Ethics Approval for Research Involving Animals Animal Ethics Committee (AEC)

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Animal Ethics Committee (AEC)
Ethics Approval for Research Involving Animals
To complete an application for submission to The Animal Ethics Committee (AEC) at the University
of New England for approval to undertake a research protocol, you are requested to follow the
steps listed below. By following these steps you will make the approval process quicker and easier
for everyone involved. As part of this process you should ensure that you are familiar with and
comply with the Australian code of practice for the care and use of animals for scientific purposes.
Animal Ethics Website
Helpful information, such as approved SOP’s, the AEC Constitution, meeting dates,
guidelines, etc., can be found here.
Sections of the application form
Section A:
Section B:
Section C:
Section D:
Section E:
Section F:
Project Summary and Researchers involved
Justification for use of animals for scientific & teaching purposes
Project details
Project details
Procedures
Declaration
Submitting your applications:
Before you submit, please note that:

Incomplete applications will not be accepted; nor will applications submitted on old
versions of the form. You must ensure that your application is complete and on the latest
version of the application form.

The application must identify all of the researchers involved with the project and they must
all sign the Declaration at Section F. A student is not and cannot be the Principal
Investigator or Project Supervisor. This responsibility must be under taken by the student’s
supervisor.


Applications are to be clipped (NOT STAPLED) together.
Applications can be submitted either electronically or as hard copy. If you choose to
submit a hard copy of your application it must be printed or photocopied single-sided and
must not be stapled.
Submit to:
Research Ethics Officer
Research Services
02 6773 3449
02 6773 3543
T.C Lamble Building
University of New England
Armidale NSW 2351
ethics@une.edu.au
It is advisable to keep both an electronic copy and paper copy for your personal records, i.e.
the full application complete with signatures, etc.
Closing date for applications:
The closing time for applications is 5pm on the nominated closing date. The closing dates can
be found on the Animal Ethics Web page under the heading Meeting Dates.
DO NOT submit this page with your application
Office
use:
Reference
Number
Date
Received
Animal Ethics Committee (AEC)
Ethics Approval for Research Involving Animals
SECTION A – PROJECT
Project Title
This title will be recorded on the
ethics database and used in all
correspondence in relation to
this project
Project Summary
Provide a lay persons snapshot
of the project.
PART A2 – PRINCIPAL INVESTIGATOR or PROJECT SUPERVISOR (this is not the research student)
This is the person whom the research team wishes the AEC to correspond with in relation to this
project. Only UNE researchers can be listed as contact person for an ethical clearance
application. In the case of student research, a member of the student’s supervisory team must be
listed.
Name (eg Dr John Smith)
(one name only)
UNE Staff Number
Animal Ethics Course Number
Qualifications
School/Employer
Mailing Address
Work Phone No.
After Hours Phone No.
Email Address
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PART A3 – CO-INVESTIGATOR/CO-SUPERVISOR other than student researchers
List all co-investigators (associates, technicians etc) on the project who are not students
conducting the research as a component of their studies. This includes Co-Supervisors. However, if
students of the University are working on the project, e.g. as research assistants, but not using the
