FORM A UNIVERSITY COMMITTEE ON LABORATORY ANIMALS APPLICATION TO USE ANIMALS FOR RESEARCH OR TEACHING – ETHICS REVIEW *Note: textbox sections will expand Principal Investigator (must have faculty appointment): Faculty Position: Department: Building: Phone: Email: Project Title: Renewal of Previous Protocol? Yes: ☐ No: ☐ Previous Protocol Number: Is this protocol for: Research: ☐ Teaching: ☐ Is the proposed work currently funded? Yes: ☐ Testing: ☐ No: ☐ Pending: ☐ Name of funding source(s): Have ALL the concepts for the experiments proposed in this protocol been peer reviewed for scientific merit? Yes: ☐ No: ☐ * Pending: ☐ * Which agency provided the scientific peer review? *All protocols must be reviewed for scientific merit. If this project has not been reviewed, or was reviewed but not funded, please see APPENDIX 2. Is this protocol a contract or part of a contract? Yes: ☐ Proposed start date: No: ☐ Proposed end date: Emergency Contacts: MUST include phone numbers for PRINCIPAL INVESTIGATOR and ONE OTHER PERSON designated to handle animal emergencies or media inquiries. Must be available for evenings and weekends. Name Certificate # Department Position After hours phone 1. 2. DECLARATION: I certify that all animals used in this research project will be cared for in accordance with the recommendations of the Canadian Council on Animal Care and the policies of Dalhousie University. I assume responsibility for providing each member of the laboratory who will perform procedures under this protocol with a copy of the final version of the approved protocol, and require that they follow the procedures described. I will notify the UCLA of any changes of the proposed project before proceeding with any animal experimentation. I certify that the number of animals requested in this protocol is the minimum number required to achieve the objectives of this protocol. SIGNATURE: _______________________________________________________________ DATE: 1 Revised August 2015 Principal investigator or course director SECTION 2 Name Certificate # Department Position Phone RESEARCH STAFF: Principal Investigator MUST have a current certification number. Add additional personnel on a separate sheet. RESEARCH PERSONNEL TRAINING: Everyone handling laboratory animals is required to be listed as research staff and have a certification number in addition to practical training for the species they are using (see Certification/Training information, or contact the University Veterinarian’s office for more information). Add additional personnel on a separate sheet. For research staff required to handle live animals, check off which workshops/training have been attended. Acronym descriptions of practical workshops currently offered are provided below: NAME RH MH ANES AS FH ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Custo m Sessio n (Descri be below) ☐ ☐ ☐ ☐ ☐ ☐ Other (Descri be Below) ☐ ☐ ☐ ☐ ☐ ☐ 2 Revised August 2015 Describe “CUSTOM SESSION” or “OTHER” training here: RH/Rat Handling: Recommended Tech Procedures Familiarization with handing, restraint, injection and blood collection procedures in the in the rat. MH/Mouse Handling: Recommended Tech Procedures Familiarization with handling, restraint, injection and blood collection procedures in the in the mouse ANES/Intro to Anesthesia Principles of Anesthesia AS/Intro to Aseptic Surgical Technique Aseptic surgical tech, post-op care, analgesia, scrub, gown, glove tech, & suture FH/Fish Handling and Water Quality Evaluation of water quality parameters. Anesthesia, tagging, blood collection & surgical techniques Custom Session Individualized sessions with Dalhousie Lab Animal Training Coordinator Other e.g. formal training from other institutions, or training from other qualified personnel Will anyone listed on the protocol require new/additional training for some procedures? Yes: ☐ No: ☐ If “Yes”, please describe what procedures: SECTION 3: Project Objectives: Briefly describe the objectives of the proposed work using animals. SECTION 4: What is the potential benefit that might result from your research? If applicable, please indicate the disease process that this work will investigate. SECTION 5 (PART 1) CHECKLIST: This YES/NO checklist will provide assistance in determining which attachments will be required. Check YES or NO for each item below, and completed the required attachment for each YES. 3 Revised August 2015 5a. ANESTHESIA and SURGERY: Does this project involve surgery and/or administration of anesthetics? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT A. It is NOT necessary to complete Attachment A if an anesthetic overdose is being administered solely as a method of euthanasia, without any surgical manipulations, recordings, etc. performed on anesthetized animals. 5b. PROGRESS REPORT: Is this protocol a renewal of a previous approved protocol? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT B (NOTE: Attachment B is different from Form B) 5c. TEACHING: Will these animals be used for teaching? