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ANIMAL USE CLASSIFICATIONCategory 1 No pain or distress is associated with the protocol and/or No pain relieving drugs or treatments are necessary. This is the number reported in column C of the USDA annual report. Category 2 Pain or distress is associated with the protocol and pain relieving drugs or treatment are provided. This is the number reported in column D of the USDA annual report. Category 3 Pain or distress is associated with the protocol but pain relieving drugs or treatment are withheld because their use would interfere with the study objectives. This is the number reported in column E of the USDA annual report. Links to pain assessment and control. As signs of pain may vary from animal to animal, the operational definition of pain described (in) the U.S. Government Principles for the Utilization of and Care of Vertebrate Animals Used in Testing, Research and Training is often the easiest to apply. This definition states, "Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain and distress in other animals." In defining animal stress, we must properly distinguish between "stress" and "distress." The National Research Council (1992) appropriately defines distress as "an aversive state in which an animal is unable to adapt completely to stressors and the resulting stress and shows maladaptive behaviors." TYPE A: STUDIES ON NON-LIVING VERTEBRATE ANIMAL MATERIAL, NON-INVASIVE OBSERVATIONS OF WILDLIFE, AND/OR WHERE THERE IS NO CONTACT WITH ANIMALS.These include vertebrate animal tissues obtained at necropsy, slaughterhouse, or meat markets (grocery stores), Observational studies on wildlife and other animals that do not involve physical restraint or handling are included. Also included in this category are projects that use commercial or other USDA registered animal facilities to produce animal products, like commercial antibody companies, since there is no use of live animals here at this facility. Category 1: STUDIES ON LIVE, VERTEBRATE ANIMALS CAUSING NO MORE THAN MINIMAL PAIN OR DISTRESS. To top of pageExamples include: routine examinations; blood sampling; injection of non-toxic materials; approved methods of euthanasia that induce rapid unconsciousness; short periods (up to 24 hours) of withholding food and water. Acceptable levels of minimal pain and discomfort in this category would be those procedures that are normally done on animals given routine physical examinations at veterinary clinics. Animals that are euthanized and then have tissues/organs removed are included in Type B. Animals that are anesthetized and then have tissues/organs removed before euthanasia are in Type C. Category 2: STUDIES ON LIVE ANIMALS INVOLVING PAIN, STRESS, OR DISTRESS WHICH IS ALLEVIATED OR CONTROLLED BY ANESTHESIA OR ANALGESIA. To top of pageConsultation with a veterinarian to discuss ways to minimize the pain distress
or discomfort of the animals involved is mandatory. The consulted
veterinarian should be experienced with the species and techniques involved in the
research, and should not be affiliated with the research activity. Examples include invasive studies on anesthetized animals that may or may not regain consciousness. Survival surgical procedures that may result in minor post surgical discomfort. Also included are studies using noxious stimuli from which escape is possible; some tumor or device implants; the use of Freund's complete adjuvant; and domestic animal production methods (following accepted veterinary practices), i.e. tail docking, neutering, dehorning, debeaking, etc. Other examples include major surgery under general anesthesia that results in significant post-operative discomfort, prolonged periods (several hours or more) of uncooperative physical restraint; deprivation of the animals' environmental necessities, such as maternal deprivation; aggression; and predator-prey interactions. Also included are studies in which diseases or toxicities are induced and the animals are expected to become sick or abnormal. Animals in Type 2 studies may experience pain, but the necessary treatments to alleviate the symptoms are available and provided, or the animals are euthanized. Involvement of trained technicians, scientists, and veterinarians is critical if this pain is to be minimized or avoided. Adherence to acceptable veterinary practices is mandatory and will vary depending on the project, i.e. post-op analgesia, fluid therapy or intensive nursing care. Comment: Animals which may be expected to show clinical symptoms of pain or distress as a result of the research objectives are treated or these symptoms are otherwise alleviated with the use of drugs or intensive care. Category 3: PROJECTS INVOLVING SIGNIFICANT PAIN OR DISTRESS WITHOUT THE BENEFIT OF PAIN-RELIEVING DRUGS. To top of pageExamples include: application of noxious stimuli from which escape is impossible; the use of muscle relaxants in surgery without concurrent use of anesthetics, induction of aggressive behavior leading to self-mutilation or fighting where death is the end-point. Also included are studies in which death is the end-point, i.e. diseases are induced and infected animals are permitted to succumb rather than be treated. Comment: Animals are expected to show clinical symptoms of pain or distress as a result of the research objectives, but these symptoms cannot be treated or otherwise alleviated with the use of drugs or intensive care because doing so would interfere with the research objectives. Type E studies place an explicit responsibility on investigators to explore alternative designs to ensure that these methods have to be used. The reasons for using these procedures must be explained in a statement by you, the Principle Investigator, justifying their use. This statement is requested in the last item of the Animal Use Approval Form. This statement is required by federal law. The IACUC submits this statement in the annual reports to the government. |
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