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. Scientific Activities include the following:

  • Research and 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.

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
  • Short term, one-off displays or demonstrations as long as they meet the criteria outlined in the The Use of Animals in Short-Term Displays and Demonstrations policy

If you're unsure whether your activities require AEC approval

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

Application Forms

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

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.

When applying you will also need to submit an ANIMAL USE SPREADSHEET, which summarises the total number of animals requested.

Observational Studies and Surveys

For projects or parts of projects that involve observation only, with no capture or trapping such as still and video camera traps, visual surveys and aerial surveys.

Where there is no direct interaction with the animals, you no longer need to estimate your potential animal usage or submit a request for animal numbers or an Animal Use Spreadsheet. Instead, you must report animal usage in your Annual and Final Reports for the project.

If there are other more invasive experiments in the same application you will still need to submit the animal usage request for those parts.

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.

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.
  • Grammatical errors.
  • 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, anesthesia.
  • 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 happening 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.
  • Proofread and/or ask a colleague to proofread the submission.
  • Seek advice from the AWO before starting the application.
  • Ask a layperson to proofread 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.

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 (see Section 2.2.23 of the Code).

To be considered minor the amendment must:

  • Not result in a major change to the aim, direction, outcomes or scientific rigor 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 the 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 have not been repeated amendments submitted of the same project previously

If you require urgent approval of your 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, retrospective amendments will not be approved unless they meet the criteria outlined in the Opportunistic Sampling, Vouchering and Amendments to Projects in the Field Policy.

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 requirements of the Code Sections 2.2.33-36.

It can be an advantage to submit an SOP 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 anesthesia techniques
  • Cattle husbandry and feeding
  • Methods and monitoring plans for commonly-used animal models
  • 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 investigators as well as the AEC when they review the applications.

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

If you amend an 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 severe 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 has 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 animals 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, New South Wales, Western Australia, and the Northern Territory, so is able to approve animal use in these states and their coastal waters. Our approvals for these states are as follows:

Queensland Registration No. 013

NSW Accreditation No. 223 (wildlife and aquatic animal field work only)

NT License No. 073

WA License No. U232

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

If you are working in another jurisdiction, you are required to learn and understand the local legislative requirements and abide by these. Links to the applicable legislation is found on the Resources page of this site under Legislation and Regulatory Documents.If you need help interpreting these documents please contact the Animal Welfare Officer.

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).

If you require approval to work in a state or territory other than QLD, NSW, NT or WA, contact the Animal Welfare Officer or Animal Ethics Officer for advice.

Reporting to the AEC

If you carry out work in more than one state or country, you will need to keep records and report animal use separately for each jurisdiction in the Annual Progress and Final Reports.

There is a column in the Animal Use Spreadsheet with drop-down boxes to allow you to choose the state, the default response is Queensland.

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.

Using Privately-Owned Animals in Research or Teaching

For projects using animals that are privately-owned, the following requirements apply:

  • Investigators must ensure that all people involved are aware of and accept their responsibilities in relation to the legislation, the Code and the AEC approvals, including the requirement to report Unexpected Adverse Events
  • All people involved with the privately-owned animals must read the AEC protocol and understand and be competent in the roles they have accepted in the project
  • Investigators must provide the owner(s) of the animal(s) with a document that provides the owner(s) with an overview of the project (in lay language) and clearly states the details and duration of the owner's responsibilities
  • Animal owners must be made aware of any risks that may arise during their animal's involvement in the project
  • The owner must acknowledge their acceptance of these responsibilities in writing and so provide consent for their animal's use

Examples of consent forms are available from the Animal Welfare Officer.

It is also recommended that investigators discuss with owners and preferably agree to actions and liability in the case where their animals may have an adverse incident related to their use in the research or teaching project.

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 2019

Submissions must be received in email by close of business on Friday, two weeks before the meeting.

Please email your submissions to ethics@jcu.edu.au. We are no longer accepting hard copies as we are fully digital.

If you are running late or are having difficulty meeting the submission deadline, please contact the Animal Ethics Officer to request an extension.

Meeting Dates

Closing Date to

Ethics Monitor

Closing Date to

Research Office

1 February 2019

15 January 2019

22 January 2019

1 March 2019

29 January 2019

5 February 2019

5 April 2019

5 March 2019

12 March 2019

3 May 2019

12 April 2019

19 April 2019

7 June 2019

17 May 2019

24 May 2019

5 July 2019

14 June 2019

21 June 2019

2 August 2019

12 July 2019

19 July 2019

6 September 2019

16 August 2019

23 August 2019

4 October 2019

13 September 2019

20 September 2019

1 November 2019

11 October 2019

18 October 2019

6 December 2019

15 November 2019

22 November 2019

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

  • Meetings 1st Friday of the month (except January)
  • Monitor (or AWO) deadline 3 weeks before AEC meeting
  • Submission deadline 2 weeks before AEC meetings
  • Notification of outcome 2 weeks after AEC meeting
  • MINIMUM APPROVAL TIMEFRAME FROM SUBMISSION - 4 WEEKS

If for some reason an AEC member cannot attend a 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 an 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.