The University of New Mexico & The Office of Animal Care and Compliance

1. The University of New Mexico& The Office of Animal Care and Compliance present Animal Care and Use A learning module developed and presented by the OACC

2. Introduction • This module was developed to assist you in understanding the humane and ethical use of animals in research

3. Background • The general principles of humane use of animals in research were formulated by Marshall Hall in 1831. • Prior to 1966 no federal law addressed laboratory animal welfare. • The Animal Welfare Act (AWA) was passed by Congress in 1966 establishing legal standards for laboratory animal care and use and fell under the purview of the USDA. • The 1971 NIH policy required institutions using warm blooded animals in research or teaching supported by NIH grants, awards or contracts to “assure the NIH that they will evaluate their animal facilities in regard to the maintenance of acceptable standards for the care, use and treatment of such animals”.

4. IACUC • The AWA consists of many Animal Care Policies and 9 Government Principles with regard to animal welfare. • An Institutional Animal Care and Use Committee (IACUC) is mandated by the Health Research Extension Act (HREA) of 1985 and the AWA to enforce the AWA and the 9 Government Principles. • IACUC’s must be composed of a chairman and at least two additional members who shall be a DVM and one other member that is not affiliated with the institution.

5. Animals • The Animal Welfare Act defines animal as any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus rattus, and mice of the genus mus, bred for use in research.

6. Animals • Horses not used for research purposes and other farm animals such as, but not limited to, livestock or poultry used as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber are also covered under the AWA.

7. Animals • An experimental animal model is an animal model that has disease which occurs naturally and mimics a human disease in some way, in which the experimentally induced condition mimics a human disease, is a model of a disease that is similar but does not entirely mimic a human disease, or is used as a replacement for studying a disease in humans for which the desired distress conditions can not ethically be produced.

8. Animals • Basically, the AWA covers all warm-blooded animals except Laboratory Rats and Mice, and Wild Birds. • However, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals defines an animal as ALL VERTEBRATES, INCLUDING POIKILOTHERMS.

9. Animals • It is the responsibility of this institution to adhere to the policies of the AWA and the PHS. • This can be accomplished if all persons working with any animals or animal tissues follow the 9 Government Principles.

10. Principle 1 • The transportation, care and use of animals should be in accordance with the AWA and other applicable federal laws, guidelines, and policies. • The IACUC shall determine that the proposed activities are in accordance with the PHS Policy and USDA AWR 9 CFR part 2, Subpart C unless acceptable justification for a departure is presented.

11. Principle 2 • Procedures involving animals should be designed and performed with due consideration of their scientific relevance to human or animals health, the advancement of knowledge, or the good of society. • The Principal Investigator must provide Assurance that the activities do not unnecessarily duplicate previous experiments

12. Principle 3 • The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Animal alternatives should be considered. • Protocols must contain the following: Identification of species and approximate number to be used, rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used.

13. Principle 4 • Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. • Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals – The PI has considered alternatives and has provided a written narrative description of the methods and sources.

14. Principle 5 • Procedures with animals that may cause more than slight or momentary pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. • Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia unless the procedure is scientifically justified by the Investigator (and approved by the IACUC). These procedures will NOT include the use of paralytics without anesthesia, and must involve, in their planning, consultation with the attending veterinarian.

15. Principle 6 • Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. • Methods of euthanasia must be in accordance with AVMA Panel on Euthanasia unless scientifically justified by the investigator.

16. Principle 7 • The living conditions of the animals should be appropriate for their species and contribute to their health and comfort. Housing, feeding, and care of all animals must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained. In any case, veterinary care shall be provided as indicated. • Medical care for animals will be available and provided as necessary by a qualified veterinarian.

17. Principle 8 • Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. In-service training shall include the proper and humane care and use of laboratory animals. • Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.

18. Principle 9 • Where exceptions are required in relation to the provisions of these Principles, the decision should not rest with the investigators directly concerned but should be made, with due regard to Principle 2, by the IACUC. Such exceptions should not be made solely for the purposes of teaching or demonstration.

19. The IACUC is Mandated to: • Review the animal care program and inspect the animal facilities every 6 months. • Prepare reports of its evaluations and inspections conducted. • Review and investigate concerns involving the care and use of animals. • Review and approve/disapprove animal use protocols.

20. Further IACUCMandates • Any experiment involving animals or animal tissues must be reviewed and approved by the IACUC before any work can begin. • This includes: Animal observations, or experiments involving NO pain, experiments in which animals are expected to become ill or undergo distress, experiments involving painless euthanasia or anesthetized animals that are not permitted to recover.

21. IACUCand Protocols • An animal use protocol is required to be approved by the IACUC before animals can be ordered. • This includes: All research and educational proposals regardless of funding source, and any animals used for display on UNM property, or representing UNM.

22. Surgery • Major survival surgery is defined as any surgical intervention that penetrates a body cavity or has the potential for producing a permanent handicap in an animal that is expected to recover. • All survival surgery requires the utilization of aseptic technique – regardless of species. • Survival surgery on all animals except rodents requires a dedicated surgical suite.

