Please refer to the University’s Glossary of Terms for policies and procedures. Terms and definitions identified below are specific to these procedures and are critical to its effectiveness:
Animal refers to all live non-human vertebrates (that is fish, amphibians, reptiles, birds and mammals encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods. It includes animals at earlier stages of their development i.e. embryonic, foetal and larval forms that have the potential to experience pain or distress based on evidence of neurobiological development.
Animal carer refers to any person involved in the care of animals that are used for scientific purposes, including during their acquisition, transport, breeding, housing and husbandry.
Animal Ethics Committee Executive as defined in the Animal Ethics Committee’s Terms of Reference refers to a body consisting of the Chairperson and at least one other member of the Animal Ethics Committee, which can approve minor amendments to projects.
Scientific purposes means all activities conducted with the aim of acquiring, developing or demonstrating knowledge or techniques in all areas of science, including teaching, field trials, environmental studies, research (including the creation and breeding of a new animal line where the impact on animal wellbeing is unknown or uncertain), diagnosis, product testing and the production of biological products.
Standard Operating Procedure (SOP) means detailed description of a standardised procedure or process.
The Act means the Queensland Government Animal Care and Protection Act (2001).
The Code means the National Health and Medical Research Council Australian code for the care and use of animals for scientific purposes (2013).
1. Purpose of procedures
This document is to be read in conjunction with the Animal Ethics – Governing Policy. It sets out steps to operationalise the Policy and determines the details provided in a number of more specific guidelines.
2.1 Responsibilities of the University of the Sunshine Coast
The University of the Sunshine Coast (USC) has the responsibility to:
- ensure, through the Animal Ethics Committee, that the care and use of animals for scientific purposes, conducted on behalf of the University, is in compliance with the Code
- promote compliance with the Code
- ensure and support the effective operation of the Animal Ethics Committee
- identify clear lines of responsibility, communication and accountability
- ensure all people involved in the care and use of animals understand their responsibilities, have the necessary expertise, and have access to appropriate educational programs and resources
- regularly monitor and review compliance with the Code, including an annual review of the operation of the Animal Ethics Committee and an independent external review every four years.
2.2 Animal Ethics Committee (AEC)
The Animal Ethics Committee (AEC) has been set up as the prime body within the USC with the responsibility for implementing the stated purpose of the Animal Ethics - Governing Policy. The Terms of Reference and Operating Guidelines of the Animal Ethics Committee are available on the staff intranet MyUSC.
The Animal Ethics Committee Secretary keeps all relevant animal records in a central repository within the Office of Research.
2.3 Application, review and approval process for new projects or activities
With the exception of animal observation-only projects, all new projects or activities need to be given ethics approval by the full Animal Ethics Committee which meets six times per year.
Applications for ethics approval of proposed research and teaching projects or activities concerning the use of animals for scientific purposes are made on the approved USC AEC form. Applications are accompanied by other relevant documents as appropriate e.g. standard operating procedures, record monitoring sheets, peer reviews, permits and licences.
If a project involves USC researchers collaborating with another institution that acts as the lead institution in a multi-centre application, then ethics approval is first sought from the lead institution. Once ethics approval has been given by the lead institution, the form for that institution may be used, but extra information may be requested, and the form is also accompanied by the USC AEC coversheet on prior ethical review. Researchers with projects that have already been approved at another Australian institution should contact the Research Ethics Officer for advice about USC AEC approval.
Researchers and teachers involved in animal projects submit proposals at least two weeks before AEC meetings. However they may seek advice at any stage about any matter relating to their projects.
Applications for approvals of projects involving only observation with no physical contact with animals, and no impact on the animals or their habitats, are made on the form Animal observation-only project form. Applications can be approved at any time by the AEC Chairperson, and once this occurs the project can be commenced. Applications are still provided to the full AEC for ratification at its next meeting. See also the detailed information in the Guidelines for observation-only projects.
Research merit needs to be established for any new projects before ethics approval can be given. Research merit can be established through peer review or by funding through a competitive funding process. See also the detailed information in the Guidelines on peer review.
Approval of projects is normally given for up to three years, unless the project is subject to a longer grant than this. Researchers may request a longer ethical clearance via an amendment to the original approval, but should provide appropriate justification. Where projects are ongoing beyond the date of ethics approval, the renewal of a project is by formal application in the same way as for new projects.
Students enrolled in doctoral and masters programs may act as the Chief Investigator of a project.
Where students are enrolled in Bachelor Honours projects, it is the student’s primary supervisor who acts as the Chief Investigator.
Written approval must be received from the AEC before the commencement of any project or activity using animals for scientific purposes. Regular Faculty safety approvals are also required before commencement of projects, while in some cases biohazard approvals may be required through the USC Institutional Biosafety Committee.
2.4 Application, review and approval process for amendments to approved projects
All amendments to approved projects must be approved. Applications for ethics approval for amendments of approved projects are made on the approved USC AECs form Application for amendment to approved project.
Amendments are classified as major or minor.
