ࡱ> -/*+, 6CbjbjWW *55: >>dNctvXXXXv'Dk$lcncncncncncnc$aehcP S^P P c>>XXc###P >lXXlc#P lc##Ft],bX& ^aTXcc0cdaPhT!hbhbZ@#)4]cch#:cP P P P h :  MBC ANIMAL STUDY PROTOCOL ADMINISTRATIVE DATA Department:Principal Investigator:Submission Date:Proposed start date:Telephone:Email:Project Title:Funding Source (include grant # if applicable): Initial Submission Renewal List the names of all individuals authorized to conduct procedures involving animals under this proposal: Personnel:Telephone:Email:Date of IACUC Training: ANIMAL REQUIREMENTS Genus:Species: Strain, subspecies, or breed:Common name:Approximate age, weight or size:Sex:Source(s):Primary housing location(s): Location(s) where manipulation will be conducted:What will be done with the animals after the study is complete:Number of Animals to be Used:Year 1:Year 2:Year 3:Total:HOUSING CONDITIONS Will standard husbandry conditions be used? [see Attachment 1 for MBC guidelines for housing of common laboratory animals]  FORMCHECKBOX  Yes, I will be using the attached MBC guidelines for care of my animals.  FORMCHECKBOX  No, I have special conditions for my animals. [Describe and justify those conditions below.]  TRANSPORTATION Transportation of animals must conform to all institutional guidelines/policies and federal regulations. If animals will be transported on public roads or out of state, describe efforts to comply with USDA regulations. If animals will be transported between facilities, describe the methods and containment to be utilized.  STUDY OBJECTIVES Briefly explain in language understandable to a layperson the aim of the study and why the study is important to human or animal health, the advancement of knowledge, or the good of society.  RATIONALE FOR ANIMAL USE Explain your rationale for animal use. [The rationale should include reasons why non-animal models cannot be used.] Justify the appropriateness of the species selected. [The species selected should be the lowest possible on the phylogenetic scale.] Justify the number of animals to be used. [The number of animals should be the minimum number required to obtain statistically valid results.]  Using databases perform a search to confirm that this study does not duplicate previous work. [Popular databases include PubMed, ISI Web of Science, Med-line, etc.] DatabaseDate of SearchKeywords UsedDuplication? 1.2. DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES 1. Will surgery be performed on the animals?  FORMCHECKBOX  Yes, I am performing surgery on the animals. [Please provide details in Section H.]  FORMCHECKBOX  No, I am not performing any surgery on the animals. 2. If the animals will be euthanized at the end of the study, will you be following the procedures outlined in the MBC Policy on Euthanasia? [See Attachment 2]  FORMCHECKBOX  Yes, I am using the procedures in the MBC Policy on Euthanasia.  FORMCHECKBOX  No, I am not using the procedures in the MBC Policy on Euthanasia. [Describe and justify your procedures below.]  3. Briefly explain the experimental design of your study.  SURGERY (if applicable) Will you be using standard MBC operating procedures for surgery on your animals [See Attachment 3]?  FORMCHECKBOX  Yes, I am using standard MBC operating procedures.  FORMCHECKBOX  No, I am using different procedures from standard MBC operating procedures. [Describe and justify those procedures below.] I. PAIN OR DISTRESS CLASSIFICATION (Descriptions of classifications in Attachment 4) Species (common name)USDA Classification B, C, D or ENumber of animals used each year3 year total number of animalsYear 1Year 2Year 3Total number of animals (should equal total from Section B): Consideration of Alternatives: If any procedures fall into USDAs Classification D or E, causing more than momentary or slight pain or distress to the animals, describe your consideration of alternatives and your determination that alternatives are not available. *Note: You must complete Attachment 5 and submit to the IACUC chair with your protocol if you are using Classification E.  J. FIELD STUDIES If animals in the wild will be used, describe how they will be observed, any interactions with the animals, whether the animals will be disturbed or affected, and any special procedures anticipated. Indicate if Federal permits are required and whether they have been obtained.  L. PRINCIPAL INVESTIGATOR CERTIFICATIONS I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research. I certify that all individuals working on this proposal who are at risk have completed the occupational health form. Submit a copy for each individual with this protocol. I certify that the individuals listed in Section A who are authorized to conduct procedures involving animals under this proposal have taken the institutionally required investigator training course and received training in the biology, handling, and care of this species; aseptic surgical methods and techniques (if necessary); the concept, availability, and use of research or testing methods that limit the use of animals or minimize distress; the proper use of anesthetics, analgesics, and tranquilizers (if necessary); and procedures for reporting animal welfare concerns. For all USDA Classification D and E proposals: I certify that I have reviewed the pertinent scientific literature and the sources and/or databases and have found no valid alternative to any procedures described herein which may cause more than momentary pain or distress, whether it is relieved or not. I certify that I will obtain approval from the IACUC before initiating any significant changes in this study. Significant changes or modifications include personnel, pain or distress, type and number of species, or procedures. I certify that I will notify the IACUC regarding any unexpected study results that impact the animals. Any unanticipated pain or distress, morbidity or mortality will be reported to the attending veterinarian and the IACUC immediately. I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules and policies. Principal Investigator: Name: Date:Signature:  Please submit completed protocol to the Chair of the IACUC Certification of review and approval by the Institutional