When a doctor delivers an unapproved treatment in a life-threatening emergency, it is classified as emergency use. Emergency use is not research. If prospective IRB approval cannot be obtained, the emergency use must be reviewed by our IRB as soon as possible (within five days of use).
Aurora Health Care’s Research Subject Protection Program (RSPP) has provisions in place to offer patients medications and devices that haven’t yet received Food and Drug Administration (FDA) approval. Any such use is considered expanded access. Expanded access also includes compassionate use.
To qualify as emergency use, all of these conditions must apply:
When using an unapproved treatment on an emergency basis, the treating physician should:
If you anticipate a subsequent use of the same investigational agent by the same physician, you must obtain prospective IRB approval (see submission requirements).
See the RSPP SOP 1 [PDF] for more information.
Read guidance and policies about emergency use of devices and treatments: