•A federal regulation (21
CFR 50.24), allows certain studies
that meet the following criteria to use this exception:
§Patients’ lives must be at risk.
§Available treatments are not
satisfactory.
§Patients are unable to give consent.
§Potential risks are reasonable.
§Participation in the research could
provide a direct benefit (increased survival) to the patient.
§The research could not be carried out
practically without this exception.
What is Exception from Informed Consent (EFIC)