The physician/investigator must submit the following materials to the IRB within five (5) working days following the emergency use of the test article:
- Please submit the Part I form preferably prior to emergency use of a test article.
- Please submit the Part II form after emergency use of a test article.
- Texas Health Resources policy highly recommends informed consent and IRB review, even in emergency situations and physicians/investigators consult with the IRB Chairperson for guidance when considering the emergency use of drugs or medical devices.
If an informed consent form was NOT obtained from the patient or the subject's legally authorized representative, you will need to arrange for an independent physician to complete Section C3 on the Initial Notification Form.
Note: The FDA may require data from an emergency use of a test article in a life-threatening situation to be reported in a marketing application. Therefore, a HIPAA/Privacy authorization should be signed as well.
Submit forms to the IRB Office using one of two preferred methods:
The IRB should issue you an acknowledgement letter after review of initial notification of an emergency use of a test article.
Click here to access the Initial Notification Form
Click here to access the Follow-Up Form
Click here to access the Unanticipated Problems/Adverse Event Form
Click here to access the Unanticipated Problems/Adverse Event Helpful Hints Document
Return to IRB Home Page