FDA regulations allow for emergency use of a drug, biologic or device in a single patient at a single site for certain life-threatening situations without prior convened IRB review and approval. However, Wright State normally requires prospective confirmation that the use of the test article (e.g., drug, biologic or device) meets FDA criteria by the IRB chair/designee in these situations. To request this review and approval, complete the following form (not available in RSP Gateway):
Whenever possible email the form to the IRB office at email@example.com prior to the emergency use to receive concurrence from the IRB chair/designee prior to use.
If not possible to send to IRB, the treating physician must obtain concurrence from an independent physician and their signature on the Emergency Use Determination Form prior to the emergency use of the test article.
After the emergency use, the treating physician must complete and submit the Emergency Use Follow Up Report Form to the IRB, along with the completed Emergency Use Determination Form. The completed paper forms must be scanned and sent to the IRB Office at firstname.lastname@example.org so the case can be reviewed at the next convened meeting of the IRB.
After the convened meeting, the treating physician will receive a letter from the IRB regarding the emergency use that must be maintain in their records for the use.
Emergency Use is regulated by the Food and Drug Administration's Expanded Access Program.
Please review the following local policies for more information about applying to the IRB for emergency use or expanded access (i.e. Compassionate Use):