Emergency Use

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, locateCreate Further Study Action. • Click Create...

5. Create Emergency Use • Select the type of FSA to be createdand 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.