research for their studies, they should be listed here.
Name (eg Dr Logan Croft)
UNE Staff/Student Number
Animal Ethics Course Number
Qualifications
Role
School/Employer
Mailing address
Work Phone No.
After Hours Phone No.
Email
Name (eg Mr Bill Dawson)
UNE Staff/Student Number
Animal Ethics Course Number
Qualifications
Role
School/Employer
Mailing address
Work Phone No.
After Hours Phone No.
Email
Copy this table and repeat for any additional co-investigators.
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PART A4 – STUDENT RESEARCHERS
List all students working on the project who are conducting the research as a component of their
studies.
Name (eg Mr Mohamed Ali)
UNE Student Number
Animal Ethics Course Number
Qualifications
School
Mailing address
Phone No.
Fax No.
Email (please use UNE email)
Name of degree program
Undergraduate
University of New England?
Yes
Honours
Postgraduate
Coursework
Postgraduate
Research
Other (please specify):
Principal supervisor
Copy this table and repeat for each additional student.
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SECTION B – JUSTIFICATION FOR USE OF ANIMALS FOR SCIENTIFIC AND TEACHING
PURPOSES
No animals may be used without prior approval of an approved Animal Ethics Committee,
which includes both scientists and lay representatives of the community. Hence all
answers in Section B must be in language a lay person can understand.
The Code of Practice states that: “Scientific and teaching activities using animals may be
performed only when they are essential:
(insert X in box)
B1
To obtain and establish significant information relevant
to the understanding of humans and or animals;
Yes
No
B2
For the maintenance and improvement of human and
or animal health or welfare;
Yes
No
B3
For the improvement of animal management or
production;
Yes
No
B4
To obtain and establish significant information relevant
to the understanding, maintenance or improvement
of the natural environment; or
Yes
No
B5
For the achievement of educational objectives
(Point 1.1, p5)
Yes
No
B6. The Code of Practice states that: “Techniques that totally or partially replace the
use of animals for scientific purposes must be sought and used wherever possible”
(Point 1.8, p 6)
B6.1
Are any alternatives other than the use of animals
available for this procedure?
Yes
No
If yes please
give details
(Max 1,000
words)
The following World Wide Web sites may help identify possible alternatives to using
live animals.
 http://www.ahc.umn.edu/rar/ethics.html - University of Minnesota –
Research Animal Resources – Ethics and Alternatives
 http://altweb.jhsph.edu – John Hopkins Bloomberg School of Public
Health – Search for Alternatives
 http://www.nal.usda.gov/awic/pubs/antibody/ - Information Resources
for Adjuvants and Antibody Production: Comparisons and Alternative
Technologies
 http://oslovet.norecopa.no/dokument.aspx?dokument=80&mnu=about
_us– The Norwegian Reference Centre for Laboratory Animal Science &
Alternatives
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If alternatives are not being used, please explain why?
B6.2
Details
(Max 1,000
words)
Briefly state the aims of the experiment, specifying anticipated outcomes.
(Complete the Appendix if this is a teaching application):
B7
Details
(Max 1,000
words)
B8
Answer the following with regard to the wellbeing of the animals used in this
protocol. This should include all measurements, dose rates, frequency, volume etc.
(Researchers are reminded that their responsibility for animals begins from the time
they receive the animals up until the time they are disposed of at the completion
of the protocol.)
a)
Briefly list in point form, what will happen to the animals?
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b)
What will be the effects of this on the animals?

