摘要
疫苗临床试验过程伴随着一定的伦理挑战,伦理审查机制不仅成为保障疫苗安全性和科学性的核心环节,而且对于受试者权益保护有重要作用。国际上,以《纽伦堡法典》《赫尔辛基宣言》等为基础,形成了严格的医学伦理审查框架;中国自20世纪90年代逐步建立伦理审查制度,并通过《药物临床试验质量管理规范》等法规不断完善。当前,国内外针对疫苗临床试验伦理审查的研究呈现出多元化态势,研究聚焦于疫苗临床试验伦理审查要点、伦理委员会运行机制探索以及在伦理风险与受试者保护、试验设计、紧急状态下疫苗试验、国际合作疫苗研发等方面的伦理审查困境及挑战。目前疫苗临床试验存在伦理审查能力不足、受试者权益保护审查困境、疫苗可及性不均及伦理审查标准差异加剧“疫苗鸿沟”、应急伦理审查机制脆弱性等问题。
The process of vaccine clinical trial is accompanied by certain ethical challenges.The ethical review mechanism not only becomes the core link to ensure the safety and scientificity of vaccines,but also plays an important role in protecting the rights and interests of subjects.Internationally,a strict ethical review framework has been established based on the Nuremberg Code,Helsinki Declaration,and other documents;Since the 1990s,China has gradually established an ethical review system and continuously improved it through regulations such as the Good Clinical Practice for Drugs.At present,research on ethical review of vaccine clinical trials both domestically and internationally is showing a diversified trend,focusing on the key points of ethical review of vaccine clinical trials,exploration of the operation mechanism of ethics committees,and ethical review dilemmas and challenges in ethical risks and subject protection,trial design,emergency vaccine trials,international cooperative vaccine research and development,etc.Currently,there are some problems in vaccine clinical trials,such as lack of ethical review capacity,difficult review of subjects'rights and interests protection,unequal access to vaccines and differences in ethical review standards,which aggravate the"vaccine gap",and the vulnerability of emergency ethical review mechanism.
作者
赵玉玲
宋晓启
唐聪
王燕
杨泳慧
吴彩霞
郭永豪
韩志伟
ZHAO Yuling;SONG Xiaoqi;TANG Cong;WANG Yan;YANG Yonghui;WU Caixia;GUO Yonghao;HAN Zhiwei(Henan Provincial Center for Disease Control and Prevention,Zhengzhou,Henan 450016,China)
出处
《现代疾病预防控制》
2025年第8期561-566,共6页
MODERN DISEASE CONTROL AND PREVENTION
关键词
疫苗临床试验
伦理
审查
Clinical trials of vaccines
Ethics
Review