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT C 5d. FIELD STUDY: Is this a field study? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT D 5e. HAZARDOUS AGENTS: Are agents hazardous to humans or animals, such as materials, chemicals or radiation administered to animals? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT E 5f. BREEDING: Is breeding required as part of this protocol? Yes: ☐ No: ☐ If yes, (multiple if required) ATTACHMENT F’s must be provided for all strains/genotypes being bred and used in this protocol. On the ATTACHMENT F’s, include the number of males and females required for breeding and the number of progeny that are expected to be produced to provide the numbers of each genotype you will actually use in this specific protocol. 5g. IMMUNIZATION of ANIMALS: Are animals being immunized in this project? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT G 5h. TUMOURS, STEM CELLS, IMPLANTABLE MATERIAL: Does this project involve the injection or implantation of tumours, stem cells or other biological materials (other than tissue transplants) into rodents? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT H 5i. REGULATORY TESTING: Does this project involve safety/efficacy/toxicity testing for regulatory purposes? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT I 5j. ANIMAL MOVEMENT: Does this project involve removing live animals from the animal facility and taking them to another location (eg. Taking them to your laboratory or to an imaging suite)? Yes: ☐ No: ☐ If yes, complete and include ATTACHMENT J 4 Revised August 2015 SECTION 5 (PART 2): PROJECT DESCRIPTION IMPORTANT—USE LAY LANGUAGE This is an animal ethics protocol and it is important that everyone reviewing it understands it. We need to know what happens to each animal/group of animals when it enters the experimental protocol until the end of the protocol. Provide a detailed description of all procedures to be performed on the animals, including timelines, group sizes, handling, special housing, endpoints, consequences and how they will be addressed, etc. Provide doses, sites, volumes, routes, and frequency of all injections. Provide any information that will help the committee members in their review of what is being done to each animal. For surgeries, provide details in the ATTACHMENT A. FLOW CHARTS are often extremely helpful especially when enough information is provided in the flow chart to show what is being done to the animals. SOP’s - provide them when required Do not use excerpts from grant applications. SECTION 6: THE THREE R’s The 3R’s (replacement, reduction and refinement) are the cornerstone of ethical animal research, and the UCLA requires investigators to implement the 3R’s when they are preparing to use animals for scientific purposes. Please show how you have considered the 3R’s in your project design and in your answers to the following questions: 6a. Justify the number of animals requested based on the experimental design of this project. Indicate how the number of animals was determined by breaking their use down into experimental groups. Include a statistical justification if possible, or a yield of tissue needed per animal. 6b. This protocol is valid for a maximum of TWO years. Indicate the number of animals you will use experimentally EACH year in the experiments described in this protocol. Do not include breeders and number PRODUCED from any breeding ATTACHMENT F’s in this section. Only provide numbers of animals that will be used experimentally. . Each genotype should be listed on a separate line(even if they have the same background strain Add additional species on a separate page If additional animals are required before the expiry date of this protocol, a FORM B may be submitted at any time to request additional animals SPECIES STRAIN or GENOTYPE WEIGHT or AGE SEX # Required in YEAR 1 # Required in YEAR 2 Total # of Animals Required SUPPLIER 5 Revised August 2015 6c. If animals for this study are produced by in house breeding, you must include an ATTACHMENT F for each strain/genotype used in the protocol. If acquiring animals from another PI - Provide their protocol number. 6d. ANIMAL HOLDING FACILITY: EXPERIMENTAL STUDIES: 6e. Why must animals be used in this study? If alternatives to animals are available, indicate why they cannot be used in this study. 6f. Explain choice of animal model or animal species. 6g. If you are using more than one rodent or fish strain or genotype, why? Please explain why each was chosen, and how the use of each relates to your objective. 6h. Can normal environmental enrichment devices be provided to captive animals on this study? Yes: ☐ No: ☐ If NO, please justify withholding these items: BUILDING: BUILDING: ROOM: ROOM: SECTION 7: HUMANE ENDPOINTS Some experimental manipulations or phenotype abnormalities can be expected to produce a degree of unavoidable pain, distress or illness in experimental animals. CCAC guidelines require that adverse effects are minimized or alleviated by choosing the earliest endpoint consistent with the scientific objectives of the research. 