ACEC-I-Research-10/2016

ACEC USE ONLYDate of Initial Approval

Date of Latest Variation Approval

The University of Newcastle Animal Care and Ethics Committee

NEW APPLICATIONfor approval to use animals in a RESEARCH/TEACHING project

(Do not use this form if seeking approval for breeding only)

To access guidelines for questions on this form, use the hidden text function: Click “Show/Hide ¶” on the Standard toolbar. When hidden text is shown, it will be red in colour, and is marked with a dotted underline.

Section 1: Administration

1.1 Project Title

1.2 Chief InvestigatorTitle First Name Last Name

1.3 Responsible Institution. Indicate the institution on whose behalf this research is being conductedCategory A:

The University of NewcastleHunter New England Area Health Service

Category B: An application fee applies. Please attach “Payment Details” document - see http://www.newcastle.edu.au/research-and-innovation/resources/animal-ethics/approval-for-carrying-out-animal-research/application-procedures-and-forms for this form

Avondale CollegeHunter Wetlands CentreIndependent researcherOther. Provide details:

1.4 Collaboration

Does this project involve collaboration with external agencies (e.g. institutions, companies, individuals etc.)?Yes. Please complete Sections (i) to (iii) No. Please go to Question 1.5

(i) Name of collaborator(s) and the relevant institutions

(ii) Briefly describe the collaboration

(iii) Has this project been approved by your collaborator’s Animal Ethics Committee?

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No Yes

If yes, please attach a copy of any application submitted to, and notification of approval from, your collaborator’s Animal Ethics Committee. See: http://www.newcastle.edu.au/research-and-innovation/resources/animal-ethics/approval-for-carrying-out-animal-research/collaborative-research

1.5 Application TypePlease indicate which one of the following types of application is appropriate for this submission

A new project

A significantly revised current project

An application that was previously submitted and not approved.

An application related to an existing project with current ACEC approval

Provide the relevant ACEC approval numbers here

An application that represents a combination of two or more projects with CURRENT approval.

Provide the relevant ACEC approval numbers here

Please note that a final report will be required for each project.

Substantially the same project as submitted to a collaborator’s Animal Care and Ethics Committee as described in 1.4

1.6 Prior Consideration

Has approval been sought for this project, or substantially the same project, from the Animal Care and Ethics Committee or another Animal Ethics Committee?

No Yes. If yes, provide reasons for the re-submission or simultaneous submission, the name of the ACEC(s) and the outcome of the application(s).

1.7 Cancellation of Authority or Licence

Has any Animal Research Authority or Animal Supplier's Licence held by the Chief Investigator or any other investigator named in this application been cancelled?

No Yes. If yes, provide details below. These details should include the researcher’s name, the institution where the cancellation occurred, the year that the cancellation occurred and the circumstances of the cancellation.

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1.8 (i) Is a research student’s project dependent upon this approval?

No Yes. If yes, provide details below and duplicate the information for each student.Program should include undergraduate, honours, MSc, PhD etc (e.g. Summer Scholar, undergraduate project)

Student’s Name:Program:

(ii) Are there any time-critical aspects relating to the research of which the ACEC should be aware?

No Yes

If

yes, please provide details:

1.9 Project datesPlease indicate the expected timeframe for the project

Anticipated start date:Anticipated end date:

Please note that ACEC project approval is for a period of one year and subject to annual review.

Section 2: Project Details

You must use PLAIN ENGLISH in your responses to these sections – everyday language that can be understood by an educated lay person who has no medical or scientific background. See guidelines.

2.1 Project classificationsThis information is required for inclusion in the University’s annual return to NSW Industry and Investment(For definitions of these classifications, click “Show/Hide ¶” on the Standard toolbar.)

(i) Purpose of the project. Indicate the most appropriate description of the primary purpose of the project.

1. Non GM Stock breeding2. Stock maintenance3. Education

4. Research: human or animal biology 5. Research: human or animal health and welfare 6. Research: animal management or production

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7. Research: environmental study 8. Production of biological products9. Diagnostic procedures10. Regulatory product testing

2.2 Project Summary and Aims

(i) Provide a clear summary of the project in plain English (Limit: 200 words). This should be easily understood by people with no scientific background.

(ii) Provide a list of the aims of the project. The aims should be specific and annual reports will require progress in relation to these aims. There is no limit to the number of aims.

2.3 Project Benefits

Provide a plain English description (Limit: 250 words) of the expected benefits of the project in terms of increasing our understanding of humans or animals, improving human or animal health and welfare, improving animal management or production, achieving education objectives, or achieving environmental objectives.

