Use of Animals in Research: IACUCs, Animal Care, and More

1. Use of Animals in Research: IACUCs, Animal Care, and More Suzanne M. Rivera, M.S.W. Director, Academic Support Services UT Southwestern Medical Center at Dallas

2. Objectives • Basic information for the relative newcomer • Just enough information to make you “dangerous” • By the time you leave, you’ll know what you don’t know

3. Base Premise “Virtually every major medical advance of the last 100 years (as well as advances in veterinary medicine) has depended on research with animals. Animal studies have provided the scientific knowledge that allows health care providers to improve the quality of life for humans and animals by preventing and treating diseases and disorders, and by easing pain and suffering.” - Foundation for Biomedical Research, “Understanding the Use of Animals in Biomedical Research”

4. Animal Welfare v. Animal Rights

5. What is Animal Care and Use? • For purposes of this session, the word “animals” means live, vertebrate animals used in research, testing, teaching, health surveillance, or for related purposes. • For purposes of this session, the phrase “care and use” means procurement, housing, transport, husbandry, health maintenance, experimentation, treatment and humane euthanasia.

6. History Minute • 1946 Post WWII boom in public funding of science • 1950 “Chicago Five” Animal Care Panel • 1963 Guide for Lab Animal Facilities and Care • 1966 Lab Animal Welfare Act • 1973 PHS Policy • 1985 PHS Act • 1991 PHS Act Amended

7. The Sundowner Principles • Respect for Life • Societal Benefit • Non-Maleficence

8. The Three “Rs” • Refine- consider alternatives to any procedure that causes more than momentary pain or distress • Reduce- the number of animals used should be the minimum that is consistent with the aims of the experiment • Replace- use non-animal models when possible (e.g., in vitro methods)

9. What are the Rules Today? • Animal Welfare Act, 1966 [USC Title 7, Sections 2131 to 2156] as amended in 1970, 1976, 1985 and 1990. • Animal Welfare Regulations [Title 9 CFR, Subchapter A, Animal Welfare, Parts 1, 2 and 3]Health Research Extension Act, 1985 [Public Law 99-158, November 20, 1985, Section 495] • US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, 1985 • PHS Policy on Humane Care and Use of Laboratory Animals, 1986 • 2000 Report of the AVMA Panel on Euthanasia [JAVMA, Vol. 218, No. 5, March 1, 2001] • Guide for the Care and Use of Laboratory Animals (Guide) [NRC, 5th Ed., 1996] • NIH Grants Policy Statement (03/01), Part II: Terms and Conditions of NIH Grant Awards Subpart A: General -- Part 2 of 7

10. Who Enforces Standards? • USDA • OLAW • AAALAC (voluntary accreditation) • State Statues and Local Ordinances • Institutional Policy • Local IACUCs • Attending Veterinarian/Institutional Animal Care Personnel

11. Animal Welfare Program Animal Welfare

12. Institutional Leadership • IO who provides leadership, promulgates campus research policies, sets “tone” • Adequate resources and staff for quality animal care, healthy IACUC • Faculty service on IACUC rewarded

13. IACUC (What is it?) • The IACUC is the institutional body with responsibility for review and oversight of the institution’s program for the humane care and use of animals. • The IACUC supports, facilitates, and promotes ethical and humane use of animals by upholding the standards set forth in the federal statutes and regulations, policies and guidelines, and applicable institution’s policies and procedures concerning animal activities. • Per PHS Policy, must consist of no fewer than five members, including a Veterinarian with direct or delegated program responsibility for activities involving animals, one practicing scientist experienced in research involving animals, one member whose primary vocation is in a non-scientific area, and one member unaffiliated with the institution.

14. IACUC Charge • Review at least once every six months institution’s animal care and use program. • Inspect at least once every six months institution’s animal facilities, laboratories, and other areas where animals are used. • Prepare and submit reports of IACUC program evaluations and facility inspections to the IO. • Review and approve, require modifications in (to secure approval) or withhold approval of proposed and continuing animal activities described in animal use protocols. • Review and approve, require modifications in (to secure approval) or withhold approval of all proposed changes (modifications) to approved animal activities. • Notify investigators in writing of its decision to approve, require modifications in (to secure approval) or withhold approval of proposed animal activities. • Review, and, if warranted, investigate concerns involving the care and use of animals in accordance with institution’s Policy and Procedures for resolving noncompliance. • Suspend animal activities that are not being conducted in accordance with applicable federal statutes and regulations, policies and guidelines, and applicable institutional policies and procedures. • Make written recommendations to the IO regarding any aspect of the institution’s animal care and use program.

