Virbac Animal Ethics Committee Terms Of Reference

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. General Principles

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:

• AEC-001 Standing Orders for AEC meetings
• AEC-002 Protocol Applications for AEC Approval
• AEC-003 Documentation, Administration and Reporting
• AEC-004 Monitoring Trials by the AEC
• AEC-005 Adverse Incidents in AEC Approved Projects
• AEC-006 Complaints and Non-compliances

3. Membership of the AEC

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):

• Category A: a person with qualifications in veterinary science that are recognised for registration as a veterinary surgeon in Australia, and with experience relevant to Virbac’s activities or the ability to acquire relevant knowledge.
• Category B: a suitably qualified person with substantial and recent experience in the use of animals for scientific purposes relevant to Virbac and the business of the AEC. This must include possession of a higher degree in research or equivalent experience.  
• Category C: a person with demonstrable commitment to, and established experience in, furthering the welfare of animals, who is not employed by or otherwise associated with the institution, and who is not involved in the care and use of animals for scientific purposes. Veterinarians with specific animal welfare interest and experience may meet the requirements of this Category.
• Category D: a person who is both independent of the institution and who has never been involved in the use of animals in scientific or teaching activities, either in their employment or beyond their under-graduate education. Category D members should be viewed by the wider community as bringing a completely independent view to the AEC, and must not fit the requirements of any other Category.

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:

• the Terms of Reference of the AEC
• a Confidentiality Agreement (Code ref 2.2.11)

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. Operations of Virbac AEC

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).

5. Responsibilities of Virbac AEC

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).

• The AEC must approve only those studies for which animals are considered essential and justified and which conform to the requirements of the Code (Code ref 2.3.1i). This should take into consideration factors including the minimisation of pain and distress of the animals, the 3Rs (Replacement, Reduction and Refinement) (Code ref 1.18-1.30) and whether the scientific or educational value is balanced with the wellbeing of the animals involved (Code ref 1.7).
• Decisions made to approve, modify, or reject the application or withdraw the project should be made by consensus (Code ref 2.3.11). The AEC may recommend modifications be made but should not make changes on behalf of the investigator. Recommendations for modifications should be sent to the investigator and the application re-presented for approval either at a later full meeting or between meetings by the AEC Executive if empowered to do so by the full AEC. Applications can also be approved subject to Special Conditions, which will be recorded on the application form and approved by the Chair at the meeting. Special conditions must be met by the Investigators in order for the trial to proceed.
• When approving an application the AEC should be aware of the length of the project and any milestones or Go/No-Go points to ensure that reporting at these points occurs and to ensure the trial does not continue for longer than has been justified (Code ref 2.3.16).
• Approval/disapproval of the application by the AEC will be recorded in the minutes of the AEC meeting. An Animal Research Authority must be completed by the Executive Officer for each approved application, signed by the Chairperson and sent to the Principal Investigator by the Executive Officer (Code ref 2.7.1).

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).

• All proposed guidelines and standard operating procedures will be reviewed at AEC meetings. Once approved, these guidelines will be available for all Virbac staff through the Documentation section of the Quality Assurance department (Code ref 2.2.34; 2.2.36).

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).

• Review of annual progress for projects is achieved by the completion of the annual report (Code ref 2.2.32ii(b)). Investigators must provide the AEC an annual report for an approved project, regardless of the duration of AEC approval for the project (Code ref 2.4.34i). If the project is still in progress, the report will be a Progress Report, and if the Project is complete then it will be a Final Report. The annual report is to be reviewed by the committee at the next AEC meeting and the approval for the project is continued, modified or discontinued (Code ref 2.3.9). The Executive Officer will advise the Principal Investigator the outcome of the report review within 3 working days of the AEC meeting in which it is reviewed.
• Proposed amendments to an approved project require the approval of the AEC. Investigators must provide the AEC with an Amendment application form which describes the requested amendment, the reason for the amendment and what impact it has on animal welfare and the study outcome (Code ref 2.2.32ii(a); 2.4.10). Amendments will only be approved if after careful consideration of factors including compliance with the Code, minimisation of pain and distress of the animals, the 3Rs (Replacement, Reduction and Refinement) and the balance of the scientific benefits with the wellbeing of the animals.
• The AEC will follow-up on any unexpected adverse events as well as project activities subsequent to the adverse event to ensure any AEC recommendations have been implemented (Code ref 2.3.2v; 2.3.24).

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).

