The University of Newcastle Animal Care and Ethics Committee
SUPPLEMENT TO NEW APPLICATION for approval to use
animals in a RESEARCH project
Use this form to supplement your RIMS application to provide information about the “Sequence of Events” and “Justification for
Animal numbers”. All ACEC attachments are provided in this document as well. Delete those attachments that do not apply to
your application prior to uploading this document into RIMS.
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.
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.
Section 1: Administration
1.1
Project Title
1.2 Chief Investigator
Title
First Name
Last Name
Section 2: Sequence of Events
2.1 Description of the project and sequence of events
Provide a detailed description of the project in the context of addressing the aims. Provide a step-bystep description of what will happen to each animal from the time they are obtained until the time the
project is completed. Use flow diagrams, diagrams or sequence of events tables where possible.
Indicate the duration of all procedures, the number and type of procedures to be performed on each
animal, and the time intervals between procedures or different aspects of the project. Where used
please refer to an attachment or a Standard Operating Procedure. Include pictures or diagrams that will
improve the understanding of the project.
2.2 Specific Procedures
2.2.1
Indicate whether the project application includes any of the following attachments. The appropriate
attachment must be appended to this supplement. Delete attachments that do not apply.
Tick those
that apply
A
C
D
Attachment Title
Authorisation for animal treatment
Non-survival surgery
Survival surgery
1
E
F
G
H
I
K
L
M
N
2.2.2
Use of anaesthesia not associated with surgery (survival or non-survival)
Blood collection (other than terminal collection)
Polyclonal antibody production
Administration of substances
Animals with altered genetic make-up (manipulated, modified, naturally-occurring
mutation)
Transport of live animals at any time during the project
Death as an end-point or LD50 tests (This does not refer to the planned euthanasia of an
animal at the conclusion of a study Requires ministerial approval)
Mandatory studies required for registration of a product or by an external body (eg. TGA,
NRA, FDA, Human Ethics Committee)
Re-use of animals that have been the subject of a previous scientific or teaching activity
Please provide a list of ACEC Approved Standard Operating Procedures (SOP) that will be used in
this project. Information concerning ACEC Approved Standard Operating Procedures is available at
the SOP website http://www.newcastle.edu.au/research-and-innovation/resources/animalethics/standard-operating-procedures
If an SOP was last approved by the ACEC more than 3 years ago, please review, modify as needed
attach the SOP to this application, leaving the header containing the previous approval date intact.
If an SOP is to be modified, please attach a tracked changed copy of the procedure.
SOP TITLE
2.2.3
SOP APPROVAL NUMBER
DATE SOP APPROVED
New SOPs
Please list any new SOPs for which you are seeking approval in this project in the table below and attach a
copy to this application.
Title of New SOP
Purpose
Are you willing for
this SOP to be made
available to other
research groups on
the ACEC website?
Yes/No
2.3 Techniques
(i)
Are there any aspects of the procedure or techniques being developed as part of this project that have
not been previously described in the literature?
No
(ii)
Yes. If yes, this project must be submitted as a pilot project and advice must
be sought from the Animal Welfare and Training Manager.
Are there any aspects of the procedure or techniques being developed as part of this project that have
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not been previously used in your laboratory with ACEC approval?
No
Yes. If yes, this project must be submitted as a pilot project and advice must
be sought from the Animal Welfare and Training Manager.
Section 3: Justification for animal numbers
Provide justification for the number of animals requested on the basis of experimental design and statistical
considerations that the number of animals requested is the minimum number to achieve the stated project
aims and statistically valid results. Present the numbers in each group in table or flowchart form, where
appropriate. Use statistical predictions as much as possible.
Prepared by: Name
Version
Date
Section 4. Attachments
Click on the link below to take you directly to the attachment. Delete those attachments you do not need.
Attachment A:
Attachment C:
Attachment D:
Attachment E:
Attachment F:
Attachment G:
Attachment H:
Attachment I:
Attachment K:
Attackment L:
Attachment M:
Attachment N:
Authorisation for Animal Treatment
Non Survival surgery (use only when an SOP for this procedure is NOT referenced)
Survival Surgery (use only when an SOP for this procedure is NOT referenced)
Use of anaesthesia not associated with surgery (use only when an SOP for this procedure is
NOT referenced)
Blood collection other than terminal (use only when an SOP for this procedure is NOT
referenced)
Polyclonal antibody production (use only when an SOP for this procedure is NOT referenced)
Administration of substances
Animals with altered genetic makeup (genetically modified or naturally occurring mutation)
Transport of live animals during the project
Death as an end-point or LD50 tests (This does not refer to the planned euthanasia of an
animal at the conclusion of a study Requires ministerial approval)
Mandatory studies required for registration of a product or by an external body
Re-use of animals that have been the subject of a previous scientific or teaching activity
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT A: Authorisation for Animal Treatment.
