Animal Ethics Committee BREEDING APPLICATION [Do not print this form. Fill it in with MS-Word, approving staff members to enter name and date of review] OFFICE USE ONLY (November 2015) FILE REF: RA/3/300/ Approved From: To: Signature AEC Chair: Date: All research involving the use of animals must comply with the Animal Welfare Act 2002 (WA) and the requirements of the Australian code for the care and use of animals for scientific purposes (8th edition, 2013), ‘The Code’. The Code www.nhmrc.gov.au/guidelines/publications/ea28 Animal Welfare Act 2002 (WA) www.austlii.edu.au/au/legis/wa/consol_act/awa2002128/ When completing your application, please refer to the attached AEC Application Administrative Review Checklist First time applications by new principal authors: An application prepared by a principal author (this need not be the chief investigator) who has not previously engaged with the UWA animal ethics system must undergo preparatory review by an Animal Welfare and Veterinary Advisor (AWVA) prior to submission to the AEC. The Animal Welfare and Veterinary Advisors (AWVAs) are available to assist you in the preparation of you application. Please contact Animal Welfare and Veterinary Advisors - 6488 4549 / 4700 vets-research@uwa.edu.au The Animal Ethics Office staff can assist with the administrative aspects of the application. Please contact Animal Ethics – 6488 7887 / 3703 / 3033 aeo@uwa.edu.au This application must be discussed with the Director Animal Care Services (DACS), or Curator for other facilities, prior to submission to the AEC. Please see section 10. Housing and location of animals. Dr Malcolm Lawson, 6488 6616, malcolm.lawson@uwa.edu.au or facility curator for non ACS or non UWA sites School of Animal Biology only If you are staff of the School of Animal Biology, this application must be discussed with the Technical Manager, School of School of Animal Biology, prior to submission to the AEC. 6488 2225 rick.roberts@uwa.edu.au Signature of DACS/Curator [type name and date of review] Technical Manager, Animal Biology or delegate [type name and date of review] 1. BREEDING PROTOCOL DETAILS Protocol Title: (full title) Chief Investigator: (full name) School: (Centre/Dept) Please indicate if this is an INITIAL APPLICATION [ ] or RENEWAL [ ] If this is a Renewal of a previous protocol, please provide a short summary (less than 300 words) which outlines all changes. Application can only be approved for the period of funding and may not exceed 5 years. At the conclusion of the funding period a Renewal application will be required. CRICOS Provider Code: 00126G R261/12 RA/3/300/ Expected commencement date: Completion date: (dd/mm/yy) (dd/mm/yy) Please make sure you submit your application so that it can be considered at a meeting at least two months before your expected commencement date. SPONSORS - SOURCE OF FUND/STATUS OF OUTCOME/COMMERCIAL IN CONFIDENCE Source of Funding: Approved? Pending [ ] Yes [ ] ID Number (if approved): Commercial in confidence: Yes [ ] No [ ] OTHER APPROVAL (if applicable) Does this project involve more than one AEC? Yes [ ] No [ ] No [ ] If Yes, an Inter-Institutional Agreement is required. Please arrange this with the Animal Ethics Office, complete the following details and attach a copy of the approved application. Name of the Institution and approval number: Outcome of the application: Approved [ ] Not Approved [ ] Under consideration [ ] PREVIOUS APPROVAL (if applicable) Protocol title: AEC Approval no: Unexpected deaths or adverse events: Please attach list of publications arising: 2. CHIEF INVESTIGATOR Title, first name, middle, last name Staff number (UWA) Qualifications: Work mailing address /school (include UWA MBDP): Email: Phone: Mobile: Please detail the relevant experience you have (including the number of years) in the procedures/techniques to be used in this project. COMPETENCE IN ANIMAL HANDLING AND EXPERIENCE Please note: All personnel named on the protocol must have a current Permission to Use Animals (PUA) A. Do you have a current UWA Permission to Use Animals (PUA) Yes [ ] No [ ] If No, Please download a PUA form available from our website and attach to this application. www.research.uwa.edu.au/staff/forms PUA application is attached [ ] B. Have you ever been suspended from working with animals or have you ever been a team member on a suspended project that used animals at this or any