1. KC IRB Implementation – Phase IV
The Questionnaire
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Human Research Protections Program
Office of Research Compliance
Office of Vice President for Research

2. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

3. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

4. Overview / Scope Questionnaires / Smart Form Elimination of HSO Forms
Retention of HSO Forms
Considerations for Active Studies
Revised HSO website
Researcher tool for determining level of review
Revised policies / procedures / SOP
Human Research Protections Program

5. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

6. Differences in KC IRB Questionnaires / Smart Form
Elimination of HSO Forms
Retention of HSO Forms
Considerations for Active Studies
Human Research Protections Program

7. Differences in KC IRB Questionnaires / Smart Form
Elimination of HSO Forms
SSS
HIPAA & Recruitment Checklist
Vulnerable Populations Request Forms
Request to Defer IRB Review
Amendment / Renewal forms
Retention of HSO Forms
Considerations for Active Studies
Human Research Protections Program

8. Differences in KC IRB Questionnaires / Smart Form
Elimination of HSO Forms
Retention of HSO Forms
Drug & Biological Products Form / Medical Device Form
Request form – In-vitro diagnostics
IU-PU-ND Deferral
Non-Human Subjects Research
Non-Research Student Projects
Noncompliance & Prompt Reports
Considerations for Active Studies
Human Research Protections Program

9. Differences in KC IRB Questionnaires / Smart Form
Elimination of HSO Forms
Retention of HSO Forms (con’t)
Consent / Assent
Protocol
Recruitment materials
Etc.
Considerations for Active Studies
Human Research Protections Program

10. Differences in KC IRB Questionnaires / Smart Form
Elimination of HSO Forms
Retention of HSO Forms
Considerations for Active Studies
Amendment and Renewal forms converted to smart forms
Maintain existing forms (SSS, etc.) and replace
Human Research Protections Program

11. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

12. Differences in the process
Submission
New studies
Amendments / Renewals
Pre-review by HSO staff
Provisional Approvals / Tabling
Approvals
Human Research Protections Program

13. Differences in the process
Submission
New studies
Populate questionnaires instead of certain IU IRB forms
Remember to click the update button
Dynamically-populated questionnaire list
Amendments / Renewals
Pre-review by HSO staff
Provisional Approvals / Tabling
Approvals
Human Research Protections Program

14. Differences in the process
Submission
New studies
Amendments / Renewals
No amendment or renewal forms – converted to questionnaire
Continue to modify attachments (remember to replace)
Exceptions:
Amending a new study which was created on/after 7/31
Amending an existing study to add:
Vulnerable population
VA as a performance site
Pre-review by HSO staff
Provisional Approvals / Tabling
Approvals
Human Research Protections Program

15. Differences in the process
Submission
New studies
Amendments / Renewals
Pre-review by HSO staff
Open your Action List Notifications
Review the Subject Line
Includes link to take user directly to Protocol Actions tab
Review Comments / Review Attachments will contain revision requests
Provisional Approvals / Tabling
Approvals
Human Research Protections Program

16. Differences in the process
Submission
New studies
Amendments / Renewals
Pre-review by HSO staff
Provisional Approvals / Tabling
Notifications to study teams (no more )
Action List Reminder from OneStart Workflow
Includes link to take user directly to Protocol Actions tab
Review Comments / Review Attachments will contain provisions
Submit to IRB once complete
Approvals
Human Research Protections Program

17. Differences in the process
Exceptions (no differences):
Noncompliance / prompt reports: no questionnaire; forms maintained
Closeouts: no questionnaire or KC IRB process – still closeout form to:
Non-Human Subjects Research, Non-Research Student Projects: no questionnaires; forms maintained
Human Research Protections Program

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Type of notification
Link to tab
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September 22, 2018

19. Differences in the process
Submission
New studies
Amendments / Renewals
Pre-review by HSO staff
Provisional Approvals / Tabling
Approvals
Signatures
Ink versus electronic
New SOP – KC IRB
Deferrals will utilize approval letter versus signed request form
Human Research Protections Program

20. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

21. Differences in the website
Redesigned
New tool for determining level of review
KC IRB info embedded into site
Revised SOP document
General updates to entire document
New SOP – KC IRB
KC IRB Crosswalk document
Human Research Protections Program

22. Protocol Decision Tree and E Learning Videos & Training Guides
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September 22, 2018

23. Agenda Overview / Scope Differences in KC IRB
Differences in the process
Differences in the website
Recap
Human Research Protections Program

24. Recap
Allot additional time for study preparation, especially for New Studies
Questions investigators will answer are different; not verbatim transfer from SSS / other documents
Review the new website & update your bookmarks
Review the updated SOP document
Review the updated Training Guides
Satisfy any pending / in-progress submissions
Don’t hesitate to call the HSO!
Human Research Protections Program

25. Questions?
Phone:
Web:
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September 22, 2018