Research Office Research Hub, Building C5C East MACQUARIE UNIVERSITY NSW 2109 Animal Ethics Secretariat Phone +61 (0)2 9850 7758 / 4456 Email Animal.Ethics@mq.edu.au Macquarie University Animal Ethics Committee Animal Research and Teaching Application Form (Version 4.3.2 – October 2012) OFFICE USE ONLY Date received: ARA no.: AEC meeting date: Use this form for research and/or teaching involving: Ex situ wildlife work (i.e. where animals are captive bred or housed for any period of time outside of their natural habitat) Laboratory animals (e.g. rodents) Instructions for completion of this form: Answer all questions in full. Double Click the Yes, No, or N/A box to indicate your answer. Alternatively answers must be typed in boxes if provided Use lay terms where possible, taking into account the full range of membership categories (A, B, C, D) of the AEC. Your responses should be directed to an educated, non-scientific audience. Refer to the Australian code of practice for the care and use of animals for scientific purposes (NH&MRC 7th Edition 2004)(“ The Code”) for guidance For further information on how to complete this form, contact the Animal Ethics Secretariat on (02) 9850 7758 / 4456 or email animal.ethics@mq.edu.au Instructions for submission of this form: 1. Submit one signed* electronic copy (Word DOC format only) with all appendices (e.g. monitoring sheets, supporting documents) included to animal.ethics@mq.edu.au. *If you are scanning signatures, please only scan the signed pages, rather than the entire document, for improved readability of the form. 2. Submit one original signed hardcopy along with 10 extra copies (with all appendices included) to: Animal Ethics Secretariat, Room 317 Research Office, Level 3, C5C East Macquarie University NSW 2109 Principal Investigator / Supervisor (please complete) Name (Title, First name, Surname) Title of Proposed Project (please complete) Page 2 of 18 SECTION 1: ADMINISTRATION 1.1. Status of AEC Application 1.1.1. This application is for: Research Teaching Both 1.1.2. Reason for application: New project (Go to 1.2) Resubmission (e.g. the MQ AEC did not approve a prior application, and requested a resubmission) Continuation of expired, or soon to expire, Animal Research Authority (ARA) at MQ or other institution (a) Name of AEC(s) (if applicable) (b) ARA(s) (if applicable) Reasons (e.g. the AEC requested that the project be (c) resubmitted / the project is a continuation of work done under a prior, now expired ARA, etc.) If the AEC requested that the project be resubmitted, (d) attach a copy of the email requesting resubmission along with a response addressing all issues raised Attached 1.2. Title of Proposed Project (should be the same as the title on the cover page) 1.3. Proposed Approval Period of Project 1.3.1 N/A Proposed start date* (dd month yyyy) 1.3.2. Proposed completion date (dd month yyyy) - 1.4. *Projects can only commence after they have been approved by the AEC and a valid Animal Research Authority (ARA) has been issued. The maximum approval duration is 36 months. After that time, a new application is required. Note that annual (or less than) reporting is a legislative requirement (so, for example a 13month project would require two annual reports). Financial Support of Proposed Project 1.4.1. Is the project being funded by an internal or external grant? Yes (complete (a)-(e) below) No (Go to 1.5) Page 3 of 18 (a) Funding body (b) Application date (c) Status (pending/approved) (d) Title as it appears on grant application (e) If approved, Grant ID/Reference 1.5. Collaborations 1.5.1. Does this project involve collaboration with other Institutions? Yes (complete 1.5.2. below) No (Go to 1.6) 1.5.2. List all Institutions involved, and whether another AEC will be responsible for each Institution: Institution Contact person and email (e.g. PI at other Institution) AEC responsible for overseeing the project Add or delete rows as necessary 1.6. Location and Licensing 1.6.1. Identify all locations where research/teaching involving animals will be conducted (including where experimental procedures will be performed, where animals will be collected, and where animals will be housed). Provide the full street address where possible. Location Full Street Address (including state, country) Add or delete rows as necessary If your research involves only laboratory animals (rats and/or mice), go to 1.7 1.6.2. Does the project involve fieldwork and/or collection of any animals here, interstate and/or overseas? Yes No Go to 1.7 1.6.3. Permits/licences are likely required. Complete the table below to indicate the status of required permits/licences. A copy of all permits/licences must be supplied to the Animal Ethics Secretariat as soon as issued by the relevant authority. Animal numbers, species etc. on the permit must match the ARA (or where there is a conflict, the smaller number must be used). No work can commence until the appropriate permits/licences are obtained. If unsure, contact the Animal Ethics Secretariat for a list of permits/licences required. Page 4 of 18 Issuing authority (e.g. NPWS) Date of submission Permit/Licence Number/ID Expiry Date Copy Attached? Add or delete rows as necessary 1.7. Biosafety and WH&S All projects must have approval from the either Biosafety Committee [for Genetically Modified Organisms (GMOs)], and/or the Biohazards Committee for all work with hazardous materials, including all work with animals or animal tissues or products, prior to the commencement of research. 1.7.1. Are the procedures under this project dealing with GMOs? Yes, GMOs No, biohazards only Go to (a) and to (b) Go to (b) (a) Please fill out the forms obtained on the biosafety website (below) and check this box http://www.research.mq.edu.au/for/researchers/how_to_obtain_ethics_approval/biosafety_r esearch_ethics/forms (b) Please fill out the Biohazard Risk Assessment Form found on the Health and Safety Website (below) and check this box http://www.hr.mq.edu.au/HealthAndSafety/PoliciesFormsGuidelines/OHSOperationalInstruction. html For further information, visit the Biosafety website, and check the flowchart, at http://www.research.mq.edu.au/for/researchers/how_to_obtain_ethics_approval/biosafety_res earch_ethics/application_process 1.7.2. WH&S Declaration I confirm that: All personnel involved with this project have been informed of the risks associated with working with animals in this project (e.g. zoonoses) and measures have been taken to mitigate these risks Appropriate measures for containment, disposal and decontamination of biohazardous material (if applicable) have been established Signed: Date: Page 5 of 18 SECTION 2: JUSTIFICATION The Code states that “Projects using animals may be performed only after a decision has been made that they are justified, weighing the predicted scientific or educational value of the projects against the potential effects of the welfare of the animals” (Section 1.2). Your responses regarding the justification of the project are crucial for the assessment of scientific merit and the necessity of animal use. 2.1. Summary, Aims and Significance of the Project 2.1.1. Purpose Number and Description*: (e.g. 4: Research: human or animal biology) *Refer to Appendix A, Table 1: Purpose (If the link does not work, download Appendix A from the Forms website here) 2.1.2. Provide a ≈100 word outline of the project in lay terms*. *Your response should be directed to an educated, non-scientific audience. 2.1.3. Outline your primary research goals in lay terms (< 1 page). 2.1.4. Indicate the significance of the project and the expected benefits (as per The Code 2.2.16 (v)). Use lay terms where possible. Your response should demonstrate to a layperson why you believe the research is worth conducting. 2.1.5. Will the results of this project be published and/or shared with other investigators or interested parties? (e.g. to inform best practice) 2.1.6. Is there any component of this project which repeats any previously performed experiments (that you have undertaken, or that has been previously been undertaken by others)? Yes No Go to (a) Go to (b) (a) Briefly describe the previous work and justify why this needs to be repeated (b) How has this been determined? Page 6 of 18 2.1.7. If the project is based upon your previous work, list up to five (5) of the most relevant publications/ presentations, remembering to: - Provide the full reference - Add a brief statement (max. 3-4 sentences) summarising the outcomes and impact or significance - Provide your research publications split into the following categories: Scholarly books; Scholarly book chapters; Refereed journal articles; Refereed conference papers (only when the paper was published in full in the proceedings); Conference presentations; Other. 2.1.8. If no relevant publications exist, briefly summarise progress to date 2.2. Justification for Animal Use 2.2.1. Complete the following table to indicate the characteristics and numbers of animals required for use over the full project duration. If an exact number is not known (e.g. for capture of wildlife), provide an upper limit. Species Code Strain Sex Weight Age (if applicable) (if applicable) (if applicable) (if applicable) Total Supplier/ Source* TOTAL Add or delete rows as necessary For Species code: (e.g. 16: Birds – Exotic Captive) *Refer to Appendix A, Table 2: Species (If the link does not work, download Appendix A from the Forms website here) 2.2.2. Explain, on the basis of experimental design and statistical considerations, why this number of animals will be required. Where possible, include a table to show how animal numbers have been calculated (e.g. show treatment groups) 2.2.3. For wildlife projects where animals are captured and removed from their habitat, what impact will these numbers have on the wider population? (e.g. could it cause population depletion?) Page 7 of 18 2.2.4. Does this project involve the use of any animals that are or have been the subject of current or previous research? Yes No Go to 2.3 (a) ARA number(s) (b) Principal Investigator(s) (c) Procedures the animals have undergone (d) The amount of time between projects 2.3. The 3Rs: Replacement, Reduction and Refinement 2.3.1. Why is it necessary to use animals in the proposed project (rather than non-animal models) and why is this species (and strain, age, sex and weight if applicable) the most appropriate model for this project? NOTE: In accordance with The Code, it is incumbent on the individual researcher to determine whether alternatives to using animals in their studies exist. See The Code Appendix 5 “Alternatives to the use of animals” See also www.animalethics.org.au/ 2.3.2. What steps have been taken to ascertain the alternatives in accordance with The Code? (e.g. literature review, etc.) 2.3.3. Outline how animals and/or animal tissue could be shared with other investigators. 