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苏格兰一项全国性研究获得当地研究伦理委员会批准。

Local research ethics committee approval for a national study in Scotland.

作者信息

Ah-See K W, MacKenzie J, Thakker N S, Maran A G

机构信息

Department of Otolaryngology, City Hospital, Edinburgh, UK.

出版信息

J R Coll Surg Edinb. 1998 Oct;43(5):303-5.

PMID:9803097
Abstract

The handling of research proposals by different ethics committees has been reported as varying widely from one district to another. Multicentre research projects are particularly liable to delay when dealing with several individual committees. We recently performed a nation-wide postal questionnaire study in Scotland on young patients with oral or oropharyngeal cancer. Our experience indicates that despite calls for standardization of the processes involved wide variations still exist between committees. Fifteen out of 19 committees approached had unique application forms, the number of copies of forms and other documentation required ranged from one to 20, and the time to final approval ranged from 39 to 182 days (mean of 90 days). Improved training and a standardized constitution of committee members is required. A uniform national application form and improved co-operation between neighbouring committees is needed.

摘要

据报道,不同伦理委员会对研究提案的处理在不同地区差异很大。多中心研究项目在与多个独立委员会打交道时尤其容易延迟。我们最近在苏格兰开展了一项针对口腔或口咽癌年轻患者的全国性邮政问卷调查研究。我们的经验表明,尽管呼吁对相关流程进行标准化,但各委员会之间仍存在很大差异。19个被联系的委员会中有15个有独特的申请表,所需表格和其他文件的份数从1份到20份不等,最终批准的时间从39天到182天不等(平均90天)。需要加强培训并规范委员会成员的构成。需要一份统一的全国申请表,并改善相邻委员会之间的合作。

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