Animal Ethics Committee

The St Vincent’s Hospital Animal Ethics Committee (AEC) is responsible for ensuring that all activities relating to the care and use of animals are conducted in compliance with the ‘Australian code for the care and use of animals for scientific purposes’ 8th Edition 2013.

All research and teaching involving the use of animals must receive approval from the St Vincent’s Hospital AEC before commencing.

 

Terms of Reference 2015

AEC Committee Composition

 

Meeting dates:

2018 AEC Meeting Dates / Agenda Closing Dates 

The AEC reviews research projects for conduction at the following sites:  

  • St Vincent's Hospital, Fitzroy campus
  • St Vincent’s Institute
  • O’Brien Institute
  • Bionics Institute
  • University of Melbourne at St Vincent’s   
  • Centre for Eye Research Australia

For further information, please contact Melanie Asquith, AEC Secretary on 03 9288 3872 or email research.ethics@svhm.org.au


Quick links

New Applications

Types of Applications

  • An application may be classified as:
  • New Project Application
  • Amendment to approved project
  • New Breeding Application (GBVML)
  • Transfer of a GBNML to an SABC

Writing an Application

As of 1 January 2014 new project applications will no longer be submitted via Tierbase.

All new project applications must be submitted by downloading and completing the new AEC Project Application form

Please note:

  • The entire AEC Project Application form must be written using lay language and where the use of scientific language is unavoidable it must be supported by a suitable lay description or glossary of terms.
  • An answer must be provided for every question (state “not applicable” if required)
    AEC Project Application form must be saved as macro-enabled document to ensure drop down boxes are functional (there may be some formatting issues if using Mac computer)
  • If you experience difficulty with the drop down boxes not working, please copy and paste your selections using the drop down menu in the 'Help' document.

New Scientific Applications

All new applications should be submitted by the monthly submission closing date:

2016 AEC Meeting Dates / Agenda Closing Dates

Please ensure the following standard templates are used when writing a new application:

The following hard copies are required:

  • Cover Sheet - 1 hard copy
  • AEC Project Application Form -  1 original and 18 double sided copies
  • Letter from Radiation Safety Officer (as applicable) - 1 hard copy
  • Fieldwork Notifcation Form (as applicable) - 1 hard copy

 

NB – Incomplete applications cannot be accepted and will be returned to the research team.
      
Please ensure all signatures are included, most importantly:

  • the Principal Investigator
  • the Head of Department  
  • the Head of the Supporting Department – the BRC or EMSU

New Breeding Application (GBNML)

The GBNML (Generate and Breed New Mouse Line) forms have recently been revised and updated.

There are now two GBNML application forms:

  • Application to generate and breed a new mouse line (Single GBNML) To be completed when requesting to generate and breed a single new mouse line.
  • Application to generate and breed new mouse lines (Multiple GBNMLs) To be completed when requesting to generate and breed multiple mouse lines, up to six lines can be included in this new form.

This form should make it easier to apply to generate mouse lines that are similar (e.g. linked to same protocol, similar phenotype, etc.)

Please note that GBNML approvals are now for three years and 1000 animals.

Once the phenotype is established/characterised an application to the AEC can be submitted to transfer the line to Specified Animal Breeding Colony Group (SABC).

Please ensure the correct symbols are used by consulting the Mutation Type / Gene Symbol List    

Please ensure the following standard templates are used when writing a new breeding application:
 

All new breeding applications (Generate and Breed a New Mouse Line, GBNML) should be submitted by the submission closing date.
 

2016 AEC Meeting Dates / Agenda Closing Dates

The following hard copies are required:

  • Cover Sheet - 1 original hard copy
  • Application to Generate and Breed a New Mouse Line (GBNML) (Single or Multiple) - 1 original and 18 double sided options

A GBNML Renewal form has recently been introduced and is to be used to renew GBNML projects where further time is required to establish/characterise the phenotype of the line.
GBNML’s can be renewed for three years, although as soon the phenotype is characterised, an application to transfer the GBNML to SABC should be submitted to the AEC.

