Museums Victoria Animal Ethics Committee Terms of Reference

20 March 2015

1. Introduction

Museums Victoria is governed by the Museums Act 1983, which provides the organisation with a mandate to:

“…develop and maintain the State collections of Natural Sciences … (and) to promote the use of those collections for scientific research” [Clause 23, (b)(d)];  “… to act as a repository for specimens upon which scientific studies have been made or which may have special cultural or historical significance” [Clause 23 (g)]; and,

“… to research, present and promote issues of public relevance and benefit in the following fields - (i) the origins, development and diversity of cultures in Australia and adjacent lands; (ii) the natural environment; (iii) science and technology and their applications to the development of society” [Clause 23 (f)].

Specimens in Museums Victoria’s collections underpin research for scientific and/or educational purposes. The specimens, along with the collection documentation that accompanies them, are stored in perpetuity. Their existence facilitates government, higher education and private needs. The collections are a public asset and are accessible to legitimate users.

In certain circumstances, scientific research and collection programs at Museums Victoria involve the care and use of live animals, including terrestrial vertebrate animals and specified aquatic animals, and these activities require a focus on ethical practice.

In 2007, Museums Victoria established its own Animal Ethics Committee (AEC) to oversee these activities.  The current Terms of Reference detail the responsibilities and operation of the AEC, in line with the requirements of the relevant legislation such as the Prevention of Cruelty to Animals Act 1986 (Victoria) and codes of practice such as the Australian Code for the Care and Use of Animals for Scientific Purposes.

2. Relevant legislation and codes

The use of animals for research and teaching at Museums Victoria is currently regulated by the Prevention of Cruelty to Animals Act 1986 (Version incorporating amendments as at 1 July 2014), and the associated Prevention of Cruelty to Animals Regulations 2008 (Version incorporating amendments as at 1 November 2014).  Part 3 of the Act ensures that animals used in research are treated as humanely as possible.  Copies of the Prevention of Cruelty to Animals Act 1986 and Prevention of Cruelty to Animals Regulations 2008 can be located at: http://www.depi.vic.gov.au/agriculture-and-food/animal-health-and-welfare/animal-welfare/animal-welfare-legislation

The Victorian legislation incorporates the provisions of the Australian Code for the Care and Use of Animals for Scientific Purposes (8^th Edition, 2013).  The current version of the Australian Code, mandatory under Part 3 of the Prevention of Cruelty to Animals Act 1986 and Regulations 2008 can be found at: http://www.nhmrc.gov.au/guidelines-publications/ea28

Under the legislation, Museums Victoria’s use of animals for research and teaching must be licenced, and projects involving animals cannot proceed without the approval of an AEC.  Museums Victoria must have an AEC to consider all proposals to use animals.  Museums Victoria, its investigators and its AEC must conduct their activities according to the Australian Code referred to above. 

The Licencing and Audit Branch – Biosecurity Division – Department of Economic Development, Jobs, Transport and Resources – DEDJTR (formerly the Department of Environment and Primary Industries – DEPI) licenses and monitors use of animals in scientific procedures.

3. Role and responsibility of the committee

In accordance with the relevant legislation and codes of practice identified above, the Museums Victoria AEC:

• Oversees the care and use of animals for scientific purposes at Museums Victoria in line with the Prevention of Cruelty to Animals Act 1986 and the Australian Code for the Care and Use of Animals for Scientific Purposes;
• Provides advice to and reports annually on AEC matters as they apply to Museums Victoria and its Research Committee; and
• Reports annually on AEC activities to the Licencing and Audit Branch – Biosecurity Division -- DEDJTR and other authorities as required.

The Museums Victoria AEC is a sub-committee of the Museums Board of Victoria’s Research Committee.  The AEC is accountable and reports to the Research Committee.  Overall governance of the AEC will be as per the methods outlined in the Museums Board of Victoria Governance Handbook (approved by the Museums Board, 28 August 2006).

4. Membership of the committee

General responsibilities for the governance of Museums Victoria’s AEC may be found in Sections 2.1 and 2.2 of the Australian Code.

