AEC Application Process

AEC Application Process

The following information outlines the AEC submission process and provides information that aims to assist you with the  process, including what activities need AEC approval, advice on completing applications, timeframe for approvals, meeting closing dates and common reasons that AEC applications are not approved.

What work requires AEC approval?

All Scientific Activities involving Animals must be approved by the James Cook University AEC.

Where:

Scientific Activities includes the following:

  • Research
  • Teaching
  • Production of biological products
  • Breeding
  • Displays and exhibits
  • Population surveys including cameras, boat and aerial surveys
  • Bird, bat and fish banding carried out as a part of university teaching or research

It also includes activities such as camera surveys, aerial surveys and other activities where the animal may not detect their participation in the project. 

An Animal is defined as any living non-human vertebrate (i.e. fish, amphibians, reptiles, birds and mammals) and cephalopods (octopus, squid and nautilus).

It also includes the following life stages:

  • mammal, reptile and bird embryos and foetuses that have progressed beyond half their gestation/incubation period
  • fish and amphibian larval stages once they become free-feeding

What activities may not need approval by the AEC?

Activities involving the following may not need AEC approval:

  • An activity involving the use of an animal that is already dead, as long as it has died for a reason unrelated to the activity and there was no change to the animal’s care or conditions while it was alive as a result of it being later used in the activity
  • Veterinary or agricultural student work experience, as long as the activities are conducted as a part of the animal’s routine husbandry or veterinary clinical management

WARNING!

DO NOT MAKE THIS DECISION ON YOUR OWN!

BEFORE MAKING A DECISION TO CARRY OUT WORK WITHOUT AEC APPROVAL 

ALWAYS SEEK ADVICE FROM THE ANIMAL WELFARE OFFICER OR ANIMAL ETHICS  OFFICER

Decisions of the Animal Ethics Committee will be released 7 to 10 working days after the meeting date.

Application Forms

There are now three types of application forms for animal use at JCU:

APPLICATION FOR ANIMAL BASED RESEARCH OR TEACHING

Use this form for any research, teaching, testing, diagnostic or production of biologicals.

APPLICATION FOR AN ANIMAL BREEDING PROGRAM

Use this form if you plan to breed animals to supply to research or teaching.

Note: if you are investigating an aspect of animal breeding or reproduction, rather than breeding only to supply animals for other projects, use the Research and Teaching Application form.

APPLICATION FOR ANIMAL HOLDING OR DISPLAY

Use this form if you plan to hold animals for display or other non-scientific use.

Advice on Writing an AEC Application

For detailed question-by-question assistance with completing an AEC Application Form, read the sections following and consult the AEC Application Guide:

AEC Application Guide.

Reasons for applications not being approved

Not all  applications are approved upon their first submission to an AEC meeting. The main reasons that applications are not approved include:

  • Not in lay language/difficult to understand for AEC members
  • Answers are cut and pasted from a grant application or similar
  • Errors, cut and paste errors etc
  • The wrong version of the form is used
  • No pain relief provided for invasive procedures
  • Insufficient details of procedures provided
  • Missing drug doses, volumes, sites, side effects
  • No humane endpoints listed
  • Inappropriate methods – euthanasia, anaesthesia
  • No contingency plans considered (field work)
  • Questions are left blank or answered with NA when they are applicable and an answer is required
  • Insufficient information for the AEC to understand exactly what is happenning to any individual animal
  • Contradictory information in different answers on the form
  • Relies too heavily on external references, refers to previous applications (all information must be in the form)
  • Insufficient information on animal monitoring
  • Animal numbers not justified/explained
  • Not considered ethical, justified or scientifically robust (rare)

In order to maximise the likelihood that your submission to the AEC will be approved at first review, you should follow the following advice:

  • Keep it simpler and brief while providing enough information
  • Proof read and/or ask a colleague to proof read the submission
  • Seek advice from the AWO before starting the application
  • Ask a lay person to proof read the submission to ensure it is in lay language 
  • Ask for a monitor/AWO pre-meeting review
  • Refer to guidelines for acceptable methods
  • Provide a glossary for technical terms, acronyms and abbreviations or define these, even if they seem obvious to you they may mean nothing to AEC members
  • Use diagrams, photos and tables to explain concepts or demonstrate equipment instead of providing a long-winded written description
  • Refer to AEC approved SOPs
  • Submit on time

AEC Amendment Application

Once your project is approved by the AEC, no changes can be made to any aspect of the project without AEC approval of the amendments. These must be submitted to the AEC for approval before any changes can take place using the form:

APPLICATION FOR A PROTOCOL AMENDMENT

When submitted, this document must provide enough information for the AEC to make a decision without having to refer to the original application or other resources. 

