CAR-T细胞免疫疗法对伦理审查的要求

Requirements of CAR-T Cell Immunotherapy on the Ethical Review

目的探讨CAR-T细胞免疫疗法在临床研究中引发的伦理问题,为临床研究中涉及该技术的伦理审查要求提供参考。方法总结国内关于CAR-T细胞免疫疗法的发展现状及存在的伦理问题,提出符合我国国情的细胞免疫疗法对伦理审查要求的建议。结果始终坚持"尊重、公正、不伤害"的伦理原则,严格知情同意,强化跟踪审查,切实保障受试者权益,推动我国CAR-T细胞免疫疗法临床应用的快速发展,惠及更多的癌症患者。结论伦理委员会要肩负起临床研究的伦理审查和监管的职责,委员和工作人员要加强相关新知识的学习,从受理CAR-T技术临床研究项目到伦理审查都严格对接政策法规,促进医学伦理学原则与生物医学临床研究紧密结合,力求受试者风险最小化和受益最大化。

Objective: To explore the ethical issues of CAR-T cell immunotherapy caused in clinical research, and to provide a reference for ethical review requirements involved in this technology in clinical research. Methods: This paper summarized the development status and ethical issues of CAR-T cell immunotherapy in China, and put forward some suggestions on ethical review requirements of cell immunotherapy in line with China’s national conditions. Results: It should always adhere to the ethical principles of “respect, justice and no harm”, strictly informed consent, strengthen tracking review, effectively protect the rights and interests of the subjects, promote the rapid development of the clinical application of CAR-T cell immunotherapy in China, and benefit more cancer patients. Conclusion: The ethics committee is responsible for the ethical review and supervision of clinical research. Members and staff should strengthen the study of relevant new knowledge, strictly docking policies and regulations from accepting the CAR-T technology clinical research projects to ethical review, to promote the close integration of medical ethical principles with biomedical clinical research and try to minimize the risk and maximize the benefit of subjects.