1.1. In accordance with the requirements of the “Australian Code for the Care and Use of Animals for Scientific Purposes” (the Code), Virbac Australia has established the Virbac Animal Ethics Committee (AEC) that has responsibility for approving and overseeing all work that involves the use of animals for scientific and/or educational purposes (Code ref 2.1.3).
1.2. The AEC is directly accountable to the General Manager of Virbac Australia (the institution) for the care and use of animals for scientific purposes by Virbac Australia. The General Manager is ultimately accountable for the institution’s governance with respect to the care and use of animals for scientific purposes (Code ref 2.2.18 ii).
1.3. This Terms of Reference will be made publicly available on the “Legal notices” page of the Virbac website. The direct web address is https://au.virbac.com/home/legal-notice/animal-ethics-committee-terms.html (Code ref 2.1.6 ii)
2.1 The AEC applies a set of principles, outlined in the Code, that govern the ethical conduct of people whose work involves the use of animals for scientific purposes. The role of the AEC is to ensure that the use of animals is justified, provides for the welfare of those animals and incorporates the principles of Replacement, Reduction and Refinement (Code ref 2.3.1).
2.2 The AEC operates according to the Code and to its approved Standard Operating Procedures (Code ref 2.2.20) as follows:
3.1 The AEC must have a membership that will allow it to fulfil its terms of reference. It must comprise at least four persons, including a separate person appointed to each of the following categories (Code ref 2.2.4):
3.2 The Chair should hold a senior position within Virbac (Code ref 2.2.2).
3.3 An Acting Chair (from within its membership) must be appointed to cover short-term absences by the Chair.
3.4 Category A and B members can be nominated by the General Manager if they have the suitable qualifications as described in 3.1. The Chair will contact the prospective member to outline the conditions of the membership category and invite them to join the AEC.
3.5 Category C members must have suitable qualifications as described in 3.1. While not representing an animal welfare organisation, the person should, where possible, be selected on the basis of active membership of and ideally be nominated by, an animal welfare organisation.
3.6 Category D members must be independent persons as described in 3.1. This member may be selected from the community via word of mouth and advertisement. Prior to commencing, the member must undergo an interview process with the Chair and the Executive Officer to determine suitability of the candidate.
3.7 Prior to appointment, all members must first attend an AEC meeting as an “observer”, after which they may accept the position. The Chair and all members of the AEC will then be formally appointed in writing by the General Manager (Code ref 2.2.9).
3.8 Prior to appointment, AEC members will acknowledge, in writing that they will accept:
3.9 The terms of membership for those appointed to the AEC shall normally be for a five year period. This period is deemed to be sufficient to permit new members to become familiar with operational procedures and the variety of product testing, research and teaching at a commercial company (Code ref 2.2.9).
3.10 A member can be re-appointed for an additional period as agreed (Code ref 2.2.9).
3.11 Members may resign from the AEC at any time by advising the Chair in writing with a minimum two month notification period. The Chair will advise the General Manager of the resignation (Code ref 2.2.9).
3.12 On the recommendation of the AEC Chair, the General Manager may request a member of the AEC to resign from the AEC (Code ref 2.2.9).
3.13 The Chair and the Executive Officer will monitor the AEC membership need in accordance to the Code.
3.14 The membership of the AEC may consist of more than a single representative of each category A, B, C, and D, however this is not essential. Multiple members in each category assists in ensuring that meetings have a quorum, but it is not a requirement under the Code. Additional members will be added at the discretion of the AEC.
3.15 All changes to the membership will be reported to the NSW “Animal Research Review Panel”, and other states where required, within 30 days of formal appointment.
4.1. The AEC will determine its meeting frequency and will hold a minimum of four (4) meetings per year (Code ref 2.2.26 iv).
4.2. Each meeting must have a quorum. One member of each category must be present at all times during the meeting and if the committee has more than four members, Categories C and D must represent no less than one third of the members (Code ref 2.2.25).
4.3. Decisions by the AEC with regard to approval, modification or rejection of an application, or withdrawal of approval for a project, should be made on the basis of consensus. Where consensus cannot be reached after reasonable effort to resolve differences, the AEC should explore with the applicant(s) ways of modifying the project that may lead to consensus. If consensus is still unachievable, the AEC should only proceed to a majority decision after members have been allowed a period of time to review their positions, followed by further discussion (Code ref 2.3.11).
4.4. The AEC may invite people with specific expertise to provide advice as required (Code ref 2.2.7; 2.4.3). The AEC should reach agreement on how advice can be sought from outside experts without breaching confidentiality.
