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首页> 外文期刊>Journal of Clinical Epidemiology >A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.
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A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.

机译：审查发现，多中心研究面临重大挑战，但存在获得机构审查委员会批准的策略。

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摘要

BACKGROUND AND OBJECTIVES: To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. MATERIALS AND METHODS: Using PubMed, we identified empirical studies, anecdotal reports, and opinion pieces addressing the process of obtaining initial IRB approval for multicenter clinical trials and observational studies. We also reviewed relevant information from federal and other national sources. RESULTS: A total of 40 peer-reviewed articles were synthesized, plus six reports from commissions or other key sources. These sources identified numerous challenges that researchers may encounter when multicenter studies undergo review by multiple IRBs, such as added time for initial review and approval and different requirements across IRBs. Strategies to alleviate these challenges include planning to accommodate multiple reviews and determining upfront whether certain variations to studyprotocols are tolerable across sites. Many researchers and commissions have proposed comprehensive reforms, such as centralized review for multicenter projects. CONCLUSION: Policy-makers, researchers, and IRBs should convene to specifically discuss optimal approaches for multicenter review. However, until structural changes are implemented, observational researchers should develop and implement strategic plans for obtaining IRB approval in multicenter studies, including adopting models successfully employed by clinical trials.
机译：背景和目的：表征多个机构评审委员会（IRB）评审对多中心观测研究的影响，并确定克服已发现挑战的策略。材料和方法：使用PubMed，我们鉴定了针对多中心临床试验和观察性研究获得初始IRB批准的过程的实证研究，传闻报道和意见。我们还审查了来自联邦和其他国家来源的相关信息。结果：总共合成了40篇经同行评审的文章，以及来自委员会或其他主要来源的六份报告。这些资料表明，当多中心研究由多个IRB进行审核时，研究人员可能会遇到许多挑战，例如增加了初步审核和批准的时间以及跨IRB的不同要求。缓解这些挑战的策略包括计划进行多次审查，并预先确定跨站点的研究协议的某些变化是否可以忍受。许多研究人员和委员会提出了全面的改革措施，例如对多中心项目进行集中审查。结论：决策者，研究人员和内部评级委员会应召集专门讨论多中心审查的最佳方法。但是，在实施结构更改之前，观察性研究人员应制定并实施战略计划，以在多中心研究中获得IRB的批准，包括采用临床试验成功采用的模型。

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