IRB reliance: An informatics approach.
J Biomed Inform
; 60: 58-65, 2016 Apr.
Article
em En
| MEDLINE
| ID: mdl-26827623
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Aplicações da Informática Médica
/
Comitês de Ética em Pesquisa
/
Modelos Teóricos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Biomed Inform
Assunto da revista:
INFORMATICA MEDICA
Ano de publicação:
2016
Tipo de documento:
Article