2.4 Project Procedure ClassificationsThis information is required for inclusion in the University’s annual return to NSW Industry and Investment(For definitions of these classifications, click “Show/Hide ¶” on the Standard toolbar.)

(i) Procedure

Indicate the category (or categories) that best describes all procedures carried out on the animals in the project. More than one category may apply to this project. Please indicate all that apply.

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1. Observation involving minor interference2. Animal unconscious without recovery3. Minor conscious intervention4. Minor surgery with recovery5. Major surgery with recovery6. Minor physiological challenge7. Major physiological challenge8. Death as an endpoint (where the death of an animal is a planned part of the procedures and animals

die but are not euthanased)9. Production of genetically modified animals

2.5 Health and/or safety risks(i) Indicate which of the following health and/or safety risks to other animals, people or the community are involved

with this project.

Anaesthetic gases

Carcinogens

Teratogens

Chemically hazardous material or cytotoxic substances (not including anaesthetic gases)

GMOs – animals

GMOs other than animals

Biologically hazardous materials (microorganisms, human tissue, fluids etc)

Radiation hazard

Potential zoonosis

Other - Provide BRIEF details here:

Not Applicable

(ii) Does this project involve persons associated with the University of Newcastle, or animals housed in the University of Newcastle Animal Services Unit facilities?

No Yes. If yes, safety approval from the relevant University of Newcastle Health and Safety Committee is required. Refer to http://www.newcastle.edu.au/current-staff/teaching-and-research/health-and-safety-for-teaching-and-research

(iii) If safety approval has already been granted please provide the safety reference number.

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Section 3: Animal Details

The information requested in Section 3 is required for inclusion in the University’s annual return to NSW Industry and Investment.

You must use PLAIN ENGLISH in your responses to these sections – everyday language that can be understood by an educated lay person who has no medical or scientific background. See guidelines.

3.1 Please download and complete the Animal Details spreadsheet and submit this spreadsheet with your application.

3.2 Justification of the use of animals

3.2.1 Why is it necessary to use animals in this project?

3.2.2 ReplacementHave you incorporated non-animal alternatives into this project?

Provide information on:

Techniques that are available to wholly or partially replace the use of animals in this project (e.g. in vitro models, computer programs or simulations, less sentient animals).

Any non-animal alternatives that will be used in this project. Reasons why you have rejected non animal alternatives as unsuitable.

3.3 Animal Numbers Required: Reduction

3.3.1 Describe any steps you have taken to minimise the number of animals required

3.3.2 At the conclusion of your experiments will animals or their tissues be suitable for use in another project? If yes, please provide brief details and indicate tissues that would be available.

3.4 Repetition or Re-use

3.4.1 Does this project include the repetition of work conducted previously?

No Yes. If yes, briefly describe the previous work done in this area, and why it needs to be repeated?

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3.4.2 Does this project involve the re-use of any animals that have been the subject of a previous scientific or teaching activity?

No Yes. If yes, please complete Attachment N.

3.5 Choice of Animal

Why have you chosen the species/strain/age/sex/genetic make-up of the animals that will be used?

3.6 Does the project involve the use or production of genetically modified animals or animals with a naturally occurring mutation?

No.

Yes. This application involves the use of an existing genetically modified strain or animals with a naturally occurring mutation. You must complete Attachment I.

Yes. This application is submitted specifically for the creation and/or use of genetically modified animals.

3.7 Animals: Source, Housing and ManagementReference: http://www.newcastle.edu.au/research-and-innovation/resources/animal-services

3.7.1 From where will animals be obtained?

Animal Services Unit, University of NewcastleDirectly from an external supplier, researcher or institution (e.g. another University). Provide details below.Animal reused from another projectAnimal captured from natural habitatAnimal in natural habitatPrivately ownedSaleyardOther. Provide details below.

If required, provide details of alternate source of animals.

3.7.2 Permits Required

If a permit is required to obtain, hold or use the animals, then provide details and attach if available. Please note that any approval would be subject to the submission of any permit to the ACEC for verification.

AQIS

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NPWS

OGTR

Other permits or licences

Details of Permits and/or Licences:

3.7.3 Holding of Animals

Animal Services Unit (ASU) Facilities

Have you consulted the Associate Director, Animal Services Unit regarding the housing of your animals?

Yes If yes, what facilities to hold your animals are available?

No If no, who have you consulted and are appropriate facilities available for theholding of your animals?

3.7.4 What level of physical containment is required for the housing/handling of the animals?

ConventionalSpecific Pathogen Free (SPF)PC1PC2Other. Please specify below.

