University of Washington HUB Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)

该提案的目的是通过更新5年前创建的NIH支持的大规模院前和住院护理网络（称为SIREN）来改善公共卫生。该网络将继续监督针对影响大脑、心脏、肺和/或血液的紧急医疗状况以及危及生命的创伤的实用临床试验的开展。本提案的组成部分包括华盛顿大学及其港景大学和大学医疗中心（作为“枢纽”），以及金县紧急医疗服务（KCEMS）。该“中心”将参与这些临床试验，并对太平洋西北地区的其他社区机构和其他学术机构（位于温哥华的不列颠哥伦比亚省大学）提供行政和学术监督和领导，后者将作为这些临床试验的招募中心（或“辐条”）。本提案不涉及或寻求批准进行临床试验本身。相反，它严格地为这些试验创建网络基础设施。这些试验本身需要独立的监管批准，这将继续通过先前成立的中央机构审查委员会（ADVARRA）进行，华盛顿大学机构审查委员会在5年前创建SIREN网络时曾将监督权移交给该委员会。

The purpose of this proposal is to improve public health through renewal of an NIH-supported large-scale network of prehospital and hospital care (called SIREN) created 5 years ago. This network that will continue to oversee the conduct of pragmatic clinical trials addressing emergency medical conditions affecting brain, heart, lung and/or blood as well as life-threatening trauma. The components of this proposal locally include the University of Washington and its Harborview and University Medical Centers (as “Hub”) in concert with King County Emergency Medical Services (KCEMS). This “Hub” will both participate in these clinical trials and provide administrative and academic oversight and leadership over additional community-based facilities in the Pacific Northwest, and an additional academic facility (the University of British Columbia in Vancouver, BC), which will serve as enrolling sites (or “Spokes”) for the conduct of these clinical trials. This proposal does not involve nor seek approval for the conduct of the clinical trials themselves. Rather it strictly creates the network infrastructure for these trials. These trials themselves require independent regulatory approval which will continue to occur through a previously established Central Institutional Review Board (ADVARRA) to which the University of Washington Institutional Review Board has previously ceded oversight upon creation of the SIREN network 5 years ago.