title: A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics.
abstract: 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.
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA. Electronic address: shan.he@utah.edu.
authors.forename: Shan
authors.initials: S
authors.lastname: He
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA; Intermountain Medical Center, Intermountain Healthcare, Murray, UT, USA.
authors.forename: Scott P
authors.initials: SP
authors.lastname: Narus
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.
authors.forename: Julio C
authors.initials: JC
authors.lastname: Facelli
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA; 3M Health Information Systems, Murray, UT, USA.
authors.forename: Lee Min
authors.initials: LM
authors.lastname: Lau
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.
authors.forename: Jefferey R
authors.initials: JR
authors.lastname: Botkin
authors.affiliation: Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: Hurdle
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards; D028744:Ethics Committees, Research; D006801:Humans; D008490:Medical Informatics / Q000379:methods / Q000592:standards; D008962:Models, Theoretical
keywords: Clinical research informatics; Domain analysis model; Electronic IRB; Electronic data processing; IRB