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Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent
Author(s) -
Biros Michelle H.,
Dickert Neal W.,
Wright David W.,
Scicluna Victoria M.,
Harney Deneil,
Silbergleit Robert,
Denninghoff Kurt,
Pentz Rebecca D.
Publication year - 2015
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/acem.12602
Subject(s) - informed consent , medicine , food and drug administration , clinical trial , family medicine , medical emergency , alternative medicine , pathology
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 likelihood that a legally authorized representative ( LAR ) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent‐related questions arising when a potential surrogate decision‐maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC .