基于德尔菲法的《突发传染病相关临床研究伦理审查及管理的特殊规范要求》研究

Study on the Special Specification Requirements of Ethical Review and Management in Clinical Research of Emerging Infectious Diseases based on Delphi Method

突发传染病严重威胁人类健康,临床研究有助于疫情防控,但中国尚未建立针对突发传染病相关临床研究伦理审查的特殊规范要求,国际医学伦理准则、指南也缺乏针对性的详细描述。采用德尔菲法,通过两轮专家咨询研制了《突发传染病相关临床研究伦理审查及管理的特殊规范要求》,从政府层面可采取措施、伦理审查关注要点、伦理委员会管理三个层面对突发传染病相关临床研究伦理审查及管理提出特殊的规范和要求,并将每个层面的特殊要求细化为36项三级指标。《突发传染病相关临床研究伦理审查及管理的特殊规范要求》对突发传染病相关临床研究及伦理审查开展方面的特殊要求做了补充建议,为相关主管部门、伦理委员会、研究者等相关人员提供具有实际可操作性的伦理支持和参考,对促进突发传染病相关临床研究的规范开展,推进疫情防治药物研发和诊疗方法研究等有一定意义。

Emerging infectious diseasessuch seriously threaten human health.Clinical research is helpful to the prevention and control of epidemic situation,but China has not yet established special specification requirements for ethical review of clinical research of emerging infectious diseases,and international medical ethics standards and guidelines lack specific detailed description.Therefore,the project team has developed the“Special Specification Requirements of Ethical Review and Management in Clinical Research of Emerging Infectious Diseases”by Delphi method with two rounds of expert consultation,which puts forward special norms and requirements for ethical review and management of clinical research during infectious disease emergencies from three levels:government supervision,ethical review and ethical committee management,and refines the special requirements of each level into 36 third-level indicators.Special Specification makes supplementary suggestions on the special requirements of clinical research and ethical review in emerging infectious diseases,which provides practical ethical support and reference for relevant government departments,ethics committees,researchers and other relevant personnel.It is of constructive significance to promote the standardized development of clinical research during sudden infectious diseases,to promote the development of epidemic prevention drugs and the research of diagnosis and treatment methods.