflict of interest avoidance,enriching its content,and refining the avoidance procedures;strengthening procedural safeguards for the legitimate interests of applicants and research participants,such as pre-disclosure of information and in-process hearings;and establishing relief channels for the evaluation functions of regional ethics committees.Procedural regulation of the review authority aims to ensure that the exercise of review authority by hospital ethics committees aligns more closely with procedural justice and the rule of law.

关 键 词：医学伦理 医院伦理委员会 伦理审查 程序规制 

分 类 号：R197.3[医药卫生—卫生事业管理]