Application for Minor Amendment

Austin Health Animal Ethics Committee

APPLICATION FOR MINOR AMENDMENT

Version: #

Date: XX/XX/XXXX

Please answer all questions in plain English and only include the relevant sections

Section 1 - Administration

Project details

AEC project number / A20_ _/0_ _ _ _
Project title
Ethics Approval date
Original Ethics lapse date
Please give a brief outline of the project in LAY terms

Project Staff

Name / Position / Department/Institution / Contact details (phone and email)
Principal Investigator
Other investigators
Person to act in Principal Investigators absence

Any previously approved minor amendments?

No
Yes / (please briefly outline)

Are all SOPs used in the approved project current and up to date?

No / (please briefly outline)
Yes

Animal Use

Species / Strain / Number Approved / Number used to date

Section 2 – Extension of Ethics Approval:

Have you previously requested for an extension on ethics approval?

No
Yes / (please answer question below)
What date does your extension on ethics approval lapse?

Are you seeking an extension on ethics approval?

No
Yes / (please answer questions below)
Please specify the new finishing date
Justification for requesting ethics extension

Section 3 – Extra Animals:

Are you requesting extra animals?

No
Yes / (please answer questions below)
Species (note you can only change a maximum of three species and/or strains)
Number of additional animals required
Does the species/strain require any special husbandry?
Justification for requesting additional animals

NOTE:

(1) The allowable increase in animal numbers is normally 10% or less. Exceptions to these guidelines will be left to the discretion of the AEC and need to be fully justified.

(2) If the amendment involves the addition or production of genetically modified animals e.g., transgenic, knockout, or of animals with spontaneous genetic mutations you will be required to complete Appendix I

Section 4 – Addition of Investigators:

Are you requesting addition of new staff member(s) or student(s)?

No
Yes (please answer sections below)

Additional Investigators

Name (Title, given name, family name)
Qualification
Department/Organisation
Internal Telephone Number
Internal Email
For each species and technique, describe the level of expertise and number of years of experience the named investigator possesses. If no experience, please complete the arrangement for training section below?
Species / Technique/Procedure / Level of Expertise (Approximate number of times you have performed the technique/procedure in this species)
Additional Investigator(s) Declaration:
I/We have read The Australian Code for the care and use of animals for scientific purposes and understood my responsibilities as an investigator.
Name (please print) / Signature / Date

Training details

Provide details on the skill and competency level of the person/s responsible for training new staff member(s) in each technique
Trainer(s) name / Species / Technique/Procedure / Level of Expertise (Approximate number of times you have performed the technique/procedure in this species)
Provide details, if any, on specific techniques and species each additional staff member is required to gain a high level of proficiency and whom will be providing the training.
New Investigator(s) name / Species / Technique/Procedure / Person Responsible for Training
Trainer(s) Declaration:
I/We have the relevant expertise and I/We accept responsibility to train and supervise the above person until I/We consider them to be competent in the necessary procedures.
Name (please print) / Signature / Date

Section 4 – Other Amendment:

Other Amendment(s)?

No
Yes / (please answer questions below)
Please provide a detailed description of your amendment
Justification for requesting ‘other amendment(s)’
If there is a change in procedure, state the impact of the change(s) on the animals and describe how that impact will be minimized
If any substances will be administered to the animals as part of the amendment e.g. drugs, chemicals, hormones, biological or radioactive agents please complete the following section:
Compound/Agent/Vehicle
Route of Administration
Dosage/Dose Rate
Volume
Frequency of administration
Purpose
Has this substance been used previously in this laboratory?
Are there any adverse effects of administration or withdrawal of drugs expected?
Does this project involve procedures or agents that might pose a health risk to other animals and/or personnel?
No
Yes / (please list below & describe what precautions will be taken)
Outline of Risk(s) / Likelihood, Consequence & Risk Rating
e.g. possible, medium & high (respectively) / Precautions taken
Will any standard operating procedures (SOPs) be added to the study?
No
Yes / (please list below & attach a copy of all SOPs to be added)
Name of SOP / Version Number / Version Date

Section 5 – Signatures:

