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研究伦理委员会:一种区域性方法。

Research ethics committees: a regional approach.

作者信息

Macpherson C C

机构信息

St. George's University School of Medicine, Grenada, West Indies.

出版信息

Theor Med Bioeth. 1999 Apr;20(2):161-79. doi: 10.1023/a:1009989104496.

DOI:10.1023/a:1009989104496
PMID:10450665
Abstract

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures.

摘要

国家和国际层面都存在机构审查委员会(IRB)或研究伦理委员会的指导方针。这些指导方针基于伦理原则,为医学研究的审查和开展确立了国际认可的标准。在就这些基本指导方针应包含的内容达成跨国共识后,IRB负责解读这些指导方针并设计自身的实施方式。个人和社区价值观会影响对指导方针的解读,因此不同的IRB有效性水平各异。在加勒比和泛美地区,IRB数量很少。在这样的发展中地区,语言、识字率和当地价值体系的差异加剧了IRB设立和运作的障碍;教育、行政专业知识、设施以及信息获取也都有限。一个区域性IRB网络或许能促进发展中国家进行更统一的伦理审查,并简化IRB程序。

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Research ethics committees: a regional approach.研究伦理委员会:一种区域性方法。
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本文引用的文献

1
Modified informed consent in a viral seroprevalence study in the Caribbean.
Bioethics. 1996 Jul;10(3):222-32. doi: 10.1111/j.1467-8519.1996.tb00121.x.
2
The "best proven therapeutic method" standard in clinical trials in technologically developing countries.
IRB. 1998 Jan-Feb;20(1):5-9.
3
The Institute of Medicine's report on women and health research: implications for IRBs and the research community.
IRB. 1996 Mar-Apr;18(2):1-3.
4
Collaborative research involving human subjects: a survey of researchers using international single project assurances.涉及人类受试者的合作研究:对使用国际单一项目保证的研究人员的调查
公共卫生研究的伦理监督:规则和机构审查委员会能在发展中国家发挥作用吗?
Am J Public Health. 2002 Jul;92(7):1079-84. doi: 10.2105/ajph.92.7.1079.
IRB. 1997 Jan-Feb;19(1):1-6.
5
Bioethics in Argentina: a country report.阿根廷的生物伦理学:一份国别报告。
Bioethics. 1996 Apr;10(2):140-53. doi: 10.1111/j.1467-8519.1996.tb00113.x.
6
Shading the truth in seeking informed consent for research purposes.在为研究目的寻求知情同意时隐瞒真相。
Kennedy Inst Ethics J. 1995 Mar;5(1):1-17. doi: 10.1353/ken.0.0116.
7
Research ethics. NIH examines standards for consent.研究伦理。美国国立卫生研究院审查知情同意的标准。
Science. 1998 Jun 12;280(5370):1688. doi: 10.1126/science.280.5370.1688.
8
Research ethics.研究伦理。
West Indian Med J. 1995 Dec;44(4):115-8.
9
Research ethics committee audit: differences between committees.研究伦理委员会审计:各委员会之间的差异
J Med Ethics. 1996 Apr;22(2):78-82. doi: 10.1136/jme.22.2.78.
10
The governance of clinical trials.临床试验的管理
Lancet. 1996 May 18;347(9012):1387-8. doi: 10.1016/s0140-6736(96)91018-1.