V. Emergency Waiver- Complete IRB form 7
 

Emergency waivers of IRB approval for the use of an unapproved drug or device are granted in "emergency use" situations that meet federal regulation criteria (see below). The IRB will work with physicians and investigators to make sure patients in critical or novel situations are cared for as soon as possible and in accordance with federal regulations.

An Emergency Waiver for use of a test article must meet the following criteria:

  1. The patient has a life-threatening or severely debilitating disease or condition; AND
     
  2. There are no standard or generally recognized alternative treatment options with an equal or greater likelihood of treating the patientís condition; AND
     
  3. The patientís condition requires immediate intervention before review at a convened meeting of the IRB, so that it is possible to avoid major irreversible morbidity or death.
     
  4. The emergency use must be formally reported to the IRB (in writing) within five workings days
     
  5. There must be no other regulatory barriers. This is basically just a reminder that the proposed use must be within the scope of the regulatory approval for testing; an emergency IND or an emergency addendum to an existing drug or device permit might be necessary if the proposed emergency use is novel.
     

IMPORTANT NOTE:

Per FDA regulations, permission for Emergency Use may only be granted one (1) time per institution for one (1) patient under the three (3) conditions listed above. If any of the above three (3) conditions do not apply, or if there is a desire to use the test article again on the same or different patient, an IRB Application must be submitted for review and approval by a convened IRB.