Accès ouvert
2022
article
OpenAlex
Katherine Ann Sward, René Enríquez, Jeri S. Burr, Julie Ozier et autres
Abstract Objective To describe process innovations related to research informed consent documents, and development and formative evaluation of Consent Builder, a platform for generating consent documents for multicenter studies. Materials and Methods Analysis of Institutional Review Board workflows and documents, followed by …
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Accès ouvert
2022
article
OpenAlex
Ann Johnson, Megan Kasimatis Singleton, Julie Ozier, Emily Sheffer Serdoz et autres
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 …
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Accès ouvert
2022
article
OpenAlex
Emily Sheffer Serdoz, Terri L. Edwards, Jill M. Pulley, Jenni Beadles et autres
For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing …
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(code pays fourni par la source)