INTERNATIONAL ANALYSIS OF INSTITUTIONAL REVIEW BOARDS REGISTERED WITH THE US OFFICE FOR HUMAN RESEARCH PROTECTIONS
INTERNATIONAL ANALYSIS OF INSTITUTIONAL REVIEW BOARDS REGISTERED WITH THE US OFFICE FOR HUMAN RESEARCH PROTECTIONS
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DOI：
10.1525/jer.2008.3.4.49
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发表时间：
2008-12-01
影响因子：
1.3
通讯作者：
Bartlett, Edward E.
中科院分区：
文献类型：
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作者：
Bartlett, Edward E.
机构审查委员会是人类受试者保护系统的支柱。然而，人们对这些委员会的特点知之甚少。该研究收集并分析了在人类研究保护办公室注册的113个国家的1，326个IRB的数据。该研究分析了以下IRB特征的数据：机构隶属关系，全职行政职位的数量，方案的近似总数，以及DHHS支持或食品药品监督管理局监管的当前有效方案的数量。分析发现，最常见的IRB概况是隶属于临床组织（41.9%的IRB），并有一名全职工作人员（40.0%）。关于方案数量，最常见的IRB概况是有26-99个当前有效的方案（42.0%的IRB），有1-25个DHHS方案（46.6%）和1-25个FDA监管的方案（45.6%）。进一步的分析表明，各国之间存在很大差异。本研究可为未来的IRB评价提供基线。
INSTITUTIONAL REVIEW BOARDS form the backbone of the human subject protection system. Yet little is known about the characteristics of these committees. This study compiles and analyzes the data on 1,326 IRBs in 113 countries registered with the Office for Human Research Protections. The study analyzes data on the following IRB characteristics: institutional affiliation, number of full-time administrative positions, approximate total number of protocols, and number of currently active protocols supported by DHHS or regulated by the Food and Drug Administration. The analysis found that the most common IRB profile is to be affiliated with a clinical organization (41.9% of IRBs) and to have one full-time staff member (40.0%). Regarding protocol volume, the most common IRB profile was to have 26-99 currently active protocols (42.0% of IRBs), to have 1-25 DHHS protocols (46.6%), and 1-25 FDA-regulated protocols (45.6%). Further analyses reveal considerable differences among countries. This study can provide a baseline for future IRB evaluations.