Paolino Andrea R, Lauf Sherry Lee, Pieper Lisa E, Rowe Jared, Vargas Ileana M, Goff Melissa A, Daley Matthew F, Tuzzio Leah, Steiner John F
Kaiser Permanente Colorado Institute for Health Research.
Group Health Research Institute Cancer Research Network.
EGEMS (Wash DC). 2014 Jul 10;2(1):1076. doi: 10.13063/2327-9214.1076. eCollection 2014.
Multi-institutional collaborations are necessary in order to create large and robust data sets that are needed to answer important comparative effectiveness research (CER) questions. Before scientific work can begin, a complex maze of administrative and regulatory requirements must be efficiently navigated to avoid project delays.
Staff from research, regulatory, and administrative teams involved in three HMO Research Network (HMORN) multi-institutional collaborations developed and employed novel approaches: to secure and maintain Institutional Review Board (IRB) approvals; to enable data sharing, and to expedite subawards for two data-only minimal risk studies. These novel approaches accelerated required processes and approvals while maintaining regulatory, human subjects, and institutional protections.
Outcomes from the processes described here are compared with processes outlined in the research and regulatory literature and with processes that have been used in previous multisite research collaborations.
Research, regulatory, and administrative staff are essential contributors to the success of multi-institutional collaborations. Their flexibility, creativity, and effective communication skills can lead to the development of efficient approaches to achieving the necessary oversight for these complex projects. Elements of these specific strategies can be adapted and used by other research networks. Other efforts in these areas should be evaluated and shared. The processes that help develop a "learning research system" play an important and complementary role in sustaining multi-institutional research collaborations.
多机构合作对于创建回答重要的比较效果研究（CER）问题所需的大型且可靠的数据集而言是必要的。在科学工作能够开展之前，必须有效应对一系列复杂的行政和监管要求，以避免项目延误。
参与三项健康维护组织研究网络（HMORN）多机构合作的研究、监管和行政团队的工作人员开发并采用了新颖的方法：确保并维持机构审查委员会（IRB）的批准；实现数据共享，并加快两项仅涉及数据的最低风险研究的分包。这些新颖的方法加快了所需流程和审批速度，同时维持了监管、人体受试者和机构层面的保护。
将此处描述的流程结果与研究和监管文献中概述的流程以及先前多地点研究合作中使用的流程进行比较。
研究、监管和行政人员是多机构合作成功的重要贡献者。他们的灵活性、创造力和有效的沟通技巧能够促成高效方法的开发，从而对这些复杂项目实现必要的监督。这些具体策略的要素可供其他研究网络调整和使用。应评估并分享这些领域的其他成果。有助于建立“学习型研究系统”的流程在维持多机构研究合作方面发挥着重要的补充作用。
