生物医药研究伦理审查的风险意识和风险管理

Risk Awareness and Management in the Ethical Review of Biopharmaceutical Research

在生物医药研究伦理审查中,应提高风险意识,加强风险管理。要在伦理审查与科学审查统一、科学研究与临床诊治统一、社会效益与经济效益统一、常规管理与危机管理统一上防控风险。提高人体试验伦理审查风险管理水平,要完善制度、落实制度。防控人体试验中的风险,要加强伦理委员会审查能力建设。

In this article, the author proposed that we should improve the risk awareness and the risk manage- ment in the ethical review of biopharmaceutical research. The risk may be prevented and controlled through unif- ying the ethical review and scientific review, unifying scientific research and clinical diagnosis and treatment, unif- ying social benefit and economic benefit as well as unifying regular management and crisis management. The ethical review and risk management of human trials should be improved and the system needs be perfected and be implemented. Ethical review ability of ethics committee must be strengthened in order to prevent and control the risks in the human trials.