Department of Pediatrics, University of Washington, Seattle, WA, USA.
Clin Transl Sci. 2013 Feb;6(1):57-9. doi: 10.1111/j.1752-8062.2012.00444.x. Epub 2012 Aug 23.
This paper is a case study of our regional Clinical Translational Science Award's (CTSA) development of a coordinated response to the advanced notice of proposed rulemaking on Human Subjects Research Protections during the fall of 2011. Our CTSA was well positioned to quickly activate and coordinate a response to this important and time sensitive issue because we had established infrastructure and resources both within our CTSA and through our partnering institutions, existing relationships with key individuals in the institutions, and credibility as a trusted source of information. Three town hall meetings were organized and a Website was created to collect online comments. Ultimately, comments were collected, prioritized, and organized into a single, coordinated response. This case study demonstrates the value of a distributed research infrastructure and the role CTSAs like our Institute of Translational Health Sciences can play to engage the regional research community about important developments in the research landscape and to respond to requests for feedback to policy makers.
本文是对我们地区临床转化科学奖（CTSA）在 2011 年秋季对人类主题研究保护拟议规则制定的预先通知做出协调反应的案例研究。由于我们在 CTSA 内部以及通过合作伙伴机构建立了基础设施和资源，与机构中的关键人员建立了现有关系，并且作为信息可信来源的信誉，因此我们的 CTSA 能够迅速启动并协调应对这一重要且时间敏感的问题。我们组织了三次专题小组会议，并创建了一个网站来收集在线评论。最终，我们收集、优先排序并组织了一条单一的、协调的回复。本案例研究展示了分布式研究基础设施的价值，以及像我们转化健康科学研究所这样的 CTSA 可以在参与区域研究社区了解研究领域的重要发展方面发挥的作用，并对政策制定者的反馈请求做出回应。