Membership of Museums Victoria’s AEC must comprise at least four people, one from each of the following four categories:

• Category A: a person with qualifications in veterinary science, and with experience relevant to Museums Victoria’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 Museums Victoria and the business of the AEC;
• 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 Museums Victoria, and who is not currently involved in the care and use of animals for scientific purposes;
• Category D: a person not employed by or otherwise associated with Museums Victoria and who has never been involved in the use of animals in scientific or teaching activities, either in their employment or beyond their undergraduate education.

Museums Victoria must appoint a chairperson of the AEC.  The Museum should consider appointing a chairperson who holds a senior position in the institution.  If the chairperson is an external appointee, the Museum must provide the chairperson with the necessary support and authority to carry out the role.  The chairperson may be appointed in addition to Category A to D members.

The chairperson is responsible for impartially guiding the operation of the AEC, resolving conflicts of interest related to the business of the AEC, and representing the AEC in any negotiations with Museums Victoria management.

At least one member from each of the membership categories A, B, C and D must be present at meetings to establish a quorum for the conduct of the meeting, and must be present throughout the meeting.  Categories C and D together must represent at least one-third of those members present.

Each committee member is responsible for deciding whether, in their own judgement, an application or other matter under consideration by the AEC is ethically acceptable and meets the requirements of the Australian Code.

During their appointment to the AEC, and before any deliberations of the AEC, committee members must declare any perceived or actual conflict of interest that could influence the objectivity of their decision making. People with a conflict of interest must remove themselves from the AEC’s decision making on matters that relate to the conflict of interest.  The AEC will advise the person with a conflict of the AEC’s response to the conflict of interest, and record any conflicts of interest in AEC meetings.

Members must maintain confidentiality regarding the content of applications and the deliberations of the AEC, in accordance with Museums Victoria’s requirements.

To further assist the AEC to function effectively, Museums Victoria may appoint as members, people with skills and background of value to the AEC. The AEC may also invite people (non-members) with specific expertise to provide advice as required.

The AEC will be coordinated to ensure that there are no fewer than four AEC meetings each year, and more frequently if required and where there is business to discuss.

The Australian Code allows for the establishment of a Committee Executive.  The AEC Executive must include the chairperson and at least one member from Category C or D.  The Executive may be delegated to approve minor amendments to approved projects or activities, for ratification at the next AEC meeting.  The AEC should provide guidance on the type of activity that would be a minor amendment.  A minor amendment may include a change to an approved project or activity where the proposed change is not likely to cause harm to the animals, including pain and distress.  Examples of minor amendments may be: addition of new staff; a small change in procedure; a change in animal numbers; or an extension of duration of the project.  The Executive must not approve new applications. 

The AEC members are appointed, re-appointed or retired according to the following procedures:

• The membership needs of the AEC will be monitored by Museums Victoria in consultation with the AEC chairperson;
• Committee members will be appointed by Museums Victoria for a term of three years, and will be eligible for re-appointment;
• Committee membership will be reviewed every three years, or as required, following retirement or resignation of members from the AEC;
• The office of a Committee member will become vacant if the member retires or resigns, becomes incapable of performing their duties, becomes bankrupt, or fails to attend three consecutive Committee meetings without providing an apology or excuse.
• Members may be granted leave of absence by Museums Victoria in special circumstances, however consideration should be given to maintenance of a quorum in accordance with the Code’s requirements.
• In the event of a member being obliged or electing to retire or resign during the term of the Committee, or being removed by the Museum, the Museum will seek nominations for a replacement member.
• The AEC shall call for expressions of interest, solicited applications and unsolicited applications if a new member is required.
• Museums Victoria recommends that the chairperson interview proposed new AEC members to ensure their suitability to serve on AEC, and that the person fills the criteria for their Category and to reveal any biases which could be detrimental to the workings of the committee.
• New AEC members will be required to complete any necessary forms, and undergo appropriate induction, and have access to appropriate educations programs and resources.

5. Specific tasks and operation

Specific responsibilities of Museums Victoria’s AEC may be found in Section 2.3 of the Australian Code.

5.1 The primary responsibility of an AEC is to ensure, on behalf of the institution for which it acts, that all activities relating to the care and use of animals are conducted in compliance with the Australian Code.

