PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS

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1 PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS Federal animal welfare regulations require that the Institutional Animal Care and Use Committee (IACUC) must review and approve all activities involving the use of vertebrate animals prior to their initiation. This includes animals used for experimental method development or for instructional purposes. In addition, approved protocols for ongoing activities must be reviewed by the IACUC at least annually. PROTOCOL TITLE: (Title should be descriptive of the animal use activity and include the common name of the species being used for these studies.) PRINCIPAL INVESTIGATOR: Name: College and Department: Work Phone: Emergency Contact Number: CO-INVESTIGATORS/RESEARCH STAFF: List personnel involved in procedural activities using live animals. All personnel who perform animal anesthesia, surgery, or other experimental manipulations must be qualified through training or experience to accomplish these tasks in a humane and scientifically acceptable manner. Updated training files regarding training, experience, and continuing education in research animal handling, procedures, and related subjects, must be provided by all personnel and maintained with the Principal Investigator and IACUC Chair. ANIMAL INFORMATION: Species: Gender: Age or Weight Range: Source: Annual Number: PROJECT OVERVIEW: (Using layperson terms, describe the purpose of the study and its intended benefits to science, medicine, or mankind. Please avoid the use of technical jargon and abbreviations that would not be understood by a nonscientist.) RATIONALE FOR USING ANIMALS: (Provide the rationale for using animals rather than non-animal alternatives in this project.) JUSTIFICATION OF SPECIES: 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 1

2 (Explain why the species and/or strain of animals selected is the most appropriate for the project.) JUSTIFICATION OF NUMBERS: (Provide a detailed justification for the number of animals requested. Include number of animals/group X number and composition of groups/study X number of studies. Whenever possible, the number of animals requested should be justified statistically.) SPECIAL ANIMAL CARE: (If housing or care of animals is different from standard Animal Facility procedures (e.g., individual housing of rodents; change in caging type or light cycle or diet or cleaning schedule), provide detailed description and scientific justification. Note that all animals will be provided with environmental enrichment (eg, PVC pipes and/or rocks for Xenopus; nesting material and/or igloos for mice) when in their normal housing tanks or cages unless requested and justified as follows: DESCRIPTION OF PROCEDURES: Will unanesthetized animals be restrained by chairs, slings, tethers, stanchions or other devices? No Yes If yes, please explain: Method of restraint: Duration of restraint; Frequency of restraint: Observation during restraint: Will animal be deprived of food or water for greater than 16 hours? No Yes If yes, provide a justification, list frequency and duration of deprivation, and describe monitoring procedures. Experimental administrations: (Under Agent, identify biological materials, reference or control standards, general category of test compounds, etc. List each administration separately.) Agent Vehicle* Route Volume Frequency Duration * The vehicle determination is dependent upon the compounds chemical properties and route of administration, as well as the lack of adverse side effects in animals as experienced previously by the research staff or reported in literature (Handbook of Pharmaceutical Excipients, 3 rd Edition, 2000). Will blood sample(s) be collected from live animals? No Yes (if yes, please fill out table below) Site Volume Frequency and Duration 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 2

3 Will anesthesia be used? No Yes (if yes, please fill out Anesthesia Table below.) Anesthetics, analgesics or tranquilizers: For procedures that are expected to cause more than momentary slight pain or distress, specify the pre- and post-procedural preparations (e.g., analgesics, tranquilizers, etc.) and specify the induction and maintenance anesthetic(s) to be used during that procedure. Drug Dose (mg/kg) Route Frequency and Duration Indication Provide a complete narrative description of the experimental procedures to be performed on animals, including timeframes and the approximate time period the animals will be on study. Include descriptions of: blood withdrawals list sites, volumes, frequency and duration of sampling; animal manipulations; and similar information. Details of surgical procedures must be provided in SURGERY section.): Provide a written statement that the experiments covered under this proposal do not unnecessarily duplicate previous experiments. CLINICAL OUTCOMES: Describe the clinical signs and/or lesions that are expected in the animals as a result of the procedures (e.g., tumors, surgical wounds, weight loss, behavioral abnormalities, illness, etc.). HUMANE ENDPOINTS: (Describe the procedures designed to ensure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of this project. Include subjective criteria or end-points, including frequency of monitoring and who will perform monitoring, that will be used to ensure that animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be euthanatized.) USDA PAIN/DISTRESS CLASSIFICATION: Check the category that indicates the highest level of pain/distress animals will experience during the course of these studies: C D E* C. No Pain or Distress (Any Use of Pain Relieving Drugs Are Not Indicated). Procedures that may result in only slight or momentary pain such as routine injections, blood collections, or other minor procedures are included in this category. D. Tests or Procedures Involving the Potential for Pain or Distress (And Appropriate Anesthetic, Analgesic E. Significant Pain or Stress Without the Benefit of Pain Relief. These are procedures for which the use of 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 3

4 analgesics, anesthetics or tranquilizing drugs would adversely affect the procedures, results or interpretation of data. Examples are toxicity where death is the endpoint, or induction of disease where animals are not treated for the disease. *For all E category classifications, provide a written statement of justification for the procedures expected to cause pain or distress and an explanation of why pain/distress cannot be treated or alleviated. ALTERNATIVES TO POTENTIALLY PAINFUL/DISTRESSFUL PROCEDURES: Provide a written statement of the methods and sources used to determine that alternatives to potentially painful/distressful procedures are not available. Reduction of animal numbers and refinement of procedures to eliminate or minimize pain and distress must be considered, as well as replacement of animals with nonanimal alternatives. If alternatives to painful or distressful procedures exist, but were not chosen, explain the reasons for not using the alternatives. What are the SPECIFIC SOURCES that you have consulted for the alternatives search? (Examples of appropriate sources include Biological Abstracts, Index Medicus, Pubmed, the Current Research Information Service, and the Animal Welfare Information Center) Date Literature Search Conducted: Date Range Used in Search: From: To: Keywords Used in Search: Database(s) Consulted: Other Information Source: (provide details) USE OF HAZARDOUS AGENTS OR BIOLOGICAL MATERIALS: Will animals be exposed to any of the following agents? If yes, specify the agent, including CDC biosafety level, as applicable. Please refer to Preclinical Guideline Agent Radioisotopes Chemical Hazards Biohazards Recombinant DNA Biological Materials Other Name, Type or Description of Agent For specific agents used, provide special handling instructions for animals, caging and equipment, and other special precautions (e.g., special housing, personal protective equipment requirements and any decontamination procedures). The use of radioactive materials requires 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 4

