What are the differences among an Emergency IND Request, an Off-Label Use and a Treatment IND?
Emergency IND: An Emergency IND is the only circumstance in which you may use an investigational drug to treat a patient without prior IRB review and approval. An Emergency IND may only be employed when the patient’s condition is life-threatening, when there are no approved alternative treatments, and when there is not enough time, due to the condition of the patient, to bring the request to the IRB. You must seek verbal approval from the Chair or Co-Chair of the Scientific Committee prior to administering the drug, and report in writing to the entire committee within 5 days. Off-Label Use: Physicians collecting data on efficacy, reactions, tolerance, etc. of FDA approved drugs used for unlisted (unapproved) indication as part of a research protocol must obtain IRB approval prior to the onset of the study. In contrast, when a physician prescribes an approved drug for treatment for unlisted indications, IRB approval usually will not be required. A physician with a permanent Illinois lic
