ANIMAL RESEARCH AUTHORITY APPLICATIONThe Chief Investigator has the responsibility to ensure all facets of animal care and use meet the requirements of the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, including the protection and promotion of the welfare of the animals used. Under the NSW Animal Research Act, approval must be sought and granted from an Animal Care and Ethics Committee (ACEC) before commencing any research or teaching with live animals.

The Code outlines the 3 R Principles which should underpin any research design or teaching activity: 1. Reduction of animal use2. Replacement of animal use3. Refinement of animal use

The completed application will be assessed by the ACEC which includes representatives of the wider-community with a non-scientific background. Please use lay language in describing research methods. The ACEC will also assess your application on the merit of the above principles and in light of the impact all procedures will have on individual animals during the project and the project as a whole. Answers should focus on what is happening to animals and what is being done to ensure their well-being from beginning to completion of the project. Impact of procedures should be clearly detailed. Finally you need to clearly justify the use and number of animals you propose to use and how you chose that number.

Note: Animal Research Authorities (ARAs) can only be issued by an Animal Ethics Committee for a 12 month period (NSW Animal Research Act 1985). Approval will be granted from the approved date until February of the following year due to annual State reporting. All ARAs require reporting for the calendar year, with or without activity, under State legislation. You may be granted an automatic renewal for the next calendar year at the Committee's discretion where the approval falls short of a 12 month period.

Submit your completed application to: animalethics.lismore@scu.edu.au by due date or three weeks prior to meeting.

ATTENTION MAC USERS: This form will be corrupted if opened in Preview.

SECTION A: ADMINISTRATIVE DETAILS

Part A.1: Project Summary

Project Title:

Estimated commencement date:

Expected duration and/or completion date (Note: research may not commence until ACEC approval is granted):

Date of Submission:

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Part A.2: Chief Investigator and Additional Investigator Details

Additional Investigator 1

School and mailing address:

Contact number:

Staff/ Student Email address:

Status (if staff member state position, lecturer, postgraduate student, undergraduate student, Honours student):

Role in Project:

Qualifications (Training and applicable education) and competence to fill the role (and/or how training will be provided):

Notes: The Chief Investigator may not be an undergraduate student. Primary Supervisors need to be investigators in the study. If more than 2 Additional Investigators, provide details and signatures on another sheet.Chief Investigator:

School and mailing address:

Contact number:

Staff Email address:

Status (state your position in University):

Role in Project:

Qualifications (Training and applicable education) and competence to fill the role:

Supervisor (If applicable):

School and mailing address:

Contact number:

Staff/ Student Email address:

Status (if staff member state position)

Role in Project:

Qualifications (Training and applicable education) and competence to fill the role (and/or how training will be provided):

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Additional Investigator 2

School and mailing address:

Contact number:

Staff/Student Email address:

Status (If staff member state position, lecturer, postgraduate student, undergraduate student, Honours student): Role

in Project:

Qualifications(Training and applicable education) and competence to fill the role (and/or how training will be provided):

Part A.3: Previous SCU Animal Ethics Approval/s and other Institutional AEC approvals for this Project

Is the Project: New Significantly Revised Submitted to another AEC Previously refused

(Complete this question only if this is an ongoing project or you are requesting significant changes to your currently approved protocol that does not fit into the definition of a minor change of protocol application. Note: if this project has been approved at another ACEC, you are not required to submit a full application. See Collaborative Research Form )Name of Approving ACEC:

Approval Number:

Date of Approval:

Date of Expiry:

If you are requesting significant changes on a currently approved protocol, quote the number of animals and species used to date (if applicable):

Part A.4. Required Scientific Licences and Permits

Yes No

Issuing Agency:

Is approval from Agency, dependent on SCU ACEC approval?

Date applied for Licences/Permits or Date you intend to make the application:

Date of approval: (if applicable)

Licence/Permit Number: (if applicable)

Have you or anyone in the project team had any Animal Research Authority/Scientific Permit or Animal Supplier’s Licence cancelled?

Yes No

If YES: Name of Person who’s Authority/Permits or Licence was cancelled:

Reason for Authority/Permits or Licence cancellation:

Date Authority/Permits or Licence was cancelled:

Who cancelled the Authority/Permits or Licence?

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SECTION B: PROJECT DETAILS

Part B.1: Scientific or Educational Aims & Significance

Aims of this Project: (Limit 100 words. Specify what you are hoping to achieve and why the use of animals is essential to achieve all stated aims)

Purpose of Project: (Select all that apply) 1. Stock breeding

2. Stock maintenance

3. Education

4. Research: human or animal biology

5. Research: human or animal health and welfare

6. Research: animal management or production

7. Research: environmental study

8. Production of biological products

9.

