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IRB Education

IRB Education. A 1-Pager Graphical Approach w ith click thru links for as needed detailed info. Ochsner IRB Education Session September 2013 Presenters: Breault, Bazzano , Gaudreau. Outline/Objectives:. Joe Breault: The rationale for a new approach to IRB education

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IRB Education

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  1. IRB Education A 1-Pager Graphical Approach with click thru links for as needed detailed info Ochsner IRB Education Session September 2013 Presenters: Breault, Bazzano, Gaudreau

  2. Outline/Objectives: • Joe Breault: The rationale for a new approach to IRB education • Lydia Bazzano: Studying the new approach for effectiveness • Stephanie Gaudreau: Implementing the new approach at the Ochsner IRB

  3. The rationale for a new approach to IRB education Joe Breault

  4. Traditional vs. New Approach • The traditional approach to IRB education involves: • Long documents • Boring regulations • Presenting everything up front instead of as needed • Who actually reads it all? • The 1-pager approach to IRB education: • Presents a graphical 1-page sheet with the key concepts of a topic • Has many links to click thru to detailed info on an as needed basis • Much more likely to be read and understood

  5. Edward Tuftehttp://www.edwardtufte.com • American statistician and professor emeritus of political science, statistics, and computer science at Yale University • He is noted for his writings on information design and as a pioneer in the field of data visualization • I attended a 1 day workshop of his and got inspired about new ways to present info

  6. Tufte’s Approach to Info • “It's all about the relationship between the viewer and the information on the screen, and the viewer's cognitive tasks in looking at that information.” source • So to redo IRB education focus on how the person interacts with the info presented; rather than focusing on getting the info carefully spelled out like an encyclopedia. • Here are a few examples of info that could be a small book or large essay, but was made into a 1-pager to quickly communicate key ideas:

  7. What IRB topics are good for 1-pagers? • Devices • Expedited review • Emergency use • Compassionate use • HUDs • Exempt from IRB review • Non-compliance • Waiver of Consent • What else? • Criteria: • High use topic • Useful at IRB meeting, or by expedited reviewer or IRB staff • Convertible to graphic or flowsheet • Method Used: • Content expert • Work with graphic artist • Great idea of how to do it • Continuously improve

  8. Studying the new approach for effectiveness Lydia Bazzano

  9. Methods • A brief 9 item survey instrument with was designed to increase awareness of and evaluate the effectiveness of IRB educational one-page reference sheets. • The anonymous survey was administered via SurveyMonkey (www.surveymonkey.com) and sent by email to all IRB panel members and alternates on September 20th.

  10. Methods

  11. Methods • 19/58 (32.8%) IRB members or alternates responded to the survey instrument • Of those, 2 (10.5%) provided open text responses suggesting additional education topics to be included as one page reference sheets

  12. Results

  13. Results

  14. Results

  15. Results

  16. Results

  17. Results

  18. Results

  19. Results

  20. Implementing the new approach at the Ochsner IRB Stephanie Gaudreau

  21. Implementation • Newsletters • Ochpoint • IRB Agenda Education items • Other ideas? CRC meetings, OLN?

  22. Education Sheets • Devices • Expedited review • Emergency use • Compassionate use • HUDs • Exempt from IRB review • Non-compliance • Waiver of Consent

  23. Education Sheets • PI Responsibilities? • Investigator Initiated Trials? • IND and IDE submissions to FDA?

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