Medical schools' attitudes and perceptions regarding the use of central institutional review boards
Medical schools' attitudes and perceptions regarding the use of central institutional review boards
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DOI：
10.1097/00001888-200407000-00007
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发表时间：
2004-07-01
影响因子：
7.4
通讯作者：
Meyer, RE
中科院分区：
文献类型：
--
作者：
Loh, ED;Meyer, RE
目的。调查美国医学院在使用中央机构审查委员会(IRBs)审查涉及人类参与者的研究方面的当前做法、态度、看法和未来计划。2003年，通过传真和电子邮件向125所经认证的美国医学院的研究主任分发了一份调查工具。每个院长都被要求由该校的官员完成仪器，该官员决定使用中央IRB还是地方IRB。调查工具主要由各种封闭式问题组成。88所医学院(69.8%)完成了该仪器；其中76%的学校表示他们从未使用过中央IRB，24%的学校使用过中央IRB。大多数答复者表示没有兴趣在未来使用中央内部审查委员会，因为他们认为他们当地的内部审查委员会工作效率很高，他们担心机构责任和在审查过程中失去当地代表的问题。在已使用中央内部评审委员会的医学院中，大部分对中央内部评审委员会的表现感到满意，并会在未来继续使用中央内部评审委员会。有趣的是，这些受访者中的大多数都不同意中央IRB帮助他们吸引了行业赞助的研究。尽管许多人讨论了中央IRB在加速人类受试者研究概述方面的优势，特别是在多中心试验中，但大多数接受调查的医学院从未使用过中央IRB，也没有表示有兴趣这样做。
Purpose. To investigate the current practices, attitudes, perceptions, and future plans of U.S. medical schools regarding the use of central institutional review boards (IRBs) to review research involving human participants.Method. In 2003, a survey instrument was distributed via fax and e-mail to the deans of research at the 125 accredited U.S. medical schools. Each dean was asked to have the instrument completed by the official at that school who decided on the use of a central versus local IRB. The survey instrument consisted primarily of a variety of closed-ended questions.Results. Eighty-eight medical schools (69.8%) completed the instrument; 76% of these indicated that they had never used a central IRB and 24% had used a central IRB. Most of the respondents expressed no interest in using a central IRB in the future because they believed that their local IRB was working efficiently, and they were concerned about issues of institutional liability and the loss of local representation in the review process. Of the medical schools that had used a central IRB, most were pleased with the performance of the central IRB and would continue to use a central IRB in the future. Of interest, most of these respondents did not agree that a central IRB had helped them to attract industry-sponsored research.Conclusions. In spite of much discussion about the advantages of central IRBs in expediting overview of human subjects research, especially in multicenter trials, the majority of medical schools surveyed had never used a central IRB and expressed no interest in doing so.