10. Regulatory product testing

Procedures used during study or experiments: (this does not include euthanasia or other impacts at conclusion of animal use - see part B8). (Select all that apply)

1. Observation involving minor interference

2. Animal unconscious without recovery

3. Minor conscious intervention

4. Minor surgery with recovery

5. Major surgery with recovery

6. Minor physiological challenge

7. Major physiological challenge

8. Death as an endpoint

9. Production of genetically modified animals

Location of the study:

Briefly describe how you are planning to fulfill the purpose ticked above.

Diagnostic procedures

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Part B.2: Impacts of Research on Animal Well Being

What is the level of impact to the animals due to the experimental procedures proposed in this application (animals are defined as target and non-target species. This does not include euthanasia or other impacts at conclusion of animal use - see part B8)?

Negligible Low Medium High

Yes No Have the animals used in this research been used in other projects?

If YES, justify the impact this will have on the animals:

Justify how the potential benefits of the research are appropriate relative to the impact on the animals involved:

Do any actual or potential interests exist, including any financial interests, other relationships or affiliations, that may affect the judgement and decisions regarding the well-being of the animals involved?

Yes No

If YES, discuss:

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Proposed Impact on Animals You MUST complete this Table or your application will be sent back for further revision.

List the Impact Procedures adopted to mitigate impacts on animal well-being (include criteria to minimise or alleviate pain and distress on the animal) (Project Design)

Procedures and criteria to identify impacts on animal well-being and planned intervention (include criteria for intervention, treatment or withdrawal of the animals from the project) (Animal monitoring and treatment).

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Details about the animal species

(If you have more species to include, attach a word document, with the same detail.)

Scientific name & Common Name

Species Code Strain or Breed where applicable

Age Sex Weight Native/ Introduced

Status (as defined by EPBC Act

1999)

Source (eg. Licenced animal

supplier details or wild)

Number of

animals

CRICOS Provider 01241G Animal Care and Ethics Committee (ACEC)Page 7

Part B.3: Study Animals

Part B.4: Replacement (Refer S1.18 -1.20 Australian Code for the Care and Use of Animals for Scientific Purposes)

Yes No Is there an alternative/s to the use of live animal/s?

If YES, why are alternatives not being used?

Part B.5: Reduction (Refer S1.21 -1.27 Australian Code for the Care and Use of Animals for Scientific Purposes)

Why have these animals been chosen?

If NO, then what is the justification for using live animal/s?

Number of animals being used in the research and justification for their use:

(Even if you are doing opportunistic studies, you will need to provide an estimation of how many animals you may use. If there are more than 4 animal species to include, please attach a word document with the same detail to this application.)

Species (scientific name) Number Justification for using this number of animals

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Where projects involve a number of different elements or methods, describe all in adequate detail, so the ACEC can evaluate impacts on animals. Include a summary of sequence of events and citation of papers to justify the use of your methods and ensure all references are included below.

Methodology/Design:

Part B.6: Refinement (Refer S1.28-1.30 Australian Code for the Care and Use of Animals for Scientific Purposes)

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Detention and housing of animals: Provide references to any guideline documentation used to determine detention and housing methods.

Species Transport Location Housing Maximum time Held

Density Feeding Animal Management

Contact Details

Animal (sp) Regime Name Experience Contact details

Part B.7: Monitoring animal well-being

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Part B.8: Conclusion of Animal Use

Give a clear step by step description of the fate of all animals used. Include a list of humane end points and specific criteria for intervention:

If any animals will be euthanised at the end of the project, describe the method of euthanasia:

What is the provision for animals at the conclusion of their use?

(i) rehousing (rehoming)

(ii) return to normal husbandry conditions or natural habitat

(iii) humane killing

(iv) reuse

(v) tissue sharing

Please provide details regarding monitoring during and after procedures (when appropriate) and for week days and weekends.

Animal 1 (sp):

Procedure details:

Location where procedure will be performed:

Responsibility/Qualifications:

Level of experience in procedures:

Animal 2 (sp):

Procedure details:

Location where procedure will be performed:

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SANCTIONS:

Does the project involve any location/organisation on the current UN or Autonomous Sanctions list?

Provide details about the security and storage location of the research data and materials.

Part B.10. Export Controls

Yes No If YES: state the location/organisation involved:

DECO:

Does the research or teaching activity involve an item and/or technology that may require a permit under Defence Export Controls ?

