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Section B More Considerations and Proposed Activities USDA Policy 11 Procedures involving animals will avoid or minimize discomfort, distress, and/or pain A painful procedure is defined as any procedure that would reasonably be expected to cause more than slight or momentary pain and/or distress in a human being 3 USDA Pain Categories Category C—no pain, distress, or use of pain-relieving drugs Category D—accompanying pain or distress for which appropriate anesthetic, analgesic, or tranquilizing drugs are used Category E—accompanying pain or distress for which use of drugs would adversely affect research outcome 4 USDA Policy 12 Principal investigators must consider alternatives (reduction, refinement, or replacement) to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of methods used and sources consulted 5 When Does an Alternative Search Need to Be Done? An alternative search must be done for any procedure that causes more than momentary pain or distress (either relieved or unrelieved) (Categories D and E) 6 Written Narrative for Alternatives Written narratives for alternatives to painful procedures must include the following: - Databases searched or other sources used - Date of search - Years covered by the search - Key words used/search strategy 7 More Refinement Considerations: Humane Endpoints Humane endpoints—euthanizing an animal prior to death in order to minimize pain and/or distress while preserving the scientific integrity of the study 8 More Refinement Considerations: Humane Endpoints Humane endpoints—common scenarios where they may be considered - Tumor biology or carcinogenesis studies - Genetically modified animal models - Infectious disease studies - Toxicity testing 9 Euthanasia Considerations AVMA guidelines on euthanasia - Minimum pain, distress, anxiety, or apprehension - Minimum delay until unconsciousness - Reliability and irreversibility - Safety of personnel; emotional effect on personnel - Compatibility with requirement and purpose - Compatibility with species, age, and health status - Drug availability and human abuse potential 10 Euthanasia Considerations—Acceptable Methods Barbiturates (DEA-controlled) Benzocaine HCl (fish, amphibians) CO2 (bottled gas only) CO (bottled gas only) (worker safety issues) Inhalant anesthetics Microwave irradiation (mice, rats) 11 Euthanasia Considerations—Acceptable Methods Penetrating captive bolt (swine, horses, ruminants) 2-phenoxyethanol (fish) Tricaine methanesulfonate (fish, amphibians) KCl (intracardially or IV in conjunction with general anesthesia) 12 Euthanasia—Conditionally Acceptable Methods Cervical dislocation (birds, small rodents, and rabbits) Decapitation (rats, mice, birds) Pithing (some ectotherms) Some pharmacological agents in some species 13 Euthanasia Considerations—Unacceptable Methods Air embolism Chloroform, cyanide (danger to personnel) Decompression Neuromuscular blockers Dry ice generated CO2 14 Other Relevant IACUC Topics Agricultural research Antibody production Breeding colonies Field studies Hazardous materials Instructional use of animals Surgery Genetically modified animals 15 Other Relevant IACUC Topics Post approval monitoring Retrospective reporting of adverse effects Over-interpretation of regulations—the more is better principle 16 Handout The handout is available from the Online Library section of the lecture page 17 IACUC Training IACUC 101/201 workshops IACUC advanced workshops (Scientists Center for Animal Welfare— SCAW) Meeting the information requirements of the Animal Welfare Act (Animal Welfare Information Center, USDA) SCAW annual conference Public Responsibility in Medicine and Research (PRIM&R) annual IACUC conference 18 Some Internet Resources Altweb (Johns Hopkins University) - http://altweb.jhsph.edu/ Office of Laboratory Animal Welfare (NIH) - http://grants.nih.gov/grants/olaw/olaw.htm AAALAC International - http://www.aaalac.org/ Animal Welfare Information Center (USDA) - http://awic.nal.usda.gov/nal_display/index.php? info_center=3&tax_level=1 Institute for Laboratory Animal Research - http://dels.nas.edu/ilar_n/ilarhome/ 19 Some Internet Resources Animal Welfare Act - http://www.nal.usda.gov/awic/pubs/AWA2007/awa.shtml IACUC.org - http://www.iacuc.org/ Public Responsibility in Medicine and Research (PRIM&R) - http://www.primr.org/ Scientists Center for Animal Welfare (SCAW) - http://www.scaw.com/ 20