从伦理效应反思伦理审查的制度化建设--兼论涉及人的医学研究利益相关方责任

Reflection on the Institutionalization of Ethical Review from the Perspective of Ethical Effect:A Discussion on the Responsi-bilities of Stakeholders Engaged in Medical Research Involving Human Participant

在科技伦理治理战略指导下,我国伦理审查制度化建设快速推进。伦理审查制度化建设有利于推动伦理审查的规范化发展,但也存在潜在的伦理风险。引入伦理效应视角,以《涉及人的生命科学和医学研究伦理审查办法》为例,在分析政策新要求及其可能的积极影响的基础上,探讨政策落地存在的责任主体界定不明、依从性管理不足等主要挑战,通过对伦理审查制度化建设本身的反思,呼吁加强对政策法规落地实施和实际效果的关注,同时还应在制度化建设之外,强化利益相关方的主体责任和能动性。

In the context of ethical governance strategy of science and technology,the institutionalization of ethical review in China has rapidly developed recently.The institutionalization of ethical review contributed a lot to the standardization of ethical review,however,there are also potential ethical risks.In this paper,from the perspective of ethical effect,the author took the Measures for the Ethical Review of Life Science and Medical Research Involving Human Participant as an example,discussed main challenges of policy implementation,such as unclear definition of responsible entities and insufficient compliance management.Furthermore,reflections on the institutionalization of ethical review policy itself were explored.The author called for more attention to the implementation and effectiveness of policies and regulations.Moreover,beyond institutionalization,it is crucial to strengthen the responsibility and agency of all stakeholders involved.