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地方研究伦理委员会。对一项全国性调查方案的反应大相径庭。

Local research ethics committees. Widely differing responses to a national survey protocol.

作者信息

Harries U J, Fentem P H, Tuxworth W, Hoinville G W

机构信息

Public Health Research and Resource Centre, Salford.

出版信息

J R Coll Physicians Lond. 1994 Mar-Apr;28(2):150-4.

Abstract

The diversity in responses of local research ethics committees (LRECs) is illustrated with reference to consideration of the protocols for a national survey of physical activity, fitness and health in healthy volunteers. The survey included a questionnaire administered in the home, followed by a physical appraisal carried out in a mobile laboratory. The study was eventually approved by the 30 local committees to which it was submitted, but there was marked variation in the type of enquiries received and the special arrangements requested. At one extreme, some committees approved the study before seeing the detailed ethical submission; at the other extreme, suggested expensive and time-consuming alterations to the standard procedures. Our experience reveals a lack of uniformity in the operation of LRECs, serious enough to delay and even inhibit useful research, and a failure of some committees to adhere to guidelines suggested by the Royal College of Physicians and the Department of Health.

摘要

通过参考一项针对健康志愿者的身体活动、健康状况和健康的全国性调查方案的审议情况,可以说明地方研究伦理委员会(LRECs)反应的多样性。该调查包括一份在家中进行的问卷调查,随后在移动实验室进行身体评估。该研究最终获得了提交申请的30个地方委员会的批准,但收到的询问类型和要求的特殊安排存在显著差异。在一个极端情况下,一些委员会在未查看详细的伦理申请材料之前就批准了该研究;在另一个极端情况下,则有人建议对标准程序进行昂贵且耗时的修改。我们的经验表明,地方研究伦理委员会的运作缺乏统一性,严重到足以延迟甚至阻碍有益的研究,而且一些委员会未能遵循皇家内科医师学院和卫生部建议的指导方针。

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