There are two types of GBNML renewals:
 

  1. GBNML renewal with no additional animals requested: Application is reviewed by AEC Executive. No additional animals are required as the balance of the original approved number of animals is sufficient to establish/characterise the line. There is no closing date for submission, submit original application only.
  2. GBNML renewal with additional animals requested: Application is reviewed at quorate AEC meeting. Additional animals are required to continue to establish/characterise the line.

Submit the required copies by the meeting closing date:
 

2016 AEC Meeting Dates / Agenda Closing Dates

 

 

 

Transferring a GBNML to an SABC (Specified Animal Breeding Colony)

All transfers of a GBNML to an SABC should be submitted by the submission closing date:

2016 AEC Meeting Dates / Agenda Closing Dates

A “Specified Animal” includes guinea pigs, rats, mice or rabbits (other than a rat, mouse or rabbit bred in the wild) and non-human primates. “Specified animals” held for stock maintenance and/or routine breeding (i.e. they are no longer being bred as part of a research project and the line is well phenotyped) should be transferred from a GBNML to an SABC. This transfer must be reviewed by the AEC.

Please ensure the following standard templates are used when writing a new application

The following hard copies are required:

  • Cover sheet - 1 original hard copy
  • Application to Transfer a GBNML to an SABC - 1 original and 18 double sided copies

All documents must be submitted in hard copy by the agenda closing date.

 

Transfer of an Established Strain from Another Institution (SABC)

This transfer must be reviewed by the full AEC.
Please complete the following templates if you wish to transfer an established strain from another institution to STV:
 

The following hard copies are required:

  • Cover Sheet - 1 original hard copy
  • Application to Transfer an Established Strain from Another Institution (SABC) - 1 original and 18 double sided copies

All documents must be submitted in hard copy by the agenda closing date.

2016 AEC Meeting Dates / Agenda Closing Dates 


Applications should be submitted to:

Research Governance Unit
Building E - Aikenhead Building, Level 5
27 Victoria Parade, FITZROY
Or:
Research Governance Unit
St Vincent's Hospital
PO Box 2900
FITZROY VIC 3065

For further information, please contact Melanie Asquith, AEC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

Amendments

An amendment is any proposed change to a current approved project. There are two types of amendments, minor change (does not raise ethical issues) and modification (raises ethical issues).  All amendments must be reviewed by the Animal Ethics Committee either by Executive (minor change) or at a quorate meeting (modification).

For projects submitted and approved on Tierbase amendments will continue to be submitted as per usual (via Tierbase). For projects submitted on the recently introduced word doc application form amendments are to be submitted using the new Application for Amendment to Approved Project Form. Proposed changes are also to be included in a revised version of the protocol with changes highlighted in bold.

Minor Change

A minor change does not raise any ethical issues and can include:

  • a different strain of animals
  • substitution of agents with similar ones
  • change in procedure/technique provided it doesn’t increase BAW impact

Minor changes are reviewed by AEC Executive and noted by the AEC at the next quorate meeting. There are no closing dates for submissions; requests can be submitted at any time.


For minor changes (projects submitted via Tierbase), please submit the following:

  • Cover Sheet - 1 original hard copy
  • Summary of changes (as generated by TierBase - 1 original hard copy
  • Revised Application Form (as generared by TierBase) - 1 original hard copy

Please ensure your revised application is signed by the Principal Investigator and Animal House Manager/Technician

For guidance on submitting a minor change on TierBase please refer to:

How to create a minor change amendment via tierbase

For minor changes (projects submitted via word doc form), please submit the following:

Please ensure your revised application is signed by the Principal Investigator
 

Modifications

A modification raises ethical issues and can include:

  • change in procedure/technique which increases impact on animals
  • additional procedure/s
  • additional animals
  • any proposed change that increases risk or impacts animal welfare

Modifications are reviewed by the AEC at a quorate meeting. Modifications must be submitted by the closing date before a scheduled meeting.

