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.

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Form Approved OMB# 0925-0648 Exp. Date 06/2024