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集中式与非集中式伦理审查:一项五国研究。

Centralized and non-centralized ethics review: a five nation study.

作者信息

Fitzgerald Maureen H, Phillips Paul A

机构信息

School of Occupation and Leisure Studies, The University of Sydney, Faculty of Health Sciences, P.O. Box 170, Lidcombe, NSW 1825, Australia.

出版信息

Account Res. 2006 Jan-Mar;13(1):47-74. doi: 10.1080/08989620600588944.

DOI:10.1080/08989620600588944
PMID:16770859
Abstract

The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fully centralized, dual, and decentralized or multicommittee) in place; all are made up of two, interrelated components (the administrative and ethics review). We suggest that both components need to be considered in discussions about centralized review. Serious consideration of centralization of the administrative component may address many concerns. Centralization of the ethics review may provide a context that deals with other issues and may encourage reviews that more effectively focus on the ethical issues involved.

摘要

研究伦理审查过程如今已成为开展研究不可或缺的一部分,也是备受热议的话题。从消极方面来看,它被认为繁琐、昂贵、耗时,而且可能是一个无法充分解决其设立初衷所涉及问题的体系。为解决其中一些问题,一个常见但常引发争议的提议是审查体系的集中化制度化。本文利用五个国家(澳大利亚、加拿大、新西兰、美国和英国)现行审查体系的数据,其中一些国家有不同形式的集中审查,一些则没有,来探讨与审查过程集中化相关的问题。研究表明,至少存在三种类型的体系(完全集中型、双重型以及分散型或多委员会型);所有这些体系都由两个相互关联的部分组成(行政部分和伦理审查部分)。我们建议,在关于集中审查的讨论中,这两个部分都需要加以考虑。对行政部分进行集中化的认真考量或许能解决诸多问题。伦理审查的集中化可能会营造一种能处理其他问题的环境,并且可能促使审查更有效地聚焦于所涉及的伦理问题。

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