eIRB 101: an Intro to SOM IRB and Submitting an eIRB Application

1. JHMeIRB eIRB 101: an Intro to SOM IRB and Submittingan eIRB Application

2. Topics • IRB Website • Compliance Training • eIRB login Accounts – No registration Required • Investigator Home Screen • Application Screens • Study Proposal • Consent Form • Update/Delete documents • Finalizing Application, Adding study team members, Submit! • Application Workflow • Responding to Reviewer Notes • How to request an extension or withdraw a study • Create a Further Study Action (intro)

3. IRB Website http://www.hopkinsmedicine.org/institutional_review_board

4. Compliance Training • All compliance training courses are available online through the Hopkins myLearning website. • Be sure to save and print your certificates at the time you complete each course.

5. eIRB Accounts: JHED Users • If you forget your JHED ID or JHED password: • Use the links (i.e., Forgot Password?) below, or • contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP.

6. Logging into eIRB

7. Investigator and Study Team Member Workspace

8. Investigator Home Page • Left Navigation Bar • Account Management (Non-JHED Users Only) • eIRB Training • My IRB Studies • Create New Application • Welcome Message • Link to Archive eIRB website • Studies List • Studies are listed by project type

9. Investigator Workspace • Studies List • Your studies are listed by type. • New Application • Change in Research • Continuing Review • Protocol Event • Termination Report • Emergency Use • Click the study name to open the study workspace.

10. Investigator Tabs • Action Required (default tab) • Studies that have been returned for PI response • Researcher Prep • Studies that have never been submitted • In Process • Studies awaiting Pre-IRB or IRB review • Approved • Studies that have been Approved • All My IRB Studies • All approved, disapproved, expired, terminated, or withdrawn studies with which you are associated.

11. Create a New Application • Select My IRB Studies on the left navigation bar. • Click the Create… button to begin a NEW eIRB application.

12. 1 – General Information • Clicking the “Create…” button on the Investigator Home Page will bring you to the first page of the application.

13. * Required Field • *Required • The red asterisk * indicates a required field that MUST be completed. • The PI will not be able to submit the application until all required fields have been completed. • Be sure to enter a title for the study. Never leave the title field blank. You need a title to access the application.

14. Select Principal Investigator • Example: Click the Help Link icon for guidance.

15. Help Link • The Help Link icons appear beside each question. • Click the help icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

16. Select Principal Investigator • Helpful information will appear above or below the question.

17. Please type in the following answers under Section 1: General Information • 1. PI: Maddox, Tyreen • 2. Yes • 3. No • 4. Ophthalmology-Broadway • 5. Title of Study: My Trainer is Awesome • 6. Brief Statement: She thanks you in advance • 7. Convened • 8. No (Single IRB) • 9. Single Site Study • 11. No • 12. No • 13. No • 15. No • 19. 2 hours

18. Add Study Team Member (Quest. 20) • Select *Add • Question 1: Search for your name • Question 2: Select “study coordinator” for Study team role • Question 3: Ophthalmology – Broadway • Question 4: Select “No” • Select *Ok

19. Assign Application Number • Complete all *required fields on the initial screen • Click Save or Continue to create the application and an IRB number will be assigned. Save will not work until the application number is assigned by eIRB. • eIRB application numbers begin with “IRB” and may be found in the upper right corner of the application screens.

20. Hide/Show Errors • Hide/Show Errors • Click to split the screen, display errors, and provide links to screens. • Click again to hide the split screen.

21. 2 - Study Team Compliance Training 2 – Study Team Compliance Training • Verify compliance training information (Q1) • Do not send compliance training certificates in advance of an eIRB submission. • If compliance training dates are incorrect or missing,upload copies of training certificates into Q2. • IRB Staff will enter the dates into the eIRB system upon submission.

22. 2 - Study Team Compliance Training • Non-Hopkins affiliated study team members are also required to upload a copy of their human subjects research (HSR) compliance training certification.

23. Application Screen • Title Bar • Application number is on the right. • Light Blue Tool Bar • Back • Does not save. It takes you to the previous screen. • Save • Saves your work in progress. • Exit • Does not save. It returns you to the Application Workspace. • Print • Allows you to print the current section of the application. • Continue • Saves your work and moves you through the application one screen at a time.

24. Jump To Drop Menu • Jump To • Displays list of required screens. • Use the list to navigate to non-consecutive screens.

25. Study ProposalSection 6 – Protocol Information

26. 6 – Protocol Information • Q1 - Select the type of protocol you wish to submit. • Click the icon to download the JHM-IRB eForm A (if applicable)

27. Download eForm A • Right click the link to JHM IRB eForm A. • Save the template to your local drive. • Use a simple naming convention, including the upload date. • ex. eFormA_010114.doc • Complete the form and save it to your local drive.

