Amendment MAJOR - Change to Approved Protocols

advertisement

Animal Ethics Committee

AMENDMENT TO APPROVED ANIMAL ETHICS PROJECT – MAJOR

[Do not print this form. Fill it in with MS-Word, approvers to enter name with comments.]

FILE REF: RA/3/

OFFICE USE ONLY (November 2015)

AMENDMENT

#

[ ] Approved

CHAIR AEC: DATE:

It is a requirement of the Animal Ethics Committee (AEC) that the Chief Investigator consult with one of the following people before lodging an Amendment form for consideration by the AEC.

 Animal Welfare Veterinary Advisors 6488 4549 / 4700

 Animal Welfare Officer 6488 7882

vets-research@uwa.edu.au awo@uwa.edu.au

PLEASE INDICATE ALL CATEGORIES WHICH ARE APPLICABLE TO THIS MAJOR AMENDMENT (  )

Extension of Approval Period

Increase in Animal Numbers (signature ACS TIC required)

Section 1

Section 4

Change in Animal Species Not permitted via Amendment application – New application required

Addressing the three Rs - COMPULSORY

Change in invasiveness of a non-surgical or surgical procedure

MUST also Complete Section 8 - ANIMAL WELL-BEING

Addition or substitution of surgical procedure

MUST also complete Section 8 - ANIMAL WELL-BEING

Section 6

Section 8

Section 6 & 7

Animal Well-being Section 9

Other (Please specify)

Declaration – For All Investigator/s COMPULSORY Section 9

1.

PROTOCOL DETAILS

Approval No: RA/3/

Protocol Title:

Chief Investigator:

School:

AEC approval start date:

Proposed Amendment start date:

(dd/mm/yyyy)

(dd/mm/yyyy)

Approved Expiry Date: (dd/mm/yyyy)

Extension of Approval Period - Proposed New Expiry Date:

NB: Extension granted will not exceed a maximum 5 year approval period for the life of the protocol.

2.

CHIEF INVESTIGATOR DETAILS

Title, first name, last name Staff number (UWA only )

Work mailing address /school (include UWA MBDP)

Email

3.

Phone

List all changes that apply to this amendment.

Mobile

JUSTIFICATION – Detail each change proposed and provide a justification / explanation for the changes compared to the original application - How will the changes link with the original approved application.

Must be written in lay language

Where new procedures are proposed, please provide details of specific training and competency of the individual performing these procedures

4. ANIMAL SUMMARY - CURRENTLY APPROVED COMPULSORY SECTION

*Animal Species Categories available at: http://www.research.uwa.edu.au/staff/forms/animals

Common species name

Mouse

Species

Category

*

01

Scientific name

Background

Strain

Mus musculus C57BL/6J

Full Research

Nomenclature

C57BL/6J MexTAg

Also Known As

(AKA)

MexTAg

Total

Numbers

6

Total number of all animals =

ANIMAL SUMMARY – REVISED TOTALS FOR APPROVAL COMPULSORY SECTION

(Total Number of Animals in the whole project)

Common species name

Species

Category

*

Scientific name

Background

Strain

Full Research

Nomenclature

Also Known As

(AKA)

Mouse 01 Mus musculus C57BL/6J C57BL/6J MexTAg MexTAg

Total

Numbers

6

Revised total number of all animals (over the life of the project) =

Source Vendors:

OGTR / Department of Agriculture, Fisheries & Forestry (DAFF) Biosecurity restrictions

Yes [ ] No [ ]

A RE THE PHENOTYPES OF THE REQUIRED ANIMALS NORMAL OR MODIFIED ?

NOTE: if new strains are a modified phenotype, a phenotype report must be attached.

NORMAL

[ ]

MODIFIED

[ ]

Animal Care Services (ACS) Technician-In-Charge - COMPULSORY SECTION

[Technician to comment and state approval and any conditions in this space – TIC: please include your name and date]

For sections with no change please indicate as NO CHANGE (except compulsory sections)

4.

HOUSING AND LOCATION OF ANIMALS (SIGNATURES REQUIRED)

UWA Animal Care Services (ACS)  OTHER Facilities / locations: 

A Block, QEII Medical Centre

M Block, QEII Medical Centre

Biomedical Research Facility, Shenton Park

Biological Resources Support Facility

Shenton Park

Harry Perkins Institute , QEII (QQ)

Z Block - Fremantle Hospital

Aquatic Research Facility (School of Animal Biology)

Aquaculture and Native Fish Breeding

(Shenton Park)

Документ1 updated 11 December 2015

Sheep Research Facility (SRF), Shenton Park

Pre-Clinical Facility (PCF), Crawley Campus

Large Animal Facility (LAF), Crawley Campus

Other -

Please provide details

Facility room number/zone

Ridgefield Farm (Pingelly)

Harry Waring Marsupial Reserve (Wattleup)

Ernest Hodgkin Marine Laboratory (Watermans)

Species

(and/or strain if applicable)

Gender

Age or initial weight

Reproductive status

Director UWA (DACS) Facilities /

Curator of other site or facilities

Name and Date

[Email this file to DACS or Curator.

DACS / Curator: Please print:

Name, Approval and Date]

A.

W HAT IS THE M AXIMUM L ENGTH OF H OLDING IN W EEKS ?

B.

W HAT ADDITIONAL ENRICHMENT WILL BE PROVIDED FOR ANIMALS WHICH WILL BE HELD LONGER THAN 3

MONTHS ?

C.

P LEASE DETAIL THE METHOD OF TRANSPORT AND ANY ANIMAL WELFARE IMPLICATIONS :

Transport and acquisition permits/approvals are attached [ ]

5.