2.3.4. Outline what consideration has been given to each of the 3Rs (Replacement, Reduction and Refinement) in developing this project. Page 8 of 18 SECTION 3: ETHICAL AND WELFARE CONSIDERATIONS 3.1. Sequence of Events and Impact on Animal Well-Being 3.1.1. Procedure Category(/ies) and Description(s): e.g. 2: Animal Unconscious Without Recovery; 5: Major Surgery With Recovery *Refer to Appendix A, Table 3: Procedure (If the link does not work, download Appendix A from the Forms website here) 3.1.2. Give details (sequentially) on what happens to the animal(s) from the time obtained to the time the project is completed, and detail how any impact on the animal(s) will be minimised. Use a flow chart or sequence of events where possible. Refer to the appended Checklist (from ARRP) to ensure all details have been considered. (a) Capture (if applicable), transportation, acclimatisation and conditions of housing and handling (b) Experimental and/or Surgical and other procedures including: - Dose and route of any substance or treatment given, including anaesthetic, analgesic and tranquillising agents - Method, volume and frequency of samples collected - Methods of monitoring their adequacy and side effects (c) The arrangements for the animal(s) at the completion of the project including, if applicable, the method of euthanasia (as well as who will perform it and their experience in the method used) (Select appropriate Fate(s) by marking with ‘X’) Fate of the animal ‘X’ Details Released Re-used Re-homed Euthanased* Other *If selected, you must demonstrate that all viable options have been considered first NOTE: Euthanasia must only be performed by experienced research personnel listed on the project. Page 9 of 18 3.1.3. Will factors affecting animals (other than the experimental endpoint) determine the endpoint of the project (e.g. tumour size, excessive weight loss)? Yes No (Go to 3.1.4) (a) Give details: 3.1.4. What will be the maximum time an individual animal is held? 3.2. Animal Monitoring 3.2.1. Who will monitor the animals during weekdays and who will be on duty on weekends and holidays? Include the species being monitored. NOTE: Outside of the routine care and husbandry provided by CAF or Fauna Park staff, monitoring (e.g. post-operative or during experimental phases) is the responsibility of the researcher(s) listed on the protocol. Person/s responsible Species Experience with the species to be monitored Weekdays Weekends Holidays Add or delete rows as necessary 3.2.2. How will animals be monitored while the procedures are carried out? Include frequency and methods used. Outline any special considerations related to the species/procedure used (e.g. pregnant animals or animals under neuromuscular blockade). 3.2.3. Attach a copy of monitoring sheets/checklists you will use. The monitoring criteria must be species-specific and procedure-specific. Attached N/A Page 10 of 18 3.3. Animal Housing and Management 3.3.1. Will animal husbandry (housing, feeding and routine care) be as per normal CAF/Fauna Park Standard Operating Procedures? If the project requires special feeding/housing arrangements, select No Yes No Go to 3.3.6 3.3.2. Where will animals be housed? 3.3.3. Describe the type of housing to be provided (include details of environmental enrichment). 3.3.4. What will be the maximum and minimum number of animals per cage/pen? 3.3.5. Outline the feeding requirements: (select appropriate Diet by marking with ‘X’) Diet ‘X’ Description of feed requirements (feed type, frequency, etc.) Standard diet for this species Special dietary requirements as part of husbandry Special dietary requirements as part of the experiment Other 3.3.6. Who will be responsible for the management of emergencies and how will you ensure that the person(s) can be contacted? (e.g. ARA with contact numbers posted in the appropriate research location; back-to-base alarm installed) NOTE: The AWO is not responsible for the management of emergencies in the first instance Page 11 of 18 3.3.7. Will animals in this project be housed at: CAF? Fauna Park? Go to (a) Go to (b) (a) If you require space or resources in the Central Animal House Facility (CAF) (Building F9A), you must consult the Manager of the facility on 9850 7780 about your requirements prior to submission of this application. Manager CAF (Signature required to indicate that CAF can accommodate requirements for this protocol, and that all housing/husbandry requirements have been discussed with Manager of