APPLICATION FOR APPROVAL TO USE VERTEBRATE ANIMALS IN RESEARCH General Information and Instruction 1. For all applications, complete each section of the questionnaire. Mark those sections, which are not applicable “N/A” (particularly Sections X and XI). A signed Applicant certification page must be returned with the completed application. 2. Every new application and every third-year renewal must be accompanied by the methods and procedures section of the proposal. 3. Submit the original of the completed application to Sue Shingle, Office of the Associate Provost, Warner Hall, 405. Any questions regarding the proper procedures for completing the questionnaire should be directed to Carl Olson, Chair of the Institutional Animal Care and Use Committee (IACUC), x8-3968. Applications will be returned if incomplete or illegible. 4. If consultation with a veterinarian is necessary, please contact Dr. Paul Bramson, our consulting veterinarian before the application is completed. Dr. Bramson’s telephone number is 383-2009. 5. It is not within the charge of the IACUC to perform scientific review. However, the committee may exercise its option to request ad hoc scientific review of any application for which it is deemed necessary. 1 APPLICATION FOR APPROVAL TO USE VERTEBRATE ANIMALS IN RESEARCH Institutional Animal Care and Use Committee (IACUC) Carnegie Mellon University Associate Provost Office Warner Hall, Room 405 I. PRINCIPAL INVESTIGATOR Faculty Title: Mailing Address: Email: Department: Work Phone: II. TITLE OF PROJECT Type of Application: New Renewal Source of Funding: Revision Submission Date: If this is a renewal or revision, have any changes been made in the sections of the proposal utilizing animals? Yes No If yes, please summarize If no, provide original approval date III. ANIMAL USAGE (ALL SPECIES OF ANIMALS USED IN THE STUDY MUST BE INDICATED IN THE PROTOCOL) A. ANIMAL CLASSIFICATION Species Species Species Species Strain Strain Strain Strain Total Number/Year Total Number/Year Total Number/Year Total Number/Year 2 Where will animals be housed? Building Room(s) Who provides animal care on weekdays? On weekends and holidays? B. ANIMAL CARE DAYS Number of animals/year Time being held (days) x x x x x Animals care days/year = = = = = C. SOURCE OR VENDOR OF ANIMAL SPECIES USED D. Will your source or vendor provide documentation that your animals are free from infectious agents? Yes No Documentation of non-infectious status of animals must be provided if they are to be housed in a facility shared by other investigators. E. Are any animals to be used for breeding purposes? If yes, please specify reason. Yes IV. ALTERNATIVES TO THE USE OF ANIMALS Is there any alternative to the use of live animals for this project? Yes No Could a phylogenetically lower species be used? Yes No What requirements necessitate the use of the species proposed in this project? 3 No V. HAZARDOUS AGENT INFORMATION A. Will radioactive substances be administered in intact animals? Yes No If yes, list isotopes and amounts administered. B. Will hazardous biological agents or recombinant DNA technology be used in intact animals? Yes No If yes, list agent(s) and classification. C. Will regulated toxic chemicals or carcinogens be used in animals that are going to be returned to the housing facility? Include copy of MSDS (Material Safety Data Sheet). Yes No If yes, list agents. VI. EXPERIMENTAL MANIPULATIONS A. What is the experimental treatment of the animals? (Do not respond to this question by answering “SEE ATTACHED PROTOCOL”). 4 B. How many animals per experimental group? How was this number selected? Can the number of animals per experimental group be reduced? Yes No C. Will food be removed prior to an experiment? Yes No How long? Justify if longer than 24 hours. D. Will water be removed prior to an experiment? Yes No How long? Justify if longer than 12 hours. E. Will animals be anesthetized? (Give regimen used for each species.) Yes No If yes, list drug(s). Dose. Route of administration. Will unanesthetized animals be subjected to painful and/or stressful procedures during the experiment? Yes No (If pain or distress cannot be alleviated, written justification including references must accompany this submittal.) How will pain or distress be assessed? 5 Will tranquilizers or analgesics be administered? If yes, list agent. Dose. Route of administration. Yes No F. Will any form of external stimulation creating distress (e.g., hot-plate, foot shock) be used? Yes No Explain: G. Will surgery be performed? Yes No Multiple survival surgeries? (A yes response to this question requires written justification as an addendum. See policy handbook.) Yes No H. Will physical restraint be necessary in unanesthetized animals? Yes No Describe the restraint device. Justify the use of restraint. How often will animals be restrained? Duration of restraint. How are animals acclimated to the restraint device? I. Will chemical adjuvants be used? (See policy handbook.) Type: Site(s) and frequency of administration. 6 Yes No VII. POST OPERATIVE CARE A. In the post-operative period, will analgesics, antibiotics, or similar compounds be administered? Yes No List agent(s). Dose. Route of administration. Duration of treatment. Who will monitor recovery from anesthesia? Who will assess general progress and return to functionality? What methods will be used to assess functionality? VIII. EXPERIMENTAL ENDPOINT Is survival time a necessary experimental variable to be measured? (e.g., Will the animals die as a direct result of the experimental treatment?) (Not euthanasia.) Yes No (A yes response to this question requires written justification as an addendum. See policy handbook.) IX. EUTHANASIA Will animals be euthanized? Method. Yes If drug is used, provide dose. Route of administration. If no, what is final disposition of animals? 7 No X. ALTERNATIVES TO PROPOSED PROCEDURES The Animal Welfare Act (Public Law 99-158, August, 1989) requires that all investigators using warm-blooded species other than rats, mice or birds consider “alternatives to procedures that cause more than momentary or slight pain or distress to the animals,” regardless of whether pain and/or distress is alleviated by tranquilizers, analgesics and/or anesthetics. If applicable, investigators must append “a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives [to the proposed experimental procedures are] not available.” (see Policy Handbook) XI. UNNECESSARY DUPLICATION OF PREVIOUS STUDIES: The Animal Welfare Act (Public Law 99-158, August, 1989) requires that all investigators using warm-blooded species other than rats, mice or birds provide “written assurance that the proposed experiments do not unnecessarily duplicate previous experiments.” In planning your study, what procedures did you follow to determine that the proposed experiments are not unnecessarily duplicative. Append your narrative, including the list of supporting references. 8 APPLICANT’S CERTIFICATION 1. I agree to abide by all Carnegie Mellon University policies and procedures regulating the use of vertebrate animals in research; by the provisions of the NIH Guide for the Care and Use of Laboratory Animals; and by all other applicable laws, policies, and regulations governing the use of animals in research. 2. I declare that all experiments involving live animals will be performed under my supervision. All participants are qualified and have been trained in proper procedures using animals, including handling, administration of anesthetics, surgery, post-procedural management, and the analgesics and euthanasia to be used in this project. 3. I certify that this application accurately reflects all procedures involving animal subjects described in the proposal submitted for the support of this project. Any proposed revision to or variation from this application as approved will be promptly forwarded to the Animal Care and Use Committee for review and approval. 4. I understand that if I cannot be contacted in the event that animals in this project show evidence of illness or pain, emergency care will be administered at the discretion of the Animal Care Facility veterinary staff. Signature of Principal Investigator Date FOR COMMITTEE USE ONLY Date Approve Committee Member Disapprove Defer decision until committee meeting Comments: 9