2016 AEC Meeting Dates / Agenda Closing Dates

For modifications (projects submitted via Tierbase), please submit the following:

  • Cover Sheet 
  • Summary of changes (as generated by TierBase - 1 original hard copy
  • Revised Application Form (as generated by TierBase) - 1 original hard copy

Please ensure your revised application is signed by the Principal Investigator

 

Conducting a procedure at another site (Fieldwork)

If you wish to conduct a procedure at another site (eg: imaging) you are required to complete a Fieldwork notification form.

There are no submission dates for submitting a Fieldwork notification form. Please submit at any time.

For Fieldwork, please submit the following:

  • Cover Sheet 
  • Field Notification Form - 1 original hard copy

Changing a Member of a Research Team

If you wish to change a member of the research team (either add or remove) you must notify the Animal Ethics Committee as soon as possible.

In order to notify the Committee please complete the 'Changing Members of a Research Team' form

Please ensure your revised application is signed by the Principal Investigator

All applications should be submitted to:

Research Governance Unit
Building E - Aikenhead Building, Level 5 
27 Victoria Parade, FITZROY
Or:
Research Governance Unit
St Vincent's Hospital
PO Box 2900
FITZROY VIC 3065
 

For further information, please contact Melanie Asquith, AEC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

Extensions

A request for a 6 month extension may be made to the Animal Ethics Committee.

There are no submission deadlines to request an extension. Please ensure your application is submitted to the Animal Ethics Committee at anytime before approval expires.

To request an extension to an approved AEC scientific protocol, please submit the following application:

Please ensure that the application for extension form includes:

  • The reason for extension
  • The status of project
  • The current animal usage and projected animal usage during the extension period

Please note: Extensions will not be granted to expired protocols.
Only one extension can be granted to a project. If subsequent approval is required, a full submission must be made to the AEC.


For further information, please contact Melanie Asquith, AEC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

Reporting Requirements

The following reporting requirements must be complied with for each approved protocols:

Annual Progress Report

The STV AEC Annual Progress Report is due on the anniversary of approval each year. A report should be submitted for all approved projects, regardless of whether any animals were used. A reminder will be sent to the Principal Investigator, approximately two weeks before the due date. Ethical approval may be withdrawn if a report is not received within 60 days of the due date.

Final Progress Report

The STV AEC Final Progress Report should be submitted as soon as the project is complete or has expired. This may mean that an Annual Progress Report and a Final Progress Report are submitted in the same year. If a Final Progress Report is submitted and the study complete, you will still need to include the study in the BAW Annual Return for that reporting year.

Bureau of Animal Welfare Annual Animal Use Report

The compulsory completion of a 'Return of Animal Usage for Scientific Procedures' (as required by the Bureau of Animal Welfare) must also be submitted.

Researchers will be contacted by the Research Governance Unit in December each year, with a request to complete the annual report from the Bureau of Animal Welfare. These forms be completed and returned by the deadline specified (February).

A report is to be completed for each protocol in which animals were used in the reporting year by completing the spreadsheet accordingly. If animals were not used for any protocols in the reporting year, then this spreadsheet is not required to be completed. Animals may have been used for a protocol, but not euthanized yet. These animals must be reported on the spreadsheet for this year and next year.

Please also complete the spreadsheet for each breeding colony you are responsible for. 

Please note: Animals used for breeding within an AEC-approved project are not considered to be part of a Specified Animal Breeding Colony (SABC) and must be reported as Project animals (quote GBNML #).

Researchers who fail to complete and return an annual report are in breach of the Code, and will have the approval for their project immediately withdrawn.

 

Review of Records - Monitoring

As a condition of approval, appropriate records specific to the experimental use of animals must be maintained. Records must be kept so that the experimental journey of one animal can be followed from start to finish.

To ensure this occurs researchers may be subject to random reviews of records. These reviews are regarded as a learning experience to assist and advise researchers on maintaining their records, applying for an AEC minor change or modification if the protocol changes and how to approach Adverse Incident Reporting.

Researchers who have been selected for a Research Records Review will be contacted by the AEC Secretary 1 week before the review to organise a mutually convenient time.  Up to three AEC members will then visit the department and review the research records. A report on the findings is submitted to the researcher, and the AEC.

