CSIRO Animal Ethics Committee Terms of Reference

Introduction

The Australian Code for the care and use of Animals for Scientific Purposes 8th Edition 2013 (The Code) requires that: -

“Before appointment, all members of Animal Ethics Committees (AEC) should acknowledge in writing their acceptance of the terms of reference of the Committee and any requirements for confidentiality required by the institution.”

Governing principles

1.   Institutions, AECs, and people involved in any aspect of the care and use of animals for scientific purposes must be aware of and accept their responsibilities, and act in accordance with the Code.

2.   All activities, including projects that involve the care and use of animals for scientific purposes must:

• be subject to ethical review, approval and monitoring by an AEC
• commence only after approval has been granted by an AEC
• be conducted in accordance with AEC approval
• cease if approval from the AEC is suspended or withdrawn.

3.   The AEC must be satisfied that there is sufficient evidence to support a case that the proposed use of animals is justified.

AEC Responsibilities

4.   The AEC shall, on behalf of the institution, ensure that all activities relating to the care and use of animals are conducted in compliance with the Code.

5.   The AEC will:

•  review applications for projects and approve only those projects that are ethically acceptable and conform to the requirements of the Code
• 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
• conduct annual 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
• monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities
• take appropriate actions regarding unexpected adverse events
• take appropriate actions regarding non-compliance
• approve guidelines for the care and use of animals on behalf of the institution
• provide advice and recommendations to the institution
• support the development of a culture of ethical reflection within the research practices of the organisation.
• report on its operations to the institution by providing the Director Science Impact and Policy with an annual report of the operations of the AEC.

Review and approve new and ongoing activities

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

7.   The AEC will make a judgement on whether the proposed use, or continued use, of animals is ethically acceptable.

8.   This judgement will:

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

9.   The AEC will approve only those projects and activities that are ethically acceptable and conform to the requirements of The Code.

10.   The AEC will 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.

11.   AEC members will be provided with meeting material with adequate time to prepare for meetings.

12.   The AEC will 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.

13.   The AEC may decide that:

•  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
• 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
• an approval is suspended or withdrawn.

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

15.   Decisions will be made on the basis of consensus. Where consensus cannot be reached after reasonable effort to resolve differences, the AEC will 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 will only proceed to a majority decision after members have been allowed a period of time to review their positions, followed by further discussion.

16.   For decision making, members with a conflict of interest will withdraw from the meeting. Once such members have withdrawn, the remaining members will still 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.

17.   Decisions of the AEC will be made as promptly as possible.

18.   Pilot studies, where proposed, will 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 will be assessed by the AEC according to the criteria applied to project approval.

19.   When considering approval for the reuse of animals, the AEC will take into account:

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

20.   In determining the duration of approval for individual projects, the AEC will consider the number of years for which the project is funded, any milestones or stages outlined in the project, any requirements of the legislation and any formal agreements between the institution and funding bodies.

Monitor the care and use of animals

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

22.   The AEC will 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 Code and decisions of the AEC. The AEC will ensure that identified problems and issues receive appropriate follow-up and, if necessary, refer suspected breaches of the Code to the institution.

23.   The AEC will monitor activities that are likely to cause pain or distress at an early phase during the conduct of the activity. This requirement will 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. This may be achieved by requesting the researcher to provide a report to the committee which must be endorsed prior to progressing with the research.

24.   A Category C or D member of the AEC will participate in animal facility inspections where possible. For AEC’s with a Victorian premises license (SPPL), Animal Facility inspections may be delegated by the AEC to the AWO.

25.   The AEC will endeavour to inspect animal facilities annually. Influencing factors on frequency 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.

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

27.   The AEC will allow the delegation of authority to suitably qualified people to monitor animal care and use, including projects and activities conducted at remote sites (e.g. fieldwork/ overseas research). Reports of such monitoring may be provided to the AEC in written form and/or using still or video images.

Take action regarding unexpected adverse events

28.   The AEC will 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.

Take action regarding non-compliance

29.   When projects or activities that are in breach of the Code are detected, the AEC will ensure that:

• 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
• actions are taken to address the issues in consultation with the person(s) involved
• when considered necessary, such matters are referred to the institution for action
• non-compliance receives appropriate follow-up.

Approve guidelines for the care and use of animals

30.   The AEC will consider approval of guidelines for the care and use of animals that are referred to it by the institution.

Provide advice and recommendations to the institution

31.   The AEC will provide advice and recommendations to the institution 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 Code are maintained and that matters affecting animal wellbeing are addressed.

32.   The AEC will liaise with relevant operations managers to ensure best practise.

Report to the institution

33.   The AEC will submit a written report on its operations annually, to the Director – Science Impact and Policy.

The report will advise on:

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

Institutional accountability and mechanisms of reporting

34.   The AEC reports to the Director – Science Impact and Policy. This person is also the animal use licence holder.

Ensure appropriate animal ethics committee membership

Composition of the animal ethics committee

Chairperson

35.   CSIRO will appoint a chairperson to the AEC. The chairperson may be appointed in addition to Category A to D members.

