He Shan, Narus Scott P, Facelli Julio C, Lau Lee Min, Botkin Jefferey R, Hurdle John F
Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.
Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA; Intermountain Medical Center, Intermountain Healthcare, Murray, UT, USA.
J Biomed Inform. 2014 Dec;52:121-9. doi: 10.1016/j.jbi.2014.05.003. Epub 2014 Jun 11.
Institutional Review Boards (IRBs) are a critical component of clinical research and can become a significant bottleneck due to the dramatic increase, in both volume and complexity of clinical research. Despite the interest in developing clinical research informatics (CRI) systems and supporting data standards to increase clinical research efficiency and interoperability, informatics research in the IRB domain has not attracted much attention in the scientific community. The lack of standardized and structured application forms across different IRBs causes inefficient and inconsistent proposal reviews and cumbersome workflows. These issues are even more prominent in multi-institutional clinical research that is rapidly becoming the norm. This paper proposes and evaluates a domain analysis model for electronic IRB (eIRB) systems, paving the way for streamlined clinical research workflow via integration with other CRI systems and improved IRB application throughput via computer-assisted decision support.
机构审查委员会（IRB）是临床研究的关键组成部分，由于临床研究的数量和复杂性急剧增加，它可能会成为一个重大瓶颈。尽管人们对开发临床研究信息学（CRI）系统和支持数据标准以提高临床研究效率和互操作性很感兴趣，但IRB领域的信息学研究在科学界并未引起太多关注。不同IRB之间缺乏标准化和结构化的申请表，导致提案审查效率低下且不一致，工作流程繁琐。这些问题在迅速成为常态的多机构临床研究中更为突出。本文提出并评估了一种电子IRB（eIRB）系统的领域分析模型，为通过与其他CRI系统集成简化临床研究工作流程以及通过计算机辅助决策支持提高IRB申请处理量铺平了道路。
