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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Bibliografski detalji
Izdano u:JAMA Netw Open
Glavni autori: Feldman, William B., Hey, Spencer P., Franklin, Jessica M., Kesselheim, Aaron S.
Format: Artigo
Jezik:Inglês
Izdano: American Medical Association 2019
Teme:
Original Investigation
Online pristup: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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