Consistency in decision making by research ethics committees: a controlled comparison
Consistency in decision making by research ethics committees: a controlled comparison
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DOI：
10.1136/jme.2005.014159
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发表时间：
2006-11-01
影响因子：
4.1
通讯作者：
Dixon-Woods, M.
中科院分区：
文献类型：
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作者：
Angell, E.;Sutton, A. J.;Dixon-Woods, M.
长期以来，人们一直对英国研究伦理委员会（REC）所做决定的一致性感兴趣，但大多数证据来自提交给多个委员会的单一研究。对18项有目的地选择的申请所作的决定进行了系统的比较，每一项申请都由一个战略卫生当局的三个不同的区域经济委员会独立审查。对11项申请的决定是一致的，但区域经济共同体对7项申请的决定存在差异。REC决策之间的一致性分析得出一致性的总体指标kappa = 0.286（95%置信区间-0.06至0.73），表明一致性水平虽然可能优于偶然性，但可描述为“轻微”。样本量小限制了这些发现的稳健性。需要进一步研究区域经济共同体之间决策不一致的原因，以及这种不一致对一系列论点的重要性。
There has been longstanding interest in the consistency of decisions made by research ethics committees ( RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of kappa = 0.286 ( 95% confidence interval -0.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as "slight". The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.