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研究伦理委员会审计:各委员会之间的差异

Research ethics committee audit: differences between committees.

作者信息

Redshaw M E, Harris A, Baum J D

机构信息

Institute of Child Health, University of Bristol.

出版信息

J Med Ethics. 1996 Apr;22(2):78-82. doi: 10.1136/jme.22.2.78.

Abstract

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated.

摘要

同一研究提案提交给了该国不同地区的24个地区卫生当局(DHA)研究伦理委员会。目的是获得一项多中心研究项目的许可。对不同类型单位(地区、次区域和区级)的新生儿护理进行研究,需要联系英格兰六个相距甚远的卫生区域中每个区域的四个卫生当局。收集并比较了有关流程方面的数据,包括申请表、所需信息、时间安排和决策制定。关键发现是伦理委员会接收和处理申请的方式各不相同,这反映了个体因素和当地问题。为提高一致性并促进多中心研究,建议采用标准表格和说明,并主张设立一个国家委员会或咨询小组。

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