DRAFT FOR CONSULTATION THE UNIVERSITY OF MELBOURNE

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DRAFT FOR CONSULTATION
THE UNIVERSITY OF MELBOURNE
ANIMAL ETHICS COMMITTEE
APPLICATION FOR APPROVAL TO USE ANIMALS FOR SCIENTIFIC PURPOSES RESEARCH OR TEACHING ACTIVITY
Additional information for applicants. Please read before you begin.
1.
ADMINISTRATIVE DETAILS
ID No:
Further information.
TITLE:
Further information.
CONTACT DETAILS
Name
Department
Project Supervisor
Primary Contact
2.
PROJECT SCOPE
2.1
Provide a plain English summary of the background to the proposed work.
2.2
Outline the overall aim and individual aims of the proposed work.
Further information.
2.3
If applicable, provide details of the relationship of the proposed work to other projects.
Further information.
3.
EXPERIMENTAL OR COURSE DESIGN
Further information.
Outline the experimental or course design listing each protocol/procedure separately. For each
protocol/procedure make reference to:
- The number and types of animals involved, including their source
Further information.
- The details of the procedure/protocol
Further information.
- The details of pain or distress experienced by the animals
Further information.
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DRAFT FOR CONSULTATION
- The details of monitoring
Further information.
- The fate of the animals
Further information.
4.
INVESTIGATORS AND COMPETENCY
Please identify individual investigators, their competencies and if applicable trainers for each of the
protocols/procedures listed in Question 3 ‘Experimental or Course Design’.
Further information.
Procedure x
Name
Institution / Department
Competency
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Trainer
Institution / Department
Competency
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Trainer
Institution / Department
Competency
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Trainer
Procedure y
Name
Procedure z
Name
5.
HOUSING OF ANIMALS
5.1
For each species/strain requested, complete a row in the table.
Species / Strain
Location
Housing
Standard / Other
Standard / Other
Standard / Other
Standard / Other
Standard / Other
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Grouping
Individual / Grouped
Individual / Grouped
Individual / Grouped
Individual / Grouped
Individual / Grouped
5.2
DRAFT FOR CONSULTATION
If relevant, provide further details of housing, including, as relevant, details of outdoor housing, any
special housing requirements, details of enrichment etc.:
Further information.
6.
REPLACEMENT
Further information.
6.1
Explain why it is necessary to use animals for this research or teaching activity.
6.2
What alternatives to animal use have been considered?
6.3
Provide justification for the choice of animal/s, including justification for:
- species/strain
Further information.
- sex
- age
7.
REDUCTION
Further information.
7.1
Provide statistical or other justification for the number of animals requested. Break down the total
number by procedures, treatments, repeats, groups, etc…
Further information.
7.2
Have the animals been used in another project? If yes, outline the cumulative burden and provide
justification for re-use.
Further information.
8.
REFINEMENT
What steps have been taken to support and safeguard animal welfare? How has the impact on the
animals been minimised?
Further information.
9.
OVERALL JUSTIFICATION
Explain how the potential effects on the wellbeing of animals in this project are justified by the potential
benefits of the proposed work.
Further information.
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DRAFT FOR CONSULTATION
10.
GLOSSARY
Scientific Term
11.
Title
Lay Description
ATTACHMENTS
Description
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DRAFT FOR CONSULTATION
THE UNIVERSITY OF MELBOURNE
ANIMAL ETHICS COMMITTEE
APPLICATION FOR APPROVAL TO USE ANIMALS FOR SCIENTIFIC PURPOSES
ADDITIONAL INFORMTION SHEET
Before Completing an application, applicants should familiarise themselves with all relevant guidelines and legislation,
including the NHMRC (2013) Australian Code for the Care and Use of Animals for Scientific Purposes.
To ensure that all AEC members are provided with sufficient information to participate effectively in the assessment of the
application, all responses must be given in plain English.
NB: Additional justification is required for activities that involve:
(a) severe compromise to animal wellbeing, and for which Replacement, Reduction and Refinement (the 3Rs) cannot
be fully applied for the project to proceed, including:
- unrelieved pain and distress, including where the planned endpoints will allow severe adverse effects to occur
(see Clauses 1.12 and 3.1.18–3.1.19 of The Code)
- death as the endpoint (see Clause 1.13 of The Code)
- reuse and repeated use of animals (see Clauses 1.22–1.24 and 2.3.15 of The Code)
- prolonged restraint or confinement (see Clause 3.3.4 of The Code)
(b) use of non-human primates
If planning to undertake a project that involves any of the above, it is best to consult an animal ethics administrator
before beginning your application.
Back to application.
1.
PROJECT TITLE AND CONTACT DETAILS
ID No:
Provide the unique identification number assigned by THEMIS when the application was created.
Back to application.
TITLE:
The title should give a clear, concise indication of the work proposed.
Back to application.
CONTACT DETAILS
Name
Department
Project Supervisor
Primary Contact
2.
PROJECT SCOPE
2.1
Provide a plain English summary of the background to the proposed work.
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DRAFT FOR CONSULTATION
2.2
Outline the aims of the proposed work.
Outline the overall aim of the proposed work as well as individual aims.
Back to application.
2.3
Provide details of the relationship of the proposed work to other projects.
Include, as relevant, application ID numbers.
Back to application.
3.
EXPERIMENTAL OR COURSE DESIGN
This section is where you provide the details of your proposed research or teaching activity. It must contain
enough detail that a proper assessment of the impacts of the protocols/procedures on each animal (or group of
animals) can be made.
Information should be presented in a logical sequence.
