no consent study

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no consent study2016-12-13T07:57:58+00:00

no consent study 

EVIDENCE-BASED MEDICINE

A clinical study in which obtaining a standard informed consent is virtually impossible–e.g., when patients are incapacitated or unconscious and thus unable to give provide valid consent for a procedure or therapy–e.g., to opt in or out of emergency use of artificial blood products.  

No consent trials can be approved by the FDA (US Food and Drug Administration) when there are one or more factors that make it impractical to get prior consent; trauma patients are often unconscious, or in no condition to understand and/or sign a consent form. 

Synonym Nonconsent study 

Reference www.seadoc.net/sd/archives/individual/2004/02/20040221-polyheme_nonconsent_trial_succeeding.php 

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