Office of Animal Welfare Research Support Services

1. UNIVERSITY of WASHINGTONOffice of Animal Welfare Office of Animal WelfareResearch Support Services How to Write an Effective Significant Change to your IACUC Protocol J. Preston Van HooserReview Scientist & Senior Scientific Liaison March 31, 2014April 4, 2014April 10, 2014

2. UNIVERSITY of WASHINGTONOffice of Animal Welfare Overview • OAW • Protocol Lifecycle • What is a Significant Change • Approval process

3. UNIVERSITY of WASHINGTONOffice of Animal Welfare Mission and Vision • Protect the integrity and excellence of vertebrate animal research and teaching at the University of Washington • Provide comprehensive resources and outstanding services to the UW IACUC, faculty, staff, and other partners for navigating and complying with the rules and regulations regarding use of vertebrate animals

4. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Office of Animal Welfare Who we are • Administrative Unit • IACUC Meeting Support • Review Scientists • Animal Use Training • Scientific Liaisons • Protocol Admin Review and Tracking • Site Visit Tracking • Protocol and Change Requests • Side by Side Grant and Protocol Review • DMR • Online Training • Hands-on Training • Certs • Protocol Life Cycle • Protocol and Change Requests • All things…

5. UNIVERSITY of WASHINGTONOffice of Animal Welfare What we value • Professionalism • Compassion • Ethics • Service • Competence

6. UNIVERSITY of WASHINGTONOffice of Animal Welfare What we do .... regulations regarding vertebrate animal use in – research, teaching and testing

7. UNIVERSITY of WASHINGTONOffice of Animal Welfare USDA DEA SPAERC EH&S OSP SAGE DOD WSBOP AUMS IBC AAALAC JIT

8. UNIVERSITY of WASHINGTONOffice of Animal Welfare Avoiding this…

9. UNIVERSITY of WASHINGTONOffice of Animal Welfare And this… grant/funding congruency

10. UNIVERSITY of WASHINGTONOffice of Animal Welfare OAW ≠ IACUC • OAW • Manages communications between the IACUC and the PI regarding protocols and site visits • Ensures grant/funding proposal is congruent with animal use protocol • Submits updates to regulatory agencies on the UW performance • Ensures that training is up to date for all personnel working with animals • IACUC • Site Visits –semi annual visits to all facilities where vertebrate animals are used or housed • Protocol Life Cycle – review/approve all vertebrate animal use proposals

11. UNIVERSITY of WASHINGTONOffice of Animal Welfare Protocol Life Cycle

12. UNIVERSITY of WASHINGTONOffice of Animal Welfare Significant Changes: • new aim or experiment • pain or distress • Δ anesthesia, analgesia, sedation, or euthanasia • Δfrequency, interval, type, number or anatomical location of: • procedures • administered substances

13. UNIVERSITY of WASHINGTONOffice of Animal Welfare Significant Changes (cont’d): • animal # • add new species • new housing/use locations • scope of an approved animal activity • Δ Principal Investigator (PI)

14. UNIVERSITY of WASHINGTONOffice of Animal Welfare Significant Change Approval Process Significant Change Approval DMR vs FCR: - assigned to a designated member reviewer (DMR) - opportunity for any member to call for a Full Committee Review (FCR)

15. UNIVERSITY of WASHINGTONOffice of Animal Welfare How do I write a Significant Change?

16. UNIVERSITY of WASHINGTONOffice of Animal Welfare General requirements • Goals and objectives (include species!) • Describe requested changes; relevant PRF items • Summarize the relevant parts of your approved protocol (IACUC will not re-read your entire protocol) • Describe experiments, not isolated procedures/drugs • Sequence of events from enrollment to euthanasia • Complex experiments: flowcharts and timelines

17. UNIVERSITY of WASHINGTONOffice of Animal Welfare Four questions: Are you… • increasing animal numbers? • adding or modifying any animal use procedures? • adding a new species? • adding a new strain/line? “Yes” to at least one

18. UNIVERSITY of WASHINGTONOffice of Animal Welfare Are you increasing animal numbers? PRF Section I H* N* PRF Section II None * required

19. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Item H: Animal numbers table

20. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Item N: Animal numbers justification Things to consider: • Experimental animals • Breeders, litter/clutch size, maintaining rare lines • Unwanted genotypes/gender

21. UNIVERSITY of WASHINGTONOffice of Animal Welfare Are you adding or modifying animal use procedures? PRF Section I D F G I/J K PRF Section II 1-32 as applicable * required items depend on specific added procedure(s)

22. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Item D: New protocol hazard(s)? Helps identify Occupational Health issues

23. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Items F/G: New housing or procedure location(s)?

24. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Items I/J: New procedure(s) (pain or distress)?

25. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Item K: Ascites production? • Section II, Items 1-32: Animal use procedures • Relevant items for new and modified procedures • Complete the entireitem • If modifying: Call out what is new (bold/italics)

26. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section II, Item 16: If adding survival surgery, identify all protocol personnel who will perform the surgical procedure(s), and list their years of experience conducting each procedure

27. UNIVERSITY of WASHINGTONOffice of Animal Welfare Are you adding a new species? PRF Section I D* F* G* H* I/J* K* L* M* N* PRF Section II 1-32* Also Identify protocol personnel who will work with the NEW species and their duties* * required

28. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section I, Items L and M: Applies to new species

29. UNIVERSITY of WASHINGTONOffice of Animal Welfare Are you adding a new strain/line? PRF Section I D* F* G* H (likely) K N (likely) PRF Section II 1-21 as applicable 22* 23-32 as applicable * required

30. UNIVERSITY of WASHINGTONOffice of Animal Welfare • Section II, Item 22: • Deleterious phenotypes? • Special husbandry (e.g., weaning variance)?

31. UNIVERSITY of WASHINGTONOffice of Animal Welfare Friendly reminders… • No new personnel! • S.O.A. • Minimize jargon (use lay speak) • Hazardous agents? BUA application/change to EH&S • Grant/contract-related? Note eGC1 #(s) • Timing (e.g., JIT requests, BUAs, subcontracts)

32. UNIVERSITY of WASHINGTONOffice of Animal Welfare All done? Submit to oawsend@uw.edu BUT, despite your best efforts…

33. UNIVERSITY of WASHINGTONOffice of Animal Welfare … you may get IACUC questions/comments • Unclear? Contact Reviewer or Scientific Liaison • Vet questions? Contact VS: vsreview@uw.edu • Hazardous agents? Contact ehsbio@uw.edu • Point-by-point responses • Highlight changes: bold/italics • “Pre-review” of responses/revision Submit revision/responses to oawsend@uw.edu

34. UNIVERSITY of WASHINGTONOffice of Animal Welfare Conclusions • Think ahead • The IACUC greatly appreciates it when groups allow plenty of time to consider and approve a protocol change • Talk to your Scientific Liaison • For help and/or to have your Significant Change pre-reviewed • Write clearly and completely about what you are changing • Summarize the relevant parts of your approved protocol • Consider joining the IACUC • You can help yourself and your colleagues by joining the committee

35. UNIVERSITY of WASHINGTONOffice of Animal Welfare Contact us • OAW main #: 685-7363 • Website: http://depts.washington.edu/oawhome/ • Scientific Liaisons: • Kelly Heffernan ksh@uw.edu • Aubrey Schoenleben, Ph.D. aubreys@uw.edu • J. Preston Van Hooser jpvh@uw.edu • Submissions: oawsend@uw.edu