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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Pubblicato in:JAMA Netw Open
Autori principali: Feldman, William B., Hey, Spencer P., Franklin, Jessica M., Kesselheim, Aaron S.
Natura: Artigo
Lingua:Inglês
Pubblicazione: American Medical Association 2019
Soggetti:
Original Investigation
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC6659147/
https://ncbi.nlm.nih.gov/pubmed/31339546
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2019.7591
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