1. What Will the Coming Electronic IRB Process Mean for Me? VCU Office of Research Information Systems September 25, 2009 Bryan Kelley 1

2. Project Goals 1.Optimize and Document IRB Process 2.Implement a solution for EVERY IRB submission package and official communication for the IRB 3.Optimize forms to reduce redundant questions and processes, thereby reducing time spent on submissions and reviews 4.Document improvements (quality and efficiency) upon IRB submission and review processes 5.Implement an efficient and intuitive application that asks for meaningful information 6.Meets (and balances) needs of different system users 7.Automate as much of the process as possible (notice generation, quality checks, etc) 8.Meet reporting needs (with QI process in mind) 2

3. Impact to Researchers Web-based form completion, submission, and review 24/7 Redesigned and streamlined process Reduction in paper use Less time spent on submission Faster approval times More transparent approval process Improved formsets 3

4. Project Schedule Goal is to be “poised for implementation” on July 31, 2010 – Per directive from the Vice President of Research to the University President Currently in Information Gathering Phase of the project 4

5. 5 August 2009 Survey Results What delivery method did you use for your initial submission? – Other 1.50 % – Not Answered 3.00 % – Interoffice Mail 11.24 % – Hand Delivery 84.27 % 5

6. August 2009 Survey Results How long does it take to prepare your initial submission paperwork (not including designing your study) – Less Than 1 Hour 1.49 % – Not Answered2.97 % – 1-2 Hours 9.67 % – 2-3 Hours 16.36 % – 3-4 Hours 21.56 % – 4+ Hours 47.96 % 6

7. 77 August 2009 Survey Results Please rate efficiency of correspondence with IRB Reviewers: – Not Answered 1.87 % – Not Applicable 4.12 % – Extremely Satisfied 18.73 % – Dissatisfied 24.34 % – Satisfied 50.94 % 7

8. 888 August 2009 Survey Results Please rate length of time to receive IRB Approval: – Not Answered 1.50 % – Not Applicable 1.87 % – Extremely Satisfied 7.49 % – Satisfied 41.57 % – Dissatisfied 47.57 % 8

9. 9999 August 2009 Survey Results What resources would you like to have available to you for the electronic solution? – Other 3.30 % – Longer Classroom Training (Hands On) 4.55 % – Not Answered 5.18 % – Short Classroom Training (Not Hands On) 6.12 % – Online Tutorial Videos 13.50 % – One-on-one Consultations 16.33 % – Searchable User Manual 25.12 % – Email Support 25.90 % 9

10. 10 August 2009 Survey Results In the past year, which initial review types (as designated by you) have you submitted to the IRB? Choose all that apply: – Unsure 2.37 % – (Not Answered) 6.84 % – Full Board Review 20.00 % – Exempt Review 27.89 % – Expedited Review 42.89 % 10