基因编辑临床研究风险责任之法律探析

The legal analysis of the risk responsibility in the clinical research on gene editing

摘要:

我国涉及基因编辑临床研究的法律规制模式应对基因编辑技术风险存在的缺陷主要包括：风险责任分配落空；监管方式有效性削弱；损害救济与补偿不足。风险社会理论为风险法律治理提供了借鉴---风险责任理念，即通过对临床研究中主体间权利义务的分配实现风险责任的合理分担。立足于风险责任的合理分担，进而提出基因编辑临床研究法律规制的具体策略：划定权利边界；创新监管方式；增强自我规制；丰富损害救济与补偿途径等。

Abstract:

This paper analyzes the defects of present legal regulation pattern of the clinical research on gene editing in China, such as it fails to allot risk responsibility among different subjects, to confront with weakness of regulatory approach effectiveness and the imperfection of damage relief and compensation. The risk society theory provides reference for law management, the concept of risk responsibility, that is to realize the reasonable sharing of risk responsibility through allotting the rights and duties among the subjects in clinical research. Based on the reasonable sharing of risk responsibility, this paper puts forward the specific strategies for Legal regulation of clinical research on gene editing: delineating the right boundary, innovating the supervision mode, strengthening self-regulation, enriching the damage relief and compensating way and so on.