Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can be...

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Detalles Bibliográficos
Autores principales: Johnson, Ann R., Kasimatis Singleton, Megan, Ozier, Julie, Serdoz, Emily, Beadles, Jennifer G., Maddox-Regis, Janelle, Mumford, Sarah, Burr, Jeri, Dean, J. Michael, Ford, Daniel E., Bernard, Gordon R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2022
Materias:
Special Communications
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120617/
https://www.ncbi.nlm.nih.gov/pubmed/35656335
http://dx.doi.org/10.1017/cts.2022.391
Descripción
Sumario:The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

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