Department of Agriculture and Fisheries Animal Ethics Committee

Terms of Reference and Procedural Guidelines

Table of Contents

Table of Contents...............................................................................................................ii

Chapter 1. Terms of Reference....................................................................................1

Chapter 2. Appointment, reappointment and retirement of Animal Ethics Committee (AEC) members................................................................................16

Chapter 3. Reporting any unexpected adverse event that may have a negative impact on the wellbeing of animals...................................................................19

Chapter 4. Complaints and appeals..........................................................................22

Chapter 5. Conducting a necropsy and access to diagnostic services................27

Chapter 6. Administrative processes (including communication and documentation/records)......................................................................................31

General references........................................................................................................39

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Chapter 1. Terms of Reference

Introduction

As a registered user of animals for scientific purposes the Department of Agriculture and Fisheries must comply with the requirements of the Animal Care and Protection Act 2001 (ACPA) and the "Australian code for the care and use of animals for scientific purposes" (8th edition, 2013) (Scientific Use Code).

In accord with the requirements of the ACPA and the Scientific Use Code, the department has established the DAF Animal Ethics Committees to apply the principles that govern the ethical conduct of departmental officers (staff) whose work involves the care and use of animals for scientific purposes.

The DAF AEC is responsible to the Director-General of the Department of Agriculture and Fisheries through the Assistant Director-General. Accordingly, the DAF AEC has the Director-General’s approval and support to act as an AEC in accord with these Terms of Reference, the ACPA and the Scientific Use Code.

The terms of reference for the DAF AEC are publicly available on request to the AEC Executive Officer and will become available through the Department’s website.

Terms of Reference for the DAF AEC

The terms of reference for the DAF AEC include the following provisions:

(i) The scope of its responsibilities for ethical review, approval and monitoring of animal care and use;

(ii) Institutional accountability;

(iii) Mechanisms of reporting; and

(iv) The way in which it meets the requirements for categories of minimum membership (clause 2.2.18).

Responsibilities of the DAF AEC

The primary responsibility of the DAF AEC is to ensure, on behalf of the Department of Agriculture and Fisheries, that all activities relating to the care and use of animals for scientific purposes are conducted in compliance with the Scientific Use Code (clause 2.3.1).

The DAF AEC must:

(i) Review applications for projects and approve those projects that are ethically acceptable (see clause 1.3) and conform to the requirements of the Scientific Use Code

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(Clause 1.3 A judgement as to whether a proposed use of animals is ethically acceptable must be based on information that demonstrates the principles in clause 1.1, and must balance whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits.)

(Clause 1.1 Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific purposes. The respect is demonstrated by:

i. Using animals only when justified

ii. Supporting the wellbeing of the animals involved

iii. Avoiding or minimising harm, including pain and distress, to those animals

iv. Applying high standards of scientific integrity

v. Applying Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:

1. The Replacement of animals with other methods

2. The Reduction in the number of animals used

3. The Refinement of techniques used to minimise the adverse impact on animals

vi. Knowing and accepting one’s responsibilities.)

(ii) 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;

(iii) Conduct follow-up review of approved projects and activities (as per clause 2.2.32[ii]), and allow the continuation of approval for only those projects and activities that are ethically acceptable and conform to the Code;(Clause 2.2.32[ii] DAF in consultation with the AEC, must develop documentation for follow-up review of an approved project or activity at scheduled times and when circumstances trigger additional follow-up review, including:

(a) proposed amendment to an approved project or activity (see clause 2.7.6)

(b) review of annual progress of an ongoing project or activity

(c) unexpected adverse event)

(iv) Monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities;

(v) Take appropriate actions regarding unexpected adverse events;

(vi) Take appropriate actions regarding non-compliance;

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(vii) Approve guidelines for the care and use of animals on behalf of the Department of Agriculture and Fisheries and other institutions covered by the AEC;

(viii) Provide advice and recommendations to the Department of Agriculture and Fisheries; and

(ix) Report on its operations to the Department of Agriculture and Fisheries.

Accountability

The DAF AEC is responsible to the Director-General of the Department of Agriculture and Fisheries through the Assistant Director-General. All communication with the Director-General should be through the Principal Project Officer (DAF Animal Ethics Committee) to the Assistant Director-General.