MUST BE COMPLETED WHERE ANIMALS ARE HELD IN UoN FACILITIES.
Animal Services Unit staff will place this form in the red monitoring folders for the project for ease of reference
if an animal requires attention.
Project Title:
Attempt to contact the following personnel (from “Monitoring Animals” section of New application
form)
Name
B/H Phone
A/H Phone
Email
If the above personnel cannot be contacted send an email to the Chief Investigator and above contact
personnel and:
A1.
For animal found dead. (Mark all that apply)
Dispose of as appropriate
Place in refrigerator for Post Mortem
Collect tissues as described below.
A2.
For Animal found moribund- collapsed, unconscious.
Contact veterinarian# (as per Procedure for emergency veterinary treatment)
Euthanase* and place in refrigerator for post mortem
Euthanase* and dispose of as appropriate
Euthanase and collect tissues as described below
A3.
For animal found sick or with significant injury.
Contact veterinarian# (as per Procedure for emergency veterinary treatment)
Follow actions described in ACEC approved monitoring checklist
Euthanase* and place in refrigerator for post mortem
Euthanase* and dispose of as appropriate
Euthanase and collect tissues as described below
A4.
If and animal is found dead or must be euthanased by Animal Services staff or the veterinarian please
detail the required collection of samples below. If fixative or sterile containers are required, please ensure that
you provide these to Animal Services Staff in case they are needed. Samples will only be collected by ASU
staff if they are confident in the procedure required.
A5. The above actions are authorised by the Chief Investigator for this project: (please tick)
*Notes:
1. Animal Services Unit staff will only be able to euthanase animal using a method with which they are
competent. For rats, mice and guinea pigs this will be via carbon dioxide inhalation. For other species
please discuss methods with ASU staff. If the required method is one with which the Animal Services
staff are not competent a veterinarian will be called in to carry out the euthanasia.
2. The Chief Investigator must submit an adverse event report to the ACEC
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# The cost of an out of hours veterinarian will be charged to the Chief Investigator.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT C: Non-survival surgery
May be replaced by an SOP- (SOP TEMPLATES)
C1. SPECIES:
If more than one species, please provide the following information for each species.
C2. Persons with primary responsibility:
Surgeon:
Person responsible for anaesthetic induction
and monitoring of the animal during surgery:
C3. Describe the surgical procedure in detail.
C4. Site of operating room.
C5. Pre-operative procedures. What procedures will be performed to prepare the animal for surgery (eg.
fasting, withholding of water, placement of vascular catheters)?
C6. Anaesthesia. Give details of the anaesthetic agent(s) and technique to be used. Include details of preoperative sedatives or tranquilisers.
Reference: http://www.newcastle.edu.au/research/animal/acecpol.html#anaesthesia
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration, and frequency
(eg. 30 minutes pre-operative, to induce
anaesthesia, during procedure, at specific
intervals during the procedure)
C7. Intra-operative medications. Provide details of any other intra-operative medications that will be
administered to the animal during surgery (eg. paralysing agents, fluids, antibiotics. Do not include
experimental drugs).
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration, and frequency
(eg. at beginning of procedure, at specific
intervals during the procedure)
C8. Are any of the above medications considered paralysing agents? If YES, why do you need to use a
paralysing agent? Note: Neuromuscular blocking agents must not be used without adequate general
anaesthesia, or an appropriate surgical procedure that eliminates sensory awareness.
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C9. Monitoring. What clinical or physiological criteria will be used to monitor the depth of anaesthesia and
general wellbeing of the animal during surgery? Please attach copies of any forms used for intraoperative monitoring.
C10.Physical support. What physical methods will be used to support the animal during surgery (eg.
heating pads, blankets, etc.)?
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT D: Survival surgery
May be replaced by an SOP- (SOP TEMPLATES)
D1. SPECIES :
If more than one species, please provide the following information for each species.