You need to give a brief overview of the relevant part of the original application, then describe exactly what you would like changed, and finally, outline any impact the proposed amendment will have on the animals, and if there is increased impact then you need to outline how you plan to minimise this impact.

Please note no retrospective amendments will be approved.

Expedited Approval of Urgent Amendments to Protocols

The AEC is able to delegate the review of amendment applications to its Executive Committee and so approval may be given within a few days if there is adequate justification for this urgency and the proposed amendment is considered to be minor

To be considered minor the amendment must:

  • Not result in a major change to the aim, direction, outcomes or scientific rigour of the original application
  • Not increase the impact experienced by the animals
  • Not significantly increase the numbers of animals required (<2.5% increase from previous approval)

Examples of amendments that meet the criteria and be classed as minor include:

  • Changes to personnel, including addition of students
  • Change or addition of a strain, breed or species, where the new species is of similar conservation status as the one approved
  • Change of administered substances, where the new substance is administered in a similar way and has similar actions and side effects
  • Any change that addresses the 3Rs eg. the replacement of animals with an alternative method, a reduction in animal numbers, changes in methods that improve animal wellbeing or result in a decreased impact on the animals
  • Where there has not been repeated amendmentds submitted of the same project previously

If you require urgent approval of you amendment and feel it meets the above criteria, answer Yes to Question 12 in the amendment form and provide a reason for the urgency and why you feel the amendment should be considered as minor. 

The Animal Welfare Officer or Animal Ethics Officer will assess this answer and decide whether it can be reviewed outside of an AEC meeting. If so, you may get approval within 1-7 days depending on the availability of reviewers.

Please note no retrospective amendments will be approved.

Using SOPs

Standard Operating Procedures (SOP) are documents that provide a detailed description of a procedure or activity. 

SOPs can be submitted for approval to the AEC instead of writing the details in the application form using the AEC SOP Template or your own template as long as it meets the requirments of the Code Sections 2.2.33-36.

It can be an advantage to submit an SOPs in place of writing details in a form if you have procedures or methods that are common to many AEC projects. For example:

  • Trapping techniques for mammals
  • Fish anaesthesia techniques
  • Cattle husbandry and feeding
  • Methods for a commonly-used animal model
  • Teaching activities

Once approved, all you need to do is reference the approved SOP's number in the application instead of providing a long description. This makes it easier for investgators as well as the AEC when they review the applications.

Once approved, SOPs must be reviewed and re-approved every 3 years.

If you amend a SOP, you need to submit an amendment with the updated version of the SOP attached.

The AEC already has a library of about 200 approved SOPs that are available for everyone to use. If you think a procedure you are currently carrying out may be in the library please contact the Animal Welfare Officer to discuss its use.

Genetically Modified Organisms

Genetically modified (GM) animals are animals that have had part of their genome modified through artificial genetic engineering techniques. This includes knock-out, knock-in and transgenic animals.

GM animals are created at the embryonic stage and so the effect of the genetic modification on the animal as a whole is generally unknown or theoretical until the animal has been born and can be assessed over its lifetime (or in most cases over several animals’ lifetimes). 

The genetic modification of the animals may have very little effect on the animals and their biology, physiology or day-to-day functioning, however, some modifications have resulted in changes that have profound effects, with the most sever being embryonic/foetal death and there is a spectrum of severity in between. This means that some GM animals have normal physiological requirements, while others require support in order for them to survive and to minimise any suffering during their life.

For this reason, GM animal have special requirements under the Code and the NHRMC Guidelines for the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes.

Details of the phenotype (expression of the genotype or genetics of the animal) must be provided to the AEC using the Phenotype Report

If the line is a new line, and there is insufficient information about the phenotype of the animals then they must be monitored for a period of time, have their genotype evaluated, a Phenotype Report completed and approved by the AEC before the aniamls can be used in research or for purposes other than breeding.

In addition to the AEC requirements, work with GM organisms must comply with the Gene Technology Act and be approved by the Institutional Biosafety Committee. Work involving GM animals must also take place in a facility that meets is certified as a Physical Containment (PC) facility - PC1 or higher depending on the work being conducted.

Working Interstate 

Each state and territory in Australia has different legislation and requirements for the regulation of scientific animal use. 

JCU is registered in Queensland and the Northern Territory, so is able to approve animal use in Queensland and the Northern Territory and their coastal waters.

JCU does not have approval to work in any other Australian states or territories or their territorial waters, so no work can take place in these jurisdictions.

JCU is currently applying for approval to work in Western Australia  and staff will be notified once these approvals have been received.

