JHM eIRB Emergency Use

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.

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.

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

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.

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

* 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.

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

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.

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.

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.

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.

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

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.

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

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

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.

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.

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