D2. Persons with primary responsibility:
Surgeon:
Person responsible for anaesthetic induction
and monitoring of the animal during surgery:
Person responsible for post-operative care:
D3. Will more than one major survival surgery be performed on each animal?
Yes
No
If Yes:
(i) Provide a complete scientific justification for performing more than one major survival surgery on an
individual animal.
(ii)
Give the interval(s) between the multiple surgeries, and the rationale for choosing the interval(s).
(iii) How will you ensure that the animal has recovered to good general health between each procedure?
If more than one survival surgical procedure will be performed, provide complete details for each
procedure OR complete a separate Attachment D for each procedure.
D4. Describe the surgical procedure in detail.
D5. Site of operating and recovery rooms.
D6. Pre-operative procedures. What procedures will be performed to prepare the animal for surgery (eg.
fasting, withholding of water, placement of vascular catheters)?
D7. Anaesthesia. Give details of the anaesthetic agent(s) and technique to be used. Include details of preoperative sedatives or tranquilisers.
Reference: http://www.newcastle.edu.au/research/animal/acecpol.html#anaesthesia
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration, and frequency
(eg. 30 minutes pre-operative, to induce
anaesthesia, during procedure, at specific
intervals during the procedure)
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Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration, and frequency
(eg. 30 minutes pre-operative, to induce
anaesthesia, during procedure, at specific
intervals during the procedure)
D8. Analgesia. Unless scientifically or otherwise justified to the ACEC’s satisfaction, you are obligated to
routinely provide pain relief for all vertebrate animals undergoing survival surgery.
Will analgesics be used to provide post-operative pain relief?
Yes
No
If NO: Provide justification for not providing analgesia.
If YES: Provide details:
Drug name
Dose rate
(generic name,
(mg/kg body
weight)
not trade name)
Route
Timing of administration & frequency
(eg. 30 minutes pre-operative, during
procedure, immediately postoperative, every 12 hours postoperatively)
Duration
(eg. days)
D9. Preparation of the surgical site. Describe how the surgical site(s) will be prepared prior to surgery (eg.
removal of hair or feathers, disinfection of skin).
D10.Sterile field. Describe the procedures that will be followed to ensure maintenance of a sterile field during
surgery (eg. disinfected/sterile operating area; surgeon's cap and face mask; sterile gown, gloves, drapes
and instruments). Note: Aseptic technique must be used on ALL animal species.
D11.Intra-operative medications. Provide details of any other intra-operative medications that will be
administered to the animal during surgery (eg. paralysing agents, fluids, antibiotics. Do not include
experimental drugs).
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration, and frequency
(eg. at beginning of procedure, at specific
intervals during the procedure)
D12.Are any of the above medications considered paralysing agents? If YES, why do you need to use a
paralysing agent? Note: Neuromuscular blocking agents must not be used without adequate general
anaesthesia, or an appropriate surgical procedure that eliminates sensory awareness.
D13.Monitoring. What clinical or physiological criteria will be used to monitor the depth of anaesthesia and
general wellbeing of the animal during surgery? Please attach copies of any forms used for intra-
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operative monitoring.
D14.Physical support. What physical methods will be used to support the animal during surgery (eg.
heating pads, blankets, etc.)?
Post-operative care:
D15.How long will the animal survive after surgery? (If multiple surgeries are planned, answer for the last
surgery before euthanasia.)
D16.Describe the post-operative care:
(i)
During the first 24 hours. Include plan for monitoring, antibiotics, fluids, methods to maintain body
temperature etc.
(ii)
Thereafter. Include plan for monitoring (particularly for procedure-related complications), suture removal,
special feeding, special housing etc.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT E: Use of anaesthesia not associated with surgery
(survival or non-survival)
May be replaced by an SOP- (SOP TEMPLATES)
E1. For which procedure(s) will anaesthesia be used? If more than one, provide the following details for
each procedure or complete a separate Attachment E for each procedure.
E2. Anaesthesia. Give details of the anaesthetic agent(s) and technique to be used. Include details of
sedatives or tranquilisers.
Species
Drug name
(generic name,
not trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration & frequency
(eg. 30 minutes pre-operative, to
induce anaesthesia, to maintain
anaesthesia, at specific intervals
during the procedure)
E3. Monitoring. What clinical or physiological criteria will be used to monitor the depth of anaesthesia and
general wellbeing of the animal during the anaesthesia? Please attach copies of any forms used for
anaesthetic monitoring.
