突发传染病相关临床研究伦理审查突出问题的总结与反思——基于文献综述的分析

Summary and Reflection on the Prominent Problems of Ethical Review in Clinical Research of Emergent Infectious Diseases:based on Literature Review Analysis

突发传染病应急情境下,传染性疾病的不确定性、防控紧迫性、临床和研究资源有限性等问题对此阶段临床研究伦理审查带来诸多挑战。通过梳理突发传染病相关临床研究伦理审查文献,分析显示:临床研究的安全性、知情同意及隐私保护、临床研究设计的合理合法性、临床研究重要资源的分配、伦理审查的方式和效率是突发传染病相关临床伦理审查中的突出问题,亟待建立针对突发传染病临床研究的伦理审查特殊规范。以伦理审查实际工作需求为着力点,结合文献梳理,提示需健全临床研究机构管理、临床研究项目管理、伦理委员会管理、突发传染病情况伦理审查要点、多中心临床研究伦理审查等方面的特殊规范,降低突发传染病相关临床研究风险,创新伦理审查方式,提高伦理审查效率,保障特殊时期受试者的安全与权益。

Under the emergency situation of sudden infectious diseases,the uncertainty of infectious diseases,the urgency of prevention and control,and the limitation of clinical and research resources bring many challenges to the ethical review of clinical research at this stage.By combing the ethical review literature of clinical research related to sudden infectious diseases,the results showed that the safety of clinical research,informed consent and privacy protection,the rationality and legitimacy of clinical research design,the allocation of important resources for clinical research,and the way and efficiency of ethical review are prominent problems in clinical ethical review related to sudden infectious diseases.It is urgent to establish special norms for ethical review of clinical research of sudden infectious diseases.Focusing on the actual work needs of ethical review,combined with literature review,it is suggested to improve the special norms in the management of clinical research institutions,clinical research project management,ethics committee management,key points of ethical review of sudden infectious diseases,ethical review of multi-center clinical research,reduce the clinical research risks related to sudden infectious diseases,innovate the methods of ethical review,improve the efficiency of ethical review and ensure the safety and rights of subjects in special periods.