other institution? Yes [ ] No [ ] If Yes, please describe the circumstances. CO-INVESTIGATORS - COPY AND PASTE ADDITIONAL TABLES AS REQUIRED FOR EACH INVESTIGATOR 3. CO-INVESTIGATOR/S Title, first name, middle, last name Staff /Student number (UWA) RA/3/300/ Qualifications: Work mailing address /school (include UWA MBDP): Email: Phone: Mobile: What is your Role in this project? Please detail the relevant experience you have (including the number of years) in the procedures/techniques to be used in this project. Competence in Animal Handling and Experience AEO checked Please note: All personnel named on the protocol must have a current Permission to Use Animals (PUA) A. Do you have a current UWA Permission to Use Animals (PUA) Yes [ ] No [ ] If No, Please download a PUA form available from our website and attach to this application. www.research.uwa.edu.au/staff/forms PUA application is attached [ ] B. Have you ever been suspended from working with animals or have you ever Yes [ ] No [ ] been a team member on a suspended project that used animals at this or any other institution? If Yes, Please describe the circumstances. 4. EMERGENCY CONTACT PERSONNEL - DURING PROJECT Name: What is their role in this project? Email: Phone: Mobile: After hours/emergency contact number: 5. ANIMAL MONITORS - DURING STUDY - ANAESTHESIA, SURGERY & POST- OP RECOVERY PERIOD To ensure animal monitoring is covered at all times, the AEC recommends two animal monitors be named. 1) Name: Details of their relevant experience: Email: Phone: Mobile: Phone: Mobile: After hours/emergency contact number: 2) Name: Details of their relevant experience: Email: After hours/emergency contact number: 6. PERSONNEL RESPONSIBLE FOR EUTHANASIA Name: Details of their relevant experience: Email: After hours/emergency contact number: Phone: Mobile: RA/3/300/ 7. REVIEWER – INDEPENDENT EXTERNAL (Non UWA staff, and must not be from the same institution as the funding body or any of the named personnel) Please note this person may be asked to review aspects of this application Title and name: Position /Business address / contact details: Email: Phone: Mobile: PROJECT DETAILS Keywords: Provide a list, including definitions, for any technical terms and acronyms to assist the Animal Ethics Committee (AEC) to understand the application: Term Lay Explanation 8. GENERAL DESCRIPTION AND AIMS It is important to use lay language to ensure that all AEC members understand the proposed project i.e. as if it was a press release. This section must not exceed one A4 page - References should be provided in an appendix. Applications exceeding one A4 page will be returned to the Chief Investigator for adjustment. NB The breeding of transgenic mice MUST be consistent with the requirements of NHMRC 2007 ‘Guidelines for the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes’. See http://www.nhmrc.gov.au/health_ethics/animal/issues.htm#a 9. ANIMAL SUMMARY (add additional lines as required) *Animal Species Categories available at: http://www.research.uwa.edu.au/staff/forms/animals Common Species Scientific Also known as Number Expected Full Research Background name species Category (AKA) Parent Number Nomenclature Strain * Stock name Offspring pig 12 Sus scrofa pig Total number of animals (parent and expected offspring)for the project 6 120 Total = Source Vendors: OGTR / Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity restrictions Yes [] No [] Genetically Modified Mice (Please provide details below for GM Mice) Common Species species Category * name Mouse 01 Scientific name Background Strain Full Research Nomenclature Mus musculus C57BL/6J C57BL/6J MexTAg Also known as Number Expected Parent Number Stock Offspring MexTAg 10 300 RA/3/300/ Total number of all animals (parent and expected offspring) for the project Total = Source Vendors: OGTR/Department of Agriculture, Fisheries A Forestry (DAFF) Biosecurity restrictions Yes [ ] Attached is the Phenotype Report No [ ] [] 10. HOUSING, LOCATION AND HUSBANDRY – Include relevant SOP’s (SIGNATURES REQUIRED) UWA Animal Care Services (ACS) OTHER UWA Facilities / locations: A Block, QEII Medical Centre Harry Perkins Institute, QEII (QQ) M Block, QEII Medical Centre Z Block - Fremantle Hospital Aquatic Research Facility Biomedical Research Facility, Shenton Park (School of Animal Biology) Biological Resources Support Facility, Shenton Park Sheep Research Facility (SRF), Shenton Park Pre-Clinical Facility (PCF), Crawley Campus Large Animal Facility (LAF), Crawley Campus Other - Please provide details Facility room number/ zone Aquaculture and Native Fish Breeding (Shenton Park) Ridgefield Farm (Pingelly) Harry Waring Marsupial Reserve (Wattleup) Ernest Hodgkin Marine Laboratory (Watermans) Species (and/or strain if applicable) Director UWA (ACS) Facilities / Curator of other site or facilities Signature and Date A. TYPE OF CAGING / HOUSING B. LIGHT CYCLE DETAILS C. SANITATION REGIME D. BEDDING MATERIALS E. ANY SPECIAL REQUIREMENTS FOR EACH PHENOTYPE 11. SAFETY AND HEALTH RISKS Does project involve use of: Teratogens or Carcinogens S7, 8 ,9 drugs (a copy of the permit will be required) Approval Y/N/ Y/N Pending If YES, explain risks involved Precautions to protect staff and/or animals RA/3/300/ Radioisotopes or X-rays Other potentially infectious or hazardous (chemical/physical / biological) agents which may pose a health risk to staff or animals IDENTIFY POTENTIAL RISKS TO STAFF AND HOW THEY WILL BE MANAGED AND MINIMISED Risk Assessment form is attached [ ] 12. GENE TECHNOLOGY / BIOLOGICAL SAFETY A. UWA requires that all potentially hazardous animal tissue, blood, and infectious microorganisms be managed by the Institutional Biosafety Committee (IBC). Does this application deal with such materials? Yes [ ] No [ ] If unsure, please contact Biosafety Office biosafety@uwa.edu.au If Yes, please complete Biosafety Risk Assessment http://www.research.uwa.edu.au/staff/biological/non-gm-bo and forward the completed form electronically to the Biosafety Office at biosafety@uwa.edu.au or provide a copy of your biosafety approval letter. B. ARE YOU DEALING WITH GENETICALLY MODIFIED ORGANISMS? If Yes, please provide details of phenotypic expression. Dealing Type: EXEMPT DEALING[ ] Yes [ ] No [ ] Established Phenotype report attached [ ] Copies of required permits/approvals are attached [ ] NLRD [ ] DNIR [ ] DIR [ ] Exempt Dealings - Requires IBC assessment Notifiable Low Risk Dealings (NLRD) - requires IBC assessment and notification to OGTR Dealings Not involving an Intentional Release of a GMO into the Environment (DNIR) - Requires IBC Assessment & application to OGTR for a licence. Dealings involving an Intentional Release of a GMO into the Environment (DIR) - Requires IBC Assessment and application to OGTR for a licence. IBC Approval Number: Approval Status: Pending [ ] Yes [ ] No [ ] (if approved) IF USING GMOS, HAVE ALL INVESTIGATORS UNDERTAKEN THE (COMPULSORY) GENE TECHNOLOGY REGULATION TRAINING COURSE? Enrolled [ ] Yes [ ] NO [ ] If NO, or Enrolled, please specify which investigator/s have not completed the course: Department of Agriculture, Fisheries and Forestry, Biosecurity (DAFF)Biosecurity import permit is attached [ ] 13. BREEDING METHODS AND MAINTENANCE – Include details of: A. RELEVANT BREEDING SYSTEMS B. OESTRUS SYNCHRONIZATION C. MALE TO FEMALE RATIOS D. NUMBER LITTERS / DAM E. AGE OF CULLING BREEDERS RA/3/300/ F. ALL PROCEDURES e.g. Ear notch / Toe clip / Tail tip / Injections etc 14. ANIMAL WELL-BEING A. HOW WILL ANIMAL WELFARE BE OPTIMIZED FOR EACH PHENOTYPE B. PAIN AND DISTRESS – How will pain and distress be monitored and scored C. MONITORING SCHEDULE – Provide a Long Term Monitoring Sheet D. CRITERIA FOR EUTHANASIA - HOW WILL ANIMALS BE ASSESSED FOR EUTHANASIA E. WHAT % OF ANIMALS DO YOU EXPECT TO DIE OR REQUIRE INTERVENTION EUTHANASIA DURING THIS PROJECT? PLEASE EXPLAIN LIKELY REASONS FOR THE ANTICIPATED LOSS RATE. PLEASE NOTE THAT ALL UNEXPECTED /UNPLANNED DEATH/S MUST BE REPORTED PROMPTLY TO THE AEC 15. COMPLETION OF BREEDING PROTOCOL Researchers are expected to share animal tissue where possible - See the Code section 1.26 Where practicable, tissue and other biological material from euthanased animals must be shared among investigators. A. HOW WILL YOU SHARE TISSUE? If you will not be sharing tissue, please explain why this is not practicable. B. CONCLUSION OF USE - Are animals euthanased at the end of the Breeding Project? If No, What is the fate of non-euthanased animals? Yes [] No [] If Yes, please complete the table below. METHOD OF EUTHANASIA - provide details of the generic constituents (not the trade name), the dose rate as mg/kg, and the route of administration. Species Agent Dose Route e.g. Rat Zolazepam / tiletamine followed by Pentobarbitone >10mg/kg Intramuscular or subcutaneous injection followed then 160 mg/kg by intraperitoneal injection C. DETAIL HOW DEATH WILL BE CONFIRMED e.g. loss of corneal reflex plus cessation of breathing and heartbeat, plus glazing of eyes D. METHOD OF DECONTAMINATION /DISPOSAL OF GMOS. E. METHOD AND DETAILS OF CARCASS DISPOSAL RA/3/300/ RA/3/300/ 16. CLASSIFICATION OF PROJECT - PROCEDURES CODES - Check the highest appropriate numerical code (1-9) from those listed below to describe the type of procedures carried out on the animals in the project. 