The Department of Agriculture and Fisheries will conduct an annual review of the operation of the DAF AEC to ensure that it is effective and consistent with the Scientific Use Code and institutional policies. The annual review process includes consideration of the annual report from DAF AEC and meeting with the Chair of the DAF AEC (clauses 2.1.9 [ii], 2.2.37, 2.3.28, 2.3.29).

The Department of Agriculture and Fisheries (including the DAF AEC) will conduct an independent external review of its compliance with the Scientific Use Code, at least every 4 years, in accordance with section 6 of the Scientific Use Code.

Reporting mechanisms

Annually, the DAF AEC is required to submit a written report on its operations to the Director-General of the Department of Agriculture and Fisheries.

The report contains the following information:

(i) Numbers and types of projects and activities assessed, and approved or not approved;

(ii) The physical facilities for the care and use of animals by the Department of Agriculture and Fisheries;

(iii) Actions that have supported the educational and training needs of AEC members and people involved in the care and use of animals;

(iv) Administrative and other difficulties experienced; and

(v) Any matters that may affect the Department of Agriculture and Fisheries ability to maintain compliance with the Scientific Use Code and any suitable recommendations (clause 2.3.29).

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Membership of the DAF AEC. The Department of Agriculture and Fisheries will ensure that the membership of the DAF AEC complies with the requirements of the Scientific Use Code, which includes:

(i) Appointing at least one person from each of the four membership categories (A, B, C & D) as outlined in clause 2.2.4;

(ii) The category C & D members must represent not less than one-third of the DAF AEC membership (clause 2.2.8);

(iii) Appointing a Chairperson from the existing membership (preferably a person holding a senior position in the Department) or a suitable external appointee (clause 2.2.2);

(iv) The option of appointing a person responsible for the routine care of the animals and persons with skills and background of value to the DAF AEC (clauses 2.2.5 & 2.2.6); and

(v) On occasions, the DAF AEC may invite persons with specific expertise to provide advice (non-member advisors) (clause 2.2.7)

The DAF AEC may also select a Deputy Chairperson (from within its membership) to cover any short-term absences by the Chairperson.

The Department of Agriculture and Fisheries has also appointed an Executive Officer to assist the DAF AEC in its operation.

Responsibilities of the Chairperson

The Chairperson is responsible for:

Impartially guiding the operation of the DAF AEC; Resolving conflicts of interest related to the business of the DAF AEC;

Representing the DAF AEC in negotiations with the Department of Agriculture and Fisheries management.

Responsibilities of DAF AEC members

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

DAF AEC members should be familiar with the requirements of the Scientific Use Code and other policies and guidelines relevant to the business of the DAF AEC.

DAF AEC members must comply with the terms of reference and operating procedures of the DAF AEC.

Role of the Executive Officer

The Executive Officer will assist the Chair and ensure the efficient operation of the DAF AEC by:

being the first point of contact for applicants wishing to access the DAF AEC.

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expediting project applications and approval processes through the provision of advice and assistance to researchers regarding ethics applications, procedures and mandatory reporting requirements. organising the distribution of information to members and scheduling meetings and monitoring sessions.

overseeing database integrity and requirements & providing management reports.

assisting with the conduct and recording of meetings of the DAF AEC; and compliance with all legal and ethical responsibilities as required by the ACPA and Scientific Use Code

any other duties as required by the Department of Agriculture and Fisheries

Operating Procedures for the DAF AEC

1. Appointment and retirement of DAF AEC members

The Executive Officer of the DAF AEC monitors the membership needs of department’s AEC in consultation with the AEC Chairs.

If a new member is required, the Executive Officer may call for ‘expressions of interest’, search the Queensland Register of Nominees to Government Bodies and/or make direct approaches to representative groups (for example, RSPCA and Animals Australia). Unsolicited applications lodged periodically by departmental officers and external persons with an interest in serving on a departmental AEC may be considered also.

An interested person must complete an AEC membership application form to acknowledge their acceptance of the terms of reference of the AEC and indicate in writing on what basis they satisfy the relevant membership category criteria as defined in clause 2.2.4 of the Scientific Use Code. An external applicant must also complete an Appointment to government body: Personal particulars form. Applicants must complete any other membership form required by the relevant state jurisdiction (e.g. Form EC14 required by Biosecurity Queensland).