In accordance with The Code, minor amendments are "not likely to cause harm to the animals, including pain and distress". The AEC Chairperson decides whether the amendment can be considered minor, taking into account the detailed information in the Guidelines on amendments. Approvals for minor amendments can be made by the AEC Executive at any time, with ratification at the next AEC meeting.
Approvals for major amendments are as described for new projects. Major amendments to a project can only be approved at an AEC meeting.
Applications concerning a change of personnel in the research or teaching team can be made on the form developed specifically for this purpose.
2.5 Projects involving more than one institution or Animal Ethics Committee
The following applies to animal projects involving research by more than one institution, or the care and use of animals at more than one institution.
USC staff and / or students inform the USC AEC of their involvement in any collaborative projects with external institutions. Where USC staff and / or students are formally part of the research team, the USC AEC formally approves the project and their involvement in the project.
Institutions involved may agree to delegate responsibility for the monitoring of the project to one AEC.
The USC AEC ensures that appropriate communication occurs so that all parties are aware of their respective responsibilities.
2.6 Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) can help in the preparation of an application to use animals.
The AEC may grant a maximum three-year approval for SOPs to be used in research or teaching activities that involve animals.
The AEC will only approve the use of an SOP in a research or teaching project when it is satisfied that each researcher, teacher or other person who implements all or part of a proposed SOP has the necessary expertise and competency to do so.
No change may be made to an approved SOP, without the express approval of the AEC.
New SOPs must be approved by the AEC before implementation, and a register of approved SOPs is maintained.
See also the detailed information in the Guidelines on Standard Operating Procedures.
2.7 Monitoring of animal welfare
Animal researchers and teachers have personal responsibility for all matters relating to the wellbeing of animals including their housing, husbandry and care throughout the period of use approved by the AEC.
The Chief Investigator or primary supervisor has the ultimate responsibility to ensure all persons involved in a project understand and accept their responsibilities for the care and use of animals in the project.
Procedures for monitoring and assessing the wellbeing of the animals must be developed by the investigators and approved by the AEC.
Monitoring should be carried out by competent people who are knowledgeable about the normal behaviour and signs of pain and distress of the animals being used. Persons responsible for monitoring and emergencies are specifically nominated on the AEC application form.
Animal researchers and teachers must ensure that animals are monitored for signs of pain and distress. The frequency of monitoring should be sufficient to ensure sick or injured animals are promptly detected and appropriate action is taken.
Appropriate records of the monitoring must be maintained and accessible by all people involved in the care of the animals. These records must be made available for audit by the institution, the AEC and authorised external reviewers.
The AEC determines the frequency of inspections of animal houses and laboratory areas, as well as animal records, but may determine that certain projects require more frequent inspections than others. Inspections are normally announced, but if appropriate (e.g. where there is an immediate concern about animal welfare) they may be unannounced.
Records of inspections are kept, and inspection reports are presented at the next AEC meeting.
2.8 Emergencies and unexpected adverse events
Animal researchers and teachers must take prompt action in response to unexpected adverse events to alleviate pain and distress of animals affected, and if necessary animals should be humanely killed without delay.
Animal researchers and teachers use the USC AEC form Report on Adverse Event to report to the AEC Chairperson within one working day of the event occurring.
The responsibilities of the AEC Chairperson and the AEC are detailed in the Operating Guidelines for the AEC.
2.9 Progress and final reports
Animal researchers and teachers provide progress and final ethics reports using the appropriate USC AEC form for review by the AEC. Progress reports are due annually on 31 January of each year, but the AEC may request these on a more frequent basis. A final report is due as soon as the research / teaching activity is complete, the end approval date has expired or the project has been discontinued.
2.10 Complaints and non-compliance
Matters relating to complaints and non-compliance are managed according to procedures in the Australian code for the care and use of animals for scientific purposes and the USC Research Misconduct – Governing Policy and related procedures. See also the detailed information in the Processes relating to complaints and non-compliance with the Code.
2.10.1 Complaints about the care and use of animals
Where complaints are made about projects that would normally require AEC approval, the AEC Chair is authorised to review the matter. The Chairperson may refer such complaints to the full AEC or to the University as appropriate. If complaints relate to activities that have the potential to adversely affect animal wellbeing, the University must ensure the activities cease immediately.
2.10.2 Non-compliance with AEC decisions
Any non-compliance with AEC decisions should be reported to the AEC Chair. The Chairperson then considers appropriate actions, and may refer the non-compliance to the full AEC or to the University as appropriate.
2.10.3 Complaints about AEC review processes
Where complaints concerning the AEC process of review of an application or report cannot be resolved by communication between the complainant and the AEC that is the subject of the complaint, the Director of the Office of Research is authorised to receive complaints in writing. The Director then reviews the complaint, and may seek further advice either internally or external to the University as appropriate. Following this review, the AEC may need to review its process in reaching its decision regarding the application or report, and re-evaluate its decision in light of the reviewed process.
2.10.4 Complaints about the merit of the AEC decision
The ultimate decision regarding the ethical acceptability of an activity lies with the AEC and cannot be overridden. Animal researchers and teachers who disagree with an AEC decision are welcome to provide their reasons to the AEC Chair, and resubmit a revised application to the next meeting of the AEC.