Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.
Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.
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DOI：
10.1002/eahr.500003
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发表时间：
2019-01-01
影响因子：
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通讯作者：
Lidz, Charles W
中科院分区：
文献类型：
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作者：
Klitzman, Robert;Pivovarova, Ekaterina;Lidz, Charles W
新的联邦政策要求对多地点研究进行单一 IRB 审查，但关于这些 IRB 将如何利用当地知识仍然存在许多问题。我们的研究首次考察了单个 IRB 如何看待对当地知识的需求，其结果揭示了一些挑战。研究受访者确定了四种潜在相关的当地知识类型：关于文化和语言学、关于地理和社会经济学、关于研究人员以及关于机构。这些知识可以通过当地站点获得，但单个IRB可能不知道潜在相关的当地信息，并且缺乏非正式关系可能会阻碍单个IRB的审查以及与研究人员的互动。虽然最近常用的标准化单一 IRB 表格提出了有关本地信息的三个基本问题，但我们的研究结果表明可能需要额外信息，因此对实践、政策和研究具有重要影响。
New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.