the facility) (b) If you require space or resources in the Fauna Park, you must consult the Manager of the facility on 9850 4109 about your requirements prior to submission of this application. Manager Fauna Park (Signature required to indicate that the Fauna Park can accommodate requirements for this protocol, and that all housing/husbandry requirements have been discussed with the Manager of the facility) Page 12 of 18 SECTION 4: PERSONNEL 4.1. Personnel history 4.1.1. Have any researchers named on this application had any AEC approval withdrawn or suspended for any period? Yes No (Go to 4.2) (a) Please provide details including the researcher’s name, the ARA number, the date on which the approval was withdrawn/suspended (and if applicable, the date on which approval was reinstated) and the reasons stated by the AEC for withdrawal/suspension. (b) What changes were made as result of the withdrawal/suspension? (e.g. extra training/ education, investigations, modifications to the project, etc.) 4.2. Qualifications / Experience and Declaration of Responsibility IMPORTANT: Personnel must only be named below if they have a specific role in the animal component(s) of this project N.B. in an emergency, a person who is not listed on the Animal Research Authority (ARA) may still step in to act if it is in the interest of animal welfare, without being in breach of the ARA. As such, students and/or researchers should NOT be listed on the protocol merely for ‘back-up’. Animal Technicians/Animal Care Staff do not need to be listed on an AEC protocol, provided that: they are only performing routine animal care/husbandry (e.g. feeding, cleaning, general maintenance, monitoring) they are competent to carry out the required procedures If however personnel are involved in specific research procedures (e.g. anaesthesia, blood collection etc.) additional to routine animal care, then they must be listed on the AEC protocol. Fieldwork volunteers do not need to be listed on an AEC protocol, provided that: they are only performing a logistical and/or administrative function (e.g. driving the boat) they are competent to carry out the required procedures If however personnel are involved in specific research procedures (e.g. anaesthesia, blood collection etc.), then they must be listed on the AEC protocol. Each person listed on the project is accountable for the welfare of the animals involved in the project All personal details provided are strictly confidential Page 13 of 18 4.3. Principal Investigator / Supervisor 4.3.1. Personal Details (a) Name (Title, First name, Surname) (b) MQ Staff ID (c) MQ Department (d) Position at MQ (if Staff) (e) Phone (mobile) (f) Phone (MQ extension) (g) Email (note all AEC correspondence will be via email) (h) Qualifications 4.3.2. Attendance at an Animal Ethics or Welfare course (a) Has the Principal Investigator/Supervisor attended an Animal Ethics or Welfare course? e.g. the University of Sydney “Introduction to Animal Research” course or Macquarie University “Working With Research Animals Workshop”. Yes No either If YES or (b) The research office has my certificate on file – go to question 4.3.3 (c) Course name and convening Institution (d) Date (e) Attach a copy of course certificate either Attached (g) I have experience in supervision of ethical conduct of animal research SUMMARISE EXPERIENCE HERE (h) Will the person be attending the next If NO or (i) available course? If not, why not? Who will be responsible for supervision of this person in the ethical/welfare aspects of this project? (Macquarie University runs a course on Animal Research Ethics every February and July. The AEC encourages all students and staff to attend.) Page 14 of 18 4.3.3. Role in this project (a) List the specific duties or tasks the person will undertake in this project (e.g. anaesthesia, tagging, etc.) and indicate their level of experience in these procedures in the species relevant to this project. Level of RECENT experience Specific duties/tasks Species (Approx. number of times this person has performed the procedure in this species in the recent past) None (EXAMPLE) Anaesthesia Rats Limited (e.g. <20) High (e.g. >20) Name of Senior staff on project who will supervise (if level of experience is "None" or "Limited") X Dr Jones 4.3.4. Declaration of Responsibility (For the Principal Investigator/Supervisor only) I confirm that: In my opinion, the proposed work described in this application is of scientific and/or educational merit. The use of animals in this project will conform to the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, NH&MRC 7th Edition 2004 and the NSW Animal Research Act 1985 and Regulation 2010. I accept responsibility for the conduct of all procedures detailed in this application, and for the supervision of all personnel delegated to perform any such procedures. I accept personal responsibility for all matters relating to the welfare of all animals used in the project. I understand that I have an obligation to treat the animals with respect and to consider their welfare as an essential factor when planning or conducting projects (see The Code 1.4). I agree to comply with any conditions imposed by the Macquarie University Animal Ethics Committee. I have read and understood the University OH&S Guideline entitled “Working with Research Animals”. Adequate resources (financial, human, etc.) are available to undertake this project Signed: Date: Page 15 of 18 4.4. Personnel other than the PI: For each additional person, copy Sections 4.4.1 through 4.4.4 below and complete. 