Changes in Research

1. JHM eIRB Changes in Research

2. Change in Research • A Change in Research may be submitted for active IRB approved studies. • Multiple changes may be submitted to the IRB in a single submission. • Additional Change in Research applications for the same study may not be created until the current change has completed its review.

3. Investigator Home Page • 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 Change in Research • Under Current Activities, locateCreate Further Study Action. • Click Create...

5. Create a Change in Research • 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. Change in Research Screens • General Information • Be sure to select each the type(s) of change request. • The application will be returned to you if you do not indicate all changes that are being made to the application.

7. Change in Research Screens • Click Continue to save the current screen and advance to the next screen.

8. * Required Field • The red asterisk * indicates a required field that MUST be completed. • You will not be able to submit the change in research until all required fields on each screen have been answered.

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

10. Change in Research Screens • All requested changes must be made on the application.  • These include any changes to application answers as well as changes to uploaded documents (e.g., protocol, consents).   • Click “Continue” to update the applicable sections of the application.

11. Application Screens • Once you have revised all applicable sections of the application, use the “Jump To” menu to get to the “Finalize Application” page. • Select “Finish” to save and exit to the Change in Research workspace. • You may continue to update the application until the change in research is submitted by the PI.

12. Change in Research 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.

13. Change in Research 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. • Stamped Documents • Displays all currently-approved stamped documents.

14. Change in Research 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.

15. Change in Research Workspace • Left Navigation Bar • Divided into two sections. • 2 - Current Activities • Displays a list of activities that may be completed.

16. Change in Research 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.

17. Change in Research Complete • Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

18. Change in Research Workspace • Select My Home to return to the Investigator Home Page.

19. Locate/Track Change in Research • Option 1: • Select the appropriate tab. • Scroll down to the Change in Research (Purple) section. • Select the application name. • This opens the application workspace.

20. Investigator Home Page • Option 2: • Select the Approved tab on the Investigator Home Page. • Scroll down to the Change in Research section. • Select the study name. • This opens the application workspace.

21. Application Workspace • Select the Further Study Action tab. • Scroll down to the Change in Research section. • Select the change in research name. • This opens the change in research workspace.

22. Locate Unstamped Documents • Select View. • This opens up the change in research screens.

23. Locate Unstamped Documents • Documents are uploaded directly into their change in research question. • Only one version of each document should be visible. • Click Continue to advance to the next screen.

24. Locate Unstamped Documents • Click Continue to go to the application.

25. Locate Unstamped Documents • Click Continue to advance to the application screen you want. • or • Click the down Jump To arrow. • Use the scroll bar to locate the screen you want. • Select the screen.

26. Locate Unstamped Docs • The IRB will upload approved, unstamped documents directly into their application questions. • These documents are to be used with changes in research. • Only one version of each document should be visible.

27. Locate Stamped Documents • Once the Change in Research has been approved, IRB stamped documents may be found on the approved Application Workspace.

28. Reviewer Notes • All applications are subject to a Pre-IRB review as well as an IRB reviewer. • Issues that require a response are referred to as “Reviewer Notes”.

29. Reviewer Notes • IRB staff will add reviewer notes to the applicable sections of the eIRB application. • The PI/study team must respond to each reviewer note and make revisions to the application (if applicable) • Select “Click here to respond…” to enter a response.

30. Reviewer Notes • Click “Ok” to save your response. Your response will be highlighted in green when complete.

31. Reviewer Notes • To edit your response, click on “Study Team Response”. • Click OK to save.

32. Reviewer Notes • You can also track and respond to reviewer notes using the “Reviewer Notes” tab on the Application Workspace.

33. Request Extension – Pre IRB • A change in research may be returned as incomplete after assignment to an IRB and before going to an IRB Committee for review. • The Principal Investigator has 60 days to resubmit the change in research. • You may seek a 60 day extension of this time limit.

34. Change in Research– Pre IRB • Click Request Extension - Pre IRB from the Current Activities section. • This opens the Request Extension – Pre IRB window.

35. Request Extension – Pre IRB • Request Extension - Pre IRB window • Click OK. • Completing this activity automatically grants a 60 day extension to respond to the IRB.

36. Request Extension – Post IRB • You may seek an extension for the submission of a response to the IRB issues waiting to be addressed. • You must submit a request in eIRB before the original response due date. • Responses cannot be accepted beyond the deadline without a JHM-IRB approved extension. • Only the Principal Investigator may submit the request. 

37. Change in Research– Post IRB • Click Request Extension from the Current Activities section. • This opens the Request Extension – Post IRB window.

38. Request Extension – Post IRB • Request Extension – Post IRB window • Click OK. • Completing this activity sends an email notification to the IRB office to consider your request. • You will receive an email response from the IRB.

39. Withdraw Application • Only the PI may withdraw a change in research. • Click “PI Withdraw” (Research Prep Only) or “Request Withdraw” from the Current Activities section. • This opens the Withdraw window.

40. Withdraw Application • Click OK. • This inactivates the change in research. • It cannot be reactivated. • If you wish to pursue this change in the future, a new Change in Research must be created and resubmitted for IRB review.