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c)
How will any negative effects of this be minimised?
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SECTION C – PROJECT DETAILS – Answer all questions
C1
Briefly in ‘plain English’, state the aims of the experiment and justify the benefits to
either humans or animals and the level of impact on the wellbeing of the animals
used in the protocol.
Details
(Max 1,000
words)
C2
Specify for each person listed in Section A their level of experience with the
procedures and animals being used in this protocol if they have no experience,
describe how the relevant experience will be obtained.
Details
(Max 100 words
per researcher)
C3
C4
Have any of the nominated researchers ever had a
research authority cancelled?
If yes, please
state which
researchers
Have all the nominated researchers completed an
Animal Ethics course or similar training (e.g. ANPR321 or
ANSC304)?
If No, please state which
researchers have not.
Yes
Yes
No
No
The researchers are reminded
that this course must be
completed before the
research can be approved.
C5
Nominate the initial contact person in the case of an emergency.
This person is listed on the authority as the emergency
C6
If applicable provide the name of farmer/manager and any other relevant personnel
involved in the day-to-day management of the study animals.
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SECTION D – PROJECT DETAILS – Answer all questions
D1.
Indicate from the list of purposes provided those that apply to this protocol. Please
bold the appropriate number(s) & description(s):
1
Stock breeding
2
3
4
5
Stock maintenance
Education
Research: Human or animal biology
Research: Human or animal health
& welfare
D2
D3
6
7
8
9
10
Research: Animal management or
production
Research: Environmental study
Production of biological products
Diagnostic procedures
Regulatory product testing
Is this a new or an ongoing protocol?
If ONGOING, please indicate the
prior AEC number (s)
Has the research been approved, or is under
consideration, by another Animal Ethics Committee
(AEC)?
If Yes, and approved, attach a copy of the approval(s).
Yes
Give
details
No
Go to D4
Duration of data collection for research. (‘Start date’ must be after meeting date)
Approval is granted for a 12-month period for a research project. Applications for teaching or
maintenance protocols may be granted for a 3 year period.
Please indicate below the expected commencement and completion dates.
Commencement cannot be before the meeting date
Start:
D5
Ongoing
Reference No.
Name of other AEC
D4
New
End:
dd/mm/yyyy
dd/mm/yyyy
Indicate from the list of procedures provided those that apply to this protocol (more
than one may apply). Please bold the appropriate number(s) & description(s) in
the list below:
6
Minor physiological challenge
2
Observation involving minor
interference
Animal unconscious without recovery
7
Major physiological challenge
3
Minor conscious intervention
8
4
Minor surgery with recovery
9
Death as an end point ie LD50 or
LC50
Production of genetically modified
animals
5
Major surgery with recovery
1
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D6
List all animals to be used in this project (complete the Appendix if this is a teaching
application):
Species Category No.:
Species (Common name):
Breed/Strain:
Age:
Sex:
Number required:
Source:
Conservation status (if
applicable):
Life span of wild-caught animals
(i) in the wild:
(ii) in captivity:
Copy and paste this section again if more than one species is used
D7
Does this project involve the use of any animals that
have been the subject of previous research? If animals
are to be re-used, individual records must be kept for
each animal and this must be indicated in the final
report.
Yes
No
If Yes, what has
previously been done
to the animals?
Also please provide
the relevant AEC
Approval number(s)
and Project Name:
Justify the re-use of
the animals, in
relation to the
potential welfare
implications for their
re-use.
D8
Provide the location(s) (and full address (es)) of where the animals will be housed from the time
of entry into the experiment until the time of its completion. (on UNE property, National Parks or
elsewhere):
Site(s) e.g. Animal House, Ring Road, UNE NSW 2351
D9
Have you booked facilities for holding the animals
Yes
Go to
D10
D10
Have you completed the Animal Entry form? (This
must be completed before animals can be held in
the Animal House Complex.)
Yes
Go to
D11
AEC Application Form – 13/04/2016
No
Go to
D11
N/A
Go to
D11
No
Go to
D11
N/A
Go to
D11
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D11
Provide the methods and means by which animals will be monitored during
maintenance.
Type of housing (building, cage, pen or paddock):
Number of animals per building, cage, pen or paddock
What arrangements have been made for the monitoring, care, feeding, etc. of the
experimental animals during each phase of the project?
