AEC Application Process

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 include 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
  • 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:

APPLICATION FOR ANIMAL BASED TEACHING

Use this form for activities that involve teaching or education.

APPLICATION FOR ANIMAL BASED RESEARCH

Use this form for any research, 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.

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
  • 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:

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, retrospective amendments will not be approved unless they meet the situations outlined in the .

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 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, 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 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 and monitoring plans for a 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 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, 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 approval to work in any other Australian states or territories or their territorial waters, so 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 owners 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 responsibilites 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 2018

Submission of new applications and amendments will not be accepted after the below closing dates unless extremely urgent, they will be held over for the next scheduled meeting.

Resubmissions or items carried over from preivous meetings will be accepted after the closing date, so call the Animal Ethics Officer to arrange a submission time.

Meeting Dates

Closing Date to

Ethics Monitor

Closing Date to

Research Office

2 February 2018

8 January 2018

15 January 2018

2 March 2018

19 January 2018

5 February 2018

6 April 2018

5 March 2018

12 March 2018

4 May 2018

9 April 2018

16 April 2018

1 June 2018

8 May 2018

14 May 2018

6 July 2018

4 June 2018

11 June 2018

3 August 2018

9 July 2018

16 July 2018

7 September 2018

6 August 2018

13 August 2018

5 October 2018

3 September 2018

10 September 2018

2 November 2018

2 October 2018

9 October 2018

7 December 2018

5 October 2018

12 November 2018

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 4 weeks before AEC meeting
  • Submission deadline 3 weeks before AEC meetings
  • Notification of outcome 2 weeks after AEC meeting
  • MINIMUM APPROVAL TIMEFRAME FROM SUBMISSION - 6 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 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.