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

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Ambrose Craig
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1 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 Mammals APPLICANT/TYPE OF PROJECT Investigator s Name: Local Address: Telephone No.: Emergency No.: Co-Investigators Names, Addresses, and Telephone Numbers: If a Student, Advisor s Name and Department: Type of Project (check the appropriate in each column): New Continuation (without modification) Student Research Independent Study Faculty Instruction Renewal (with modifications) Faculty Research Other (please specify): Period of Experimentation (Inclusive Dates):

2 2 Assurance of Investigator: I will abide by all Federal, State, and local regulations governing the use of animals in research. I will advise the Animal Care and Use Committee at the College of Wooster, in writing, of any significant changes in the procedures described below. NOTE: Federal regulations require that you report violations of the Animal Welfare Act to the Office of the Animal Care and Use Committee or to a member of that committee. The proposed research does not unnecessarily duplicate previous work and is justified on scientific grounds. The chief investigator assures the College that an appropriate search of the literature has been made to verify this justification. ANY CHANGE TO THE PROTOCOL WHICH YOU DESCRIBE BELOW MUST BE APPROVED BY THE IACUC BEFORE IT IS IMPLEMENTED. Signature of Principal Date Typed Name of Principal Investigator Adviser's Endorsement: I have reviewed this proposal and discussed it with the investigator in the context of provisions of the Animal Welfare Act, the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, and other statutes and regulations relating to animals. I have determined that s/he has been provided with a copy of these regulations and information concerning the care of laboratory animals. The investigator assures me that he/she has received appropriate training in the use and care of animals necessary to conduct the proposed research from a member of the IACUC. Comments: Signature of Advisor Date Typed Name of Advisor Endorsement of Radioisotope Officer: (to be completed if radioisotopes are used): I have reviewed this proposal and discussed with the applicant the correct handling and disposal of the radioisotopes proposed for use. The applicant is adequately trained to use radioisotopes as per the proposal. Comments: Signature of Radioisotope Officer Date Typed Name of Radioisotope Officer

3 3 Description of Project Potential Value of the Study: State the potential value of the study including scientific documentation. Animal Characteristics Species: Sex: Age/Weight: Number: Location of Housing: Vendor/Source and USDA License No.: Reason for selecting these species for use; include literature citations supporting the reasons given: If you are using wild or exotic species, have you or your adviser obtained State and Federal permits to keep them? Yes No N/A If so, list permit numbers and source of licenses: Justification for the numbers of animals to be used: Is the above number the minimum required to obtain statistically valid results? Explain your reasoning and include documentation (e.g., what numbers are recommended in statistics handbooks or in related published reports?).

4 4 PROCEDURES: Describe sequentially all procedures (surgical and non-surgical) to be carried out on live animals. Where appropriate the end point of procedures must be clearly defined (add additional page(s) if necessary). Include documentation. ALTERNATIVES TO THE USE OF LIVE ANIMALS Justify the use of living animals rather than alternatives such as mathematical models, cell/tissue/organ culture, or computer simulations.

5 5 LEVELS OF PAIN/BIOHAZARDS Describe the level of pain, discomfort, or distress to which the animals in this project will be exposed by checking the appropriate blank(s) below. Also circle or highlight parts of the checked category which apply to your project. Category A B C D Levels of Pain - Discomfort Distress The research involves no pain, discomfort or distress greater than that produced by routine injections or venipuncture. Includes simple invasive procedures (e.g., injection, blood sampling) terminal anesthetic surgery, collection of tissues preceded by standard euthanasia. Involves behavioral testing with minor stress. The research involves only short-term pain, discomfort or distress. Includes anesthetic survival surgery without significant postop pain and/or functional deficit (e.g., gonadectomy, exploratory abdominal surgery), implantation of chronic catheters, short-term physical restraint (less than 60 min) of awake animals. Involves induction of short-term behavioral stress. The research involves chronic maintenance of animals with a disease/functional deficit and/or procedures inducing moderate to significant, but tolerable pain, discomfort or distress. Includes major anesthetic survival surgery with significant postop pain and/or functional deficit (e.g., orthopedic surgery on femur, amputation, invasion of large muscle mass); tumor inducement, radiation sickness, toxicity testing, physical restraint (more than 60 min) of awake animals, induction of moderate to significant behavioral stress. The research involves pain, discomfort or distress (greater than that attending routine injection) which cannot/will not be alleviated/minimized through the administration of appropriate anesthetic, analgesic or tranquilizer drugs. NOTE: The USDA has determined that any use of analgesics, anesthetics, or tranquilizers inflicts more than momentary or slight pain or distress on an animal. If the procedures described in the protocol inflict more than momentary or slight pain or distress, how will the pain or distress be recognized?