ADDRESSING THE THREE R’S – COMPULSORY SECTION

How will this amendment affect the three R’s of Reduction, Refinement & Replacement?

How are the 3R’s, addressed in this amendment?

A.

REPLACEMENT - describe the alternatives to animal use that you have considered and/or adopted.

B.

REDUCTION - describe the ways this amendment will minimise the use of animals.

C.

REFINEMENT – describe the ways this amendment will minimise the adverse impact of the intended project on animals.

6.

NON SURGICAL PROCEDURES – GIVE DETAILS OF CHANGE

Full description of changes to

non-surgical

procedures as listed in the BELOW.

If substances are being administered to animals please include details of route, volumes, frequency, intervals and duration.

Summary description of changes to

non-surgical

procedures.

Документ1 updated 11 December 2015

Type of non-surgical procedure to be carried out e.g. gavage

Expected impacts of the procedure

Minor discomfort rarely substance enters airway or oesophagus is damaged

Expected frequency of adverse impacts

Some discomfort on each occasion. Substance in airway or oesophageal damage in less than

1 in 1000 administrations.

Who will perform these new procedures?

Provide details of their skills and specific training and competency in these procedures

7.

SURGICAL PROCEDURES – GIVE DETAILS OF CHANGE

Full description of changes to all

surgical

procedures listed BELOW

Refinement taken to minimise impacts

Good handling to minimise discomfort and observation after dosing with humane killing of any animal showing signs of mis-dosing or damage.

Type of surgical procedure to be carried out e.g. insertion of catheter

Expected impacts of the procedure

Pain

Expected frequency of adverse impacts

Always

Refinement taken to minimise impacts

Analgesia

Who will perform these new procedures?

Provide details of their skills, specific training and competency in these procedures

ANAESTHETICS AND NEUROMUSCULAR BLOCKADE

Species e.g. Rat

Agent (s) Dose Route

Ketamine

Xylazine

80 mg/kg

10 mg/kg ip ip

Frequency

Once only

Duration

Single injection is sufficient for the 10 minute procedure

Who will perform these new procedures?

Provide details of their specific training and competency in these procedures

ANALGESICS DETAIL CHANGES TO Analgesics to be used intra - and post-operatively

Species e.g. Mouse

Agent buprenorphine

Dose

0.05-0.1mg/kg

Route

Sub cut

Frequency & Duration

Initial dose given at induction of anaesthesia then continued every

8 hours for 3 days post-op

Who will perform these new procedures?

Provide details of their specific training and competency in these procedures

8.

ANIMAL WELL-BEING - Give details

A.

Post-procedural pain and distress – How will pain and distress be monitored, scored and treated

Документ1 updated 11 December 2015

B.

Monitoring schedule – Provide a Post-Procedural Monitoring Sheet and /or Long Term Monitoring Sheet

C.

Criteria for Euthanasia - How will animals be assessed for euthanasia

D.

What % of animals do you expect to die or require intervention euthanasia during this

project? Please explain likely reasons for the anticipated loss rate.

Potential cause of death or euthanasia e.g. vessel rupture

Impact on welfare irreversible haemorrhage

Steps taken to minimise impact Percentage of animals affected

<1% haemorrhage apparent to surgeon, animal would be euthanased whilst still under general anaesthesia

Документ1 updated 11 December 2015

9.

DECLARATION

As chief investigator, I declare that I

(i) have read and agree to abide by the conditions and constraints of the Australian Code for the Care and Use of Animals for Scientific Purposes (8 th edition, 2013);

(ii)

(iii) acknowledge that the information contained in this form is a true and accurate record; understand any non-compliance with

‘The Code’

must be reported immediately to the AEC and may result in the withdrawal of project approval and possible disciplinary action;

(iv) understand that in keeping with AEC and ACVS policy, all animals are to be monitored as detailed in the application. The Animal Welfare Officer (AWO) has the authority to euthanase distressed animals. Every attempt will be made to inform the (CI) before any action is taken;

(v) understand It is the responsibility of the CI to maintain animal record and to supply annually, an Annual

Report on animal usage to the AEC;

(vi) understand that in the event of an animal death, or an unplanned euthanasia, we will immediately report the death to the AWO, complete a Notification of UNEXPECTED DEATH FORM and email to AWO within 48 hours, and arrange for an autopsy to be carried out and the results of the autopsy report to be sent to the AWO;

(vii) will ensure that the qualifications and/or experience of all listed personnel are appropriate to the procedures to be performed;

(viii) certify that the resources in the School or department, including housing and personnel, are appropriate for the welfare of the animals and the satisfactory completion of the project.

(ix)

have obtained agreement from all research personnel listed on this application that they agree to all of the above statements of declaration.

I agree to all of the above

CHIEF INVESTIGATOR

[Type name - do not sign and/or scan ]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

CO-INVESTIGATOR

[Type name - do not sign and/or scan]

Head of School

As Head of the School (or Acting), I acknowledge that I have reviewed this application and I confirm that sufficient financial and other resources are available to enable the research to occur in compliance with the Regulations above.

A review of this application has taken place within the school / faculty.

HEAD OF SCHOOL/(*DEAN OF FACULTY) Acting

[ Type name, do not sign and/or scan and email to aeo@uwa.edu.au

]

SUBMISSION OF APPLICATION – PLEASE EMAIL THIS FORM TO:

aeo@uwa.edu.au

UWA policy deems this document as signed if you type your name and send it attached to an email. Please send the documents as MS-Word or pdf, NOT Scanned!

Документ1 updated 11 December 2015

Download