4.3. Principal Investigator / Supervisor - Research Office

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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
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