5.2 The AEC must:

1. review applications for projects and approve only those projects that are ethically acceptable and conform to the requirements of the Australian Code;
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 Australian Code;
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 Australian Code;
4. monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities;
5. take appropriate actions regarding unexpected adverse events;
6. take appropriate actions regarding non-compliance;
7. approve guidelines for the care and use of animals on behalf of Museums Victoria;
8. provide advice and recommendations to Museums Victoria;
9. report on its operations to Museums Victoria.

5.3 The AEC must provide competent, fair, consistent and timely review of applications and reports related to the care and use of animals.

5.4 The AEC must make a judgement on whether the proposed use, or continued use, of animals is ethically acceptable. This judgement must:

1. be based on information provided by the applicant that demonstrates the application of the principles outlined in Section 1 of the Australian Code;
2. balance whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits.

5.5 The AEC may approve only those projects and activities that are ethically acceptable and conform to the requirements of the Australian Code.

5.6 The AEC must consider and approve applications for new projects and activities, and the ongoing approval for existing projects and activities, only at quorate meetings of the AEC.

5.7 Procedures should describe how applications and reports will be assessed in a manner that is fair to applicants and acceptable to all members, including the need to provide AEC members with information in a timely manner.

5.8 The AEC must base its decisions on the information it receives from the applicant in the documentation and in any direct discussions with the applicant, and may use information in addition to that obtained from the applicant.

5.9 The AEC may decide that:

1. an application to commence a project or activity, or amend an approved project or activity, is approved with or without conditions, deferred subject to modification, or not approved;
2. following review of the annual report for an approved project or activity and possible consultation with the applicant, the approval for the project or activity is continued, suspended, modified or discontinued;
3. an approval is suspended or withdrawn.

5.10 Decisions should be based on a thorough, fair and inclusive process of discussion and deliberation by AEC members, and should be made only by those present throughout the discussion.

5.11 Decisions 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 or activity that may lead to consensus. If consensus is still not achieved, 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.

5.12 For decision making, members with a conflict of interest must withdraw from the meeting. Once such members have withdrawn, the remaining members must constitute a quorum, that is, one member from each of the membership categories A, B, C and D, with Categories C and D together representing at least one-third of members present.

5.13 Decisions of the AEC must be made as promptly as possible.

5.14 Pilot studies, where proposed, should be regarded as integral to the overall project, especially to enable assessment of the feasibility of the project and the potential for refinement and reduction. They must be assessed by the AEC according to the criteria applied to project approval.

5.15 When considering approval for the reuse of animals, the AEC must take into account:

1. the pain and distress, and any potential long-term or cumulative effects, caused by previous activities and conditions;
2. the time allowed for recovery of the animals between activities;
3. whether an animal has fully recovered from the previous activities;
4. the pain and distress likely to be caused by the next and subsequent activities;
5. the total time over which an animal will be used.

5.16 In determining the duration of approval for individual projects, the AEC should take into account the number of years for which the project is funded, any milestones or stages outlined in the project, and any formal agreements between the institution and funding bodies.

5.17 The AEC monitors the care and use of animals by inspecting animals, animal housing and the conduct of procedures, and/or reviewing records and reports.

5.18 The AEC must monitor all activities relating to the care and use of animals (including the acquisition, transport, breeding, housing and husbandry of animals) on a regular and ongoing basis to assess compliance with the Australian Code and decisions of the AEC. The AEC must ensure that identified problems and issues receive appropriate follow-up and, if necessary, refer suspected breaches of the Australian Code to Museums Victoria.

5.19 The AEC should monitor activities that are likely to cause pain or distress at an early phase during the conduct of the activity. This requirement should be a condition of approval for the project or activity. These activities could include the study of pain, responses to stressors, models of human and animal diseases, or attempts to change behaviour by physical or chemical means.

5.20 A Category C or D member of the AEC should participate in animal facility inspections.

5.21 The AEC should determine the frequency and timing of inspections. Influencing factors include the number and accessibility of sites, the number and types of projects and activities, and whether inspections can be combined with scheduled AEC meetings. In addition, the AEC may decide that certain projects or activities require more frequent inspection than others. Inspections may be announced or unannounced.

5.22 The AEC must maintain records of inspections that include the names of attendees, observations, any identified problems, recommended actions, ongoing or outstanding issues, and outcomes.

