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Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

The revised Common Rule requires using a single institutional review board (sIRB) for U.S.‐based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences bet...

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Detalles Bibliográficos
Autores principales: Corneli, Amy, Dombeck, Carrie B., McKenna, Kevin, Calvert, Sara B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251897/
https://www.ncbi.nlm.nih.gov/pubmed/34019339
http://dx.doi.org/10.1002/eahr.500092