He Shan, Hurdle John F, Botkin Jeffrey R, Narus Scott P
Department of Biomedical Informatics.
AMIA Annu Symp Proc. 2010 Nov 13;2010:291-5.
Human subjects are indispensable for clinical and translational research. Federal and local agencies issue regulations governing the conduct of research involving human subjects in order to properly protect study participants. Institutional Review Boards (IRBs) have the authority to review human subject research to ensure concordance with these regulations. One of the primary goals of the IRB oversight is to protect research participants' privacy by carefully reviewing the data used and disclosed during a study. However, there are major challenges for IRBs in the typical research process. Due to the information disconnect between the data providers (e.g., a clinical data warehouse) and the IRB, it is often impossible to tell exactly what data has been disclosed to investigators. This causes time-consuming, inefficient, and often ineffective monitoring of clinical studies. This paper proposes an integrated architecture that interconnects a federated healthcare data query platform with an electronic IRB system.
人类受试者对于临床和转化研究不可或缺。联邦和地方机构发布有关涉及人类受试者研究行为的法规，以妥善保护研究参与者。机构审查委员会（IRB）有权审查人类受试者研究，以确保符合这些法规。IRB监督的主要目标之一是通过仔细审查研究期间使用和披露的数据来保护研究参与者的隐私。然而，在典型的研究过程中，IRB面临重大挑战。由于数据提供者（例如临床数据仓库）与IRB之间存在信息脱节，往往无法确切知道已向研究人员披露了哪些数据。这导致对临床研究的监测既耗时又低效，而且往往无效。本文提出了一种集成架构，将联邦医疗数据查询平台与电子IRB系统互连。