Yes No

If YES: email export.controls@scu.edu.au

How long will the data and materials be stored? (Note: Minimum term is 5 years)

Part B.9: Data Management & Storage (Australian Code for the Responsible Conduct of Research, Section 2.1)

Note: Any euthanasia procedures that will be carried out as a result of an adverse event (severe injury), please provide those details in Proposed Impact on Animals table

Will you be tissue sharing?

If YES, provide details:

Yes No

Level of experience in procedures:

Responsibility/Qualifications:

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SECTION C: DECLARATIONS AND SIGNATURES

Chief Investigator I certify that the use of animals in this Project will conform to the NSW legislation and the general principles of the NHMRC/CSIRO/AAC "Australian Code of Practice for the Care and Use of Animals for Scientific Purposes". 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 assure that adequate resources will be available to conduct the project.

I confirm that all personnel have read relevant areas of the "Australian Code of Practice for the Care and Use of Animals for Scientific Purposes", this Application, any relevant NHMRC Animal Ethics guidelines and agree to comply with procedures described and any conditions imposed by the ACEC.

Name:

Signature: Date:

SupervisorI have read an understood the above application. I can vouch that the student has the ability to carry out the procedures in this application proficiently and safely. I agree to support the project as a named investigator and to make appropriate arrangements in the event the lead investigator leaves Southern Cross University or is unable to carry out their duties satisfactorily.

Name:

Signature: Date:

Additional Investigator 1I have read this application and am satisfied that the use of animals is justified on scientific, educational or diagnostic grounds.

Name:

Signature: Date:

Additional Investigator 2I have read this application and am satisfied that the use of animals is justified on scientific, educational or diagnostic grounds.

Name:

Signature: Date:

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Appendix 1 Descriptions

Purpose of Project

1. Stock breeding - Breeding projects to produce new teaching or research stock. Include the animals used toproduce progeny and any breeders or progeny culled in the process, NOT the final progeny themselves (asthese will be counted under the project in which they go on to be used).

2. Stock maintenance - Holding projects for animals maintained for use in other projects. These animals may bemaintained under an ethics authority because they require special management. If they are not held under anauthority, (eg. normal stock animals kept mainly for commercial production, but occasionally used in research)then they are only counted in the project where they are used for teaching/research.Examples• Fistulated ruminants which are maintained under a holding project, for use in other short term feedingtrial projects• Non-breeding colony of diabetic rats held for research in other projects

3. Education - Projects carried out for the achievement of educational objectives. The purpose of the project isnot to acquire new knowledge, rather to pass on established knowledge to others. This would includeinteractive or demonstration classes in methods of animal husbandry, management, examination andtreatment.Examples• Animals used by veterinary schools to teach examination procedures such as pregnancy diagnosis• Sheep used in shearing demonstration classes for students; Dogs used to teach animal care to TAFEstudents

4. Research: human or animal biology - Research projects which aim to increase the basic understanding of thestructure, function and behaviour of animals, including humans, and processes involved in physiology,biochemistry and pathology.

5. Research: human or animal health and welfare - Research projects which aim to produce improvements inthe health and welfare of animals, including humans.

6. Research: animal management or production - Research projects which aim to produce improvements indomestic or captive animal management or production.

7. Research: environmental study - Research projects which aim to increase the understanding of animals’environment or their role in it. These will include studies to determine population levels and diversity and mayinvolve techniques such as observation, radio tracking or capture and release.Examples• Pre-logging or pre-development fauna surveys

8. Production of biological products - Using animals to produce products other than milk, meat, eggs, leather,fur, etc.

Examples • Use of a sheep flock to donate blood to produce microbiological media• Production of commercial anti-serum• Production of products, such as hormones or drugs, in milk or eggs from genetically modified animals• Quality Assurance testing of drugs but do not include animals which come under Purpose 10, below.

9. Diagnostic procedures - Using animals directly as part of a diagnostic process.

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10. Regulatory product testing - Projects for the testing of products required by regulatory authorities, such asthe APVMA. If the product testing is not a regulatory requirement, eg. it is part of a quality assurance systemonly, those animals should be included in the appropriate category selected from above. (This would benormally be category 8 in the case of QA testing.)Examples• Pre-registration efficacy or toxicity testing of drugs and vaccines

Procedures used

1. Observation Involving Minor Interference - Animals are not interacted with or, where there is interaction, itwould not be expected to compromise the animal's welfare any more than normal handling, feeding, etc.There is no pain or suffering involved.