3.7.5 Where will the animals be housed (tick all facilities which are applicable)?

Central Animal House Amphibian Facility: Nursing Building Courtyard

Medical Sciences Building Animal Facility: Level 2 Amphibian Holding Room (Room BLG06)

Medical Sciences Building Animal Facility: Level 3Amphibian Facility: Amphibian Controlled Environment Room (ACER)

Medical Sciences Building ABL Amphibian Facility: Frog Ponds (north west of Forum)

Behavioural Sciences Animal Facility Hunter Wetlands Centre

Research Support Unit, John Hunter Hospital Brickpit, Sydney Olympic Park, Homebush

HMRI Bioresources Facility Ourimbah Science Lab

Ash Island Ourimbah Aviaries

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Skywood Equestrian Centre Central Coast Marine Discovery Centre

Details of other housing (not listed above).

If the facility or location is not listed contact the Animal Ethics Officer in the Research Integrity Unit on 16377 to arrange an inspection of the site and an application to NSW Industry and Investment.

3.8 Duration of animal use, housing and procedures

3.8.1 Once allocated to the project, what is the maximum time that an individual animal will be held? Specify how the care of the animals will be addressed in 3.8.2.

3.8.2 Describe the housing and husbandry requirements. Duplicate this table if there are different requirements for particular groups of animals.

Standard Animal Services Unit (ASU) housing

If not standard ASU housing please provide the following information:

Species/StrainCaging or housingMaximum and minimum number of animals per cage/penEnvironmental enrichment:Diet:Water:Special care:

3.8.3 Indicate where procedures will be performed.

(i) If at a University of Newcastle facility, specify the Campus site, Building and Room Number:Procedure Location

(ii) If not a University of Newcastle facility, provide details of where the research procedures will be performed.

3.9 Fate of Animals at the End of Experiments

3.9.1 If animals will be euthanased at the end of the experiment please complete parts (i) and (ii) below:

(i) Detail the method of euthanasia to be used. Reference: http://www.newcastle.edu.au/research-and-innovation/resources/animal-ethics/managing-approved-projects#specifictechniques

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Species Method Drug name (generic name, not trade name)

Dose rate (mg/kg body weight)

Route

(ii) Where will euthanasia normally be performed if part of the study? It is the expectation of the ACEC that animals will be euthanased in a quiet, clean environment away from other animals.

(iii) If animals will not be euthanased, please describe their fate below.

3.9.2 Substances Administered

Are you administering any substances other than registered drugs (Investigational)?

Yes (If yes, please complete Attachment H in the Supplement to New Application)

No

3.9.3 Drugs

List registered drugs below:

3.10 Refinement

3.10.1 Animal Welfare Impact

Identify all aspects of this project that may adversely impact on the well-being of the animals using the table below. Anticipate and describe any potential adverse effects on the animals, and the steps you will take to avoid, minimise or manage these effects.

Justification. Provide justification for the impact of procedures on animals in this project taking into account the ethical considerations, the impact on the welfare of the animals and the anticipated scientific or educational value.

Note: The legislation requires provision of particular justification for specific situations (see guidelines).Factor

(Delete or add rows as needed)The factors listed below are a guide only. Ensure that you

include all other factors that may adversely impact animals in this

project.

Potential adverse effects on the animals

Justify the adverse event risk and indicate how potential adverse effects on the animals will be

minimised.

Anaesthesia with recovery

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Anaesthesia without recoveryAntigen & adjuvant administrationBehaviour testingBlood / body fluid collectionCapture of free-living (including feral) animalsChronic instrumentation (e.g. electrodes, catheters, transmitters etc)Diet / water modificationEffect of genetic modificationEuthanasiaExperimental housing or environmentExperimental restraintHandlingInduction of tumoursInfection with microbial agents, parasites etcOther treatmentsSubstances administeredMust be outlined in Attachment HSurgical procedure(s)Techniques used to administer substances (e.g. Injection, gavage, intra-tracheal)Transport Must be outlined in Attachment KOther (add rows as necessary)

3.11 Monitoring of Animals

Researchers are responsible for the day-to-day monitoring of the well-being of animals from the time the animals are allocated to your project until the time of their disposal at the completion of the project. This applies even if animals are used for the collection of tissues only.See Guidelines

3.11.1 Who will monitor the animals?

Note: Details of these personnel and their experience with animal welfare monitoring must be included in Section 4.

(i) On weekdays including outside regular working hours?

(ii) On weekends and public holidays?

3.11.2 (i) How will the animals be monitored during the project day-to-day?

Please attach a copy of the monitoring checklist(s) that will be used for the routine day-to-day monitoring.

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(ii) How will the animals be monitored during and after procedures?

