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KC IRB Implementation – Phase IV

KC IRB Implementation – Phase IV. The Questionnaire. ___________________________________________ Human Research Protections Program Office of Research Compliance Office of Vice President for Research. Agenda. Overview / Scope Differences in KC IRB Differences in the process

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KC IRB Implementation – Phase IV

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  1. KC IRB Implementation – Phase IV The Questionnaire ___________________________________________ 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

  3. Agenda • Overview / Scope • Differences in KC IRB • Differences in the process • Differences in the website • Recap

  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

  5. Agenda • Overview / Scope • Differences in KC IRB • Differences in the process • Differences in the website • Recap

  6. Differences in KC IRB • Questionnaires / Smart Form • Elimination of HSO Forms • Retention of HSO Forms • Considerations for Active Studies

  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 • SSS • Amendment / Renewal forms • Retention of HSO Forms • Considerations for Active Studies

  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

  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

  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

  11. Agenda • Overview / Scope • Differences in KC IRB • Differences in the process • Differences in the website • Recap

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

  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

  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

  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

  16. Differences in the process • Submission • New studies • Amendments / Renewals • Pre-review by HSO staff • Provisional Approvals / Tabling • Notifications to study teams (no more email) • 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

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

  18. Type of notification Link to tab Customize footer: View menu/Header and Footer

  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

  20. Agenda • Overview / Scope • Differences in KC IRB • Differences in the process • Differences in the website • Recap

  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

  22. Protocol Decision Tree and E Learning Videos & Training Guides • http://researchadmin.iu.edu/HumanSubjects/hs_pdt.html • http://researchadmin.iu.edu/HumanSubjects/hs_elearning.html Customize footer: View menu/Header and Footer

  23. Agenda • Overview / Scope • Differences in KC IRB • Differences in the process • Differences in the website • Recap

  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!

  25. Questions? • Email: • kcirb@iu.edu • Phone: • 274.8289 • Web: • www.researchadmin.iu.edu Customize footer: View menu/Header and Footer

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