Delays and diversity in the practice of local research ethics committees
Delays and diversity in the practice of local research ethics committees
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DOI：
10.1136/jme.22.5.263
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发表时间：
1996-10-01
影响因子：
4.1
通讯作者：
Nicholson, KG
中科院分区：
文献类型：
--
作者：
Ahmed, AH;Nicholson, KG
目的-比较地方研究伦理委员会的做法和他们获得多中心研究伦理批准所需的时间。设计-对地方研究伦理委员会多中心研究申请结果的回顾性分析。设置-36个地方研究伦理委员会，覆盖英格兰38个地区卫生当局。主要措施-主席和妇女的反应，获得批准所需的时间，结果-我们收到了所有36位主席的回复：4位（11%）同意了他们的批准，32位（89%）要求我们的建议由当地的研究伦理委员会审议。三个委员会请我们参加他们的会议。该申请获得了所有36个当地研究伦理委员会的批准，但获得伦理批准的时间从6天到208天不等。三分之一的委员会没有在三个月内批准该项目，三个委员会花了六个月以上的时间。当地研究伦理委员会提出的问题有相当大的变化，没有完全符合的皇家医学院的guidelines. Conclusion获得伦理批准的多中心研究是耗时的。地方研究伦理委员会的做法多种多样。我们的数据支持建立一个多中心研究的中央或区域审查机构的建议，这将是所有当地研究伦理委员会可接受的。
Objectives-To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study.Design-A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees.Setting-Thirty-six local research ethics committees covering 38 district health authorities in England.Main measures-Response of chairmen and women, the time required to obtain approval, and questions asked in application forms.Results-We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines.Conclusion-Obtaining ethical approval for a multicentre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.