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

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

3. 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 UNIVERSITY of WASHINGTON Office of Animal Welfare

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

5. What we value Professionalism Compassion Ethics Service Competence UNIVERSITY of WASHINGTON Office of Animal Welfare

6. What we do.... regulations regarding vertebrate animal use in – research, teaching and testing

7. UNIVERSITY of WASHINGTON Office of Animal Welfare

8. Avoiding this…

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

10. 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 UNIVERSITY of WASHINGTON Office of Animal Welfare

11. Protocol Life Cycle Grant review Change review

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

13. Significant Changes (contd): animal # add new species new housing/use locations scope of an approved animal activity Δ Principal Investigator (PI) UNIVERSITY of WASHINGTON Office of Animal Welfare

14. Significant Change Submission Protocol change submitted to the IACUC Semi-monthly distribution 1 week for IACUC to review and comment Questions compiled and sent to PI PI responds to questions/comments Sends answers and/or revisions back to the OAW Reviewer Reviews answers/revisions to IACUC comments Works with PI to resolve any outstanding issues IACUC Significant Change Approval A few more steps…. Hazards – environmental/occupational Alignment with grant Training of personnel Rooms on list of approved sites Significant Change Approval Significant Change Approval Process - opportunity for any member to call for a Full Committee Review (FCR) - assigned to a designated member reviewer (DMR) DMR vs FCR:

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

16. 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 UNIVERSITY of WASHINGTON Office of Animal Welfare

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

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

19. Section I, Item H: Animal numbers table UNIVERSITY of WASHINGTON Office of Animal Welfare

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

21. Are you adding or modifying animal use procedures? UNIVERSITY of WASHINGTON Office of Animal Welfare 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. Section I, Item D: New protocol hazard(s)? UNIVERSITY of WASHINGTON Office of Animal Welfare Helps identify Occupational Health issues

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

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

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

26. 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 UNIVERSITY of WASHINGTON Office of Animal Welfare

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

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

29. Are you adding a new strain/line? UNIVERSITY of WASHINGTON Office of Animal Welfare 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. Section II, Item 22: Deleterious phenotypes? Special husbandry (e.g., weaning variance)? UNIVERSITY of WASHINGTON Office of Animal Welfare

31. 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) UNIVERSITY of WASHINGTON Office of Animal Welfare

32. All done? Submit to oawsend@uw.edu BUT, despite your best efforts…

33. … 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 UNIVERSITY of WASHINGTON Office of Animal Welfare Submit revision/responses to oawsend@uw.edu

34. 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 UNIVERSITY of WASHINGTON Office of Animal Welfare

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