4.5. Members of the AEC are required to declare general potential conflict of interest at the commencement of the meeting. Should a member identify a conflict of interest at any time during the meeting, this should be declared at that time (Code ref 2.2.21; 2.2.26).
4.6. Members of the AEC whose objectivity may be influenced by an interest (including consideration of an application submitted by that member or by a colleague) are required to leave the meeting during the decision making process (Code ref 2.2.21; 2.3.12).
The primary responsibility of the Virbac AEC is to ensure, on behalf of Virbac Australia, that all activities relating to the care and use of animals are conducted in compliance with the Code. The AEC has the responsibilities to:
5.1. Review applications for projects involving the use of animal for scientific purposes and approve only those projects that are ethically acceptable and conform to the requirements of the Code (Code ref 2.3.1).
5.2 Review applications for activities associated with the care and management of animals in facilities, including procedures applicable to breeding programs integral to the maintenance of an animal line, and approve only those activities that are ethically acceptable and conform to the requirements of the Code (Code ref 2,3,2).
5.3 Conduct follow-up review of approved projects and activities and allow the continuation of approval for only those projects and activities that are ethically acceptable and conform to the requirements of the Code (Code ref 2.3.2iii). Follow-up will be at scheduled times (most frequently annually) and also when circumstances trigger additional follow-up (for example when an amendment is requested or an adverse event occurs) (Code ref 2.2.32ii; 2.3.24; 2.3.25).
5.4. Monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities (Code ref 2.3.17).
5.5. Take appropriate actions regarding unexpected adverse events (Code ref 2.3.24).
5.6. Take appropriate actions regarding non-compliance (Code ref 2.3.25).
5.7. Approve guidelines for the care and use of animals on behalf of the institution (Code ref 2.1.5v).
5.8. Provide advice and recommendations to the institution (Code ref 2.3.27)
5.9. Report on its operations to the institution (Code ref 2.3.28-2.3.29)
5.10. Perform all other duties required by the Code.
6.1. The AEC must comply with the reporting requirements of Virbac and the Code.
6.2. The AEC must submit a written report on its activities at least annually to the General Manager (Code ref 2.3.28). The report should include information (Code ref 2.3.29) on:
6.3. The Committee reports annually to the NSW Department of Primary Industries. The AEC will also report to other State and Territory Governments in which we hold research licenses as per state requirements.
7.1. According to the Code the AEC may establish an Executive that “must include the chairperson and at least one member from Category C or D” (Code ref 2.2.23i) who:
7.2. At the beginning of each year, Virbac AEC appoints (by nomination) a sub-committee from its members called the Executive. This will include the chairperson and at least one member from Category C or D.
7.3. The Executive has been established to streamline the animal ethics process, to increase the efficiency of the AEC and to reduce workload on the AEC thus allowing additional time for discussion of ethical considerations, invitations to researchers and continuing education.
7.4. The role of the executive is to approve minor and straightforward modifications to protocols where the proposed change is not likely to cause harm to the animals. Examples include minor changes to procedures, or approving the additions/deletions of associate investigators (Code ref 2.2.23ii).
7.5. All decisions by the Executive are reviewed and ratified by the entire AEC at the next meeting (Code ref 2.2.23ii).
The Chair must (Code ref 2.2.13):
8.1. Ensure that the AEC operates in accordance with the principles and requirements of the Code; the relevant policies of the institution and the agreed AEC procedures.
8.2. Ensure that an agenda is produced prior to each meeting and the meeting will consider AEC business as required to fulfil the Committee’s responsibilities.
8.3. Ensure that applications are considered by the AEC and the outcomes are conveyed to the researchers in a timely fashion.
8.4. Advise the General Manager the levels of resources required by the AEC.
8.5. Represent the AEC in negotiations with the institution.
8.6. Oversee all requirements of the AEC to report and review its operation as outlined in the Code.
8.7. Ensure AEC records are maintained and made available for review by the institution and authorised external reviewers.
The Executive Officer:
9.1. Is a person appointed by Virbac and is authorised by the AEC to ensure that projects are proceeding in compliance with the Code and the decisions of the AEC (2.2.19).
9.2. Assists the Chair in maintaining the efficient operation of the AEC.
9.3. Is the first point of contact for investigators wishing to access the AEC. This person provides the investigators with advice and assistance regarding ethics applications and general advice on relevant ethics procedures.
9.4. Maintains a record of all applications and relevant correspondence.
9.5. Organises the distribution of information to all new members with a copy of the Code, meeting schedule, SOPs and animal house inspections.
10.1. Virbac will provide and facilitate training for AEC members, investigators and animal staff employed at Virbac (Code ref 2.1.8 ii).