Animal Facility Monthly Reports

(For staff working within the Animal Facility)

Researchers and personnel responsible for animal facilities are required to submit a Monthly Report.

  • As a holder of a Scientific Procedures Premises License issued by the Bureau of Animal Welfare we are obliged to keep monthly records of:
  • the number and species of specified animals on the first working day of each month
  • the number and species of specified animals sold or delivered to other scientific establishments
  • the number, species and date of specified animals destroyed without being used in scientific procedures

Please ensure the monthly report is sent to research.ethics@svhm.org.au

For further information, please contact Melanie Asquith, AEC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

Adverse Event Reporting

Adverse events are any events that have a negative impact on the wellbeing of an animal or group of animals, as evidenced by abnormal physiological or behavioural response.

Adverse events are unpredictable or unanticipated consequences of research activities.

Adverse events can include (but are not limited to):

  • Unexpected death of an animal or group of animals
  • Unexpected welfare deterioration, either during or post procedure, including diarrhoea, vomiting, respiratory issues, collapse, abdominal swelling, rapid weight loss or neurological symptoms.
  • Adverse effects in a larger group of animals than was expected

All adverse events are to be dealt with immediately by the responsible researchers, Animal Facility Manager and Veterinarian.

To report an adverse event, please complete and submit the following form:

This report summarises the event for the Animal Ethics Committee and the actions being taken.

For further information, please contact Melanie Asquith, AEC Secretary on 03 9231 3872 or email research.ethics@svhm.org.au

Clinical SOPs

Animal Ethics Committee Standard Operating Procedures

To create a new Standard Operating Procedure (SOP) please use the SOP template.
To revise an SOP please contact research.ethics@svhm.org.au

The following Standard Operating Procedures have been approved by the St Vincent's AEC.
NB – the following SOPs are locked documents that require passwords to access them.
If you do not have the password, please contact the AEC Secretary Mrs Melanie Asquith at melanie.asquith@svhm.org.au


Administrative SOPs

Chapter 1 – Pre-Approval

1.1 Experimental Projects
1.2 Licensing for scientific procedures
1.3 Fieldwork
 

Chapter 2 – Post Approval

2.1 Safety Reporting
2.2 Monitoring Experimental Projects
2.3 Project Amendments
2.4 Change to Research Team
2.5 Annual Reporting
2.6 Bureau of Animal Welfare returns
2.7 Extension of Approval for Experimental Projects
 

Chapter 3 – General Governance

3.1 Reporting and Accountability
3.2 Complaints Handling and Research Misconduct
3.3 Collaborative Groups
3.4 Management of Research Data and Primary Materials
3.5 Minimising Duplication of Ethical Review
3.6 Fees and Charges
 

Chapter 4 - Committee

4.1 Appointment of New Members
4.2 Induction of New Members
4.3 Conflicts of Interest
4.4 Committee Training
4.5 Committee Membership
4.6 Delegation of Authority
4.7 Making and Communicating Decisions
4.8 Executive Group
4.9 Facility Inspections
4.10 Record Management  
 

Chapter 5 – Researchers

5.1 Researcher Roles and Responsibilities
5.2 Responding to Conditions of Approval
5.3 Creating Clinical Standard Operating

Procedures

5.4 Researcher Record Management
5.5 Training for Animal Researchers

Executive Officer

Ms Susan Miller

BA LL B
Ms Susan Miller joined St Vincent’s as the Executive Officer and Company Secretary in February 2008. Ms Miller has held leadership roles in a range of government and not-for-profit organisations working in legal aid, disability, health and welfare services at organisations including Australian Red Cross, MS Victoria and Victoria Legal Aid. In her previous roles she has had responsibility for functions including legal services and compliance, organisational development and industrial and employee relations. She is currently completing studies towards a Graduate Diploma of Applied Corporate Governance.

Forms

Resource for Researchers

Resources

News

  • 2015 AEC Meeting Dates / Agenda Closing Dates

Training Manuals

  • Session one – the 3 R's  


Contact Us

For more information visit the Research Governance Unit Contact page