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英国国家医疗服务体系(NHS)伦理委员会成员对教育研究应如何进行审查的看法。

Views of National Health Service (NHS) Ethics Committee members on how education research should be reviewed.

作者信息

Brown Jeremy, Ryland Ida, Howard John, Shaw Nigel

机构信息

Faculty of Health, Edge Hill University, University Hospital Aintree, Liverpool, UK.

出版信息

Med Teach. 2007 Mar;29(2-3):225-30. doi: 10.1080/01421590701300179.

DOI:10.1080/01421590701300179
PMID:17701637
Abstract

BACKGROUND

A Local Research Ethics Committee (LREC) may not be appropriate for reviewing research projects involving trainees as participants.

AIMS

This study aimed to obtain views of LREC members regarding education research being reviewed by LRECS.

METHODS

A questionnaire describing six medical education research projects was sent to an opportunistic sample of LRECs. Respondents were asked to indicate the type of ethics review and consent that would be required for each project. Free text comments were also invited.

RESULTS

The majority of the 68 respondents felt that committee review (LREC or institutional) was required for contacting trainees to obtain taped or written interviews. Most felt that some form of consent was appropriate for all the studies. Themes arising from the free text responses were that: there were concerns about this study itself; the requirements for ethical approval for education research should be no different from those of clinical research; there are problems defining 'research', 'audit' and 'course evaluation'; ethical approval should be acquired for education research but not through LRECs; the COREC system is over-complex; and, high standards of research have to be maintained.

CONCLUSION

The majority of ethics committee members feel that most education research needs independent review but not necessarily by LRECs.

摘要

背景

地方研究伦理委员会(LREC)可能不适用于审查涉及实习生作为参与者的研究项目。

目的

本研究旨在获取LREC成员对LRECs正在审查的教育研究的看法。

方法

向一个机会抽样的LRECs发送了一份描述六个医学教育研究项目的问卷。要求受访者指出每个项目所需的伦理审查类型和同意方式。还邀请了自由文本评论。

结果

68名受访者中的大多数人认为,联系实习生以获取录音或书面访谈需要委员会审查(LREC或机构审查)。大多数人认为所有研究都需要某种形式的同意。自由文本回复中出现的主题包括:对本研究本身存在担忧;教育研究的伦理批准要求应与临床研究无异;定义“研究”“审计”和“课程评估”存在问题;教育研究应获得伦理批准,但不应通过LRECs;COREC系统过于复杂;并且,必须维持高标准的研究。

结论

大多数伦理委员会成员认为,大多数教育研究需要独立审查,但不一定由LRECs进行。

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