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Delays and diversity in the practice of local research ethics committees.

机译:当地研究伦理委员会在实践中的延误和多样性。

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摘要

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 multi-centre 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.
机译:目的:比较当地研究伦理委员会的做法及其在多中心研究中获得伦理批准的时间。设计:对本地研究伦理委员会进行多中心研究的申请结果的回顾性分析。地点:覆盖英格兰38个地区卫生局的36个地方研究伦理委员会。主要措施:主席和妇女的答复,获得批准所需的时间以及申请表中提出的问题。结果:我们收到了所联系的所有36位主席的答复:四位(11%)批准了该批准,而32位(89%)要求我们的建议由其当地研究道德委员会审议。三个委员会要求我们参加他们的会议。该申请已获得所有36个地方研究伦理委员会的批准,但获得伦理批准的时间为6至208天。三分之一的委员会在三个月内未批准该项目,三个委员会的时间超过六个月。地方研究伦理委员会提出的问题存在很大差异,没有一个完全符合皇家医师学院的指南。结论:获得多中心研究的伦理学批准非常耗时。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多中心研究的中央或区域审查机构的建议,这将为所有地方研究伦理委员会所接受。

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  • 作者

    Ahmed, A H; Nicholson, K G;

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  • 年度 1996
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  • 原文格式 PDF
  • 正文语种 en
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