28. Upload Protocol • Q3 - Click Add to upload the completed eForm A.

29. Upload Protocol • Use the “Browse” button to locate the document. • Once the document is located, select the document and click “open”. • Click“OK” when finished.

30. Upload Protocol • Remember:For new applications that have not been submitted, only a clean copy of the protocol is required. • Save the screen.

31. Upload Revised Protocol • Q: What happens when the IRB wants me to make changes to my protocol? • Download the previously uploaded protocol – make a tracked changes copy and a new clean copy. • Q2. Click Update to upload a new clean version. • Q3. Click ADD to upload the tracked changes version.

32. 8-Conflict of Interest Conflict of Interest & Professional Commitment. Institutional policies require that outside activity and financial and fiduciary interests be disclosed for two reasons. Disclosures must be reviewed for conflicts of interest with research and conflicts of interest with other Johns Hopkins responsibilities. • All conflicted individuals must disclose potential conflicts of interest for each relevant study application vie eDisclose • This applies to current interests/relationships within the past 12 months. • For more information about disclosure requirements and conflict of interest review, visit the Office of Policy Coordination (OPC) Website https://www.hopkinsmedicine.org/research/resources/offices-policies/OPC/

33. 9 - Support InformationMonetary and Material If your protocol is receiving monetary support (quest. 1), Funding or Material source may not be listedin quest. 4 Email jhmeirb@jhmi.edu with the name of the funding or material source and we will add it to eIRB.

34. 12 - Participant InformationPlease type the following responses: • 1. Yes • 2. 18-55 • 3. Check male adults and Female adults • 4. Pregnant Women • 5. Yes • 6. Check 2-3 Study Populations **Make sure the Participant Information matches the Participant Information in the Protocol and Consent form**

35. 13 - Recruitment Information • All recruitment documents should include the PI’s name, IRB application # and the phrase “research study” • Recruitment Document Formatting Requirements: • “All advertising or other recruitment material must be reviewed and approved by the JHM IRB before they are used.  Flyers and other advertising materials must be marked as approved by the JHM IRB before distribution or posting.  Letters to potential participants must be submitted to JHM IRB for review and approval prior to mailing.” • This policy applies to all documents uploaded to the eIRB application under “Recruitment Information” (currently Section 13) as well as all other documents that require an IRB approval stamp. This may include, but is not limited to: flyers, posters, letters to potential participants, social media advertisements, scripts for radio or television advertisements, and story boards for television or video advertisements. (Please see policy 111.13 for more information regarding requirements / limitations for recruitment of study subjects.)

36. Consent FormSection 14 – Consent&Waivers

37. What type of consent are you planning to use for your study? • Select14: Consent and Waivers • Select the type of consent planned for your study: Written Consent • Click Continue. • You will only see the screens relating to your selection.

38. Consent FormSection 15 – Written Consent

39. Download Consent Form Template • Right click the consent form template link. • Save the form to your local drive. • Use a simple name including the upload date. • Consent Sample_010114.doc • The IRB will modify the name you give your approved consent form. • The modified name will appear in all letters. • Complete the consent form and save it to your local drive.

40. Upload Consent Form You must select “Add ” to: • Upload a NewDocument • Only one version of each consent form should be visible.

41. Upload Consent Form • Use the “Browse” button to locate the document on your PC. • Once the document is located, select the document and click“open”. • Click“OK” when finished.

42. Add/Update/Delete Documents Add Documents You must select “Add ” to: • Upload a NewDocument

43. Add/Update/Delete Documents UpdateDocuments You must select “Update” to: • Upload a Reviseddocument

44. Upload Revised Consent Form • Click Update to upload the tracked changes version into the consent form field. • This replaces, but does not delete, the previous version of the same consent.

45. Delete Documents If you upload the wrong document… • Use “Update” to change the status of the document to “Deleted” • Click “OK” • A “strikethrough” will appear through the document name. • The status of the document will read “Deleted”.

46. Delete Documents • Click “Update” to upload the correct document • Remember to change the status of the updated document to “Submitted” before clicking “OK”.

47. Document History

48. Add/Upload/Delete Documents Things to remember… • You must select “Add ” to: • Upload a NewDocument • You must select “Update” to: • Upload a Reviseddocument • View the history of a document • Delete a document (4. change dropdown from “Submitted” to “Deleted”) • Use “Update” to change the status of the document to “Deleted” • Click “OK” • A “strikethrough” will appear through the document name. • Click “Update” to upload the correct document • Remember to change the status to “Submitted” before clicking “OK”.

49. 20 - Supplemental Study Documents • You may be using other documents that require IRB approval. • Upload supplemental study documents that require the JHM IRB approval logo into Q1.

50. 20 - Supplemental Study Documents • Upload supplemental study documents that do not require the JHM IRB approval logo into Q2. • All supplemental documents will be listed in the approval letter.