Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
Med Care. 2012 Jul;50 Suppl:S77-81. doi: 10.1097/MLR.0b013e31825a76eb.
Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks.
A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned.
Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects.
Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.
获得机构审查委员会（IRB）对多中心研究的批准可能是一个漫长而耗时的过程。这可能会增加同意书的复杂性，降低患者的理解程度，并降低招募人数。此外，由于重复工作，还会导致成本增加。本文探讨了一些简化多中心研究 IRB 审查过程的策略，并提供了两个现有的多中心比较效果研究网络所使用的示例。
进行了文献检索，以确定描述促进多中心 IRB 批准的挑战和潜在策略的来源。确定了最有前途的途径，并将其纳入本综述。对两个成功的多中心研究网络的主要研究者和项目经理进行了电话访谈，以了解他们的“成功关键”和经验教训。
确定了三种最有前途的策略：在提交前与 IRB 合作、使用中央和/或联邦 IRB 以及建立保护伞协议。案例研究项目在某种程度上使用了这些策略中的每一种。
尽管这里记录的方法可以帮助简化 IRB 批准过程，但它们并不是“灵丹妙药”。由于其中一些方法仍然相对较新，因此经验数据很少。然而，人们相信它们将大大减轻整个项目的行政负担，并导致协议批准的总体时间缩短。
