The purpose of this form is to capture the 5-day reporting requirement when a physician-investigator utilizes a test article in an emergency situation for a single patient. A test article is generally defined as a drug, biologic, or device that is currently pending FDA approval. A test article may also be in post-marketing follow-up. This form is not intended to be used for IRB approval of a prospective, emergency use or treatment IND study. These types of studies must be submitted via a full research (new study) application.
Refer to SOP 502G on the Policies & Procedures page for additional information and specific requirements.
Instructions for submitting the emergency use form to the IRB for review are noted below.
- Log into iRIS (https://iris.ouhsc.edu)
- Click Add a New Study under the Study Assistant tab on the left.
- Choose the HSC Application option and click the Start Selected Application button.
- Respond to the questions in Sections 1.0 - 3.0. Click the Save and Continue to Next Section button to proceed throughout the form.
- In Section 4.0, select the One-Time Emergency Use of a Test Article (5-Day Notice of Use) option and click save and continue.
- In Section 5.0, click the grey bar that says: Click here to start this form.
- Respond to the questions using the Save and Continue to the Next Section button proceed through the form.
- At the end of the form, select either the Exit Form or Close Form button. This will take you back into the original application.
- Click the Save and Continue to the Next Section button to proceed through and complete the application portion of your submission.
- Once you get reach the “1.0 Study Application” screen you will click the save and continue button to proceed to "2.0 Upload Support Documents" to upload and attach any study documents you may have.
- Click the gray button that says: Add Multiple Documents and upload your attachments.
- Select Save Document(s) when you have finished. You should now see the documents listed under the gray bars in Section 1200 - Upload Support Documents.
- Click the Save and Continue to the Next Section button to proceed to the next section and select the Signoff and Submit button.
- Input your HSC username and password, select the Approve button, and the select Save Signoff.
This will route the submission to our office for processing. Your submission will be assigned to a full board IRB meeting for review. You will be notified of the IRB’s approval/determination via email correspondence from iRIS with an attached outcome letter.