Examples • Observational study only• Breeding animals for supply, where only normal husbandry procedures are used• 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

2. Animal Unconscious Without Recovery - Animal is rendered unconscious under controlled circumstances withlittle or no pain or distress. Capture methods are not required. Any pain is minor and brief and does notrequire analgesia. Procedures are carried out on the unconscious animal which is then killed without regainingconsciousness.Examples• Laboratory animals killed painlessly for dissection, biochemical analysis, etc• Teaching surgical techniques on live, anaesthetised patients which are not allowed to recover followingthe procedure

3. Minor Conscious Intervention - Animal is subjected to minor procedures which would normally not requireanaesthesia or analgesia. Any pain is minor and analgesia is usually unnecessary, although some distress mayoccur as a result of trapping or handling.Examples• Injections, blood sampling in conscious animal• Minor dietary or environmental deprivation or manipulation, such as feeding nutrient-deficient diets forshort periods• Trapping and release as used in species impact studies• Trapping and humane euthanasia for collection of specimens• Stomach tubing, shearing

4. Minor Surgery With Recovery - Animal is rendered unconscious with as little pain or distress as possible. Aminor procedure such as cannulation or skin biopsy is carried out and the animal allowed to recover.Depending on the procedure, pain may be minor or moderate and post-operative analgesia may beappropriate.Field capture using chemical restraint methods is also included here.Examples• Biopsies• Cannulations•Sedation/anaesthesia for relocation, examination or injections/blood sampling

5. Major Surgery With Recovery - Animal is rendered unconscious with as little pain or distress as possible. Amajor 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.

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6. Minor Physiological Challenge - Animal remains conscious for some or all of the procedure. There isinterference with the animal's physiological or psychological processes. The challenge may cause only a smalldegree of pain/distress or any pain/distress is quickly and effectively alleviated.Examples• Minor infection• Minor or moderate phenotypic modification• Early oncogenesis• Arthritis studies with pain alleviation• Induction of metabolic disease• Prolonged deficient diets• Polyclonal antibody production• Antiserum production

7. Major Physiological Challenge - Animal remains conscious for some or all of the procedure. There isinterference with the animal's physiological or psychological processes. The challenge causes a moderate orlarge degree of pain/distress which is not quickly or effectively alleviated.Examples• 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• Monoclonal antibody raising in mice

8. Death As An Endpoint - This category only applies in those rare cases where the death of the animal is aplanned part of the procedures and animals die but are not euthanased. Where predictive signs of death havebeen determined and euthanasia is carried out before significant suffering occurs, they may be placed incategory 6 or 7.Examples• Lethality testing (including LD50, LC50)It does not include: death by natural causes; animals which are euthanased as part of the project; animalswhich are euthanased if something goes wrong; animals euthanased for dissection or for use as museumspecimens; or accidental deaths.

9. Production of genetically modified animals - This category is intended to allow for the variety of procedureswhich occur during the production of genetically modified animals. As animals in this category may besubjected to both minor and major physiological challenges and surgical procedures, this category reflects thevaried nature of the procedures carried out. It effectively includes ALL animals used in GM production otherthan the final progeny which are used in a different category of procedure.Examples

• Initial breeding animals for GM production• Animals culled as part of the GM production process

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Column 1: Animal Species Codes: Lab Animals 01 Mice Native Animals 38 Macropods

02 Rats 39 Possums and Gliders 03 Guinea Pigs 40 Native rats and mice 04 Rabbits 41 Dasyurids 05 Hamsters 42 Wombats 06 Ferrets 43 Koalas 07 Other Lab mammals (not primates) 44A Monotremes

44B Bandicoots Domestic Mammals 08 Sheep 44C Bats

09 Cattle 44D Other Native Mammals 10 Pigs 44E Seals 11 Horses 44F Wales and dolphins 12 Goats 14 Deer Exotic Ferals Mammals 45 Camels 31 Cats 46 Cats 32 Dogs 47 Cattle 33 Other Domestic Mammals 48 Goats

49 Hares Birds 13 Poultry 50 Horses

16 Exotic Captive Mammals 51 Mice 17 Exotic Wild 52 Pigs 18 Native Captive 53 Rabbits 20 Native Wild 54 Rats 21 Other Birds 55A Dingo/Wild Dogs

55B Foxes Aquatic Animals 23 Fish 55C Other Exotic Feral Mammals

23A Cephalopods (not mandatory to report) Exotic Zoo Animals 56 Exotic Zoo Animals. 23B Crustaceans (not mandatory to report)

Amphibians and Reptiles 24 Amphibians 27 Lizards 28 Snakes 29 Turtles and Tortoises 30 Other Reptiles

Appendix 2 Animal Species Codes