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
- The patient has a
life-threatening or severely debilitating disease or condition;
- There are no standard or
generally recognized alternative treatment options with an equal
or greater likelihood of treating the patientís condition; AND
- 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.
- The emergency use must be
formally reported to the IRB (in writing) within five workings
- 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.
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