首例TCR-T细胞治疗晚期胰腺癌的伦理审查实践

Practice of Ethics Review on the First TCR-T Cell Therapy for Advanced Pancreatic Cancer

回顾性报告北京大学深圳医院伦理委员会对院内开展的首例TCR-T技术治疗晚期胰腺癌个案研究进行伦理评估、讨论、审查和做出决定的情况,讨论的问题包括该案例的性质、风险获益评估、知情同意以及风险控制。最后提出加强创新性治疗研究项目的监管,运用医患共同决策模式实行充分有效的知情同意和提升伦理实质审查能力等三个方面的建议,以期为伦理委员会审查细胞治疗等前沿技术的临床研究项目提供参考。

This paper retrospectively reported the ethical evaluation,discussion,review and decision made by the ethics committee of Peking University Shenzhen hospital on the first case study of TCR-T technology in the treatment of advanced pancreatic cancer.The issues discussed included the nature,risk-benefit assessment,informed consent and risk control of the case.Finally,three suggestions were put forward,including strengthen the supervision of innovative treatment research projects,implement full and effective informed consent by using doctor-patient joint decision-making mode,and improve the ability of ethical substance review,in order to provide reference for the ethics committee to review clinical research projects with cutting-edge technologies such as cell therapy.