医事伦理审查制度的法律实现

On the Legal Realisation of Medical Ethics Review System

随着我国涉及人的生命科学和医学研究活动的蓬勃发展,以伦理审查制度为核心的规范群逐渐形成。尽管伦理审查制度已然建立,但关涉伦理审查的法律规范层级较低,对其建构目标、建构理念以及建构原则尚缺乏系统性规定。同时,在医事伦理审查制度的具体构建中,囿于伦理审查委员会法律地位不明、审查标准不明晰、监管机制不健全、法律责任规定粗疏等问题,导致立法旨在强化伦理约束的目标难以达致。在医学科学进步日益对个体发展和社会安全产生强大作用力的背景下,现有的医事伦理审查制度迫切需要革新。为助益医事伦理审查制度运行的有效实现,可从体系化的立法模式、科学化的建构理念以及规范化的审查模式着手,通过构建全链条、立体化的动态评估体系来丰盈医事伦理审查制度的灵魂,进而在法治化轨道上实现医学科学高质量发展与高水平安全之间的良性互动。

With the vigorous development of life sciences and medical research activities involving human beings in China,a cluster of norms centered on ethics review system has gradually taken shape.Although the ethics review system has been established,the legal norms related to it are at a low level.There is a lack of systematic provisions on its construction goals,con-cepts,and principles.Additionally,in the specific construction of the medical ethics review system,issues such as the unclear legal status of ethics review committees,ambiguous review standards,inadequate regulatory mechanisms,and vague legal responsibility provisions hinder the achievement of the legislative goal to strengthen ethical constraints.In the context of the growing impact of medical progress on individual development and social safety,the current medical ethics review system urgently needs reform.To effectively realize the operation of the medical ethics review system,efforts can be made from a systematic legislative model,a scientific construction concept,and a standardized review model.By constructing an all-chain,dynamic evaluation system,the essence of the medical ethics review system can be enriched.This,in turn,will promote a positive interaction between high-quality development and high-level safety of medical science on the track of the rule of law.