The history and role of institutional review boards.

The history and role of institutional review boards.
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DOI:
10.1001/virtualmentor.2009.11.4.pfor1-0904
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发表时间:
2009-04-01
期刊:
The virtual mentor : VM
影响因子:
--
通讯作者:
Khin-Maung-Gyi, Felix
Khin-Maung-Gyi, Felix
中科院分区:
其他
文献类型:
--
作者:
Moon, Margaret R;Khin-Maung-Gyi, Felix

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编者按:自20世纪60年代中期以来,机构审查委员会(IRB)已经发展成为研究方案的独立审查者,如果获得批准,将由美国政府资助或测试由食品和药物管理局监管的药物或设备。正如其名称所示,IRB开始并发展于学术研究机构。最近,独立的所谓“中央”机构审查委员会出现了。以下两篇文章回顾了IRB的历史,并研究了地方机构附属IRB和中央非附属IRB的优势和劣势。
Editor’s Note: Institutional review boards (IRBs) have evolved since the middle of the 1960s as independent reviewers of research protocols that, if approved, will be funded by the US government or will test drugs or devices regulated by the Food and Drug Administration. As their name suggests, IRBs began and developed at academic research institutions. More recently, independent, so-called “central” IRBs have come on the scene. The following two articles recap the history of IRBs and examine the strengths and weaknesses of local, institution-affiliated IRBs and central, nonaffiliated IRBs.