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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...
Autores principales: | Corneli, Amy, Dombeck, Carrie B., McKenna, Kevin, Calvert, Sara B. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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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 |
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