1 2 3 4 5 6 7 8 9 Description: Observation Involving No or Minor Interference Animals are not interacted with or, where there is interaction, it would not be expected to compromise the animal's welfare any more than normal handling, feeding, etc. There is no pain or suffering involved. ● Observational study only ● Breeding, or reproductive study with no detriment to the animal ● Feeding trial, such as Digestible Energy determination of feed in a balanced diet ● Behavioural study with minor environmental manipulation ● Teaching of normal, non-invasive husbandry such as handling and grooming Animal Unconscious Without Recovery Animal is rendered unconscious under controlled circumstances with little or no pain or distress. Any pain is minor and brief and does not require analgesia. Procedures are carried out on the unconscious animal which is then killed without regaining consciousness. ● Teaching surgical techniques on live, anaesthetised patients which are not allowed to recover following the procedure Minor Conscious Intervention Animal is subjected to minor procedures which would normally not require anaesthesia or analgesia. Any pain is minor and analgesia usually unnecessary, although some distress may occur as a result of trapping or handling. ● Injections, blood sampling in conscious animal ● Minor dietary or environmental deprivation or manipulation, eg feeding nutrient-deficient diets for short periods ● Trapping and release as used in species impact studies ● Trapping and humane euthanasia for collection of specimens ● Trapping and humane euthanasia for feral animal control research ● Stomach tubing, shearing Minor Surgery With Recovery Animal is rendered unconscious with as little pain or distress as possible. A minor procedure is carried out and the animal allowed to recover. Depending on the procedure, pain may be minor or moderate and post-operative analgesia may be appropriate. Field capture using chemical restraint methods are also included here. ● Biopsies ● Cannulations ● Sedation/anaesthesia for relocation, examination or injections/blood sampling Minor Physiological Challenge Animal remains conscious for some or all of the procedure. There is interference with the animal's physiological or psychological processes. The challenge may cause only a small degree of pain/distress or any pain/distress is quickly and effectively alleviated. ● Minor infection ● Early oncogenesis ● Arthritis studies with pain alleviation ● Induction of metabolic disease ● Prolonged deficient diets ● Antiserum production ● Polyclonal antibody production Major Surgery With Recovery Animal is rendered unconscious with as little pain or distress as possible. A major procedure, such as abdominal or orthopaedic surgery, is carried out and the animal allowed to recover. Post operative pain is usually considerable and at a level requiring analgesia. ● Orthopaedic surgery ● Abdominal or thoracic surgery ● Transplant surgery Major Physiological Challenge Animal remains conscious for some or all of the procedure. There is interference with the animal's physiological or psychological processes. The challenge causes a moderate or large degree of pain/distress which is not quickly or effectively alleviated. ● Major infection ● Major phenotypic modification ● Oncogenesis without pain alleviation ● Arthritis studies with no pain alleviation ● Uncontrolled metabolic disease ● Isolation or environmental deprivation for extended periods Death As An Endpoint This category only applies in those cases where the death of the animal is a planned part of the procedures and animals die but are not euthanased. Where predictive signs of death have been determined and euthanasia is carried out before significant suffering occurs, they may be placed in category 7. ● Lethality testing (including LD50, LC50) It does not include: death by natural causes; animals which