The effects of local review on informed consent documents from a multicenter clinical trials consortium
The effects of local review on informed consent documents from a multicenter clinical trials consortium
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DOI：
10.1016/s0197-2456(03)00003-5
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发表时间：
2003-06-01
期刊：
影响因子：
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通讯作者：
Vernon, A
中科院分区：
文献类型：
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作者：
Burman, W;Breese, P;Vernon, A
关于地方机构审查委员会在多中心临床研究审查中的适当作用，有越来越多的争议。我们评估了25个研究地点的本地审查过程对来自结核病试验联盟（一个多中心试验组）的两项研究的同意书的影响。两名独立审查员对中央批准的同意书中的所有更改进行了分类；如果两位最初的审稿人意见不一致，则由第三位审稿人评估这些变更。初始本地批准的中位时间为104.5天（范围31-346天）。由于局部审查，研究方案没有变化。当地审查后，同意书变得更长，可读性更差，年级水平平均增加0.9（+/-0.9）阅读年级水平（p < 0.001）。在中央批准的表格中，更改的中位数为46.5（范围为3-160）。大多数（85.2%）的改变涉及在不影响意思的情况下改变措辞。错误通常被引入（11.2%的更改），并且50个本地批准的同意书中有33个（66%）在协议表示或所需的同意书元素中至少包含一个错误。两项多中心临床试验的地方批准耗时，并导致中央批准的同意书发生了许多变化。这些更改经常降低可读性并引入错误。(C) 2003年Elsevier Inc.版权所有。
There is increasing controversy about the appropriate role of the local institutional review board in the review of multicenter clinical studies. We evaluated the effects of the local review process at 25 study sites on the consent forms from two studies of the Tuberculosis Trials Consortium, a multicenter trials group. Two independent reviewers classified all changes made in the centrally approved consent forms; a third reviewer evaluated those changes if the two initial reviewers disagreed. The median time to initial local approval was 104.5 days (range 31-346). There were no changes in the study protocols as a result of local review. Consent forms became longer and less readable after local review, with a mean increase in grade level of 0.9 (+/-0.9) reading grade levels (p < 0.001). A median of 46.5 changes (range 3-160) were made in the centrally approved forms. Most changes (85.2%) involved altering wording without affecting meaning. Errors were commonly introduced (11.2% of changes), and 33 of 50 (66%) locally approved consent forms contained at least one error in protocol presentation or a required consent form element. Local approval of two multicenter clinical trials was time-consuming and resulted in many changes in centrally approved consent forms. These changes frequently decreased readability and introduced errors. (C) 2003 by Elsevier Inc. All rights reserved.