新冠疫苗人体挑战试验相关伦理思考--基于英国的经验和视角

Ethics Considerations on COVID-19 Vaccine Human Challenge Trials:Based on UK's Experiences and Perspective

通过梳理新冠疫苗研发过程中对人体挑战试验风险与社会效益的伦理讨论,以及相关伦理观点在近代随着科技及社会需求变化的演变,探讨科研伦理理念和全球临床研究需求共同发展的过程。英国在人体挑战试验方面一直处于国际领先地位,不仅体现在科研团队的研发能力和医疗方面的制度支撑,更包括信息的公开透明、社区参与和社会多方面协助等,这些经验对于跻身世界新冠疫苗的研发行列的中国具有借鉴意义。

This article demonstrates the co-evolution of the interpretation of key ethical principles and the recognition of global clinical needs through the recent risk-benefit evaluations on human challenge trials(HCT)in COVID-19 vaccine development and its historical context.The United Kingdom has been a leader in the design,delivery and regulation of HCT.Its experiences on structural support,managing openness and transparency,organizing public participation and engagement all provide useful insights for key COVID-19 vaccine developers such as China.