Members

36.   The AEC will comprise at least one person from each of four categories of membership:

• 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 the institution’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 the institution and the business of the AEC. This must include possession of a higher degree in research or equivalent experience. If the business of the AEC relates to the use of animals for teaching only, a teacher with substantial and recent experience may be appointed.
• 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 currently 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. While not representing an animal welfare organisation, the person should, where possible, be selected on the basis of active membership of, and endorsement by, such an organisation.
• Category D—a person not employed by or otherwise associated with 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 undergraduate 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.

Animal Ethics Committee Executive

37.   The AEC may establish an AEC Executive which must include the chairperson and at least one member from Category C or D

38.   The AEC Executive may be delegated to approve minor amendments to approved projects or activities, for ratification at the next AEC meeting. 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. The types of amendments that an Executive Committee can consider include:

1. Changes to appropriately qualified/supervised staff
2. Changes to tissues/samples collected.
3. Changes to project dates/approval period
4. Changes in animal numbers not exceeding 10% of the originally approved number.
5. Changes to an approved project that improve animal welfare.

39.   The AEC Executive are not permitted to approve new applications.

Additional members to assist the AEC to function effectively

40.   A person responsible for routine care of animals within the institutions may be appointed to the AEC. This will occur for CSIRO AEC’s that consider research in South Australia and will be a voting member of that AEC.

41.   Additional members with skills and background of value to the AEC may be appointed to the AEC.

Access to expertise

42.   The AEC may invite people with specific expertise to provide advice, as required.

Balance of membership

43.   Categories C and D must together represent at least one-third of the AEC voting membership.

Appointment, reappointment and retirement of members

44.   Procedures for the appointment, reappointment and retirement of AEC members:

• AEC members are appointed following nomination and informal interview with the AEC Chair, Executive Officer or member of the CSIRO Ethics team to assess suitability. Initially, they are appointed for a term of no more than three years, subsequent appointments may be longer.
• Before appointment AEC members must declare any conflict of interest.
• Before appointment, AEC members must acknowledge in writing their acceptance of the terms of reference of the AEC and any requirements for confidentiality required by the CSIRO.
• Upon expiry of the term, the Chair / Executive Officer/ Ethics team member will review the appointment and a further term may be offered at the discretion of the Chair/ Executive Officer/ Ethics team member bearing in mind the need for a turnover of members over a period of time.
• The appointment of any member may be terminated by the Institution or its delegate, in writing, at any time.
• To aid with induction, new AEC members will be provided with the ‘Information Package for Members of Animal Ethics Committees’, ANZCCART and asked to complete ComPass Phase 1 (ANZCCART / University of Adelaide website)

Introduction

The Australian Code for the care and use of Animals for Scientific Purposes 8th Edition 2013 (The Code) requires that: -

“Before appointment, all members of Animal Ethics Committees (AEC) should acknowledge in writing their acceptance of the terms of reference of the Committee and any requirements for confidentiality required by the institution.”

Governing principles

1.   Institutions, AECs, and people involved in any aspect of the care and use of animals for scientific purposes must be aware of and accept their responsibilities, and act in accordance with the Code.

2.   All activities, including projects that involve the care and use of animals for scientific purposes must:

• be subject to ethical review, approval and monitoring by an AEC
• commence only after approval has been granted by an AEC
• be conducted in accordance with AEC approval
• cease if approval from the AEC is suspended or withdrawn.

3.   The AEC must be satisfied that there is sufficient evidence to support a case that the proposed use of animals is justified.

AEC Responsibilities

4.   The AEC shall, on behalf of the institution, ensure that all activities relating to the care and use of animals are conducted in compliance with the Code.

5.   The AEC will:

•  review applications for projects and approve only those projects that are ethically acceptable and conform to the requirements of the Code
• 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
• conduct annual 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
• monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities
• take appropriate actions regarding unexpected adverse events
• take appropriate actions regarding non-compliance
• approve guidelines for the care and use of animals on behalf of the institution
• provide advice and recommendations to the institution
• support the development of a culture of ethical reflection within the research practices of the organisation.
• report on its operations to the institution by providing the Director Science Impact and Policy with an annual report of the operations of the AEC.

Review and approve new and ongoing activities

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

7.   The AEC will make a judgement on whether the proposed use, or continued use, of animals is ethically acceptable.

8.   This judgement will:

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

9.   The AEC will approve only those projects and activities that are ethically acceptable and conform to the requirements of The Code.

10.   The AEC will 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.

11.   AEC members will be provided with meeting material with adequate time to prepare for meetings.

12.   The AEC will 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.

13.   The AEC may decide that:

•  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
• 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
• an approval is suspended or withdrawn.

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

15.   Decisions will be made on the basis of consensus. Where consensus cannot be reached after reasonable effort to resolve differences, the AEC will 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 will only proceed to a majority decision after members have been allowed a period of time to review their positions, followed by further discussion.

16.   For decision making, members with a conflict of interest will withdraw from the meeting. Once such members have withdrawn, the remaining members will still 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.

17.   Decisions of the AEC will be made as promptly as possible.

18.   Pilot studies, where proposed, will 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 will be assessed by the AEC according to the criteria applied to project approval.

