irb education
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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IRB EducationA 1-Pager Graphical Approach
with click thru links for as needed detailed info
Ochsner IRB Education SessionSeptember 2013Presenters: Breault, Bazzano, Gaudreau
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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
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The rationale for a new approach to IRB education
Joe Breault
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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
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Edward Tufte http://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
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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:
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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
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Studying the new approach for effectiveness
Lydia Bazzano
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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.
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Methods
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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
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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Results
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Implementing the new approach at the Ochsner IRB
Stephanie Gaudreau
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Implementation
• Newsletters
• Ochpoint
• IRB Agenda Education items
• Other ideas? CRC meetings, OLN?
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Education Sheets
• Devices • Expedited review• Emergency use• Compassionate use• HUDs• Exempt from IRB review• Non-compliance• Waiver of Consent
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Education Sheets
• PI Responsibilities?
• Investigator Initiated Trials?
• IND and IDE submissions to FDA?
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