Office of the Institutional Review Board

Emergency Use

Emergency Use of an Investigational Drug/Device

step 1
step 2
step 3

Complete the Checklist

Use the Drug or Device

Notify the IRB

...to determine whether the use of the drug or device qualifies as
Emergency Use.
…after obtaining informed consent
(or statement from independent physician) you may proceed with treating the subject.
...within 5 days of use,
the IRB must be notified of the use.
Select the appropriate checklist:
Select the appropriate document:
Submit these to the IRB via IRBMail@uthscsa.edu:
  • IRB Notification Form
  • FDA EIND Letter (applicable to drug only)
  • Informed Consent OR Certification (see step 2)
  • Drug Checklist OR Device Checklist (see step 1)
 

Guidance / Policies / Regulations