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Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likeliho...

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Detalhes bibliográficos
Publicado no:Acad Emerg Med
Main Authors: Biros, Michelle H., Dickert, Neal W., Wright, David W., Scicluna, Victoria M., Harney, Deneil, Silbergleit, Robert, Denninghoff, Kurt, Pentz, Rebecca D.
Formato: Artigo
Idioma:Inglês
Publicado em: 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7272239/
https://ncbi.nlm.nih.gov/pubmed/25716051
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/acem.12602
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