5 prior approval by the Radiation Safety Officer. Use of radioactive materials will take place in designated areas only. Any hazardous agent use requires prior review and approval by the Environmental Health and Safety Manager. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY: (Provide details on method of euthanasia or final disposition of animals. Euthanasia methods must comply with the current recommendations of the American Veterinary Medical Association's Panel on Euthanasia. Justification must be provided for any proposed alternative methods. If injectable agents are used, provide agent name, dose and route of administration.) (Check all applicable boxes) CO2- followed by secondary method (e.g. bilateral thoracotomy, cervical dislocation) Isoflurane overdose Cervical Dislocation (rodents < 200 gm) w/ sedation Decapitation/Guillotine w/ sedation IV Euthanasia Solution (Specify agent, route, dose IP Euthanasia Solution (Specify agent, route dose): Other (Specify): SURGERY (To be completed only if surgery is involved.) Check the statements that describes your project: Non-survival surgery (animals are euthanized under anesthesia without regaining consciousness) Vendor conducted Major survival surgery (penetration and exposure of a body cavity, or resulting in a permanent impairment of physical or physiologic functions) Minor survival surgery Multiple surgical procedures--provide the timeframe between surgeries, describe any differences in surgical procedures, and provide a scientific justification for conducting multiple survival surgical procedures, if applicable. List the names of personnel who will perform surgeries and their training/qualifications to do so. List the anesthetic(s), including dosage(s), frequency of dosing, and route(s) of administration that will be used, and describe how you will monitor the depth/quality of anesthesia to ensure it is adequate. Please refer to IACUC guidelines. Describe the preoperative care of the animal, e.g., withholding of feed and water, etc. Describe the methods employed to minimize microbial contamination of the surgical site. Include brief descriptions of the preparation of the animal, surgeon, and instruments. Describe the surgical procedure. Include descriptions of methods and materials for ligatures and wound closure Protocol for the Humane Care and Use of Live Vertebrate Animals 5

6 Describe the post-surgical care. Include information regarding the use of pain-relieving drugs (give the drug(s), route(s) of administration, frequency), monitoring of animals for normal recovery from anesthesia and wound healing, and provision of supportive care, such as supplemental heat and fluid or antibiotic therapy. Describe who will perform post-surgical observations, and the frequency and duration of observations. Reminder: Documentation of the surgical procedure and post-surgical care is required and is the responsibility of the Principal Investigator. Copies of the surgical/post-surgical records must be readily available to the veterinary staff, the IACUC and other regulatory officials Protocol for the Humane Care and Use of Live Vertebrate Animals 6

7 ANY INDIVIDUAL MAY CONTACT A MEMBER OF THE IACUC (ANONYMOUSLY, IF SO DESIRED) IF THERE ARE ANY COMPLAINTS OR CONCERNS REGARDING THE CARE AND USE OF RESEARCH ANIMALS AT TOURO UNIVERSITY. THE INDIVIDUAL REPORTING VALID ANIMAL WELFARE CONCERNS SHALL NOT BE DISCRIMINATED AGAINST OR SUBJECT TO AN REPRISAL FOR REPORTING SUCH CONCERNS. PRINCIPAL INVESTIGATOR STATEMENT OF ASSURANCE: I hereby certify that as principal investigator for this proposed activity involving the use of animals: o This protocol does not unnecessarily duplicate previous experiments. o Paralytics will not be used without appropriate anesthesia. o Medical care for animals will not be withheld and will be available and provided or supervised as necessary by a qualified veterinarian. o The animals living conditions, including housing, feeding, and non-medical care, will be appropriate for the species, contribute to their health and comfort, and will not deviate from USDA, ILAR or other applicable standards o Animals that would otherwise experience severe or chronic pain/distress that cannot be relieved will be euthanized at the end of the procedure, or if appropriate, during the procedure. o Personnel conducting animal procedures will be appropriately qualified and trained in those procedures and the training and qualifications of such personnel have been appropriately documented. o I agree to abide by all applicable laws, regulations and guidelines for the care and use of animals at Touro University. o No animal will be used in more than one major operative procedure from which it is allowed to recover unless scientifically justified or required as a veterinary procedure. Signature of Principal Investigator _ Date 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 7

8 FOR IACUC USE ONLY: Date Submitted: Date Approved/Declined: Review Approved by: Full Committee Subcommittee Committee Decision: Approved Approved with modification Declined approval Comments/Explanation of Committee Action: Signature of reviewer(s): Signature of Environmental Health & Safety Manager: Signature of IACUC Chairperson: Signature of Attending Veterinarian: 2011 Protocol for the Humane Care and Use of Live Vertebrate Animals 8

Biohazard: yes no Radioisotopes: yes no Chemical Carcinogen: yes no Agent: Agent: Agents: Project Title: Objective:

1 Date of Submission: Biohazard: yes no Radioisotopes: yes no Chemical Carcinogen: yes no Agent: Agent: Agents: Protocol No. Species Project Title: Objective: Application to Perform Research Involving