6 6 What measures will be taken to alleviate or minimize such pain or distress; or what is the justification for not taking such measures? A literature search covering the last five years, and consultation with colleagues, are required to determine that alternatives to the proposed painful procedures are not available. Sign below indicating that such a search was made using appropriate keywords.* Signature of the Principal Investigator Date Key words used in the literature search: * Less painful alternatives to the stress of injecting an anesthetic might, for example, include the use of topical agents to numb the injection site before injection is made. A possible alternative method of analgesia for some procedures might be hypothermia. There are a number of literature searches databases which you can consult in your search. Those of the National Library of Medicine include Medline, Bioethicsline, Cancerlit, Health Planning and Administration, Toxline, and Catline. A complete list of all available Literature Searches appears in each issue of Index Medicus and Abridged Index Medicus. Other databases include AGRICOLA (National Agriculture Library), CAB Abstracts, and BIOSIS. Possible keywords for initiating database searches include: pain, anesthesia, analgesia, alternatives. Searches can also be made in the following journals: Laboratory Animal Science Journal, Laboratory Animals Journal, Alternatives to Laboratory Animals Journal, and Lab Animal. Relevant bibliographies and books include Laboratory Animal Welfare Bibliography (QL55L ), Benchmarks: Alternative Methods in Toxicology (ISBN No )(RA1230D451989), and Alternatives to Animal Use in Research, Testing and Education (published by U.S. Congress Office of Technology Assessment). Or, consult the Animal Welfare Information Center (telephone: ).

7 7 Does the study involve the use of Biohazardous Materials: Yes No If so, check the appropriate category and specify the material(s) being used. Infectious Agents Radioisotopes Carcinogens Toxins Other Materials used: Does the use of such materials pose any hazard for personnel performing the project or caring for animals? Yes No If so, describe the hazards and precautions taken to minimize them. Surgery Will surgery be done on animals? Yes No If so, complete the following series of questions: Type of surgery: Non-recovery surgery Recovery surgery Multiple surgeries If multiple surgeries are involved, justify their use: Surgeon(s): Location(s) of surgical suites to be used (building and room): Specify anesthetic agents, analgesics, tranquilizers, and/or other methods used to alleviate pain during surgery. Include dose (e.g., mg/kig body weight), frequency of administration (e.g., daily) and route of administration (e.g., intraperitoneally) of each. NOTE: Federal regulations prohibit the use of muscle relaxants or paralytic drugs (e.g., succinylcholine or curariform drugs) alone for surgical restraint. Agent: Name: Dose: Frequency of Administration: Route of Administration:

8 8 Anesthetic: Analgesic: Tranquilizer: Other:_ By means of checks indicate the vital signs that will be used to monitor the presence of appropriate levels of anesthetic during surgery: Respiratory Reactivity Pedal Reflex Skin Color Body Temperature Corneal Reflex Other (please specify): If any anesthetic agent, analgesic, or tranquilizer listed above is a "controlled substance," identify the source: Supplier: State and Permit No.: Federal Permit No.: Describe the surgical procedures, including aseptic techniques that will be used during surgery: NON-SURGICAL INVASIVE MANIPULATIONS Will non-surgical invasive manipulation, such as blood collection, intubation, catheterization, be performed? Yes No If yes, describe them:

9 9 POST-SURGICAL CARE How long will animals be maintained postoperatively? Where will animals be housed for postoperative care (building and room) Initial 6-24 hours After 24 hours Will animals(s) be able to function normally (i.e., eat, drink, maintain their weight, move, etc.) postoperatively? Yes No If not, what steps will be taken to maintain them? How frequently will postop exams be done? by whom? What analgesics and/or antibiotics (include the dose and route of administration, and frequency of use) will be used during postop care? Administered by whom? Describe the postop care and identify the caretaker(s): OTHER ASPECTS OF ANIMAL CARE Will special foods (i.e., other than the normal diet) and/or water be required for the animals used in this project? Yes No If so, describe them and justify their use:

10 10 If surgery is not involved, but drugs or other synthetic or natural products, other than those used to alleviate pain, will be administered to the animals, identify them and indicate the dosage, route of administration, and frequency of their use: Will animals be restrained by chairs, slings, tethers, stanchions, metabolism cages or other devices? Yes No If yes, indicate: Method of Restraint: Duration of Restraint (days, hours): Frequency of Restraint: How often the animal will be observed when restrained: Who will observe the restrained animal: Will animals be feed- or water-deprived? Yes No If so, indicate: Food- or water-deprivation? Deprivation schedule (How long? How frequent?): Justify the use of food- or water-deprivation:

11 11 EUTHANASIA/DISPOSITION OF ANIMALS If death (rather than euthanasia) of the animal the endpoint of the experiment: Explain why the animals must be allowed to die - why can't they be euthanized at some earlier point in the study? If the animals will be euthanized at the end of the experiment: Who will euthanize them? Will they be euthanized with an overdose of Isoflo followed by cervical dislocation? Yes No If not, what agent/procedure will be used (include dose and route of administration): NOTE: The method of euthanasia must conform to the AVMA guidelines Will disposal of the animal carcasses be by triple bagging and involve Laidlaw Disposal Company? Yes No If not, how will the animal carcasses be disposed? If animals will not be euthanized at the end of the experiment, what will happen to them?

12 12 INVESTIGATOR: EXPERIENCE/TRAINING Describe your qualification/experience to do this project and of any assistant(s) you may employ. Are you qualified to perform the surgeries, control pain, do euthanasia, and other aspects of this project? If you are a student and this is a student project (e.g., an Independent Study), who will train you in techniques required for the project? What are the qualifications of this trainer? In what techniques will you receive instruction?

PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS

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