Title: Emergency Care Research: What is the difference between waiver versus exception for informed consent?<br/>Author: Jon Mark Hirshon<br/><a href='http://umem.org/profiles/faculty/96/'>[Click to email author]</a><hr/><p>
        The terms and concepts of “waiver of informed consent’ versus “exception from informed consent” are often confused.  Within the U.S., these concepts are not the same.</p>
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                <strong>Waiver or alteration of informed consent is for minimal risk research and requires the following 4 conditions:</strong>
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                                Research involves no more than minimal risk to the subjects;</li>
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                                Waiver or alteration will not adversely affect the rights and welfare of the subjects;</li>
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                                Research could not practicably be carried out without the waiver or alteration; <strong>and</strong></li>
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                                Whenever appropriate, the subjects will be provided with additional pertinent information after participation</li>
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                <strong>Exception from informed consent (EFIC) is permissible for emergency research:</strong>
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                                Rarely used, only for true emergencies</li>
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                                Recognition that there are times/conditions when informed consent is not feasible
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                                                Length of potential therapeutic window is defined (i.e.- short window)</li>
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                                Must hold the potential for direct benefit for the subject</li>
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                                Requires special protections and conditions, in addition to the regular ethical review
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                                                Including a community consultation process</li>
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        <strong>Bottom line:</strong></p>
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        <strong>Waiver of Informed Consent ≠ EFIC</strong></p>
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                Exception from informed consent (EFIC) is rarely used and is only for true, life threatening situations.  It requires substantial review and special steps to obtain.</li>
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                Waiver of informed consent is commonly used for retrospective chart reviews and similar minimal risk research.</li>
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        These are the rules and regulations for the U.S. The regulations for emergency research in other countries may or may not be similar to these.</p>
<fieldset><legend>References</legend>

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        45 CFR 46.116(d)</p>
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        21 CFR 50.24 and 45 CFR 46.101</p>
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