Emergency Review Steps for Physicians to Take When Requesting Emergency Use of an Investigational Drug and/or Protocol
"Emergency Use is defined as the use of a test article (e.g., investigational drug or biologic) on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval for the use. The investigator is still required to obtain informed consent under these circumstances."
FDA exempts from IRB review the emergency use of a test article so long as the emergency use is reported to the IRB within five working days of its occurrence. Any subsequent use of the test article is subject to IRB review [21 CFR 50.23; 21 CFR 56.104(c)]. 'Subsequent' use means any use of the test article that occurs after its initial emergency use. When an IRB receives a report by a clinical investigator of an emergency use, the IRB must examine each case to assure itself and the institution that the emergency use was justified."
1. Submit a copy of the complete protocol (including any FDA or Drug Company literature) and a copy of the informed consent to your Chief of Service with a cover letter (addressed to the Chair, Institutional Review Board) requesting approval for emergency use.
2. Obtain letter of support [addressed to the Chair, Institutional Review Board (Human Rights committee)] for use of the protocol from your Chief of Service.
3. Submit your Chief of Service supporting letter, copy of the protocol, copy of the informed consent and your cover letter to:
Cindy Clukey, IRB Coordinator
Vice President for Medical Affairs Office â€“ Webber-1
Easter Maine Medical Center
489 State Street
Bangor ME 04401
EMMC ext. 7906
NOTE: Emergency processing of above request requires several hours - if received prior to 11:00 a.m. requests can usually be approved or disapproved on the same day.
4. Following protocol approval, attend the next Institutional Review Board (Human Rights Committee) to present and answer questions from Board members and to receive ratification of protocol approval.
Submit periodic reviews as requested by the Institutional Review Board (Human Rights Committee).