1. Karen Moe, PhD Director, Human Subjects Division Assistant Vice Provost for Research Revising the IRB Application A HSD Process Improvement Initiative

2. The standard IRB application Current name The Human Subjects Review Committee Application The 13-11 or form 13-11 Created in 1994 No significant revisions since initial creation

3. Why do a major revision now? Numerous regulatory changes Changing research areas & methods Repositories, genetics, GWAS, data sharing with dbGaP Internet research IRBs: “We don’t get the information we need” Researchers: “The form doesn’t fit my research” Researchers: “I don’t understand the questions” Improve efficiency of the IRB review process

4. General plan Step 1: Revise content Implementation in spring 2010 Step 2: Revise format (from Word to PDF) Implementation in summer/fall 2010

5. Content changes New name = IRB Application: Standard New questions addressing regulatory issues New questions for specific research areas & methods New explanatory material and definitions New examples Questions that are not applicable to many researchers will be separated out into application Supplements Example: Department of Defense Supplement Example: Genetics Research Supplement

6. Many IRB applications are not approved at the first IRB review (green bar); very few are fully approved at the first IRB review (blue bar)

7. Impact of changes Yes, the application will be longer. But… Faster, more efficient IRB review Fewer deferrals, more approvals with first IRB review Shorter, faster, review letters (no more letters with 40 points!) Less “back and forth” between IRB and researcher Overall: faster turn-around time for IRB review & approval Increased capacity of IRB committees Why: fewer applications go back to the IRB for a 2 nd review Important transitional step toward electronic submission PDF: “smart” forms that show only relevant questions PDF: “rollover” definitions, examples, guidance

8. The process Draft revision Feedback IRB members and HSD staff Human Subjects Policy Board Other compliance partners (OSP, ITHS, etc.) Beta testing cycle Final review Campus-wide communication and training Implementation

9. Questions? Requests? Karen Moe kemoe@u.washington.edu hsdforms@u.washington.edu 206-543-0098