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:
- Production of biological products
- 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
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
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.
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.
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.
1. Purpose and Objectives
These Procedures explain the requirements for holding laboratory animals in locations outside of The University of Queensland Biological Resources facilities.
2. Definitions, Terms, Acronyms
AEC – Animal Ethics Committee
Designated and Certified Animal Containment Facility – Facilities designed to ensure that the Laboratory Animals, and the microorganisms that may be used in conjunction with the Laboratory Animals do not escape from containment and meet the regulatory requirements for certification.
GM – Genetically Modified.
Genotrack - Animal Colony and Facility Management Software for animal tracking, breeding, research, management and reporting.
Holding/Held – Using Laboratory Animals in a facility for any procedure, test experiment, inquiry, investigation, teaching activity, or study and “Hold” has a corresponding meaning.
Laboratory – Defined space where research, experiments, teaching, study or investigations are performed. May or may not be certified by the OGTR or the UQ-IBC.
Laboratory Animals – Rats, mice, guinea pigs and rabbits.
OGTR - Office of the Gene Technology Regulator.
OHS – Occupational Health and Safety.
PC1-4 - Physical containment levels 1-4, usually certified by the OGTR.
Personnel – Any UQ staff member, student, or person working with Laboratory Animals.
Project Supervisor – First-named investigator on animal ethics application.
Tracking – The process of recording the status of live Lab Animals continuously in a central database once they have left UQBR facilities, and the timely provision of information on their fate to that database irrespective of the length of time.
UQAEC - the University of Queensland Animal Ethics Committees established in accordance with the Animal Care and Protection Act 2001 (Queensland) (as amended from time to time) and the Australian code for the care and use of animals for scientific purposes being:
- Anatomical Biosciences AEC
- Production and Companion Animals AEC
- Molecular Biosciences AEC
- Health Sciences AEC
- Native/Exotic Wildlife and Marine Animals AEC
UQBR – The University of Queensland Biological Resources.
UQBR Facilities –Designated and Certified Animal Containment Facilities operated by the UQBR
UQ-IBC – The University of Queensland’s Institutional Biosafety Committee.
3. Procedures Scope/Coverage
This document is for use by all individuals associated with the University of Queensland who use Laboratory Animals for research or teaching purposes, and for Personnel accessing animals from UQBR Facilities. These procedures are to assist individuals associated with the University and Personnel in ensuring they are compliant with the relevant requirements and safe working procedures when Holding Laboratory Animals outside UQBR Facilities.
4. Procedures Statement
The Holding of Laboratory Animals in Laboratories outside UQBR Facilities constitutes a potential significant risk to the University and its Personnel including risks relating to animal welfare, occupational health and safety and regulatory compliance. This potential risk is significantly increased if such animals are GM or contain GM organisms or microorganisms.
Risk management analyses, supported by the University Senior Executive, have identified a real and urgent need to introduce uniform procedures and greater institutional oversight for situations where Laboratory Animals are being held outside UQBR Facilities.
The following Procedures seek to minimise these risks by specifying the steps to be followed regarding Holding of Laboratory Animals outside UQBR Facilities. The Holding of Laboratory Animals outside a UQBR Facility is contingent upon there being a sound scientific or animal welfare justification and that the period of Holding is of the absolute minimum duration.
5. Roles and Responsibilities when working with Laboratory Animals outside UQBR Facilities
The following Personnel have specific roles and responsibilities which are required to be complied with, when working with Laboratory Animals outside a UQBR Facility.
All Personnel must:
- Complete appropriate training – both theory and practical, prior to handling Laboratory Animals.
- Ensure they are listed on the animal ethics approval for the project.
- Ensure a risk assessment has been undertaken of the procedure for the project and that procedure is being followed.
5.2 Project Supervisor
It is the responsibility of the Project Supervisor to:
- Ensure all Personnel are listed on the animal ethics approval for the project.
- Ensure all Personnel have completed required training before handling the Laboratory Animals.
- Ensure the UQAEC-approved procedure for the project is being followed.
- Ensure all GM proposals for Laboratory Animal work outside UQBR Facilities includes a procedure for Holding Laboratory Animals outside of UQBR Facilities.
- Ensure welfare of Laboratory Animals being used for their project e.g. daily checks are being conducted and animal husbandry care conducted. Welfare includes providing and documenting, at the very minimum daily animal care.