- After confirming that emergency use criteria is met for a drug or biologic, the treating physician must notify the local pharmacy and Manufacturer to coordinate shipment of the drug.
- If time permits prior to treatment with an investigational agent, the treating physician should secure the following:
An independent assessment by a physician uninvolved with the investigation, as required in 21 CFR 50.23. The assessment must certify the physician’s agreement that all of the criteria have been met:
The subject was confronted by a life-threatening situation (including one involving risk of serious, irreversible morbidity), necessitating use of the product.
At the time of the procedure, there was no available alternative method of approved or generally recognized therapy that would have provided equal or greater likelihood of saving the subject’s life or avoiding serious, irreversible morbidity.
Informed consent OR certification from an Independant Physciain
Informed consent from the recipient or recipient’s legally authorized representative. See: Emergency Use ICF template
An outside physician’s certification that:
it was not feasible to secure the recipient’s legally effective consent (for example because the recipient was unconscious or sedated or legally incompetent); and
time was insufficient to secure consent from the recipient’s legal representative.
See: IRB Form: Emergency Use of Investigational Drug, Device, or Biologic
Concurrence from the RI&P/IRB office that there is an emergency or, preferably, prospective IRB approval (in which case the use is not an emergency use) exists.
Permission from the IND or IDE holder of the drug, device or biologic (i.e., the sponsor of a trial/drug or device manufacturer).