7a. What is the expected time course of the study? (i.e. how long are animals maintained from the first experimental manipulation until the end of the experiment or planned euthanasia?) For field studies what is the period of observation? For invasive procedures, SOP’s tailored to the specific procedures are required. If invasiveness is in question, contact vet to determine if SOP’s are required. Do you expect this study to cause any pain, distress or illness? Yes: ☐ No: ☐ If yes, please describe, including time course. 7c. Specific to your experimental manipulation, what clinical signs/observations may indicate that animals used in this project are experiencing pain, distress or illness? (e.g. behavioural changes such as decreased grooming, vocalization or postural changes, or physical abnormalities such as anorexia, dehydration, diarrhea, etc.) 6 Revised August 2015 When are these signs expected to occur and when would they be most severe? 7d. Animals must be monitored by research staff throughout the course of the experiment. Monitoring records must be kept within the animal facility. Any unexpected morbidity or mortality must be reported to the veterinary staff. How frequently will animals be monitored during the course of the study as well as during the critical times when signs are most severe? Who will monitor the animals? 7e. What criteria, specific to the animal and to the procedures/treatment, will trigger the decision to end the study, stop the procedure, or humanely euthanize an animal before the experimental objective is achieved? (Examples could include the following: a weight loss limit as a percentage of body weight, allowable durations of anorexia, ulcerative skin lesions). 7f. The veterinarian has the authority to immediately euthanize animals in distress. A reasonable attempt will be made to communicate with the research group before taking action. Who in the research group can authorize the euthanasia of animals if contacted? 7 Revised August 2015 SECTION 8: CCAC CATEGORIES OF INVASIVENESS Using APPENDIX 1 indicate the Level of Invasiveness that best identifies this protocol. B☐ C☐ D☐ E☐ For LEVEL A experiments - the use of invertebrates (excluding higher invertebrates e.g. all cephalopods), eggs, protozoa or other single-celled organisms, tissue obtained from sources such as a slaughterhouse or from another source, please use a Form C. PURPOSE OF ANIMAL USE: (CCAC requirement) Pick ONE statement which BEST describes the purpose of animal use in this protocol. 0. ☐ 1. ☐ 2. ☐ 3. ☐ 4. ☐ 5. ☐ Breeding ONLY Studies of a fundamental nature in sciences relating to essential structure or function (eg. Biology, psychology, biochemistry, pharmacology, physiology). Studies for medical purposes, including veterinary medicine, that relate to human or animal diseases or disorders Studies for regulatory testing of products, for the protection of humans, animals, or the environment. Studies for the development of products or appliances for human or veterinary medicine. Education and training of individuals in post-secondary institutions or facilities CCAC Animal Care Classification Category: An acute study is one in which animals are euthanized without an extended holding period or prior invasive manipulations, unless these are performed under anesthesia without recovery. This would include animals euthanized for tissue collection, or anesthetized for a surgical procedure and euthanized before waking up. A chronic study involves experimental manipulations on conscious animals, or recovery from anesthesia. Is this study ACUTE ☐ or CHRONIC ☐? SECTION 9: EUTHANASIA 9a. METHODS OF EUTHENASIA ACCEPTABLE SPECIES METHODS Anesthesia overdose Anesthesia with subsequent CO2 Anesthesia with subsequent exsanguination Anesthesia with subsequent decapitation Anesthesia with subsequent cervical dislocation DRUG ROUTE DOSE 8 Revised August 2015 SPECIES 9b. CONDITIONALLY ACCEPTABLE METHODS decapitation WITHOUT sedation or anesthesia (see 9b) cervical dislocation WITHOUT sedation or anesthesia (see 9b) CO2 Chamber WITHOUT sedation or anesthesia (see 9b) Other method (please specify and also see 9b) DRUG N/A ROUTE N/A DOSE N/A N/A N/A N/A N/A N/A N/A IMPORTANT: If a conditionally acceptable method of euthanasia was indicated above, provide scientific justification (with references where available) for why sedation or anesthesia cannot be used: Describe the training or experience of personnel performing the conditionally acceptable method of euthanasia: 9c. If animals are NOT to be euthanized at the completion of the study, please indicate what will happen to them: SECTION 10: CONTROLLED DRUGS 10. The use of controlled drugs (such as ketamine, buprenorphine and sodium pentobarbital) requires an exemption from Health Canada (http://laws.justice.gc.ca/en/C-38.8/index.html). Yes: ☐ No: ☐ Not Applicable: ☐ 9 Revised August 2015