临床研究伦理审查风险与受益评估指标体系研究

英国新冠“人体挑战试验”引发全球对临床研究伦理审查风险与受益问题的关注。如何权衡好研究风险与受益比，避免让受试者承担额外风险是医疗机构伦理委员会（IRB）重要职责。然而，当前研究项目的风险受益评估主要依靠IRB成员个人主观经验来判断，严重影响伦理决策的科学性。本研究认为“建立可量化的风险与受益评估体系”是减少伦理决策主观判断的关键手段。围绕这一科学问题，本项目将在申请人前期研究基础上：①深入挖掘国内外临床研究风险相关数据，系统识别研究风险与受益；②构建基于客观数据的风险与受益评估体系并予以验证，实现研究风险与受益的量化；③建立风险与受益等级评判标准，为判断风险与受益大小提供依据。本项目有较强的理论和实践意义：①可补充完善临床研究伦理审查风险受益评估理论；②破解当前伦理决策依赖个人主观经验判断的难题；③创新伦理审查新方法，提升我国伦理审查质量与效率，为国家多中心伦理审查政策落地提供技术参考。

First Covid-19 human challenge study has aroused global attention to the risks and benefits of ethical review in clinical research. It is an important responsibility of the IRB to balance the risks and benefits of the study and avoid exposing the subjects to additional risks. However, the risk benefit assessment of current research projects mainly relies on the individual subjective experience of IRB members, which seriously affects the scientific nature of ethical decision making. This study suggests that "establishing quantifiable risk and benefit assessment system" is a key means to reduce subjective judgment in ethical decision making. Centered on this scientific problem, this project will be based on the applicant's previous research: (1) In-depth mining of domestic and foreign clinical research risk related data, systematic identification of research risks and benefits; (2) To establish and verify the risk and benefit assessment system based on objective data, and to realize the quantification of research risks and benefits; (3) Establish evaluation criteria for risk and benefit levels to provide a basis for judging risk and benefit levels. The implementation of this project is of great significance: (1) It can supplement and improve the risk and benefit assessment theory of ethical review in clinical research; (2) Solve the problem that the current ethical decision depends on personal subjective experience judgment; (3) Innovate new methods of ethical review, improve the quality and efficiency of ethical review in China, and provide technical reference for the implementation of national multi-center ethical review policy.