Citation
Slutsman, Julia; Dole, Nancy; Leuthner, Steven; & Schreiner, Mark S. (2018). Implementing Single IRB Review of Multisite Research: Lessons Learned from the National Children’s Study. IRB: Ethics & Human Research, 40(3), 14-20.Abstract
In keeping with recent regulatory and policy requirements, a large proportion of multisite studies will be using a single institutional review board (IRB) of record. Further research is needed to better understand how to effectively establish reliance relationships and to understand the pros and cons of different models for implementing a single IRB. We describe a case study in the adoption and implementation of a single IRB model, the federated model of IRB review, by seven institutions that participated in the initial stage of the National Children’s Study Vanguard Study—a planned large-scale epidemiological cohort study. We highlight lessons learned in the process of establishing a single IRB model and facilitating adoption of the model by academic medical centers. These lessons include the need to plan sufficient time to obtain support from key stakeholders in institutions considering adoption of the model and the importance of standardizing policies and mechanisms related to review of local context issues.URL
https://doi.org/10.1002/eahr.403004Reference Type
Journal ArticleYear Published
2018Journal Title
IRB: Ethics & Human ResearchAuthor(s)
Slutsman, JuliaDole, Nancy
Leuthner, Steven
Schreiner, Mark S.