Research and teaching using animals: Regulation, ethics, and oversight

1. Research and teaching using animals: Regulation, ethics, and oversight • Eric Sandgren, VMD, PhD • Associate Professor of Pathobiological Sciences • Chair, All Campus Animal Care and Use Committee • Holly McEntee, BA, MA • IACUC Administrator, UW-Madison

2. The character of public support for use of animals in biomedical research is highly variable • How is the polling question asked? • Who asks the question; who is asked? • Does the question state whether possible animal pain or distress is a part of the research? Education is, sadly, deficient.

3. Use of animals in research and teaching is highly regulated • Animal Welfare Act (AWA) • USDA Animal Care Policies • Public Health Service Policy (Office of Laboratory Animal Welfare, OLAW) • AAALAC: Association for the Assessment and Accreditation of Laboratory Animal Care, International

4. The Animal Welfare Act • Passed in 1965 by the US Congress; multiple amendments • Enforced by the USDA; failure to follow the law can result in fines or jail • Unannounced inspections at least once per year • Does not cover rats, mice, or birds bred for research

5. Animal Welfare Act--significant requirements • The Institution must have an IACUC (Institutional Animal Care and Use Committee) • The Institution must provide for the psychological well being of non-human primates • The Institution must provide exercise for dogs

6. Public Health Service • Institutions using PHS funds must follow “The Guide for the Care and Use of Laboratory Animals” (Guide) • Covers all vertebrate species • Failure to follow the Guide can result in loss of funding to the institution

7. The Guide defines the requirements of a Laboratory Animal “Program” • Program integration • Physical plant • Animal environment, housing, and management • Personnel qualifications and training • Occupational health and safety • Veterinary medical care • IACUC • Institutional official

8. IACUC • Must have at least a laboratory animal veterinarian, a scientist, and a community member not affiliated with the institution and who does not use animals in research • Reviews all facilities and programs twice a year; identifies and ensures correction of any deficiencies • Reviews “Protocols”, the researcher’s or teacher’s proposal for animal use • Monitors animal use; can suspend any animal activity that does not meet standards

9. The protocol review process (simplified)

10. AAALAC: Association for the Assessment and Accreditation of Laboratory Animal Care • Not regulatory, but evaluates the quality of a program; provides an independent “seal of approval” • Graduate (includes Primate Center), Medical, and Veterinary Schools at UW-Madison are accredited • CALS and L&S have made the decision to become accredited

11. The ethics of animal use • Utilitarianism: the view that an action is right if and only if it produces a better balance of benefits and harms than available alternative actions • Consider the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training”

12. U.S Government Principles (summary) • Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. • The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. [Alternative] methods…should be considered. • Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. • Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. • Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painless killed at the end of the procedure or, if appropriate, during the procedure.

13. U.S Government Principles (continued) • The living conditions of animals should be appropriate for their species and contribute to their health and comfort….veterinary care shall be provided as indicated. • Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. • …exceptions…should be made by…an appropriate review group such as an IACUC Utilitarianism! Stewardship

14. The three “R’s”:a consensus in the research community • Reduce • Refine • Replace

15. IACUC Protocol Review • Does the research address an important question? • Does the research require the use of animals? • Is the research necessary, in that it does not needlessly repeat previous work? • Is the experience of each animal in the study adequately described and justified?

16. Back to Utilitarianism: Animal researchers and PETA have the same ethical underpinnings. Go figure.

17. What are animals used for? • Rowan 1968 (accurate numbers are hard to find) • Teaching………………………………8% • Research……………………………..40% • Toxicology…………………………..20% • Drug development……………………6%

18. How many animals are used each year? • AWA regulated animals • 1-2 million per year • Does not include mice, rats, or many birds bred for research • Trends from the 1970s to the 1990s • Reduction in dogs: 200,000 down to 100,000 • Reduction in cats: 75,000 down to 40,000 • Primate number stable at about 50,000

19. UW-Madison: animals used

20. UW-Madison (Oct 2004 - Sept 2005)

21. Opponents of animal in research • It is unethical to use animals regardless of the benefits (animal rights perspective) • Most human health advances have come from improved sanitation • Research animals live impoverished lives, filled with fear and pain • Stressed animals are poor models • Most of the research can be done using alternative methods

22. Proponents of animal research • We cannot do this research on humans; utilitarianism can guide our use of animals in a way that is ethical • Dramatic improvements in both human and animal health have been made possible by animal research • Research animals are well cared for, and if used properly provide good models of human and animal biology and disease • There are no alternatives that can replicate the complexity of a living organism

23. Environmental Enrichment • Non-human primate enrichment; also AV, cage mates • Rodent enrichment: nestlets, structures, cage mates

24. Case study: Harry Harlow • Harry Harlow, 1905-1981. Deborah Blum wrote about Harlow in her 2002 book “Love at Goon Park” • Background: The discovery of disease transmission had led to a belief in a sterile, isolated environment as the IDEAL environment for raising infants. • During the early 1900s: • Workers at orphanages avoided contact with children as much as possible • Mothers were instructed not to kiss or cuddle their infants • Behaviorist Watson wrote “obvious affection always produced ‘invalidism’ in a child.”

25. Harlow, continued • Harlow was attempting to prove that touch, affection, and “a mother’s love’ all are important and valid aspects of biology and human relationships. • His studies profoundly changed the way children were raised • Experiments employing his methods would not be approved today

26. Pig Taser Study • Importance of the issue: People are dying from the supposedly non-lethal taser; how can this alternative to bullets be made safer? • Need for animals: The study purpose is to map the flow of electricity through a body, and specifically through the heart; this can only be modeled in a living organism. Pigs have a cardiovascular system that resembles that of humans.

27. Pig Taser Study (continued) • Lack of alternatives: Human volunteers cannot be implanted surgically with recording electrodes, and shocked to look for ventricular fibrillation; cadavers provide no physiological information • Animal experience: Pigs are anesthetized throughout the entire procedure (anesthesia was designed by human and veterinary anesthesiologists), and they are euthanized before waking; therefore, they can have no sensation of pain

28. The future at UW-Madison • Currently there are major organizational changes; we recently have conducted the first campus-wide program review in addition to the existing unit-specific reviews • Ensuring compliance on campus: FIFIs • 3 R’s • Continue to communicate with the public about the use of animals in research and teaching

29. Thank you for caring;thanks to the animals