Animal Care and Use Committee: Name: Signature: Date: Attachment 1 MBC Housing Conditions for Mice and Shrews Light Cycle: 14 hours light; 10 hours dark Temperature Range: 68-74oF Humidity Range: 40-70% Food/water: Food and tap water will be checked daily, refilled as needed, and replaced two times per week. Mice will receive mouse chow and shrew will receive one part mink chow to 10 parts cat chow. Bedding: Animals will be placed in cages with pine bedding that will be cleaned and replaced every two weeks. Shrews will be housed individually in 27 x 21 x 13 cm cages while mice will be housed in same-sex groups of five in 43 x 27 x 19 cm cages. Attachment 2 MBC Policy on Euthanasia of Rats, Mice, and Musk Shrew The term euthanasia is derived from the Greek terms eu meaning good and thanatos meaning death. A good death would be one that occurs with minimal pain and distressEuthanasia is the act of inducing humane death in an animal... Euthanasia techniques should result in rapid loss of consciousness followed by cardiac or respiratory arrest and the ultimate loss of brain function. In addition, the technique should minimize distress and anxiety experienced by the animal prior to loss of consciousness. (AVMA Guidelines on Euthanasia) Euthanasia must be performed in a professional and compassionate manner by personnel skilled in methods appropriate for the species and should avoid creating distress in the subject and other animals in the area. The selection of specific drugs and/or methods for euthanasia depends on the animal species and the objectives of the protocol. For mice, rats, and musk shrew, MBC IACUC currently has approved the use of liquid inhalant anesthetics (e.g. halothane) for euthanasia. Animals should not be placed in physical contact with the anesthetic agent nor performed in the immediate presence of other animals. Animals should be monitored until cardiac activity has ceased. To ensure death and prevent revival, the diaphragm of the animals should be opened prior to disposal. These procedures comply with the Guide for the Care and Use of Laboratory Animals, the Animal Welfare Act (CFR 9 as amended), and with the methods set forth in the 2007 Report of the AVMA Panel on Euthanasia ( HYPERLINK "http://www.avma.org/resources/euthanasia.pdf" http://www.avma.org/resources/euthanasia.pdf) Attachment 3 MBC Procedures on Pre- and Post-Surgery Care All anesthetics and analgesics administered to laboratory animals must be within their expiration dates. Surgery must be conducted on a clean, uncluttered lab bench or table surface. The surface should be covered with a clean drape. All animal handlers will wash hands thoroughly and wear sterile gloves. All animals must be sufficiently anesthetized prior to surgery using isoflurane. For rodents this can be assessed by a lack of response to toe pinching. Isoflurane will be administered in a chamber and maintained by mask. Assistants will monitor animals respiration and adjust anesthesia levels as appropriate. Hair must be removed from the surgical site and cleaned with Betadine. All instruments must be autoclaved. If multiple animals are used, two sets of instruments must be autoclaved and one will be sanitized in Benzall while the other is in use. Animals will be kept warm with a heating pad. The abdominal or thoracic body wall will be closed with absorbable suture material. The skin will be closed with wound clips. The wound should be observed for swelling, heat, discharge and opening of the incision (dehiscence) at least once daily and treated with an antimicrobial agent if an infection is noted. 1mg/kg subcutaneous of ketoprofen, an analgesic agent, must be administered prior to recovery from anesthesia. The animals will be observed for signs of pain, distress, and incision problems two times a day. Some signs of acute pain are: Decreased appetite, decreased urine and fecal output, decreased activity, piloerection, ungroomed appearance, excessive licking and scratching that may progress to self-mutilation, abnormal stance or hunched posture, respiration can be rapid and shallow with grunting or chattering on expiration, pupils might be dilated, vocalization, or increased aggressiveness when handled. Records must be kept of all surgeries performed, anesthesia and analgesia administered, and any complications encountered. Attachment 4 USDA Classifications and Examples Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes. Examples: Breeding colonies of any animal species (USDA does not require listing of rats, mice, birds) that are held in legal sized caging and handled in accordance with the Guide and other applicable regulations. Breeding colony includes parents and offspring. Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations. Animals held under proper captive conditions or wild animals that are being observed. Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs. Examples: Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic, cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances. Euthanasia performed in accordance with the recommendations of the most recent AVMA Panel on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death. Manual restraint that is no longer than would be required for a simple exam; short period of chair restraint for an adapted nonhuman primate. Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used. Examples: Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy. Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs. Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics. Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Examples: Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain. Surgical and postsurgical sequella from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress. Negative conditioning via electric shocks that would cause pain in humans. Chairing of nonhuman primates not conditioned to the procedure for the time period used. Attachment 5 Explanation for USDA Classification E (This report is required to accompany USDA Form 7023 to support any USDA Classification E listings.) This document must be typed. 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