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SHARE: Research Involving an Exception from Informed Consent
It is a fundamental ethical principal that all medical research should involve the consent of the subject. Sometimes, however, the subject cannot consent because of the severity of their condition. In order to improve the care of patients with severe head injury, for example, or those who are seizing or having a stroke, subjects must be enrolled in clinical trials, but of course they are unable to give a timely consent, and their health proxy may not be available.

In certain situations, the Food and Drug Administration allows some emergency clinical research to be carried out using an exception from informed consent, (EFIC). In order to encourage the best practices in performing studies of this type, the NINDS together with NHLBI have supported workshops to better understand the experience of patients and their families who take part in emergency care research in general, and EFIC studies in particular.

Further details may be found in the three documents, linked below.

Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research
	The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health–Funded Workshop
	Understanding Paramedic, Trial Network, and Patient’s Family Experiences in Emergency Research Clinical Trials Current Research
  
    

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      Last reviewed on July 25, 2022
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