D12
Are animals likely to be bred from during the
period of the protocol?
AEC Application Form – 13/04/2016
Yes
No
Unknown
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SECTION E – PROCEDURES
E1.1
Describe the experimental design (label or number multiple procedures and
complete the Appendix if this is a teaching application).
E1.2
Explain how the number of animals used is appropriate for the level of
significance required, the minimum difference expected and the variability
existing for the trait measured.
E1.3
Provide a full sequential description of what happens to the animals from the time
you obtain them to the time the experiment is completed. (This must be provided
in the table below using the headings in the table.)
Study Day
Eg: -14 to -1
Activity
Sheep acclimatise to paddock. Sheep drenched (with BZ+LV anthelmintic) and
vaccinated if required.
E2
For the procedures you have listed in answer to Question D5 provide details on how
the impact on the animals’ wellbeing will be minimized. If available identify any
appropriate SOP(s).
E3
What procedures are in place to minimise distress in case of injury or major compromise
to animal wellbeing? (If euthanasia, see Question E9)
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E4
Will surgery be performed on the animal(s)?
Yes
No
Go to E7
If Yes, describe the
procedures.
Will it be performed; under
general anaesthesia, under
local anaesthesia or without
anaesthesia (quote standard
procedure if possible.
E5
Give details of any anaesthesia process
E6
What post-operative care, monitoring and analgesia will be used?
E7
Describe how animals will be disposed of at the end of the experiment, (e.g. returned
to flock, passed on to another researcher, euthanised, released to the wild, re-homed,
etc.)
E8
If animals are to be released to the wild, outline the methods for ensuring maximum
success and indicating how the site of capture/release has been considered.
E9.1
If, as the result of serious illness, serious accidental injury or in order to fulfil any other
ethical requirement, animals need to be euthanised, please provide details of:
the method of euthanasia:
the names and qualifications of the persons carrying out the euthanasia:
Names:
Qualifications:
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E9.2
Are animals to be euthanised as part of this protocol? If Yes,
please provide details of:
Yes
No
the method of euthanasia:
the names and qualifications of the persons carrying out the euthanasia:
Names:
Qualifications:
Are any drugs, chemicals, ionising or non-ionising
radiation, or biological agents to be used?
Yes, go
to
Question
E11
No, go to
Question
E18
E11
Are neuromuscular blocking agents to be used?
Yes, go
to
Question
E11.1
No, go to
Question
E12
E11.1
Will an anaesthetic or analgesic agent be
administered simultaneously?
Yes
No
E11.2
Will an anaesthetic or analgesic agent be
administered for each agent?
Yes
No
E10
E12
List all drugs, chemicals, ionising or non-ionising radiation or biological agents to be
used.
For each agent indicate:
Name of agent:
Dose of agent:
Route of administration:
Likely effects of agent:
Duration of effects:
Method of determining effectiveness of
agent:
Method of determining pain responses
occurring during neuromuscular blockage:
Availability of reversing agent(s):
Availability of cardio-respiratory support
facilities:
Possible side-effects of or toxicity reactions
to the agent:
Copy and paste this section again if more than one agent is used.
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E13
E14
Has the appropriate Safety Officer been
notified?
Yes
Are any imported biological products or their derivatives
to be used in any
of the animals?
If Yes, give the
AQIS approval
numbers:
No
N/A
Yes
No
E15
Are there any anticipated health risks to staff:
If Yes, describe
how these will
be minimised.
Yes
No
E16
Are there any anticipated health risks to other animals?
If Yes, describe
how these will
be minimised.
Yes
No
Yes
No
E17
Do the proposed waste disposal procedures comply with
the Protection of the Environment Administration Act
(1991) the Occupational Health and Safety Act (2000)
and Regulations and the Radiation Control Act (2003)?
E18
For experiments involving Native wildlife, is a
licence or permit from the relevant State
wildlife authority (e.g. NPWS, NSW Agriculture)
required?
Yes
No
N/A
If Yes, Is one held by the
Principal Investigators?
Name of Licensing
Body/Organisation:
Licence
Class/Descriptions(s)
and Number(s):
Expiry Date of
Licence(s)?
A copy of this permit is
required to be provided
with this application.
If No, explain why a
licence or permit is not
required.
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E19
Is the research funded by an internal or external grants
body or sponsor?
Yes
No
Go to
Section F
Yes
No
Go to
Section F
Give
details
Organisation or Funding Body
Project title on contract or
funding application
First named investigator
