Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys

IMPORTANCE: The US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigator...

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Detalles Bibliográficos
Autores principales: Feldman, William B., Hey, Spencer P., Franklin, Jessica M., Kesselheim, Aaron S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2019
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6659147/
https://www.ncbi.nlm.nih.gov/pubmed/31339546
http://dx.doi.org/10.1001/jamanetworkopen.2019.7591

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6659147/
https://www.ncbi.nlm.nih.gov/pubmed/31339546
http://dx.doi.org/10.1001/jamanetworkopen.2019.7591

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