关注临床试验中非预期不良事件的伦理审查

Ethical Review of Unanticipated Adverse Events in Clinical Research

临床试验中非预期不良事件的伦理审查越来越受到重视,根据2007年美国人类研究保护办公室(OHRP)指南,以案例的形式对非预期不良事件的定义、判断、伦理审查等方面进行了分析介绍,供研究者、申办方、伦理审查人员共同参考。

Ethical review of unanticipated adverse events in clinical research has been paid attention more and more closely. Based on guidance on reviewing and reporting unanticipated adverse events involving risks to subjects or others and adverse events issued by US office for human research problems（OHRP） in 2007, this paper introduced the deifnition of unanticipated adverse events and analyzed the review procedure of ethical committee by listing examples in order to be referred for researchers and ethical committee.