23. Analgesia • Analgesia refers to relief from pain. • Regional anesthesia is insensitivity in a relatively large but limited area of the body. • If a painful procedure must be conducted without the use of an anesthetic, analgesic, or tranquilizer, it must be approved by the IACUC prior to performing it.

24. Pain and Distress • The USDA and UNM define pain and distress of animals to 5 categories, A, B, C, D, and E. • Category A refers to NO pain and distress and is associated with Animal Observations in the field or the use of Animal Tissues only. • However, the collection of the animal tissues could change the category.

25. Pain and Distress • Category B refers to NO pain and distress and is associated with Captive Breeding Colonies only. • These animals have minimal human interaction and have NO experimental procedures performed on them.

26. Pain and Distress • Category C refers to NO MORE THAN MOMENTARY or SLIGHT PAIN OR DISTRESS. Procedures for which NO analgesics are indicated to alleviate pain such as simple injections and restraint. • These are procedures that do NOT require analgesics or anesthetics.

27. Pain and Distress • Category D refers to MORE THAN MOMENTARY or SLIGHT PAIN OR DISTRESS is expected, or is possible, and appropriate analgesics or anesthetics have been employed or; other methods of alleviating pain or distress. • The USDA and NIH guidelines state that any procedure considered painful or potentially painful in humans, and for which humans would be administered analgesics, should be included in this category .

28. Pain and Distress • Category E refers to MORE THAN MOMENTARY or SLIGHT PAIN OR DISTRESS is expected, or is possible, and appropriate analgesics or anesthetics can NOT be employed. • This includes: Euthanasia by decapitation or cervical dislocation without anesthesia or sedation, repeated foot shock, contextual fear conditioning. • Must be justified by the PI and approved by the IACUC.

29. Euthanasia • Euthanasia is often referred to as “painless death”. • Examples include: Inhalant anesthetics, carbon dioxide asphyxiation, exsanguination under anesthesia, and penetrating captive bolt. • If mechanical means are used, then anesthesia is required unless justified and approved by the IACUC.

30. Euthanasia: Example • Recommended euthanasia methods in mice includes: • Cervical dislocation, exsanguination, decapitation, carbon dioxide asphyxiation, and anesthetic overdose.

31. The Three R’s • Replace - Replacement of animals with non-animal methods and choosing the phylogenetically lowest species whenever possible is essential. Scientists are requested to establish that animals are necessary to reach the scientific objective. It is imperative that scientists determine that alternatives to using the proposed species to achieve the scientific objective are not available. • Reduce – Reduction of the number of animals to that which is the least number required to achieve the scientific objective is the second premise. • Refine – Refinement of all procedures employed in the protocol to minimize pain, stress and distress is a major consideration.

32. Alternatives • The Principal Investigator is required to determine that there is not an alternative technique to animal use and list the source(s) used in this determination. This must be done before a protocol is submitted.

33. Alternatives • The Animal Welfare Information Center (AWIC) provides information on alternatives and was established at the National Agriculture Library. • The primary responsibility for seeking alternative methods rests with the Principal Investigator. • An example of an alternative could include: replacement of a mammal with an invertebrate, redesigning an experiment to use fewer animals, or utilization of a tranquilizer to minimize anxiety. • Alternatives to the use of animals is concerned with minimizing pain and suffering.

34. Ethics • Here is an excerpt from the Mammology Guidelines on Ethics • "Different institutions have varying requirements, but as scientists we have developed an ethos towards animal use. Ethics is typically defined as a study of moral values meaning expectations about beliefs and behaviors that we judge ourselves and others by (Macrina 2004). For instance, we would not tolerate the practice of the mid-1800’s where fully conscious dogs were nailed to a board by their 4 paws before being cut open to view the beating heart. However, all procedures that may be used commonly today but still cause even momentary pain and distress must be considered and discussed. This document is intended as a resource for those instances where difficulties arise in defining what is appropriate..."

35. Ethics • Ethical principles of humane use of animals in research specify that an experiment should be done with the least possible infliction of pain, suffering, and distress. • The ethical theory that is based upon an analysis of cost and benefit is referred to as Utilitarian Theory. • Traditionally, many moral theorists consider an individual to have moral standing if it can be shown that the individual possesses autonomy. • In some respects the animal protection debate and movement is a reconsideration of the human’s place in nature.

36. Ethics • Ethical principles of humane use of animals in research specify that an experiment should be done with the least possible infliction of pain, suffering, and distress. • The ethical theory that is based upon an analysis of cost and benefit is referred to as Utilitarian Theory. • Traditionally, many moral theorists consider an individual to have moral standing if it can be shown that the individual possesses autonomy. • In some respects the animal protection debate and movement is a reconsideration of the human’s place in nature.

37. General Rules for Working with Animals • The use of any animal or animal tissue is a privilege, not a right. • Animals feel pain and distress just as humans do. • Experiment should be done with the lease possible infliction of pain, suffering, and distress. • The Principal Investigator is required to determine that there is not an alternative technique to animal use. • ANY experiment involving animals or animal tissues must be approved by the IACUC.

38. This Concludes Module 1A – Animal Care and Use. • Please download the exam, complete it, then e-mail it to KMirowsky@salud.unm.edu