Information should be structured under headings and subheadings as appropriate.
Include graphs, tables, timelines and diagrams as necessary.
Back to application.
Outline the experimental design listing each protocol/procedure separately. For each
protocol/procedure make reference to:
- The number and types of animals involved, including their source
If using genetically modified animals, describe the genetic modification, its relevance to the work, and any
associated welfare concerns.
Back to application.
- The details of the procedure
Provide a clear timeline of events, including the duration of, and between, procedures.
Provide, as relevant, details of capture of animals.
Provide, as relevant, details of transport of animals.
Provide, as relevant, doses of all agents (e.g. drug, analgesics, anaesthetics in mg/kg), delivery routes,
volumes of blood collections.
Provide details of the location/s where procedures will be performed.
Clearly outline what will be done to the animals.
Back to application.
- The details of pain or distress experienced by the animals
Provide an assessment of the potential adverse impacts on animal wellbeing for the duration of the project.
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DRAFT FOR CONSULTATION
Include, as relevant, an assessment of cumulative burden.
Back to application.
- The details of monitoring
Explain how the wellbeing of animals will be monitored and assessed throughout the project.
Outline the frequency of monitoring and assessment, the actions to be taken if problems are identified, and the
criteria for intervention points and humane endpoints.
Make reference, as relevant, to attached monitoring and intervention criteria sheets.
Back to application.
- The fate of the animals
Clearly outline what will happen to the animals at the end of the project.
The planned endpoint of the project must be as early as feasible to avoid or minimise pain and distress to the
animals
Provide, as relevant, details of re-use and/or re-homing.
Provide, as relevant, the details of killing of animals.
Back to application.
4.
INVESTIGATORS AND COMPETENCY
For each of the protocols/procedures listed in Question 3, complete a table.
If related, and where the details of competency and training are the same, multiple procedures may be combined
in the one table (e.g. IV injection, IP injection, IM injection, etc.…).
Back to application.
Procedure x
Name
Institution / Department
Competency
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Trainer
Institution / Department
Competency
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Training / Competent
Trainer
Institution / Department
Competency
Training / Competent
Trainer
Procedure y
Name
Procedure z
Name
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DRAFT FOR CONSULTATION
Training / Competent
Training / Competent
Training / Competent
Training / Competent
5.
HOUSING OF ANIMALS
5.1
For each species/strain requested, complete a row in the table.
Species / Strain
5.2
Location
Housing
Standard / Other
Standard / Other
Standard / Other
Standard / Other
Standard / Other
Grouping
Individual / Grouped
Individual / Grouped
Individual / Grouped
Individual / Grouped
Individual / Grouped
If relevant, provide further details of housing, including:
Failure to provide appropriate housing has clear impacts on the wellbeing of animals and potentially, on
research quality. Provide details such that the AEC can be assured that the housing is appropriate and meets
relevant guidelines or other requirements.
Include, as relevant, details of outdoor housing.
Include, as relevant, details of special housing requirements.
Include, as relevant, details of environmental enrichment.
Include, as relevant, justification for individual housing
Back to application.
6.
REPLACEMENT
The unjustified use of animals is not ethical. Describe why animals are needed for this activity and provide
evidence for the consideration of alternatives.
Back to application.
6.1
Explain why it is necessary to use animals for this research or teaching activity.
6.2
What alternatives to animal use have been considered?
6.3
Provide justification for the choice of animal/s, including justification for:
- species/strain
Include, as relevant, justification/relevance of genetic modification.
Back to application.
- sex
- age
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DRAFT FOR CONSULTATION
7.
REDUCTION
Applicants must demonstrate that the minimum number of animals required to attain meaningful or statistically
significant results will be used.
Back to application.
7.1
Provide statistical or other justification for the number of animals requested. Break down the total
number by procedures, treatments, repeats, groups, etc…
Animal numbers and calculations should be presented clearly and logically.
Include tables as necessary.
The use of too few animals may invalidate results and result in the wastage of animals.
Back to application.
7.2
Have the animals been used in another project? If so, outline the cumulative burden and provide
justification for re-use.
Include, as relevant, application ID numbers.
To reduce animal use, could the animals or their tissues be used in another project upon completion of the
proposed work?
Back to application.
8.
REFINEMENT
What steps have been taken to support and safeguard animal welfare? How has the impact on the
animals been minimised?
Describe, as relevant, how protocols have been changed since this work was last conducted to minimise the
impact on animals.
Back to application.
9.
OVERALL JUSTIFICATION
Explain how the potential effects on the wellbeing of animals in this project are justified by the potential
benefits of the proposed work.
A research or teaching activity that uses animals is considered ethical where the potential benefits outweigh the
impacts on the animals. Use this question to describe why the impacts are reasonable given the potential
benefits.
Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific
purposes. This respect is demonstrated by:
(i) using animals only when it is justified
(ii) supporting the wellbeing of the animals involved
(iii) avoiding or minimising harm, including pain and distress, to those animals
(iv) applying high standards of scientific integrity
(v) applying Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:
(a) the Replacement of animals with other methods
(b) the Reduction in the number of animals used
(c) the Refinement of techniques used to minimise the adverse impact on animals
(vi) knowing and accepting one’s responsibilities.
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DRAFT FOR CONSULTATION
A judgement as to whether the proposed use of animals is ethically acceptable must be based on information that
demonstrates the principles above, and must balance whether the potential effects on the wellbeing of the
animals involved is justified by the potential benefits.
Back to application.
10.
GLOSSARY
Scientific Term
11.
Title
Lay Description
ATTACHMENTS
Description
Page 10 of 10
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