IRB EducationA 1-Pager Graphical Approach

with click thru links for as needed detailed info

Ochsner IRB Education SessionSeptember 2013Presenters: Breault, Bazzano, Gaudreau

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

The rationale for a new approach to IRB education

Joe Breault

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

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

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:

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

Studying the new approach for effectiveness

Lydia Bazzano

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.

Methods

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

Results

Results

Results

Results

Results

Results

Results

Results

Implementing the new approach at the Ochsner IRB

Stephanie Gaudreau

Implementation

• Newsletters

• Ochpoint

• IRB Agenda Education items

• Other ideas? CRC meetings, OLN?

Education Sheets

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

Education Sheets

• PI Responsibilities?

• Investigator Initiated Trials?

• IND and IDE submissions to FDA?