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涉及北部平原部落国家的多地点项目的伦理审查。

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

作者信息

Angal Jyoti, Petersen Julie M, Tobacco Deborah, Elliott Amy J

机构信息

Sanford Research, Sioux Falls, SD, USA

DM-STAT, Inc., Malden, MA, USA.

出版信息

J Empir Res Hum Res Ethics. 2016 Apr;11(2):91-6. doi: 10.1177/1556264616631657. Epub 2016 Feb 28.

Abstract

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research.

摘要

部落国家越来越多地组建伦理审查小组,这些小组与机构审查委员会(IRB)分开运作。强大的社区代表的出现,恰逢美国卫生与公众服务部及其他联邦机构支持的一项广泛努力,即针对所有多中心研究设立单一的IRB。本文强调了部落伦理审查委员会的价值,并描述了对“安全通道研究”的部落监督——这是一个位于大平原北部的多中心、基于社区的项目。我们的经验证明了部落伦理审查的益处,并有力地主张在未来针对多中心、基于社区研究的监管指南中纳入部落监督。

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