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Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov

INTRODUCTION: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a “concise and focused” key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sectio...

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Detalles Bibliográficos
Autores principales: Gelinas, Luke, Morrell, Walker, Tse, Tony, Glazier, Ava, Zarin, Deborah A., Bierer, Barbara E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514692/
https://www.ncbi.nlm.nih.gov/pubmed/37745937
http://dx.doi.org/10.1017/cts.2023.605