Please attach a copy of the monitoring checklist(s) that will be used specific to the procedures to be undertaken.

3.11.3 What is the anticipated morbidity or mortality rate and why? Indicate if this will vary in different parts of the project.

3.11.4 If an animal dies or is euthanased due to complications, who will perform the post mortem?

Note: An adverse event report must be submitted to the ACEC should this occur.

University Veterinarian Other

Note: If other, please ensure this person(s) is listed in Section 4 detailing their level of experience at performing ‘Post Mortems’.

3.12 Animal Emergency Contacts

Please list at least two individuals who are authorised by the Chief Investigator for this project to make decisions regarding the treatment of an animal in the event that is it found sick, injured, moribund or dead. An after-hours contact number MUST be provided in case the Animal Services Unit staff or veterinarian need to contact these people out of business hours.

Attachment A in the Supplement to New Application must be completed and attached. It authorises emergency treatment of your animals in case Animal Services Unit staff are unable to contact your emergency contact personnel.

Name B/H Phone A/H Phone Email

Section 4: Details of Personnel Involved with the Project

4.1 Chief Investigator

Name: Title/first name/family nameQualifications:School/Faculty:

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Name of Persons performing Post Mortem

Contact Phone:Email:Number Plate e.g. ABC123Attendance at CARE training program (Code & Animal Research Ethics)? Yes/No

If yes, please indicate modules completed and date of attendance.

Will this researcher be monitoring the animals?

No Yes. If yes, please outline this researcher’s experience in relation to the monitoring of the species to be used in this project

Experience with techniques to be performed on live animals, and species to be used, by this person IN THIS PROJECT:

Technique or Procedure Species Level of RECENT experience(Approx. number of times this person has performed the

procedure in this species in the previous 5 years)None

(eg. <5)Limited

(eg. 5-20)High

(eg. >20)

If inexperienced with either the species or procedure(s), how will experienced be gained and who will provide technical guidance to other personnel on this project?Details for person providing technical advice must be provided under Question 4.3, even if the person is an external expert.

4.2 Alternate Chief InvestigatorNote: This person will assume the responsibilities of the Chief Investigator during any absence of the Chief Investigator, and must be associated with the institution nominated in Q1.3

Name: Title/first name/family nameQualifications:School/Faculty:Contact Phone:Email:Number Plate e.g. ABC123Attendance at CARE training program (Code & Animal Research Ethics)? Yes/No

If yes, please indicate modules completed and date of attendance.Place ‘x’ in the box if this is the first time this person has been named on a University of Newcastle animal ethics application.

Will this researcher be monitoring the animals?

No Yes. If yes, please outline this researcher’s experience in relation to the monitoring of the species to be used in this project.

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Experience with techniques to be performed on live animals, and species to be used, by this person IN THIS PROJECT:

Technique or Procedure Species Level of RECENT experience(Approx. number of times this person has performed the

procedure in this species in the previous 5 years)None

(eg. <5)Limited (eg. 5-

20)

High(eg. >20)

If inexperienced with either the species or procedure(s), how will experienced be gained and who will provide technical guidance to other personnel on this project?Details for person providing technical advice must be provided under Question 4.3, even if the person is an external expert.

4.3 Key personnel associated with this project

Name: Title/first name/family nameQualifications:Role in project: Insert as necessary; e.g. Investigator, Collaborative Researcher, Student,

External Researcher, Volunteer, etc.If student: Program: Undergraduate / Honours student/ Masters student/ PhD student/ Other (please

specify) (delete as necessary)Student Number:

School Faculty:Contact Phone:Email:Attendance at CARE training program (Code & Animal Research Ethics)? Yes/No

If yes, please indicate modules completed and date of attendance.Place ‘x’ in the box if this is the first time this person has beennamed on a University of Newcastle animal ethics application.

Will this researcher be monitoring the animals?

No Yes. If yes, please outline this researcher’s experience in relation to the monitoring of the species to be used in this project.

Experience with techniques to be performed on live animals, and species to be used, by this person IN THIS PROJECT:

Technique or Procedure Species Level of RECENT experience(Approx. number of times this person has performed

the procedure in this species in the recent past)

Supervisor's name (if "None" or "Limited")

None(eg. <5)

Limited (eg. 5-20)

High(eg. >20)

For each additional person, copy the table above and complete.