are euthanased as part of the project; animals which are euthanased if something goes wrong; animals euthanased for dissection or for use as museum specimens; or accidental deaths. Production of genetically modified animals This category is intended to allow for the variety of procedures which occur during the production of genetically modified (GM) animals. As animals in this category may be subjected to both minor and major physiological challenges and surgical procedures, this category reflects the varied nature of the procedures carried out. It effectively includes ALL animals used in GM production other than the final progeny which are used in a different category of procedure. ● Initial breeding animals for GM production ● Animals culled as part of the GM production process RA/3/300/ 17. DECLARATION As chief investigator, I declare that I (i) have read and agree to abide by the conditions and constraints of the WA Animal Welfare Act 2002 and the Australian Code for the Care and Use of Animals for Scientific Purposes (8th edition, 2013); (ii) understand any non-compliance with the Australian Code must be reported immediately to the AEC and may result in the withdrawal of project approval and possible disciplinary action; (iii) understand that in keeping with AEC and Animal Facility policy, all animals are to be monitored as detailed in the application. The Animal Welfare Officer (AWO) has the authority to euthanase distressed animals. Every attempt will be made to inform the CI before any action is taken; (iv) understand that it is the responsibility of the CI to maintain animal records annually to the AEC on animal usage; (v) understand that in the event of an animal death, or an unplanned euthanasia, we will immediately report the death to the AWO, complete a Notification of Unexpected Death from and email to AWO within 48 hours, and arrange for an autopsy to be carried out and the results of the autopsy report to be sent to the AWO; (vi) understand that once an animal is allocated to the project, the investigators listed are responsible for the dayto-day monitoring of the animal wellbeing. (vii) will ensure that the qualifications and/or experience of all listed personnel are appropriate to the procedures to be performed; (viii) certify that the resources in the school or department, including housing and personnel, are appropriate for the welfare of the animals and the satisfactory completion of the project; (ix) will maintain in strict confidence all information contained in this application and acknowledge that the information is both true and accurate. (x) have obtained agreement from all research personnel listed on this application that they agree to all of the above statements of declaration. [] I agree to all of the above [PRINT NAME – do not sign or scan] DATE CO-INVESTIGATOR [PRINT NAME – do not sign or scan] DATE CO-INVESTIGATOR [PRINT NAME – do not sign or scan] DATE CO-INVESTIGATOR [PRINT NAME – do not sign or scan] DATE As Head of the School (or Acting), I acknowledge that I have reviewed this application and I confirm that sufficient financial and other resources are available to enable the research to occur in compliance with the Regulations above. I understand that when I am named on an application as an investigator, the Dean of the Faculty will be required to sign below. [ ] A review of this application has taken place within the school / faculty. HEAD OF SCHOOL/(*DEAN OF FACULTY) Acting [ ] [PRINT NAME, and email to aeo@uwa.edu.au] DATE SUBMISSION OF APPLICATION – PLEASE EMAIL THIS FORM TO: aeo@uwa.edu.au UWA policy deems this document as signed if you type your name and send it attached to an email. Please send the documents as MS Word or pdf, NOT Printed and Scanned! RA/3/300/ ATTACHMENTS TO SUPPORT THIS BREEDING APPLICATION. Please label all attachments and indicate below (X) documents which are attached to this application Analgesia/Anaesthetic plan Department of Agriculture, Fisheries and Forestry, Biosecurity – DAFF Biosecurity (Section 12B) Department of Parks and Wildlife (DPaW) permits – formally DEC Department of Fisheries permit Fieldwork Notification - Department of Agriculture and Food WA Flow Diagram with timelines Genetically modified organisms / OGTR assessment (Section 12) List of publications arising Monitoring sheet – Long Term (Sections 14) Monitoring sheet – procedural Monitoring sheet – post