摘要
疫苗临床试验作为疫苗研发的关键环节,在当前的开展过程中出现了诸多伦理问题,包括疫苗临床试验的不确定性风险、预防性误解导致的知情同意不充分问题、参与者补偿存在不合理现象,以及伦理倾销导致的新型剥削问题等。这些问题不仅影响了试验的科学性,也对社会公平和脆弱群体的权益保护构成挑战。国际疫苗临床试验的现行伦理规范为解决这些问题提供了改进方案和参考依据,可以通过建立独立的疫苗临床试验伦理委员会、关注临床前研究、消除预防性误解、制定合适的补偿标准等促进我国疫苗临床试验伦理审查制度的进一步完善。
As a critical phase in vaccine development,clinical trials face numerous ethical challenges,including the uncertain risks of vaccine trials,issues with informed consent due to preventive misconception,unreasonable participant compensation,and new forms of exploitation resulting from ethical dumping.These challenges affect the scientific and ethical integrity of the trials and pose risks to social equity and the protection of vulnerable populations.The existing international ethical norms of vaccine clinical trials provide valuable insights and practical strategies for addressing potential ethical issues.Enhancing the ethical review system for vaccine clinical trials in China can be achieved by establishing independent ethical committees for vaccine trials,focusing on preclinical research,addressing preventive misconception,and setting appropriate compensation standards.
作者
张琰
张馨予
睢素利
ZHANG Yan;ZHANG Xinyu;SUI Suli(School of Humanities and Social Sciences,Chinese Academy of Medical Sciences/Peking Union Medical College,Beijing 100730,China)
出处
《医学与哲学》
北大核心
2024年第23期1-5,15,共6页
Medicine and Philosophy
基金
2021年教育部人文社会科学青年基金项目(21YJCGJW006)
2023年辽宁省社会科学规划基金一般项目(L23BGJ001)
2023年辽宁省教育厅高校基本科研项目(JYTMS20231741)。
关键词
疫苗临床试验
预防性误解
研究参与者补偿
伦理倾销
伦理审查
vaccine clinical trials
preventive misconception
research participant compensation
ethical exploitation
ethical review