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4.4 Other people participating with the use of animals in this project

Name: Title/first name/family nameQualifications:Role in project: Insert as necessary; e.g. Investigator, Collaborative Researcher, Student,

External Researcher, Volunteer, etc.If student: Program: Undergraduate / Honours student/ Masters student/ PhD student/ Other (please

specify) (delete as necessary)Student Number:

School Faculty:Contact Phone:Email:Attendance at CARE training program (Code & Animal Research Ethics)? Yes/No

If yes, please indicate modules completed and date of attendance.Place ‘x’ in the box if this is the first time this person has beennamed on a University of Newcastle animal ethics application.

Will this researcher be monitoring the animals?

No Yes. If yes, please outline this researcher’s experience in relation to the monitoring of the species to be used in this project.

Experience with techniques to be performed on live animals, and species to be used, by this person IN THIS PROJECT:

Technique or Procedure Species Level of RECENT experience(Approx. number of times this person has performed

the procedure in this species in the recent past)

Supervisor's name (if "None" or "Limited")

None(eg. <5)

Limited (eg. 5-20)

High(eg. >20)

For each additional person, copy the table above and complete.

Section 5: Peer review

Part A:

The research proposal described in this application has been peer reviewed by:

(i) Competitive research grant body (e.g. NHMRC) or Government Authority (e.g. Department of Environment and Conservation) as follows:

Name of competitive research grant body:

Year of review:

Are the aims, experimental procedures and animal details outlined in the grant application the same as those included in this application?

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Yes NoIf no, peer review by the competitive research grant body or Government Authority is not sufficient. Independent peer review is required.

(ii) At least one peer reviewer in accordance with the Research Peer Review Guideline for Ethics Applications https://policies.newcastle.edu.au/document/view-current.php?id=101

Part B: Peer Review by independent peer reviewer(s)

Name(s) of independent peer reviewer:

Date review requested:

As part of this process, the applicant must: provide a copy of this application to one peer reviewer, together with the Peer Review Report form and any other

information necessary to enable adequate review of the project (Note: If the funding application was unsuccessful, and reports from a funding body peer reviewer support the scientific merit of the project, you may provide this reports as evidence of the scientific merit of your project. Attach copies to your application.)

choose a senior, experienced researcher choose a reviewer who is sufficiently expert in the field to provide adequate peer review; choose a reviewer who is independent of your research group or team and independent of the research project request the reviewer to forward their report directly to the Committee (c/- ACEC-

Submissions@newcastle.edu.au) ensure the timely submission of this application, and report from a peer reviewer, so that consideration of

approval is not unduly delayed

Note: To facilitate this process: The applicant may attach to this application, the report from the peer reviewer, AND the response to any matters raised by the peer reviewer. In this case, the applicant should ensure that, where relevant, all issues have been resolved to the satisfaction of the peer reviewer and that the application has been revised prior to submission.

Section 6: FundingIdentify the sources of funding for this project. Duplicate the table if more than one source.

Nature of the funding source: Internal departmental funds, Internal grant scheme, External Agency, Commercial, Private, Other(delete as necessary)

Name of Funding body/source/scheme:

Commercial-in-Confidence: Yes/No

Exact title of funding application:

1st Named Investigator on funding application:Grant Reference Number(G Number) if known:Administering Institution

Date of submission of application:

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Period of funding: Start Date: End Date:

Is all of the animal based research funded by the grant included in the approved animal ethics protocol?

Yes No Please provide details below.

Note: Funding Application

If the funding application is not administered by the University of Newcastle Research Services, you must include a copy of your funding application with this ethics application.

Section 7: Investigator Declaration of Responsibilities

I confirm that I and members of the research team have read the NSW Animal Research Act and Regulations, and the Australian code for the care and use of animals for scientific purposes, and accept responsibility for compliance with all aspects of the legislation and the Code relating to the project.

I declare that I have the appropriate qualifications and experience to perform the procedures described in this application or to ensure that they are done correctly.

I accept responsibility for ensuring that each person involved with this project has the necessary experience to perform the procedures they are to carry out. If they are not already skilled in the procedures, I accept responsibility for ensuring that they obtain the necessary training in advance, and appropriate supervision, so that each procedure on an animal will be carried out in the most appropriate manner.

I confirm that all other persons involved with this project have received or have access to a copy of this application, and will receive a copy of any associated correspondence or documentation from the ACEC.

I confirm that all other persons involved with this project have read this application and have agreed to conduct the project as outlined in this application in accordance with the legislation, and the requirements of the University of Newcastle ACEC.

Each member of the research team is being identified in this submission with his/her knowledge and consent; they have access to the submission; and I have made them aware of the requirement for the research to be conducted according to the approved protocol.

Yes No

Name Signature Date

Chief Investigator:

Please note: Should this application be forwarded by the Chief Investigator via email, a signature is not required.

Please ensure that you have responded to every question (even if your response is “not applicable”).

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