Blustein Jan, Regenstein Marsha, Siegel Bruce, Billings John
Wagner Graduate School, New York University, Puck Building, 295 Lafayette Street, New York, NY 10012, USA.
Health Serv Res. 2007 Aug;42(4):1773-82. doi: 10.1111/j.1475-6773.2006.00687.x.
To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies.
Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative.
Case series.
DATA COLLECTION/EXTRACTION: Participant observation, supplemented with review of written and oral communications.
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.
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.
确定在多中心研究中促进当地机构审查委员会（IRB）审查准备工作的策略。
11家急症护理医院申请参与一项由基金会资助的质量改进合作项目。
病例系列研究。
数据收集/提取：参与观察，并辅以对书面和口头交流的审查。
申请参与的医院对让其参与IRB审查流程早期规划的努力反应积极。特别有效的策略包括提供申请模板、采用模块化方式进行研究描述，以及通过电话会议让潜在研究者、当地IRB成员以及评估/国家项目办公室团队共同参与。一旦医院被选中参与学习合作项目，这些策略共同作用，使得问题能够早期识别、意图得以明确，并且当地IRB审查流程能相对及时地完成。
让潜在合作者参与IRB审查规划可能有助于加快和促进审查，同时不损害拨款过程的公正性或人类受试者保护的完整性。