operative Monitoring sheet – anaesthesia * Permission to Use Animals (Sections 2 & 3) * Phenotype report (compulsory if using GM animals) (Sections 9 & 12B) Photographs/diagrams Poisons Act permit (Sections 11) References * Risk Assessment (Section 11) Skills Declaration and Training (Section 3) * Standard Operating Procedures (SOP) Teaching protocol – Unit Outline Teaching protocol – Student feedback (SURF) Transport permits - If applicable. Other – please specify * Available from the UWA Animal Ethics forms webpage at www.reseach.uwa.edu.au/staff/forms/animals X RA/3/300/ AEC APPLICATION ADMINISTRATIVE REVIEW CHECKLIST Please check each section against in the application form. As this is a legal document, please ensure spelling is checked throughout the application. The current application form available must be used see http://www.research.uwa.edu.au/staff/forms/animals General Comments Application forms and attachments, must be submitted electronically to the Animal Ethics Office (AEO): aeo@uwa.edu.au Permission to Use Animals All personnel named on the project must have a valid PUA, including the Chief PUA Investigator (CI), even if they will not handle animals. Ideally, the title should contain the species being used eg “The testing of agent XX in a murine model”. Section 1 - Protocol details Project approval dates will be in accordance with the funding periods up to a maximum of 5 years. Expected Commencement Date must not precede the AEC meeting date. Section 2 - Chief Investigator Students cannot be the named as the Chief Investigator (CI) on the project. Section 3 - Co-Investigator/s Emergency contact personnel must be named co-investigator/s (Co-I) Section 4 - Emergency Provide an after hours contact number is essential (usually mobile number). The AEC strongly recommends 2 animal monitors be nominated to ensure Section 5 - Animal Monitors monitoring is covered at all times. Animal Monitors must be named as co-investigator/s. Personnel responsible for euthanasia must be named co-investigator/s. Nb. The Section 6 - Personnel exception to this rule may be on a farming property. In these instances, the responsible for Euthanasia farm manager will often assume this responsibility. Reviewer must not be affiliated with any of the named investigators, same Section 7 - Reviewer institution, or the funding body Overview to be written in lay language and MUST not exceed one A4 page. Section 8 - Overview / Aim Applications exceeding the maximum one A4 page limit will be returned to the CI for adjustment. References should be provided in an appendix. Statistical Justification advice is available from the Centre for Applied Statistics to Section 9 - Animal Summary support Research Students. For assistance email consulting-cas@uwa.edu.au The signature of the Director Animal Care Services or Curator must be obtained if animals are held at UWA facilities. Section 10 - Housing For research outside licenced facilities (fieldwork / wildlife) in the state of Western Australia, include a Department of Agriculture and Food (DAFWA) Field Work notification form available at http://www.research.uwa.edu.au/staff/forms/animals Section 11 - Safety / Health Section 12 - Biosafety UWA requires that all potentially hazardous animal tissue, blood, and infectious microorganisms be managed by the Institutional Biosafety Committee (IBC). A Biosafety Risk Assessment must be completed. See www.research.uwa.edu.au/staff/biological/non-gm-bo If genetically modified animals are used, include a phenotype report http://www.research.uwa.edu.au/staff/forms/animals Section 13 – Breeding methods and maintenance Section 14 - Well-being Monitoring sheets must include emergency contact details for the CI and Animal Welfare Officer (AWO) ie After Hours (A/H) Phone numbers Body Weight Loss (BWL) – When referring to BWL (monitoring sheets), avoid using symbols ie ≥ as is it creates confusion for some personnel. The AEC requests researchers to express body weight loss limits as ‘no more than XX% body weight’. Section 15 - Completion Section 16 - Classification Section 17 - Declaration If euthanasia is via drugs, doses must be entered as mg/kg. Classification procedures codes are required for the Annual Use report each year. Check the highest appropriate code only. CI, Co-I, Head of School (HOS). When the HOS is named as investigator, the Dean of the Faculty is required to sign.