• The AEC’s review of applications addresses and seeks clarification on a case by case basis concerning the acquisition, transportation, production, housing, care, use and fate of animals.
• The AEC will inspect all animal houses at least three times per year. In addition, an AEC subcommittee or delegated AEC member will conduct announced or unannounced inspections of facilities and AEC approved studies (Code ref 2.3.21).
• Trials being conducted outside of Virbac facilities (eg on-farm) will be monitored by means such as AEC member attendance, reviewing of raw data sheets, viewing videos and photos of procedures (Code ref 2.3.23).

5.5. Take appropriate actions regarding unexpected adverse events (Code ref 2.3.24).

• Immediate action is required by the person who firsts notices the adverse event. The investigator, their delegate or in their absence a person nominated by the AEC should direct the response.
• It is crucial that the welfare issues are addressed as soon as possible and that experimental activity ceases if it is likely to cause any further risk to the animal. The welfare of the animal must take precedent over the experiment or test being conducted.
• The AEC’s veterinarian (including veterinarians in membership Category A and the Company Veterinarian) may in their veterinary capacity deem that emergency treatment or euthanasia is necessary.
• The Chairperson must be notified of any unexpected adverse events as soon as possible. The Chairperson, in consultation with the AEC’s veterinarian (including veterinarians in membership Category A or the Company Veterinarian) may deem that emergency treatment or euthanasia is necessary. In cases of emergency, before an animal is treated or euthanased, all reasonable steps must be taken to consult with the responsible investigator. Any treatment or euthanasia must be reported promptly to the responsible investigator and the AEC with reasons for the action taken, and confirmed in writing.
• The AEC must review the Adverse Incident report at the next AEC meeting and provide recommendations to prevent recurrence. This can include:
   
  • Re-training of staff
  • Upgrade to facilities
  • Temporary suspension of the project
  • Increased inspection or reporting
  • Withdrawal of project approval

5.6. Take appropriate actions regarding non-compliance (Code ref 2.3.25).

• The AEC must investigate and address any complaints and instances of non-compliance.
• An immediate response to the complaint will focus on the care and wellbeing of the animal(s) to ensure that animal wellbeing is not compromised, and activities that have  the potential to adversely affect animal wellbeing cease immediately.
• The AEC can withdraw the approval of any project or activity based on detection of non-compliance or serious misconduct. In addition, if new information becomes available with respect to the 3Rs and the way it can be applied to a particular project, the AEC can suspend or withdraw approval of any project based on this new evidence.
• The AEC must refer to the approved procedure for handling complaints and non-compliance of the use of animals, complaints concerning the AEC process and complaints concerning the process for independent external review. This includes referring matters to the institution for action when considered necessary.
• Actions that are taken to address complaints and non-compliance will be done in consultation with the person(s) involved.
• All matter of non-compliance will receive appropriate follow-up within an agreed timeframe.
• The AEC must keep records of any breaches of the Code.

5.7. Approve guidelines for the care and use of animals on behalf of the institution (Code ref 2.1.5v).

• The AEC must examine, comment on and approve all institutional plans and policies that may affect the welfare of animals used for scientific purposes. In addition to the above, the AEC must conduct a final inspection of any new animal facility prior to final approval.

5.8. Provide advice and recommendations to the institution (Code ref 2.3.27)

• The AEC may recommend to the Institution any measures needed to ensure that the standards of the Code are maintained.

5.9. Report on its operations to the institution (Code ref 2.3.28-2.3.29)

• The AEC will maintain all records of applications, approved projects and related correspondence.
• The AEC will provide the Institution an annual report as per Section 6.2 below.

5.10. Perform all other duties required by the Code.

• Virbac AEC undertakes all other duties as described in the Code.

6. Reporting

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:

• numbers and types of projects assessed and approved or rejected;
• the physical facilities for the care and use of animals by the institution;
• activities that have supported the educational needs of AEC members, and of personnel involved in the care and use of animals;
• administrative or other difficulties being experienced; and
• any matters that may affect the institution’s ability to maintain compliance with the Code and if necessary the provision of suitable recommendations.

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. AEC Executive

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:

• may approve minor modifications to approved projects for ratification at the next AEC meeting (Code ref 2.2.23ii) ;
• may not approve new applications (Code ref 2.2.23iii).

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).

8. Responsibilities of the Chair

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.

9. Duties of the Executive Officer

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. Training of animal researchers

10.1. Virbac will provide and facilitate training for AEC members, investigators and animal staff employed at Virbac (Code ref 2.1.8 ii).