Klitzman Robert, Pivovarova Ekaterina, Murray Alexandra, Appelbaum Paul S, Stiles Deborah F, Lidz Charles W
Professor of psychiatry and the director of the Master of Science in Bioethics Program at Columbia University.
Assistant professor of psychiatry at the University of Massachusetts Medical School in Worcester.
Ethics Hum Res. 2019 Jan;41(1):22-31. doi: 10.1002/eahr.500003.
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.
新的联邦政策要求对多中心研究进行单一机构审查委员会（IRB）审查，但关于这些IRB将如何利用本地知识仍存在许多问题。我们的研究首次探讨了单一IRB如何看待本地知识需求，研究结果揭示了几个挑战。参与研究的受访者确定了四种可能相关的本地知识类型：关于文化和语言、关于地理和社会经济、关于研究人员以及关于机构。此类知识可能通过本地研究点获取，但单一IRB可能未意识到潜在相关的本地信息，并且缺乏非正式关系可能会妨碍单一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表格询问了关于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更多信息，因此对实践、政策和研究具有重要意义。
