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

He, Shan; Narus, Scott P.; Facelli, Julio C.; Lau, Lee Min; Botkin, Jefferey R.; Hurdle, John F.

doi:10.1016/j.jbi.2014.05.003

Cited by 9 publications

(17 citation statements)

References 15 publications

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“…As noted above, in many sections of the application, the core model had to be extended with several custom data elements that were required in order to support the differences in IRB forms and workflow at different sites. This effort could inform future more rigorous analysis to support a sharable common data model, such as the analyses by He et al [18]. However, we should not ignore existing protocol data models such as the CDISC ODM along with the Study Design Model extension, which could serve as a good starting point, not only for interchange of protocol metadata between IRB systems, but also between protocol management systems across the life cycle of clinical studies, such as, Clinical Trials Management Systems or protocol registration with ClinicalTrials.gov.…”

Section: Discussionmentioning

confidence: 99%

“…While implemented as a single system, the approach illustrates the potential value of interoperability between electronic IRB systems as an alternative to administrative reliance or use of dedicated systems for sharing of protocols across institutions. Moreover, we believe our effort in determining commonalities amongst five disparate institutions along with efforts by other institutions [18], pave the way for establishing a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions. This however will not be possible without a multi-institutional national collaboration within the translational research community.…”

Section: Discussionmentioning

confidence: 99%

“…One report describes the development and evaluation of a detailed domain analysis model [18], but does not describe an implementation based on this new model. Huser et al examined the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) and related extensions, as a protocol data interchange format between administrative clinical research systems including a couple of eIRB systems [19], and found partial support within the systems but no adoption of ODM.…”

Section: Introductionmentioning

confidence: 99%

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IRB reliance: An informatics approach

Obeid

Alexander

Gentilin

et al. 2016

Journal of Biomedical Informatics

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Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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IRB reliance: An informatics approach

Obeid

Alexander

Gentilin

et al. 2016

Journal of Biomedical Informatics

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“…Institutional Review Boards (IRBs) are also 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 [5]. A last challenge in the context of distributed research networks is to provide flexible and scalable service for record linkage that are widely needed to enable health researchers to mine longitudinal information for entire populations [2].…”

Section: Discussionmentioning

confidence: 99%

Information Technology for Clinical, Translational and Comparative Effectiveness Research

Daniel

Choquet²

2015

Yearb Med Inform

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Summary Objectives: To select and summarize key constributions to current research and to select best papers published in 2014 in the field of Clinical Research Informatics (CRI).Method: A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind literature review. Results: The review process yielded four papers, illustrating various aspects of current research efforts done in the area of CRI. The first paper exemplifies the process of developping a domain ontology for integrating structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research. In the second paper, the authors analysed in five sites’ hospital information system environments in Germany the possibility of implementing a patient recruitment process and provided recommendations for the development of dedicated patient recruitment modules. The third paper describes the IMI EHR4CR project which developed an instance of a platform, providing communication, security and semantic interoperability services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. The last paper describes the relation between health status severity and the availability of data in EHR systems. They demonstrate that it introduces a biasis in patient selection for clinical research. Conclusions: Distributed research networks are growing in importance for clinical research and population health surveillance and current research demonstartes that different projects and initiatives could be well placed to deliver international scale solutions to enable the reuse of hospital EHR data to support clinical research studies. Selected articles demonstrate the potential of formal representation of multimodal and multi-level data in supporting data interoperability across clinical research and care domains. With the development of pragmatic research, designed with input from health systems and producing evidence that can be readily used to improve care, a key issue for “learning health care organizations” is to systematically assess the quality of their data.

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“…The diversity between e-IRBs arises from different interpretations of federal regulations, organizational policy and priority variations, the increasing complexity of human subject studies, and a lack of standardization and harmonization efforts. The IRB domain analysis model we presented elsewhere (He et al, 2014) is an attempt to promote best practice in e-IRB design by standardizing information collection and work flow. The content design of each institution's application templates or forms also varies widely, even for institutions using the same commercial product.…”

Section: Discussionmentioning

confidence: 99%

An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States

Botkin

Hurdle

2014

Journal of Empirical Research on Human Research Ethics

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The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large academic medical centers have a high electronic IRB adoption rate; however, the capabilities of electronic IRB systems vary greatly. We discuss potential use-cases of a fully exploited electronic IRB system that promise to streamline the clinical research work flow. The key to that approach utilizes a structured and standardized information model for the IRB application.

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

Cited by 9 publications

References 15 publications

IRB reliance: An informatics approach

IRB reliance: An informatics approach

Information Technology for Clinical, Translational and Comparative Effectiveness Research

An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States

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