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医学学术部门研究伦理委员会审批时间分析

Analysis of research ethics board approval times in an academic department of medicine.

作者信息

Tsang Teresa S M, Jones Meaghan, Meneilly Graydon S

机构信息

University of British Columbia, Vancouver, Canada

University of British Columbia, Vancouver, Canada.

出版信息

J Empir Res Hum Res Ethics. 2015 Apr;10(2):145-50. doi: 10.1177/1556264615571557. Epub 2015 Feb 20.

Abstract

As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols.

摘要

作为持续深入了解学术研究障碍工作的一部分,我们回顾并分析了2006年至2011年医学部内研究伦理申请流程,重点关注伦理批准时间。我们的分析纳入了总共1268份使用人类受试者进行研究的批准申请。风险类别(最小风险与非最小风险)、资金类型和提交年份这三个变量在预测伦理批准时间方面具有统计学意义,其中风险状态最为重要。最小风险研究的协变量调整后平均批准时间(35.7天)不到非最小风险方案(76.5天)的一半。通过营利性赞助商资助的研究批准时间明显长于通过其他方式资助的研究,但这些研究也主要(87%)是非最小风险方案。需要进一步调查观察到的差异背后的原因,以确定对研究伦理委员会(REB)成员进行更好的培训和/或与研究者进行更多对话是否可以减少与非最小风险方案相关的冗长批准时间。

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