一则疫苗临床试验中方案违背案例伦理审查浅析

Case Analysis on Ethical Review of Protocol Violation in the Process of Vaccine Clinical Trial

疫苗临床试验中发生方案违背/偏离是不可避免的,伦理审查委员会应提高对违背/偏离方案报告伦理审查的效率和质量,切实维护受试者的安全和权益,促进疫苗临床试验科学有序地开展。通过对1则违背方案报告的案例分析,探讨疾病预防控制中心伦理审查委员会如何审理疫苗临床试验中的违背/偏离方案报告。

It is inevitable that protocol violation/deviation occurs in a vaccine clinical trial.The ethical review committee should improve the efficiency and quality of ethical review of protocol violation/deviation reports,effectively safeguard the safety and rights of subjects,and promote the scientific and orderly development of vaccine clinical trials.This paper discussed how the ethics review committee of the center for Disease Control and Prevention(CDC)adjudicates a protocol violation/deviation report in a vaccine clinical trial by analyzing a case of protocol violation report.