Administering institution
Does the funding body have
ownership of or control over the
dissemination of results? If yes
give details.
Copy this table and repeat for each contract or grant.
E19.2
Does the funding constitute a conflict of interest for
either the researcher(s) or provider(s) of the funding?
Give
details
Details
(Max 300
words)
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SECTION F – DECLARATION MADE BY THE PERSON(s) RESPONSIBLE:
IT IS EXPECTED THAT YOU WILL COMPLY WITH THE CONDITIONS OF THIS DECLARATION, SO PLEASE READ
CAREFULLY BEFORE SIGNING.
(a)
I acknowledge that:
1. The care and maintenance of all animals is my responsibility though the work may
be delegated to suitably trained or experienced staff or students;
2. The Australian Code of Practice for the Care and Use of Animals for Scientific
Purposes (1997) requires an autopsy to be performed when animals die
unexpectedly; and
3. I may proceed with the experiment only when UNE has issued an Animal Research
Authority, which names all suitably qualified and/or experienced persons who are
to be involved in the described project.
(b)
I certify that:
1. My Animal Research Authority will be displayed where the animals are housed
and where animal experimentation is to occur, and the AEC will be notified
immediately should any changes in participating personnel occur;
2. Where appropriate I am the holder of a current permit from the relevant state
wildlife authority to capture and hold Australian native fauna;
3. All personnel involved in the described animal experiment have appropriate and
adequate qualifications and skills and/or they will be under suitably close
supervision to enable them to competently carry out the necessary tasks;
4. All unplanned deaths will be reported to the UNE Animal House Manager and the
AEC Secretary and I will comply with his/her instructions concerning an autopsy;
5. Any information required to facilitate the maintenance of animals will be sought
from suitably informed personnel; and
6. The care of animals during the proposed experiment will conform with the
principles and regulations of: the Animal Research Act 1985, the Australian Code
of Practice For the Care and Use of Animals For Scientific Purposes 1997, the
Animal Research Regulation 1995, the Amendments to the Animal Research
Regulation 1997, and the UNE Code of Practice for the Care and Welfare of Nonhuman Vertebrate Animals Used for Scientific Purposes.
7. That all personnel listed have read this application and have agreed to comply
with procedures described and any conditions imposed by the AEC.
All investigators named at A2 , A3 and A4 are to sign this declaration.
Print Name
Signature
Date
Principal
investigator or
project supervisor
Co-Investigator ,
Associate or
Student Researcher
Co-Investigator ,
Associate or
Student Researcher
Co-Investigator ,
Associate or
Student Researcher
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Comments
You are invited to add comments to supplement your application if you think something has not been
covered, or to provide feedback on this form.
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APPENDIX: SCHEDULE OF PRACTICAL CLASSES
Course Code:
Date
Lecturer
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Title/Description of Unit/Course
Species
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No. of
Purpose
Animals
No.
Procedure
No.
APPENDIX – How to submit your application
DO NOT submit these instructions with your application
Before you submit:

Incomplete applications will not be accepted so ensure that your application is complete
and collated in the format listed below.

The application must identify all of the researchers involved with the project and they must
all sign the Declaration at Part F1. The Student is not and cannot be the Principal
Investigator or Project Supervisor this must be the Supervisor

Note: It is the applicant’s responsibility to ensure the completed declaration is submitted
with their application.


Applications are to be clipped (NOT STAPLED)
Applications can be submitted either electronically or hard copy. If you choose to submit a
hard copy of your application it must be printed and photocopied single-sided
and must not be stapled.
Submit to:
Research Ethics Officer
Research Services
T.C Lamble Building
University of New England
Armidale NSW 2351
02 6773 3449
02 6773 3543
(International prefix +61 2)
ethics@une.edu.au
It is advisable to keep both an electronic copy and paper copy for your personal records, i.e.
the full application complete with signatures etc.
Closing date for applications:
The closing time for applications is 5pm on the nominated closing date. The closing dates can
be found on the Animal Ethics Web page under the heading Meeting Dates, or can be
obtained by clicking on the heading above.
DO NOT submit these instructions with your application
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