1. Winter 2014 1 Karen Moe, Director Human Subjects Division

2. PreviouslyNow Rotation among the appropriate type of IRBs (biomedical or social/behavioral). Always assigned to the same IRB, based on: Type of research Academic unit IRB Assignment 2

3. Benefits You Consistency of review Relationships with IRB, staff Predictability HSD & IRBRelationships, knowledge ProtectionMatch with IRB member expertise ComplianceMatch with IRB member expertise IRB Assignment 3

4. 4 What if my department isn’t on the list? What if I don’t like my department’s assignment? Will my applications always be assigned to the same IRB?

5. PreviouslyNow Someone you know Guess “Look-up” widget on HSD contact page based on academic unit assignment Who to contact? 5

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7. Benefits You Faster, less frustrating Confidence you are working with the right person HSD & IRBImproved ability to help ProtectionMatch with staff expertise ComplianceMatch with staff expertise Who to contact? 7

8. 8 What if the person is sick or on vacation? What if I don’t like my department’s assignment? Why doesn’t [name] answer the phone?

9. PreviouslyNow Lead researcher (PI) Everyone interacting with subjects Lead researcher (PI) Subject contact person Names on Consent Forms 9

10. Benefits You Consent forms shorter, faster Fewer modifications Personnel changes may not require IRB approval HSD & IRBFewer modifications ProtectionClearer about who to contact ComplianceNo change Names on Consent Forms 10

11. Names on Consent Forms 11 Should I revise my approved consent forms, to remove unnecessary names? What if I want my subjects to know my research staff names? Won’t I still have to submit Modifications when I change research personnel, because they are listed on the IRB application?

12. PreviouslyNow Lead researcher (PI) IRB contact person Faculty advisor Everyone interacting with subjects All co-investigators & consultants Lead researcher (PI) Subject contact person IRB contact person Study coordinator* Faculty advisor* * If applicable Names on IRB Applications 12

13. Names on IRB Applications 13 RequirementBased on role NamePI; subject contact; IRB contact; study coordinator; faculty advisor Qualifications (not names) Personnel performing procedures involving risks to subjects Example: Behavioral therapy intervention Example: Cerebrospinal fluid tap NeitherAll others Example: Person doing phone screens Example: Statistician

14. Names on IRB Applications 14 Type of personWhen is a Modification required? PI; subject contact; IRB contact; study coor- dinator; faculty advisor When person changes. Personnel performing procedures involving risks to subjects Only when role qualifications change. All othersNot required.

15. Benefits YouFewer modifications Personnel changes may not require IRB approval. HSD & IRBFewer modifications ProtectionBetter assessment of personnel qualifications ComplianceNo change Names on IRB Applications 15

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17. Names on IRB Applications 17 Should I modify my approved application, to remove unnecessary names? How will you know that our team has the people we need to do the research? How will you know when other institutions or locations are involved?

18. PreviouslyNow “Chutes and Ladders” format Required to cut and/or copy-and- paste sections “Smart” Adobe Acrobat fillable form Modification Form 18

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20. Benefits You Clearer Faster to complete “Back & forth” is less likely Usually shorter HSD & IRBEasier & faster to review Protection & compliance Less chance of overlooking something important Modification Form 20

21. Modification Form 21 For how long can I keep using the old form? I don’t like PDF forms, because they don’t have the ability to “track changes”.

22. Sneak Preview: March 2014 22 What to report to the IRB Consolidated, easy, single form for reporting Clarity about CLIA Genetics Supplement

23. Download forms and templates from the HSD website. Don’t save and re-use. (Cutting & pasting is OK.) Please 23

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25. HSD e-Newsletter On the first Monday of each month plus occasional special editions and reminders Send your subscription request to: hsdinfo@uw.edu STAY INFORMED 25