CRISPR/Cas9基因编辑技术在临床研究中的伦理审查问题探讨

Discussion on Ethical Review Question of CRISPR/Cas9 Gene Editing Technology in Clinical Research

目的探讨CRISPR/Cas9基因编辑技术在临床研究中引发的伦理审查问题,为临床研究中涉及该技术的伦理审查注意事项提供参考。方法总结国内外CRISPR/Cas9基因编辑技术存在的伦理问题,分析其原因并提出符合我国国情新技术应用的建议。结果应该允许将基因编辑技术应用于体细胞基因治疗,禁止用于生殖系基因治疗和不考虑用来增强;鉴于CRISPR/Cas9缺乏明确的责任伦理主体,带来安全性、权利冲突和社会公平问题,需采取的措施包括加强文化沟通、尽快形成基因编辑技术伦理规范、在国家层面上设立独立的基因编辑技术项目伦理审查机构、健全法律规范、制定技术标准和伦理准则以及在国家层面应对基因编辑研究领域进行重点支持。结论鉴于CRISPR/Cas9技术潜在的临床应用,国家应逐步从禁止到限制性开展人类胚胎基因编辑技术的研究。伦理委员会要负起临床研究的伦理审查和监管。伦理委员会委员和伦理工作人员应加强相关新知识的学习,从受理涉及CRISPR/Cas9技术的临床科研项目到伦理审查都严格对接政策法规,确保有效审查基因编辑技术项目的伦理问题。

Objective： To explore the ethical review questions of CRISPR/Cas9 gene editing technology caused in clinical research, and thus to provide a reference for matters needing attention of the ethical review involved in this technology in clinical. Methods： This paper summarized the ethical problems of CRISPR/Cas9 gene editing technology at home and abroad, analyzed the reasons and put forward some suggestions for the application of new technology in line with China＇ s national conditions. Results： It should allow CRISPR/Cas9 gene editing technolo- gy to be applied in somatic cell gene therapy, forbidden for genital gene therapy and not considered to enhance. Since CRISPR/Cas9 lack clear subject of responsibility ethics, it brings security, conflict of rights and social equal- ity issues. The measures that need to be taken include the strengthening of cultural communication, the formation of ethic forms of gene editing technology, the establishment of independent ethical review body at national＇ s level, the improvement of legal norms, the formulating of technical standards and ethical principles and the major support to gene editing research field at the national level. Conclusion： In view of the potential clinical application of CRISPR/Cas9, our country should progressively restrictively develop the embryonic gene editing techniques from the prohibition. The ethics committee is responsible for the ethical review and supervision of clinical research.Members of the ethics committee and ethical staff should strengthen the study of new knowledge, policies and regulations from accepting the clinical research and thus to ensure the effectively review the ethical problems projects involving of genetic editing CRISPR Cas9 to technology project. strictly docking ethical review,