In certain circumstances, an investigator/physician may need access to an unapproved device or agent to treat a life-threatening condition. Such uses are treated as emergency requests. More information about the criteria for emergency use can be found at: http://www.fda.gov.
The nurse manager on duty MUST be notified prior to use so that proper arrangement for the clinical care and patient safety can be made. All attempts should be made to contact the Office of Clinical Research Director at 813-415-6137; at the very least, a message must be left. The following forms must be submitted to TGH.
The IRB must be notified of the emergency use by phone, fax or email (fax or email after hours) as soon as possible. If time allows, the IRB should be notified before; however, they can be notified immediately after if there is not time to notify them before. TGH requires copies of all IRB correspondence related to the emergency use for its files as well.