Ahmed A H, Nicholson K G
Department of Microbiology and Immunology, School of Medicine, Leicester University.
J Med Ethics. 1996 Oct;22(5):263-6. doi: 10.1136/jme.22.5.263.
To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study.
A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees.
Thirty-six local research ethics committees covering 38 district health authorities in England.
Response of chairmen and women, the time required to obtain approval, and questions asked in application forms.
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.
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.
比较地方研究伦理委员会的做法以及它们为一项多中心研究获得伦理批准所需的时间。
对向地方研究伦理委员会提交的一项多中心研究申请结果进行回顾性分析。
覆盖英格兰38个地区卫生当局的36个地方研究伦理委员会。
男女主席的回复、获得批准所需的时间以及申请表中提出的问题。
我们收到了所有36位被联系主席的回复：4位（11%）给予批准，32位（89%）要求其地方研究伦理委员会审议我们的提案。三个委员会要求我们参加其会议。该申请得到了所有36个地方研究伦理委员会的批准，但获得伦理批准的时间在6天至208天之间不等。三分之一的委员会在三个月内未批准该项目，三个委员会花费的时间超过六个月。地方研究伦理委员会提出的问题存在很大差异，且没有一个完全符合皇家内科医师学院的指南。
为一项多中心研究获得伦理批准耗时良久。地方研究伦理委员会的做法存在很大差异。我们的数据支持设立一个所有地方研究伦理委员会都能接受的多中心研究中央或区域审查机构的建议。