Animal Research in the Northern Territory is regulated under the Animal Welfare Act. If you are working or plan to work in the Northern Territory, there are different requirements to follow than if you were only working in Queensland. You need to complete a NT Animal Research Permit Application in addition to your AEC application and submit both documents to the AEC. You must have the Permit Application witnessed by an adult (over 18 years of age). JCU's License Number for the NT is 073

If you require approval to work in another state or territory, contact the Animal Welfare Officer or Animal Ethics Officer for advice.

If you are working in another jurisdiction, you will be required to learn and understand the local legislative requirements and abide by these.

Working Overseas

If you are planning to work overseas you need to be aware that other countries may have their own laws and requirements that relate to animal research and teaching. The JCU AEC may not be able to approve your work in some of these countries.

Therefore, if you do plan to carry out work overseas, you need to find out about the legislative requirements for that country before applying to the JCU AEC, acquire any local approvals and abide by these local requirements.

Even though you are working overseas, you still need to follow the Australian code for the care and use of animals for scientific purposes, obtain JCU AEC approval and comply with JCU policies and procedures.

Contact the Animal Ethics office if you are unsure about overseas approvals.

Collaborating with Other Institutions 

If you are carrying out animal work in collaboration with another organisation or individual, you need to notify the JCU AEC even if the work has been approved by another AEC and is being carried out elsewhere. 

In some cases, the Research Office and AEC may need to develop an agreement to cover this collaboration, which outlines the responsibilities of each organisation in relation to animal ethics oversight.

Please email the Animal Ethics Officer and provide details of the work and collaboration so it can be noted by the AEC at their next meeting.

Other Legislative Requirements and Approvals 

As well as the Animal Care and Protection Act and the Code, investigators may also need to abide by other legislation. The AEC needs to be sure that any approvals/licenses/permits have been applied for or approved by the investigator before it can approve a project. These approvals apply to the following:

  • Work in a Queensland or federal national park
  • Work with wildlife
  • Use of endangered or threatened species
  • Use of any genetically modified animals or vectors (viral etc)
  • Release of any genetically modified organisms into the environment
  • Use of infectious agents

For information on other legislation and approvals please contact the Animal Welfare Officer.

AEC Monitors and Application Pre-meeting Review

Animal Ethics Monitors have been chosen with expertise in various types of research and with different types of animals. There is a Monitor in each area who is available to pre-review your AEC applications and provide feedback  before submission to the AEC. This review aims to pick up any problems with your application and to improve the likelihood that it will be approved at the AEC meeting. For a Monitor to review your application, you must email the monitor in your area at least 1 week prior to the AEC meeting closing date.

Alternatively, you can request a pre-review of your application by the Animal Welfare Officer at any time.

Closing Dates for Submissions and AEC Meeting Dates 2017

Submissions will not be accepted after the below closing dates unless extremely urgent, they will be held over for the next scheduled meeting.

Meeting Dates

Closing Date to

Ethics Monitor

Closing Date to

Research Office

3 February 2017

9 January 2017

16 January 2017

3 March 2017

6 February 2017

13 February 2017

7 April 2017

6 March 2017

13 March 2017

5 May 2017

10 April 2017

18 April 2017

2 June 2017

8 May 2017

15 May 2017

7 July 2017

5 June 2017

12 June 2017

4 August 2017

10  July 2017

17 July 2017

1 September 2017

7 August 2017

14 August 2017

6 October 2017

11 September 2017

18 September 2017

3 November 2017

9 October 2017

16 October 2017

8 December 2017

6 November 2017

13 November 2017

Pre-meeting Questions

Once the submissions are received, the Animal Welfare Officer will review all documents, and if there are any issues foreseen will contact the Principal Investigators to provide clarification.

The AEC submissions are posted onto a secure site and forum, and so members of the AEC may ask questions on that forum about your documents. If this happens the AWO will forward these to the Principal Investigator to be answered before the meeting.

This will ensure that any issues or questions can be resolved before the AEC meeting, reducing the likelihood that the application will not be approved. If you have submitted documents to a meeting, always ensure you check emails over the two weeks before the AEC meeting.

Timeframe for Approval

The AEC meets on the first Friday of each month (except January). If for some reason an AEC member cannot attend the meeting, it may be postponed to the next available date, but we usually aim for this to be within 2 weeks of the planned meeting.

Outcomes of Review

An application will be reviewed by the AEC and the outcome will be one of the following:

  • Approved 
  • Approved with conditions 
  • Deferred subject to modification or the provision of more information or clarification
  • Not approved

Appealing a Decision of the AEC

If any applicant is concerned by the way an application has been processed or by the decision of the AEC, the first point of contact is the Animal Ethics Officer or Animal Welfare Officer.

There are procedures in place to deal with appeals to AEC decisions in a fair and independent manner.