作者：赵 鹏
作者介绍：中国政法大学法治政府研究院教授
出版日期：2021年12月9日
内容提要 伴随生物医学研究活动引发的伦理问题日益凸显，法律确认了行业层面自 发探索的伦理治理机制。但是，这种伦理规制依据层级较低、内容抽象原则的伦理规范展开， 且执行主要依赖研究机构层面的自我规制，只能达到“弱约束”的效果。这导致立法强化 科学研究伦理约束的目标难以实现。在科学与社会关系已呈现结构性变化的情况下，这种 体制愈发不可持续。因此，有必要以受国家规制的社会自我规制为方向，将伦理规制适度法 治化，既推动科学界形成更为系统化、组织化、规范化的自我规制，又为这种社会自我规制设 定基本的框架秩序，并确保政府对自我规制活动的监督、调控能力，保障法律的要求能够有 效地投射到相关研究活动中。
关键词 生物医学 生命伦理 伦理规制 法治
Abstract: With the increasingly prominent ethical issues caused by biomedical research activities, the law has confirmed the ethical governance mechanism spontaneously explored at the industry level. However, such ethical regulation is based on the ethical norms of low-level and abstract principles, and its implementation mainly relies on self-regulation at the research institutions level, which can only achieve the effect of‘weak restraint’. This makes it difficult to achieve the goal of strengthening the ethical restraint of scientific research by legislation. Given the structural changes in science and social relations, this system is becoming increasingly unsustainable. Therefore, it is necessary to take the social self-regulation regulated by the state as the direction and legalize ethical regulation appropriately, which not only promotes more systematic, organized and standardized self-regulation of scientific communities, but also sets a basic framework order for such social self-regulation, and ensures the government’s ability to supervise and regulate self-regulation activities and ensures that the requirements of the law can be effectively projected into relevant research activities.