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本文引用的文献

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The safe passage study: design, methods, recruitment, and follow-up approach.安全通道研究:设计、方法、招募及随访方法
Paediatr Perinat Epidemiol. 2014 Sep;28(5):455-65. doi: 10.1111/ppe.12136. Epub 2014 Aug 5.
2
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Am J Public Health. 2013 Dec;103(12):2146-52. doi: 10.2105/AJPH.2013.301522. Epub 2013 Oct 17.
3
Genetic research among the Havasupai--a cautionary tale.哈瓦苏派部落的基因研究——一个警示故事。
Virtual Mentor. 2011 Feb 1;13(2):113-7. doi: 10.1001/virtualmentor.2011.13.2.hlaw1-1102.
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The ethics police?: IRBs' views concerning their power.伦理警察?:IRB 对其权力的看法。
PLoS One. 2011;6(12):e28773. doi: 10.1371/journal.pone.0028773. Epub 2011 Dec 13.
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Reforming the regulations governing research with human subjects.改革有关人体研究的管理规定。
N Engl J Med. 2011 Sep 22;365(12):1145-50. doi: 10.1056/NEJMsb1106942. Epub 2011 Jul 25.
6
How local IRBs view central IRBs in the US.美国地方 IRB 如何看待中心 IRB。
BMC Med Ethics. 2011 Jun 23;12:13. doi: 10.1186/1472-6939-12-13.
7
How do IRB members make decisions? A review and research agenda.机构审查委员会成员如何做出决策?一项综述与研究议程。
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Increasing research literacy in minority communities: CARES fellows training program.提高少数族裔社区的研究素养:CARES研究员培训计划。
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Community-based participatory research: a capacity-building approach for policy advocacy aimed at eliminating health disparities.社区为基础的参与式研究:一种旨在消除健康差异的政策倡导能力建设方法。
Am J Public Health. 2010 Nov;100(11):2094-102. doi: 10.2105/AJPH.2009.170506. Epub 2010 Sep 23.

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.

DOI:10.1177/1556264616631657
PMID:26928897
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4917412/
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。