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IRB-RDC Workshop

IRB-RDC Workshop. Introduction. Thank You. To all the travelers a nd your families and office mates who support you To all those who are helping to make this meeting run ORPP&E staff EES staff Hotel staff Speakers Your facilities for giving you the time

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IRB-RDC Workshop

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  1. IRB-RDC Workshop Introduction

  2. Thank You • To all the travelers • and your families and office mates who support you • To all those who are helping to make this meeting run • ORPP&E staff • EES staff • Hotel staff • Speakers • Your facilities for giving you the time • The VHA leadership for giving us this chance to meet

  3. Housekeeping • Restroom locations • Breaks • Snack bar • Water, pens, and pads • Meals • Local restaurants • Wholefoods • Parking Lot Issues

  4. Objectives – Provided to Decision Makers • To outline the responsibilities of the institution (R&DC) in overseeing research • To define the scope of the local IRB/staff in research studies utilizing a single IRB • To identify the critical functions and responsibilities for R&D Committees and IRBs under the single IRB review mandate Key Results: • Evaluate and strengthen the proposed changes to Directives 1200.01/1200.05 • Educate and begin cultural shift of institutional oversight responsibilities

  5. Ulterior Motives • We want to meet all of you • We want your input • This is a workshop – ask questions – give us your opinion • We wanted you to meet each other

  6. Badges • Color scheme standup • RDC (small, medium, large) • IRB (small, medium, large) • Other • ORPP&E Staff Large: >400 protocols Medium: 101-399 protocols Small: <100 protocols

  7. Color-Coded Groups IRB Small IRB Medium IRB Large 24 present 27 present 5 present R&D Small R&D Medium R&D Large 27 present 27 present 7 present Other (RCO, AO, ACOS, etc.) 9 present 86 represented 41 present ORPP&E Medical Centers

  8. Overview • We designed this to be practical • We designed this to give you a strategic view • We have brought in the big guns (Drs Ramoni and Clancy) • To hear about priorities and the future of research • We are rewriting 1200.01 and 1200.05 and want to know how the changes we are proposing might affect your institution

  9. EXPECTATIONS • This IS a workshop about the future • This IS an opportunity to interact and ask questions • This IS an opportunity to express your opinions • This is an opportunity to learn from each other • This IS NOT a training event to teach you your job

  10. You are here as the SMEs over process at your sites • You are here to be sounding boards for ideas • You are hear to stop us from stepping off a cliff • We are leveraging your experience to build process and policy for a better tomorrow in research

  11. TWO DAYS • Make the most of it: • Ask • Speak UP • Meet • Learn • Teach • Understand • Help Us Understand

  12. WELCOME • Lean In and Participate!!

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