15. Is Your IACUC Healthy?

16. Animal Care • Attending Veterinarian • Animal Care Staff: vet techs, husbandry techs, procurement staff, transport staff, cagewash personnel, etc. • Compliance/post-approval monitoring (may reside with IACUC)

17. Attending Vet’s Duties • Monitor the care and use of animals • Provide technical assistance and training to personnel involved in animal activities, including selection and procurement of animals, husbandry and care, handling and restraint, identification and records, animal health and welfare, employee safety and health concerns, specific experimental and surgical techniques and euthanasia • Assist investigators with protocol preparation pertaining to animal housing, requirements for surgery, proper use of anesthetics, analgesics, and tranquilizer drugs, methods of euthanasia and other animal health and welfare issues • Manage animal housing facilities, including space allocation • Halt any animal activity if the safety or welfare of an animal is at risk or if the work being performed is not in accordance with an IACUC approved animal use protocol • Report animal welfare concerns and/or possible non-compliance to the IACUC

18. Animal Care Duties • Housing • Daily Health Checks • Pathogen Control • Feed, Bedding • Transport • Monitoring of Surgery/Other Procedures • Necropsy • Physical Plant Upkeep • Equipment Maintenance • Scientific/Clinical Input on IACUC Review • IACUC’s “eyes and ears” in the Field

19. PI Responsibilities • Obtain IACUC approval prior to commencement of any live vertebrate animal care or use activity • Purchase any animals to be used at through approved means • Make no changes to the approved protocol without first having submitted those changes for review and approval by the IACUC • Provide the IACUC with any information requested relative to the care and use of animals • Comply with an IACUC decision to suspend or withdraw its approval for an animal activity • Obtain continuing approval prior to the expiration date approval of the study and recognize animal activities must cease until current IACUC approval is obtained • Ensure all personnel having direct live animal contact have been or will be trained in applicable humane and scientifically acceptable procedures for animal handling, administration of therapeutic drugs and euthanasia prior to beginning any procedures with live animals • Enforce requirements for study personnel participation in institution’s occupational health program • Maintain and make available for inspection by the IACUC, Attending Veterinarian and federal agency inspectors all IACUC protocol and animal care and use records in accordance with federal regulations

20. Noncompliance Procedures • Distinguish garden variety noncompliance from scientific misconduct • Honor due process--avoid S.L.A.G.I.A.T. • Keep track so repeat violations will be noticed • Document corrective action plan • Report to OLAW (and UDSA, if covered) serious or continuing problems in a timely fashion • Include summary of incidents in AAALAC annual report

21. Keep Good Records

22. Program Oversight • OLAW • Annual Report/Renewal of Assurance • Update program changes • For-cause site visits • Will waive not-for-cause site visits if AAALAC accredited • USDA • Annual Report/Numbers of Animals Used • For-cause site visits • Not-for-cause on-site inspections 2x/annually • AAALAC • Annual Report • Update program changes • On-site visits every 3 years

23. What is AAALAC? • AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. Formal site visits are conducted at three-year intervals and are a method of ensuring that animal care and use programs maintain high standards.

24. What Does AAALAC Do? • AAALAC site visitors evaluate all aspects of an animal care and use program, including conformance with established procedures and overall performance in the area of animal care and use in research, education, testing or breeding. • The basic components of a program that are evaluated include (but are not limited to) institutional/IACUC policies, animal husbandry, veterinary care, and the physical plant.

25. AAALAC Check List • Adherence to IACUC policies, procedures and guidelines • Availability of approved protocols in the lab areas where animals are used (i.e., all personnel in the lab have access to the protocols and are aware of what is approved) • Availability and accuracy of controlled drug logs, surgical/post-operative/recovery records, breeding records and daily husbandry logs for housing variances • Enrollment of all laboratory personnel (including students) in the Occupational Health Program • Condition of animal use space (clean, orderly, and in satisfactory condition) • Good communication among components of the Program (IACUC, IO, Attending Vet, Occupational Health, PIs, etc.)

26. 5 Things I’ve Learned the Hard Way 5. An ethos of care starts at the top. 4. Some problems CAN be solved by throwing money at them. 3. Lab techs, department administrators, and graduate students are great sources of information. 2. If it ain’t broke, you are not looking closely enough. (Corollary: The one thing you try to keep quiet WILL end up on the front page of the local paper.)

27. 1. Communication is Essential