5.23 AEC procedures should cover the delegation of authority to suitably qualified people to monitor animal care and use, including projects and activities conducted at remote sites (eg, fieldwork). Procedures should include how reports of such monitoring are to be provided to the AEC (eg, using still or video images).

5.24 The AEC must take appropriate action in response to unexpected adverse events to ensure that animal wellbeing is not compromised, the issue is addressed promptly, and activities that have the potential to adversely affect animal wellbeing cease immediately. Actions may include consulting with relevant people and, where necessary, suspending or withdrawing approval for the project or activity.

5.25 When projects or activities that are in breach of the Australian Code are detected, the AEC must ensure that:

1. actions are taken to ensure that animal wellbeing is not compromised, the issue is addressed promptly, and activities that have the potential to adversely affect animal wellbeing cease immediately. Actions may include suspending or withdrawing approval for the project or activity;
2. actions are taken to address the issues in consultation with the person(s) involved;
3. when considered necessary, such matters are referred to Museums Victoria for action.
4. non-compliance receives appropriate follow-up.

5.26 The AEC must consider approval of guidelines for the care and use of animals that are referred to it by Museums Victoria.

5.27 The AEC must provide advice and recommendations to Museums Victoria regarding the care and use of animals for scientific purposes conducted on behalf of the institution, and strategies required to ensure that the requirements of the Australian Code are maintained and that matters affecting animal wellbeing are addressed.

5.28 The AEC must submit a written report on its operations at least annually to the Research Committee of the Museums Board of Victoria.

5.29 The report should advise on:

1. numbers and types of projects and activities assessed, and approved or rejected;
2. the physical facilities for the care and use of animals by Museums Victoria;
3. actions that have supported the educational and training needs of AEC members and people involved in the care and use of animals;
4. administrative or other difficulties experienced;
5. any matters that may affect Museums Victoria’s ability to maintain compliance with the Australian Code and, if appropriate, suitable recommendations.

6. Other responsibilities of the Museums Victoria AEC

Certain other responsibilities of Museums Victoria’s AEC may be found in Section 2.6 of the Australian Code.

Projects involving more than one institution and/or AEC:

The Museums Victoria AEC must ensure that projects involving investigators from more than one institution, or the care and use of animals at more than one institution, are approved and monitored by the responsible AECs. The AEC must ensure that:

• all parties involved are aware of, and can meet, their respective responsibilities under the requirements of the Code;
• a project does not commence before each AEC approves activities to be conducted by members of its institution. Each AEC should be responsible for approval and monitoring of animal care and use that occurs at the institution for which it acts;
• The responsible AECs are aware of all aspects of the proposed use of animals, and consider the cumulative effects on the wellbeing of the animals involved;
• The responsible AECs can inspect the animals so that all phases of the project are monitored, including any animal transport between sites;
• Animals will receive appropriate care in all phases of the project, including any animal transport between sites;
• Clear communication channels are established between all AECs and all investigators.

Museums Victoria may agree to one AEC (the delegate AEC) approving the entire project, provided that all institutions involved agree to delegate the responsibility for decision making to, and support the necessary actions of, that AEC.

In cases where AEC approval is obtained by an institution other than Museums Victoria, written evidence of the approval by that institution’s AEC must be provided to the Museums Victoria AEC.  Approvals and clearances must be obtained from the collaborating institution before the project work commences.

Projects conducted by Australian investigators and institutions in other countries:

The Museums Victoria AEC must ensure that, as a minimum, projects conducted on behalf of the institution in other countries:

• comply with the governing principles of the Australian Code, provided that such compliance does not breach relevant local legislation;
• are not conducted in other countries as a mechanism of avoiding compliance with the Australian Code.

When considering approval for a project to be conducted in another country, the AEC may accept approval granted by a local AEC or its equivalent in that country if it is satisfied that outcomes would be equivalent to those expected through application of the Code.

The AEC must ensure that animal care and use in the other country is adequately monitored. The AEC may appoint an agent or delegate to conduct the monitoring and inspection on its behalf.

7. Revision of the Terms of Reference

These Terms of Reference will be reviewed by the AEC as necessary in response to changes in legislation and Museums Victoria policy.  Any changes to the Terms of Reference will require the approval of the Research Committee of the Museums Board of Victoria.