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. 2014 Dec:52:121-9.
doi: 10.1016/j.jbi.2014.05.003. Epub 2014 Jun 11.

A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics

Shan He  1 , Scott P Narus  2 , Julio C Facelli  3 , Lee Min Lau  4 , Jefferey R Botkin  3 , John F Hurdle  3
Affiliations

A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics

Shan He et al. J Biomed Inform. 2014 Dec.

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.

Keywords: Clinical research informatics; Domain analysis model; Electronic IRB; Electronic data processing; IRB.

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Figures

Figure 1
Figure 1. Overview of the IRB Domain Analysis Process
The IRB domain analysis process consists of three phases: context analysis, domain modeling and interaction architecture modeling. The white document-shaped boxes are the deliverables associated with each phase. The dashed boxes indicate that only preliminary work has been done.
Figure 2
Figure 2. Context Analysis for the IRB Oversight Domain
This defines the scope of the modeling domain. Analysis of the relationship between the candidate domain and its parent domain, subdomains, and peer domains is useful to identify which data elements can be consolidated from existing standards and which should be defined.
Figure 3
Figure 3. Overview of the Entity-relationship Modeling Process
This is an iterative process. Feedback from domain experts led us to revisit the knowledge sources and revise the draft model.
Figure 4
Figure 4. An Overview of the Concept Map for the IRB Oversight Domain
This diagram illustrates the eight core areas of the IRB domain over the concept map for display purposes only. It is not intended to show the individual entities and relationships in detail. To view that detail, navigate to: http://irb-dam.bmi.utah.edu/
Figure 5
Figure 5
The Study Protocol Typology for the IRB Oversight Domain. This classification is designed especially for IRB review purpose. Each child study protocol type has its own characteristics that differentiate it from its parent. More specific study design types will be captured in the “designConfiguration” attribute defined in the StudyProtocol class.
Figure 6
Figure 6
Data-Access Request Related Classes in the IRB Model: the dataCategory and dataElementName attribute from the DataElement class will be bound to the ROHDR model to achieve semantic interoperability.
See this image and copyright information in PMC

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