1. JHM eIRB
Emergency Use

2. Emergency Use
Emergency Use requests may be submitted for active IRB approved studies.
A second Emergency Use may not be submitted for the same study until the first has completed its review.
Emergency Use requests may be submitted while other FSAs for the same study but of a different type have not completed their review.

3. Create Emergency Use
Select My IRB Studies from the left navigation bar.
Locate the Approved tab on the Investigator Home Page.
Scroll down to the New Applications section.
Select the name of the currently approved study.
This opens the application workspace.

4. Create Emergency Use
Under Current Activities, locate Create Further Study Action.
Click Create...

5. Create Emergency Use
Select the type of FSA to be created and select Continue.
You can only select one FSA at a time.
Once the FSA has been created, you can return to this screen, following the previous steps, to select a different type of FSA.

6. Emergency Use Screens Complete each screen.
Click Continue to save the current screen and advance to the next screen.

7. * Required Field
The red asterisk * indicates a required field that MUST be completed.
You will not be able to submit the emergency use until all required fields on each screen have been answered.

8. Help Link The Help Link icon appears beside each question.
Click the icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

9. Finalize Emergency Use
Click Finish
This returns you to the application workspace.
Finish indicates the last page of application.
You may continue to edit the continuing review until it is submitted.

10. Emergency Use Workspace
Application Waiting To Be Submitted
Purple text disappears upon submission.
Study Vital Statistics
Displays important information such as the study title, date submitted and last scheduled review.
Current Status
Displays the current state of the change in research in the submission/review process.

11. Emergency Use Workspace
IRB Review Items
Displays the review date, review type, outcome, and letter sent.
Workspace Tabs
History Log
Reflects completed activities.
Reviewer Notes
Displays a collective list of IRB issues that require a response by the study team.

12. Emergency Use Workspace
Left Navigation Bar
Divided into two sections.
1- Project Editor
View/Edit gives access to the existing application.
Printer Friendly displays a scrollable version of the application with the option to print.
View Differences lists changes made to the change in research since the previous submission.

13. Emergency Use Workspace
Left Navigation Bar
Divided into two sections.
2 - Current Activities
Displays a list of activities that may be completed.

14. Emergency Use Workspace
View the Current Status box to monitor progress through the IRB review process.
Select View/Edit to open an existing application.
Use the Current Activities to submit/withdraw the application.
View the History Log to track activities.
Use the Review List to retrieve the review outcome letter.

15. Emergency Use Complete
Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

16. Emergency Use Workspace
Select My Home to return to the Investigator Home Page.

17. Locate/Track Emergency Use
Option 1:
Select the In-Process tab.
Scroll down to the Emergency Use (Yellow) section.
Select the application name.
This opens the application workspace.

18. Investigator Home Page
Option 2:
Select the Approved tab on the Investigator Home Page.
Scroll down to the Emergency Use section.
Select the study name.
This opens the application workspace.

19. Application Workspace
Select the Further Study Action tab.
Scroll down to the Emergency Use section.
Select the application name.
This opens the application workspace.