临床研究不良事件的伦理审查

Ethical review of adverse events in clinical research

临床研究过程中发生的不良事件的伦理审查一直是难点,文中参考了美国人类研究保护办公室2007年发布的"Guidanceon Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events",提出对不良事件的伦理审查应侧重关注"非预期事件"。同时,对内部不良事件和外部不良事件区别对待处理。

Ethical review of serious adverse events （SAE） encountered in clinical research is challenging. Based on ＂Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events＂ issued by US Office for Human Research Protections （OHRP） in 2007, this paper lays stress on unanticipated problems when reviewing adverse events. In addition, internal adverse events should be treated differently from external adverse events.