Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM Associate Director

2. Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM Associate Director

3. Institutional Responsibility To create an environment for a synergy between research and animal care.

4. Components of a Quality Animal Care and Use Program • The Research Team • Institutional Official • Researchers • IACUC • Animal Care Staff (AV and technical staff) • Policies, Procedures, Resources and Facilities

5. Role of the IO • Be informed about the program • Be engaged in the program • Sustained and visible support • In a position to influence institutional priorities • Can assure sufficient monetary and personnel resources are allocated

6. Role of the IACUC • Clearly articulate policies and procedures so that everyone understands expectations • Implement regulations using scientifically sound, performance-based standards • Establish effective training programs that are realistic • Assure the public of quality animal care

7. Role of Veterinarian and Staff • Ensure adequate and proper animal care and use • Work in concert with the IACUC and Investigators • Exercise professional judgment to facilitate the science in the context of animal welfare

8. The Scientist’s RoleJ.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University • Plan research in the context of quality animal care • Accept the responsibility • Work to strengthen your animal care and use program • Engage in the process • IACUC participation • Know the regulations

9. The Scientist’s RoleJ.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University • Be willing to communicate with administrators, regulators, and Congress • Embrace change • Be proactive

10. AV & Staff IACUC Investigator Animal Care and Use Program Components Administration Each component must make its contribution so that the whole is greater than the sum of the parts.

11. In a Successful Animal Care and Use Program… …each person in each component of an animal care program must know and understand his or her contribution as it relates to the whole effort.

12. Keys to Successful AAALAC Accreditation • Ensure adequate veterinary care and compliance oversight • Ensure clear lines of authority • Ensure strong institutional commitment to the animal care and use program

13. Roles and responsibilities of the Institutional Official The Journey and Perspective of a New IO Stan Nosek, Vice Chancellor, Administration, UC Davis

14. Program Accountability • IO – An individual who signs, and has the authority to sign the institution’s Assurance, making a commitment on behalf of the institution that the requirements of the PHS Policy on Humane Care and Use of Laboratory Animals will be met.

15. First Challenge: Acronyms • PHS • OLAW • NIH • IACUC • AAALAC • ARENA • AALAS • ARENA/OLAW IACUC Guidebook

16. Examining the Intricacies and Expectations of the Institutional Official (EI EI O) • The Office of Laboratory Animal Welfare has a Guide: EI EI O

17. Mission • To ensure the ethical and sensitive care and use of animals in research, teaching and testing.

18. Our Grand VISION • Through self-regulation and oversight, we will develop and maintain a model animal care program.

19. Program Values • Humane Treatment of Animals • Benefits of animal research to human and animal health • Stewardship • Training • Striving for Excellence

20. The Institutional Official’s Role • Taken from Arena IACUC 101 5/9/02 • Key Components of an Effective Animal Care and Use Committee presentation • Marky Pitts – UC San Diego • Molly Greene – University of Texas Health Science Center, San Antonio

21. Recognized and Respected Authority • Must have the administrative and operational authority to commit institutional resources to ensure compliance with the PHS Policy

22. Committed to a Quality Program • Provides leadership to achieve the desired result • Provides a high level of service • Makes decisions based on our commitment to become a model animal care program

23. Provides Sufficient Resources • Occupational Health & Safety • Personnel • Training • Technology/Equipment • Maintenance of Facilities

24. Ensures Compliance

25. Supports Education • Understanding of the mission and values – the destination and the route identified to get there • Invests in people through ongoing training and development that is aligned with program priorities

26. Partners • IACUC committee members • IACUC professional and administrative staff • Attending Veterinarian

27. Full Support • IO needs the full support of the CEO • IACUC Chair needs the full support of the IO

28. The IO Provides Leadership and Support in to achieve the Mission

29. But it requires a team effort to get there !

30. The Roles and Responsibilities of the IACUC Richard C. Van Sluyters, O.D., Ph.D. Associate Dean, School of Optometry & IACUC ChairUniversity of California, Berkeley

31. The Institutional Animal Care and Use Program • Institutional Official (IO) • Attending Veterinarian (Vet) • Institutional Animal Care and Use Committee (IACUC)

32. IACUC “If Columbus had an advisory committee he would probably still be at the dock.” Justice Arthur Goldberg, 1908-1990

33. IACUC “What is a committee? A group of the unwilling, picked from the unfit, to do the unnecessary.” Richard Long Harkness, 1907

34. IACUC • Oversees and evaluates entire animal care and use program • Ensures compliance with Guide, Policy, AWRs • Represents institution and community • Serves as local oversight arm for APHIS/AC, NIH/OLAW, AAALAC

35. Well-Balanced Program

36. Imbalanced Program

37. The “Weak” IACUC • Chair rotates annually • Inadequate relief/support for Chair • Members only serve 1 year • Few members who are PIs

38. The “Weak” IACUC • Insufficient staff • Insufficient/no office space • Insufficient funding • Inadequate computer expertise/equipment

39. The “Weak” IACUC • Inadequate/no member training • Inept protocol review • Staff “runs” the committee/meetings • Designated member review only • PHS applications not reviewed

40. The “Weak” IACUC • Deficient recordkeeping (minutes, protocols, reports) • Delegated facility inspections • Inadequate semiannual facility inspections/program reviews

41. The “Overpowering IACUC” (no such thing!)

42. The “Overpowering IACUC” • IACUC ignores Vet’s recommendations • Dictatorial Chair • Overzealous facility inspections/program reviews

43. The “Overpowering IACUC” • IACUC’s policies handcuff PIs, Vet, IO • Inflexibility (rigid deadlines, rules, etc.) • Refusal to use performance standards • Refusal to consider exceptions to the Guide

44. AAALAC Site Visits • A retrospective analysis of recent AAALAC site visit findings indicates how the IACUC “leg” of the animal care and use program needs to be strengthened.

45. Impact of the 1996 Guideon site visit findings

46. AAALAC Site Visit Deficiencies

47. IACUC Site Visit Findings

48. IACUC Deficiencies in Rank Order • Protocol Review • Semiannual Evaluations • Committee Composition & Member Participation • Policies & Documentation • Training

49. Protocol Review • Husbandry exceptions to Guide (e.g. wire-bottom cages, cage cleaning intervals) • Justification for the numbers of animals used • Expedited review • Review of amendments/addenda • Alternatives to painful procedures (Policy #12) • * Management/evaluation of pain and distress *

50. Protocol Review:Management/evaluation of pain and distress(By far the greatest number of mandatory items related to protocol review) • Inadequate justification for withholding analgesia • Inconsistency in evaluating pain categories or inadequate evaluation of potential for pain and distress • Humane endpoints