17 8 915 16 182022242627

Days 1-7: Acclimatisation period.

Surgery1. Subcutaneous administration of substance “X” or saline AND2. Collection of blood

Euthanase

Recovery from surgery: days 9-15

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 InvestigatorTitle 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-by-step 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.

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2.2 Specific Procedures

2.2.1 Indicate whether the project application includes any of the following attachments. The appropriateattachment must be appended to this supplement. Delete attachments that do not apply.

Tick those that apply

Attachment Title

A Authorisation for animal treatmentC Non-survival surgeryD Survival surgeryE Use of anaesthesia not associated with surgery (survival or non-survival) F Blood collection (other than terminal collection)G Polyclonal antibody productionH Administration of substances I Animals with altered genetic make-up (manipulated, modified, naturally-occurring

mutation)K Transport of live animals at any time during the projectL 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 ) M Mandatory studies required for registration of a product or by an external body (eg. TGA,

NRA, FDA, Human Ethics Committee)N Re-use of animals that have been the subject of a previous scientific or teaching activity

2.2.2 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/animal-ethics/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 SOP APPROVAL NUMBER DATE SOP APPROVED

2.2.3 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

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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 Yes. If yes, this project must be submitted as a pilot project and advice must be sought from the Animal Welfare Officer.

(ii) Are there any aspects of the procedure or techniques being developed as part of this project that have 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 Officer.

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: Authorisation for Animal Treatment Attachment C: Non Survival surgery ( use only when an SOP for this procedure is NOT referenced ) Attachment D: Survival Surgery ( use only when an SOP for this procedure is NOT referenced ) Attachment E: Use of anaesthesia not associated with surgery ( use only when an SOP for this procedure is

NOT referenced ) Attachment F: Blood collection other than terminal ( use only when an SOP for this procedure is NOT

referenced ) Attachment G: Polyclonal antibody production ( use only when an SOP for this procedure is NOT referenced ) Attachment H: Administration of substances Attachment I: Animals with altered genetic makeup (genetically modified or naturally occurring mutation) Attachment K: Transport of live animals during the project Attackment L: 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 ) Attachment M: Mandatory studies required for registration of a product or by an external body Attachment N: 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 appropriatePlace in refrigerator for Post MortemCollect 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 mortemEuthanase* and dispose of as appropriateEuthanase 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 checklistEuthanase* and place in refrigerator for post mortemEuthanase* and dispose of as appropriateEuthanase 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

# 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 pre-operative 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 intra-operative 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 surgeryMay 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 pre-operative 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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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

(generic name, not trade name)

Dose rate (mg/kg body

weight)

Route Timing of administration & frequency(eg. 30 minutes pre-operative, during

procedure, immediately post-operative, every 12 hours post-

operatively)

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-operative monitoring.

D14.Physical support. What physical methods will be used to support the animal during surgery (eg. heating

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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 collectionMay 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 siteTotal volume administered at one timeTime interval between each immunisationTotal 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:

SpeciesName of Compound / AgentVehicleRoute of administrationDose rate (eg mg/kg body weight)Volume administeredFrequency of administrationPurposeLikely 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 animalPossible health and safety issues for personnel working with this substancePrevious 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-operating-procedures/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 REPORTAnimals with altered genetic make-up (manipulated, modified, naturally-occurring mutation)

ACEC Use ONLYPhenotype Report Number Version Number:Date Approved:Date for Review:PR Reference(for use in ACEC applications):

1. Strain DetailsSpeciesDescription of the mutation(s), genetic modification(s), or allele nomenclature (genotype)Genetic background strainNickname (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 characterisedPartially-characterised/some information availableUnknown

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, lactation defects)?

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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 testsThis 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 productPreclinical human trialOther - 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

SexM/F/Any

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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