关于我国涉及人的生物医学研究管理规范的思考

Thoughts on the regulation of biomedical research involving human beings in China

摘要:

我国在涉及人的生物医学研究管理规范方面，虽然从伦理规范、法律规范、行政管理三个角度出台了一系列政策，但换头术、基因编辑婴儿等事件表明我国管理还存在着一些问题。从表层来说这些问题体现在法律制度不完善、伦理执行有漏洞、行政管理缺位。从深层来说，这些问题还折射出我国传统文化对于管理态度的影响以及社会发展过程中功利心对于道德底线的冲击。改进的建议包括提高社会大众的伦理知识水平；提高研究者的道德修养；完善法律制度；提高伦理审查效果；加强行政管理建设。

Abstract:

Although China has issued a series of policies on the management of biomedical research involving human beings from the perspectives of ethical norms, legal norms and administrative management, events such as head-changing surgery and gene editing baby show that there are still some problems in China's management.On the surface, these problems are reflected in imperfect legal system, flawed ethical implementation and absence of administrative management.From the deep level, these problems also reflect the impact of China's traditional culture on the management attitude and the impact of utilitarianism on the moral bottom line in the process of social development.Suggestions for improvement include raising the level of ethical knowledge of the general public;Improve the moral cultivation of researchers;Improving the legal system;Improving the effectiveness of ethical review;We will strengthen administrative management.