Notes from the field: Jumpstarting the IRB approval process in multicenter studies
Notes from the field: Jumpstarting the IRB approval process in multicenter studies
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DOI：
10.1111/j.1475-6773.2006.00687.x
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发表时间：
2007-08-01
影响因子：
3.4
通讯作者：
Billings, John
中科院分区：
文献类型：
--
作者：
Blustein, Jan;Regenstein, Marsha;Billings, John
目标。在多中心研究中，确定促进当地机构审查委员会（IRB）审查的策略。研究设置。11家急症护理医院，因为他们申请参加基金会赞助的质量改进协作。研究设计。系列。数据收集/提取。参与性观察，辅之以书面和口头交流的审查。主要的发现。申请医院积极响应让它们参与内部审查委员会审查程序的早期规划的努力。特别有效的策略是应用程序模板的规定，研究描述的模块化方法，以及依靠电话会议集体参与潜在的研究者，当地IRB成员和评估/国家项目办公室团队。总之，这些策略允许及早发现问题，澄清意图，并相对及时地完成当地IRB审查过程，一旦医院被选中参与学习协作。让潜在的合作者参与计划IRB审查可能有助于加快和促进审查，而不会损害拨款过程的公平性或人类受试者保护的完整性。
Objective. To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies.Study Setting. Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative.Study Design. Case series.Data Collection/Extraction. Participant observation, supplemented with review of written and oral communications.Principal Findings. Applicant hospitals responded positively to efforts to engage them in early planning for the IRB review process. Strategies that were particularly effective were the provisions of application templates, a modular approach to study description, and reliance on conference calls to collectively engage prospective investigators, local IRB members, and the evaluation/national program office teams. Together, these strategies allowed early identification of problems, clarification of intent, and relatively timely completion of the local IRB review process, once hospitals were selected to participate in the learning collaborative.Conclusions. Engaging potential collaborators in planning for IRB review may help expedite and facilitate review, without compromising the fairness of the grant-making process or the integrity of human subjects protection.