论疫情不同时期Ⅰ期临床试验受试者的权益保护

The Subject Protection in PhaseⅠClinical Trial in Different Periods of Epidemic

疫情的不同时期会有不同的风险和规定要求,开展Ⅰ期临床试验项目,需要从伦理的角度考虑,在不同时期需要采取不同措施以充分保护受试者权益。针对疫情初现、疫情暴发、疫情可控且逐渐稳定和疫情解除四个阶段,从提高受试者保护意识、科室标准操作程序的制定、防护培训、方案或知情同意书的修订、流程的优化、采用云视频会议新方式、每个环节人员和环境的准备等方面进行探讨,以保证受试者的安全和权益,符合伦理原则。这种应对策略有助于目前开展的Ⅰ期临床试验项目顺利实施,保证了受试者的安全和试验的质量。

Due to the ever-changing risks and regulations in different periods of epidemic,phase I clinical trial needs to protect subjects'rights from the perspective of ethics.In this article,given the four stages during the epidemic:the early outbreak,the outbreak,stable status under control and the elimination,some measures were explored to raise protection awareness of the subjects,to institute standard operating procedure,to provide protection training,to revise the protocol of informed consent,to optimize the process,to hold cloud video conference,to better prepare the staff and environment,to ultimately protect the safety of subjects with ethical principles.These strategies are conducive to the implementation of the current phase I clinical trial to ensure the safety of subjects and the quality of trial.