提高伦理定期跟踪审查监管的实践经验分享

Practical experience sharing of improving the ethics supervision to periodic follow-up review

目的改变定期跟踪审查管理相对薄弱的现状,进一步提高伦理委员会持续跟踪审查能力。方法通过梳理分析定期跟踪审查中存在的问题,采取相应的解决措施。细化管理要求,加强日常监督。专项伦理培训并加强沟通以增强研究者的伦理意识。优化伦理办公室人员分工提高工作效率和委员定期跟踪审查质量。信息化审查系统助力加强定期跟踪提醒等。结果在实践工作中,定期跟踪的迟报、漏报情况明显减少,提高了伦理委员会对定期跟踪审查的监管能力。结论定期跟踪审查中,只有研究机构、伦理委员会、研究者各方足够重视,各尽其责,积极配合才能有效提高定期跟踪审查质量。

Objective To change the current situation of the relatively weak management of periodic follow-up review,and further to improve the continuous review capacity of the ethics committee.Methods Through sorting out and analyzing the problems existing in the periodic follow-up review,corresponding solutions are taken:to detail management requirements;to strengthen daily supervision;special ethics training and communication to enhance the ethical awareness of researchers;to optimize the division of labor in the ethics office to improve work efficiency and the quality of committee review;the information review system helps strengthen tracking and reminding.Results In one year′s practice,the omission of periodic follow-up has been significantly reduced,and the supervision ability of the Ethics Committee on periodic follow-up review has been improved.Conclusions In periodic follow-up review,research institutions,ethics committees and researchers pay enough attention to fulfill their responsibilities and actively cooperate can effectively improve the quality of periodic follow-up review.