E4. Is this a recovery procedure? If YES, please detail how the animal will be monitored to ensure
satisfactory recovery from anaesthesia.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT F: Blood collection
May be replaced by an SOP- (SOP TEMPLATES)
This attachment does NOT apply to terminal blood collection at the time of euthanasia of the animal. Details of
terminal blood collection should be provided in the body of the application.
F1. From which species will blood be collected?
If more than one species, please provide the following information for each species.
F2. From which anatomical location will blood be collected?
F3. Will the animal be sedated during the procedure? If YES, provide details below:
If Yes, provide DETAILS:
Species
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing of administration and
frequency?
F4. Will the animal be anaesthetised during the procedure? If YES please complete Attachment E.
F5. Detail the total number of blood collections, and the time interval between each collection.
F6. What volume of blood will be collected on each occasion?
F7. What percentage of the animal’s circulating blood volume does this volume represent? (Note: In most
species, total blood volume is approximately 70 mls/kg body weight.)
F8. How will the animal be monitored for the effects of acute and/or chronic blood loss?
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT G: Polyclonal Antibody Production
G1. What species will be used?
If more than one species, please provide the following information for each species.
G2. List antigen(s).
G3. List or describe adjuvants.
Initial immunisation
Subsequent immunisations
G4. Provide details of immunisations.
Anatomic site/route
Number of sites
Volume administered per injection
site
Total volume administered at one
time
Time interval between each
immunisation
Total number of immunisations
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT H: Administration of substances (investigational substances
only - do not include drugs used for anaesthesia, euthanasia, analgesia etc)
H1. Please give the following details for each substance to be administered:
Species
Name of Compound / Agent
Vehicle
Route of administration
Dose rate (eg mg/kg body
weight)
Volume administered
Frequency of administration
Purpose
Likely or anticipated effects in
terms of the experiment (eg.
effects on physiology, immune
system, function of organ
system)
Likely or anticipated effects on
the welfare of the animal
Possible health and safety
issues for personnel working
with this substance
Previous experience with the
use of this compound?
For additional substances, copy the table above and complete.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT I: Animals with altered genetic make-up (manipulated,
modified, naturally-occurring mutation)
(For the purpose of this document Strain is defined as: A group of animals developed by breeding to maintain certain defining
characteristics. Note: When cross breeding two different strains (outcrossing), the offspring is considered to be a different strain from
either of the parental strains. Where the cross produces offspring with segregating genotypes (eg homozygous, hemi-/heterozygous or
wild-type for any of the genes) all individuals are considered members of the same strain.)
1. Please indicate which of the following is involved with this project:
Use of an existing genetically modified strain.
Production/creation and use of a new genetically modified strain of animal (Including outcrossing or
backcrossing onto a different background strain)
Use of animals with a naturally occurring mutation.
2. Explain the relevance of the genetic modification (s) to this project (in plain English).
(Where more than one genetically modified strain is used in this project, provide this information for each strain used).
3. Describe the method of collection of tissue used for genotyping in this project
(Note: The ACEC expects the use of the least invasive method of tissue collection ag swabbing, collection of ear punch tissue. Please
justify the use of more invasive methods.)
4. What will be the fate of animals that are not of the appropriate genotype in this project?
(If this differs between strains, describe the fate on a strain by strain basis)
5. Does an ACEC approved ‘Animal Wellbeing Phenotype Report’ exist for the genetically modified strains
used in this project? (Approved Animal Wellbeing Phenotype reports are available at:
http://www.newcastle.edu.au/research-and-innovation/resources/animal-ethics/standard-operatingprocedures/animal-wellbeing-phenotype-reports.
Yes. Please provide the Phenotype reference number and Nickname (common name)
below for all animals with an existing phenotype report. If all animals are covered by
an existing phenotype report you have now completed this attachment.
No . Please complete the “Animal Wellbeing Phenotype Report” that appears over the
page. Copy and complete a separate phenotype report for each NEW genetically
modified strain used in this project.
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University of Newcastle Animal Care and Ethics Committee
ANIMAL WELLBEING PHENOTYPE REPORT
Animals with altered genetic make-up (manipulated, modified, naturally-occurring mutation)
ACEC Use ONLY
Phenotype Report Number
Date Approved:
Date for Review:
PR Reference
(for use in ACEC applications):
Version Number:
1. Strain Details
Species
Description of the mutation(s),
genetic modification(s), or allele
nomenclature (genotype)
Genetic background strain
Nickname (s) (if relevant)
Origin (e.g., supplier, JAX Mice stock
#, EMMA strain ID)
2. How much is known about the biological characteristics/phenotype of this strain?
Well characterised
Partially-characterised/some information available
Unknown
3. Provide references to publications describing the creation of this animal or its characterisation. If this
information is not available indicate the approximate date this genetic modification was created or discovered.