19.   When considering approval for the reuse of animals, the AEC will take into account:

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

20.   In determining the duration of approval for individual projects, the AEC will consider the number of years for which the project is funded, any milestones or stages outlined in the project, any requirements of the legislation and any formal agreements between the institution and funding bodies.

Monitor the care and use of animals

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

22.   The AEC will 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 Code and decisions of the AEC. The AEC will ensure that identified problems and issues receive appropriate follow-up and, if necessary, refer suspected breaches of the Code to the institution.

23.   The AEC will monitor activities that are likely to cause pain or distress at an early phase during the conduct of the activity. This requirement will 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. This may be achieved by requesting the researcher to provide a report to the committee which must be endorsed prior to progressing with the research.

24.   A Category C or D member of the AEC will participate in animal facility inspections where possible. For AEC’s with a Victorian premises license (SPPL), Animal Facility inspections may be delegated by the AEC to the AWO.

25.   The AEC will endeavour to inspect animal facilities annually. Influencing factors on frequency 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.

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

27.   The AEC will allow the delegation of authority to suitably qualified people to monitor animal care and use, including projects and activities conducted at remote sites (e.g. fieldwork/ overseas research). Reports of such monitoring may be provided to the AEC in written form and/or using still or video images.

Take action regarding unexpected adverse events

28.   The AEC will 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.

Take action regarding non-compliance

29.   When projects or activities that are in breach of the Code are detected, the AEC will ensure that:

• 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
• actions are taken to address the issues in consultation with the person(s) involved
• when considered necessary, such matters are referred to the institution for action
• non-compliance receives appropriate follow-up.

Approve guidelines for the care and use of animals

30.   The AEC will consider approval of guidelines for the care and use of animals that are referred to it by the institution.

Provide advice and recommendations to the institution

31.   The AEC will provide advice and recommendations to the institution 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 Code are maintained and that matters affecting animal wellbeing are addressed.

32.   The AEC will liaise with relevant operations managers to ensure best practise.

Report to the institution

33.   The AEC will submit a written report on its operations annually, to the Director – Science Impact and Policy.

The report will advise on:

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

Institutional accountability and mechanisms of reporting

34.   The AEC reports to the Director – Science Impact and Policy. This person is also the animal use licence holder.

Ensure appropriate animal ethics committee membership

Composition of the animal ethics committee

Chairperson

35.   CSIRO will appoint a chairperson to the AEC. The chairperson may be appointed in addition to Category A to D members.

Members

36.   The AEC will comprise at least one person from each of four categories of membership:

• 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 the institution’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 the institution and the business of the AEC. This must include possession of a higher degree in research or equivalent experience. If the business of the AEC relates to the use of animals for teaching only, a teacher with substantial and recent experience may be appointed.
• 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 currently 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. While not representing an animal welfare organisation, the person should, where possible, be selected on the basis of active membership of, and endorsement by, such an organisation.
• Category D—a person not employed by or otherwise associated with 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 undergraduate 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.

Animal Ethics Committee Executive

37.   The AEC may establish an AEC Executive which must include the chairperson and at least one member from Category C or D

38.   The AEC Executive may be delegated to approve minor amendments to approved projects or activities, for ratification at the next AEC meeting. 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. The types of amendments that an Executive Committee can consider include:

1. Changes to appropriately qualified/supervised staff
2. Changes to tissues/samples collected.
3. Changes to project dates/approval period
4. Changes in animal numbers not exceeding 10% of the originally approved number.
5. Changes to an approved project that improve animal welfare.

39.   The AEC Executive are not permitted to approve new applications.

Additional members to assist the AEC to function effectively

40.   A person responsible for routine care of animals within the institutions may be appointed to the AEC. This will occur for CSIRO AEC’s that consider research in South Australia and will be a voting member of that AEC.

41.   Additional members with skills and background of value to the AEC may be appointed to the AEC.

Access to expertise

42.   The AEC may invite people with specific expertise to provide advice, as required.

Balance of membership

43.   Categories C and D must together represent at least one-third of the AEC voting membership.

Appointment, reappointment and retirement of members

44.   Procedures for the appointment, reappointment and retirement of AEC members:

• AEC members are appointed following nomination and informal interview with the AEC Chair, Executive Officer or member of the CSIRO Ethics team to assess suitability. Initially, they are appointed for a term of no more than three years, subsequent appointments may be longer.
• Before appointment AEC members must declare any conflict of interest.
• Before appointment, AEC members must acknowledge in writing their acceptance of the terms of reference of the AEC and any requirements for confidentiality required by the CSIRO.
• Upon expiry of the term, the Chair / Executive Officer/ Ethics team member will review the appointment and a further term may be offered at the discretion of the Chair/ Executive Officer/ Ethics team member bearing in mind the need for a turnover of members over a period of time.
• The appointment of any member may be terminated by the Institution or its delegate, in writing, at any time.
• To aid with induction, new AEC members will be provided with the ‘Information Package for Members of Animal Ethics Committees’, ANZCCART and asked to complete ComPass Phase 1 (ANZCCART / University of Adelaide website)