Principal Investigator Signature

Name (please print) / Signature / Date

Minor Amendment Approved

Minor amendments may be approved by the Executive subcommittee of the AEC. All minor amendments approved by the Executive on behalf of the AEC must be ratified by the full committee at the next meeting.
(A) Approved by the Executive of the AEC
Chairperson Name (please print) / Chairperson Signature / Date
(B) Approved and/or ratified by the AEC at meeting on <insert date>
Chairperson Name (please print) / Chairperson Signature / Date

Minor Amendment Not Approved

Your application for the above outlined minor amendment has NOT been approved by the Executive subcommittee of the AEC for the following reason(s):

Appendix I: Genetic modification or cloning of animals

This report must be completed for all projects involving the use or production of genetically modified animals. Descriptions should be concise and expressed in lay language where possible.

Animal Details (A separate report is required for each strain)

Species (and common name) / Strain name / Background strain

Genotype

Describe the function(s) of the gene(s) that have been/will be modified?
Explain the relevance of the genetic modification to the project
Will tissue be collected to use for genotyping? / No
Yes (describe how and when)
What will be the fate of animals that are not of the appropriate genotype?

Phenotype

Is the phenotype of this strain well characterised? / No (briefly describe the potential or anticipated behavioural, physiological, reproductive developmental features of the strain and identify whether the modification(s) will affect the health, welfare, breeding or lifespan of the animals)
Yes (briefly describe the known behavioural, physiological, reproductive & developmental features of the strain and identify whether the modification(s) will affect the health, welfare, breeding or lifespan of the animals.)
Does the strain require any special husbandry? / No
Yes (describe the particular requirements for care)

Breeding

Describe the breeding program (e.g. heterozygous, homozygous, back-crossing) that will be used to produce the genetically modified or cloned animals to be used in the project. Provide estimates of the number of animals that will be used in the breeding program.

Guidelines for Minor Amendments to Approved AEC projects

Some changes are obviously Minor Amendments. Others are more difficult to assess and may need to be considered by the full committee. In every case the welfare of the animals must be considered.

1. Request for minor amendment to approved project form: This form must be used for all minor amendments and a Microsoft Word version is available on our Website http://www.austin.org.au/REU/AEC or from Research Ethics, (03) 9496 4099 or .

2. Extension of time: If the procedures are the same, the Project could be extended by up to one year. It is expected that only one extension of time would be given.

Maximum approval for applications = 4 years.

3. Increase in animal numbers: The definition of a minor amendment for an increase in animal numbers is normally 10% or less. Exceptions to these guidelines will be left to the committee’s discretion and need to be fully justified. An appropriate example would be equipment failure where a repeat of experiments is warranted and the procedures remain exactly the same.

4. Change to a procedure: Where this is a minor change or addition which will not significantly affect the welfare of the animals it can be approved as an amendment. However, if the new procedure has not been previously approved by the AEC in any Project, then this is not a Minor Amendment and should be submitted as a New Project.

5. Change of animal species: Where this uses an animal of similar sentience, or lesser sentience, and the same or fewer animals will be used, then this can be an Amendment if the procedures remain the same. If another species is being added, with extra animals being used, then this will need to be properly justified as to why it should not be a New Application.

6. Change of strains within species: This can be an Amendment when it is justified and in line with the other points above.

7. Addition/removal of staff members/students: When there is a change in staff listed on an approved project the AEC must be notified formally using this form. For addition of staff members/students, the request must include their relevant experience with the techniques and type of animals used in this project, if any training is required, and who will give that training. For removal of staff members/students, these changes can be listed in section 4.

It is implicit in this minor amendment that any items not specifically addressed in this form are covered in the original approved application and any previous/subsequent minor amendments

Application Fee: Minor Amendments requesting a PROTOCOL change (e.g., increase in animal numbers, change in strain/species or change in procedures) attracts an application fee.

Submission Process: Submit one electronic copy (this can be scanned e-copy) to the Office for Research at

Minor Amendments will NOT be processed until all signed copies are received.

Minor Amendments with multiple projects on the one form will NOT be accepted.

Minor Amendment form Version 1.7 19122016 Page 1