4. How many generations of this genetic modification or mutant animal have been produced?
5. Briefly describe the function of the gene(s) that have/will be modified or have mutated.
6. What organs/tissues are affected (eg. gene expressed in liver only)
.
7. What abnormalities are known to exist, or do you expect, in these animals (eg. behaviour, physiology,
reproductive or developmental measures). Your answer to this question should inform the AEC about
abnormalities or changes which have an animal wellbeing or welfare impact.
8. Describe any problems with the breeding of heterozygous or homozygous animals (e.g. subfertility,
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lactation defects)?
9. Describe any exceptional housing requirements (e.g., IVCs or isolators, bedding, medicated feed or
water)?
10. Describe any special husbandry or care procedures required to minimise adverse effects of the genetic
modification?
11. Does this animal require a specific monitoring checklist for known animal wellbeing effects?
Yes. Attach the specific monitoring checklist to this attachment.
No. Ensure that a standard general health monitoring checklist is included with your ACEC
application so that unexpected animal wellbeing impacts are identified, recorded and
appropriate action taken.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT K: Transport of animals
K1.
Species:
If more than one species, please provide the following information for each species.
K2.
Where will the animals be taken from, and where will the animals be taken to?
K3.
How will they be transported? Provide details of type of caging/ restraint used during transport, and
type of vehicles used (if any).
K4.
Will food and water be provided? If Yes, please describe.
K5.
How long will they be held outside of the animal facility?
K6.
Will live animals be returned to the animal facility?
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT L: Projects that require death as an end-point, or include LD50
tests
This attachment applies to situations where the death of an animal is the deliberate measure used for
evaluating biological or chemical processes, responses or effects. That is, where the investigator or teacher
will not intervene to euthanase the animal before death occurs in the course of a scientific activity. Death as
an end-point must be avoided whenever possible. Ministerial approval is required for the conduct of
lethality or LD50 tests. This attachment does not apply to the planned euthanasia of an animal at the
conclusion of a study.
L1. Are these tests required by State or Commonwealth legislation? If YES, give details of the relevant
legislative provisions.
L2. Are these tests required for export of the compound being tested? If YES, name the countries that
require these tests.
L3. What alternatives are available to avoid the use of death as an endpoint? (For example, use of clinical,
biochemical or pathological changes as an indicator of the potency of the compound).
L4. What are the anticipated immediate and delayed effects of the compound on the health and well-being of
the experimental animals?
L5. Will analgesia or anaesthesia be used? If YES, provide details below. If NO, why not?
If Yes, provide DETAILS:
Species
Drug name
(generic name, not
trade name)
Dose rate
(mg/kg body
weight)
Route
Timing and frequency of
administration? Include stage of
experiment.
L6. Describe the level of care and supervision that will be given to animals that develop clinical illness during
the study.
L7. How many animals are expected to die with acute toxicity in the course of the experiment?
L8. What provisions have been made to treat or euthanase animals adversely affected by the procedures?
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT M: Mandatory studies required for registration of a product or
by an external body (eg. TGA, NRA, FDA, Human Ethics Committee)
M1. Please indicate the nature of the study:
Registration of a product
Preclinical human trial
Other - please describe.
Other details as requested:
M2. What is the name of the external body that requires these studies?
M3. Provide details/evidence of the requirements of the external body that support the experimental design
described in this application (eg. name of policy document or guidelines). Attach a copy of documentation
that outlines these requirements.
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Please DELETE this attachment if it is not relevant to your application.
ATTACHMENT N: Re-use of animals
N1. Please provide details of the animals involved.
Animal
Strain/Type
Age/Size
range
Sex
M/F/An
y
SPF #
(Y/N)
Genetic
Status
(N/M/GM)
Number
# Specific Pathogen Free
 N = Normal; M = naturally occurring Mutation: GM = Genetically modified.
N2. Provide the title of the previous project.
N3. Provide the ACEC Approval Number of the previous project.
N4. What was previously done to these animals?
N5. Provide details of the current condition of the animals.
N6. Justify their use in this project.
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