In 1996, the Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway for planned emergency clinical research. This pathway has stringent criteria, requires extensive community consultation and disclosure, and includes provisions to seek informed consent as soon as feasible. [21 CFR 50.24] [HTML] Note: EFIC is for research conducted in emergency settings and is NOT the same as single-subject emergency use which is detailed in the Emergency Use Single-Subject SOP [PDF].