4.4.1. Personal Details (a) Name (Title, First name, Surname) (b) MQ Staff/Student ID (c) MQ Department (d) Phone (mobile) (e) Phone (work) (f) Email (note all AEC correspondence will be via email) (g) Institution (if external to MQ) (h) Position at MQ (if Staff) (i) Degree enrolled in (if Student) (j) Qualifications 4.4.2. Attendance at an Animal Ethics or Welfare course (a) Has this person attended an Animal Ethics or Welfare course? e.g. the University of Sydney “Introduction to Animal Research” course or Macquarie University “Working With Research Animals Workshop” Yes No either If YES or (b) The research office has my certificate on file – go to question 4.3.3 (c) Course name and convening Institution (d) Date (e) Attach a copy of course certificate either Attached (f) I have experience in supervision of ethical conduct of animal research SUMMARISE EXPERIENCE HERE (g) Will the person be attending the next If NO or available course? If not, why not? (h) Who will be responsible for supervision of this person in the ethical/welfare aspects of this project? (Macquarie University runs a course on Animal Research Ethics every February and July. The AEC encourages all students and staff to attend.) Page 16 of 18 4.4.3. Role in this project (a) Role (e.g. Associate Investigator / Research Assistant etc.) (b) List the specific duties or tasks the person will undertake in this project (e.g. anaesthesia, tagging, etc.) and indicate their level of experience in these procedures in the species relevant to this project. Level of RECENT experience Specific duties/tasks Species (Approx. number of times this person has performed the procedure in this species in the recent past) None (EXAMPLE) anaesthesia Rats X Limited (e.g. <20) High (e.g. >20) Name of Senior staff on project who will supervise (if level of experience is "None" or "Limited") Dr Jones 4.4.4. Declaration of Responsibility (For Personnel other than the PI) I confirm that: I have read and understood this application. I agree to comply with the procedures described and with any conditions imposed by the Macquarie University Animal Ethics Committee. I am familiar with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, NH&MRC 7th Edition 2004 and the NSW Animal Research Act 1985 and Regulation 2010, and agree to work within these codes. I have read and understood the University OH&S Guideline entitled “Working with Research Animals” Signed: Date: Page 17 of 18 CHECKLIST What is happening to the animals? What will be the effects? How will the effects be minimised? Anaesthesia Drug treatments Substance Fasting Induction drug, dose, route Maintenance drug, dose, route Methods of monitoring anaesthesia and recovery Additional support during anaesthesia and recovery (eg heat, intravenous fluids) Location of induction and recovery areas Volume Route Frequency/total number per animal Local and systemic effects Anaesthesia or analgesia Possible side effects Restraint Euthanasia Behaviour modification Stimulus (type, duration, frequency) Method Location (where procedure will be performed) Expertise of personnel Blood/body fluid collection Genetic manipulation Volume Route Frequency Anaesthesia or analgesia Restraint Animal monitoring (methods, frequency) Methods Potential effects Diet/water modifications Type Amount Effects Measurement of intake Animal monitoring ARRP Guideline 12 Updated February 2000 Animal Research Application Form (model) Housing Location Isolation Group housing (stocking rates, sexes) Shelter Bedding Hiding areas Environmental enrichment Duration held Conditioning period Page 18 of 18 In-vitro studies Tumour/neoplasia induction Source of animals Duration held Euthanasia Method Site Endpoint Animal monitoring (methods, frequency) Surgery Anaesthesia Location of pre-operative preparation area Pre-operative preparation Surgical procedure (site, technique) Sterile technique (instruments, drapes, surgeon) Location of and housing in post-operative recovery area Post-operative management Post-operative monitoring (methods, frequency, duration) Use of analgesics (type, dose, route, frequency, means of determining necessity for use) Expertise Toxicology Substance Volume Route Frequency of treatments / total number per animal Local and systemic effects Anaesthesia or analgesia Restraint Animal monitoring (methods, frequency) Endpoint/duration Transport Type Duration Confinement Numbers of animals Airconditioning ARRP Guideline 12 Updated February 2000 Animal Research Application Form (model) Teaching Source of animals Housing Duration held Method of disposal Wildlife studies Location Methods Capture methods Handling/restraint Housing Monitoring Release Effects on population