The completed forms must be submitted to the Executive Officer. The Executive Officer will provide any relevant forms or other information as required by any the relevant state jurisdiction (e.g. forward completed Form EC14 to Biosecurity Queensland within 28 days of the member’s appointment as a member of the DAF AEC).

The Executive Officer will confirm the availability of departmental officers with line managers. The Executive Officer, in consultation with the AEC Chairs, will assess applications and make recommendations to the Deputy Director-General. The Deputy Director-General will recommend AEC appointments to the Director-General. The Director-General may accept or reject recommended appointments.

The Executive Officer will prepare a briefing note to the Minister and letter seeking the Premier’s support for the proposed appointment(s).

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The Executive Officer will obtain a signed confidentiality agreement from each prospective new member before producing letters of appointment for the Director-General’s signature. Where the appointee is a departmental officer, a copy of the letter of appointment will be forwarded to the appointee’s line manager.

The Executive Officer will maintain a record of all appointments to the DAF AEC and associated documents.

Members are appointed to the DAF AEC until either they resign, are retired by the Director-General or die. A member may resign from the AEC at any time by advising the Chair in writing.

2. Acceptance of Terms of Reference

Prior to appointment, all DAF AEC members will acknowledge, in writing, that they accept these Terms of Reference.

3. Declaration of interests and management of conflicts of interest

All DAF AEC members and experts, whose advice is sought by the DAF AEC, are required to declare any real or perceived financial, professional or personal interests that may influence their objectivity in their decision making with regard to any business to be discussed by the DAF AEC at its meetings. Declarations are to be made:

(i) Prior to their appointment - by making a signed declaration of all real or potential interests as part of the member application process;

(ii) As matters arise - by declaring all real or potential interests and the nature of that interest to either the Chair or Executive Officer of the AEC as soon as is reasonable after they become aware of that their objectivity could be impacted;

(iii) At each meeting (as an early item of the meeting agenda) - by declaring all interests (real or perceived) which could affect their objective decision making in relation to any items on the meeting agenda or any other matter relating to membership of the AEC.

All declarations of interest (as part of the appointment process, between or at meetings) need to be recorded in the relevant meeting minutes.

4. Confidentiality

AEC members will sign a confidentiality agreement or deed prior to appointment.

All visitors and persons advising or assisting the DAF AEC will sign a confidentiality agreement or deed prior to their first meeting.

5. Meeting procedures

(i) The DAF AEC will determine its meeting frequency but should aim to meet on a monthly basis.

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(ii) The Chair will ensure that an agenda is produced by the Project Officer prior to each meeting and the meeting will consider AEC business as required to fulfil the Committee’s responsibilities.

(iii) The Executive Officer will ensure that: all relevant documents (for example, minutes, correspondence and applications) are distributed prior to the meeting allowing reasonable time for members to read, consider and prepare questions. The secretary will also maintain the filing system for the animal ethics system.

(iv) Each meeting will be quorate (i.e. at least one member from each of Categories A, B, C and D). Category C and D members must represent not less than one-third of the members participating in a meeting.

(v) Meetings of the DAF AEC are face to face meetings. In exceptional circumstances, when a member is required to achieve a quorum they may participate in the meeting using videoconferencing or web conferencing if it is not possible and/or practical to attend the meeting in person. Teleconferencing is only permitted in special circumstances.

(vi) The participation of a member via videoconferencing or web conferencing or teleconferencing must be clearly noted in the AEC minutes and the member may authorise the Chair to record their support on the application.

(vii)The Project Officer will maintain minutes of decisions and other aspects of AEC business for each meeting.

6. Communication

The DAF AEC will clearly communicate its decisions, the reasons for its decisions and any conditions attached to an approval to investigators, in writing, as soon as possible after the meeting.

7. DAF AEC Executive

The DAF AEC establishes an AEC Executive whose membership includes the Chairperson and a Category C or D member.

The DAF AEC Executive has been delegated to only approve minor amendments to approved project or activities which will be ratified at the next quorate meeting of the DAF AEC. Minor amendments 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 (clause 2.2.23). The DAF AEC Executive must not approve new applications.

8. Specific DAF AEC Tasks

1. Review and decide on new and ongoing activities

(i) The DAF AEC must make a judgement on whether the proposed use, or continued use, of animals is ethically acceptable. This judgment is must be based on information that demonstrates that the principles in clause 1.1 of the Scientific Use Code, and must balance whether the potential effects on

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the wellbeing of the animals involved is justified by the potential benefits (clause 1.3).

Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific purposes. The respect is demonstrated by:

Using animals only when justified

Supporting the wellbeing of the animals involved

Avoiding or minimising harm, including pain and distress, to those animals

Applying high standards of scientific integrity

Applying Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:

The Replacement of animals with other methods

The Reduction in the number of animals used

The Refinement of techniques used to minimise the adverse impact on animals

Knowing and accepting one’s responsibilities (clause 1.1)

(ii) The DAF AEC may approve only those projects and activities that are ethically acceptable and conform to the requirements of the Scientific Use Code.

(iii) The DAF 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.

(iv) Decisions are based on thorough, fair and inclusive discussion and deliberation by DAF AEC members present throughout the discussion. Decisions should be made on a basis of consensus. Where consensus can’t be reached and reasonable efforts made to resolve differences, the DAF AEC should explore with the applicant ways to modify the project to activity that may lead to consensus. If consensus is still not achieved, a majority decision is required after the members have been allowed time to review their positions and further follow up discussion.

(v) Approval of an ongoing project or activity must be based on the review of the annual progress report and further information from unexpected adverse events, complaints, records and inspections.

2. Monitor the care and use of animals

(i) The DAF AEC monitors the care and use of animals by inspecting animals, animal housing on DAF sites and non-DAF sites where the AEC has

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approved activities and the conduct of procedures and reviewing records and reports.

(ii) The DAF 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 basis to assess compliance with the Scientific Use Code and decisions of the DAF AEC. The DAF AEC will monitor activities that are likely to cause pain or distress at an early stage of the activity and this will be included as a condition of approval.

(iii) All inspections by the DAF AEC should (if possible) include a Category C or D member as part of the inspection team.

(iv) Authorising suitably qualified delegates to carry out inspections of project and activities being conducted at remote sites on behalf of the DAF AEC. Delegates must prepare written reports for the AEC following inspections.

(v) Viewing animals during site inspections and monitoring activities and ensuring that appropriate records are being kept of animal care and use. A copy of the report of the inspection or monitoring will be provided to the person with ultimate responsibility for the project and the person in charge of the animals and managers where appropriate.

(vi) Receiving reports of and commenting on unexpected or adverse effects that impact on the wellbeing of animals used for scientific purposes.

(vii) Reviewing long-term projects at least annually by requiring annual reports for each activity from the person with ultimate responsibility for the project. Annual Reports must be reviewed by the DAF AEC to monitor that animal use is consistent with and in accord with the approved application for the activity.

(viii) Reviewing activity completion reports to confirm that animal use is consistent with and in accord with the approved application for the activity.

(ix) Annual and completion reports should contain as a minimum all detail as outlined in clauses 2.2.32 and 2.4.34 of the Scientific Use Code.

3 Taking action regarding unexpected adverse events

(i) The DAF AEC will take appropriate action in response to reported unexpected adverse events to ensure animal wellbeing is not compromised, the issue is addressed promptly and activities that have the potential to adversely impact animal wellbeing cease immediately (clause 2.3.24)

(ii) In taking appropriate action, the DAF AEC can:

Ensuring the wellbeing of the animals involved is being addressed

Consult with relevant people including the person with ultimate responsibility for the project/ activity, other researchers, the animal facility manager, animal care staff, etc.

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Suspend or withdraw DAF AEC approval for the project/ activity

Take further action, if it constitutes non-compliance with the Scientific Use Code or approved project procedures (see next section).

4. Taking action regarding non-compliance

If the DAF AEC detects a breach of the Scientific Use Code, in connection with a project or activity, the DAF AEC will:

Ensure that the wellbeing of the animals being used is not compromised

Ensure activities that have the potential to adversely affect animal wellbeing are ceased immediately

Ensure the issue is addressed promptly by consulting with the person(s) involved

Ensure the suspension or withdrawal of approval for the project or activity if appropriate

Refer the matter to Biosecurity Queensland for further action

Ensure the DAF legislation non-compliance procedures are followed

Ensure appropriate follow–up of the issue is undertaken.

5 Approve guidelines for the care and use of animals

The Department of Agriculture and Fisheries, an institution which cares for and uses animal for scientific purposes, is required to develop guidelines for the care and use of these animals in line with clause 2.1.5 [v] of the Scientific Use Code.

This process will be conducted in consultation with the DAF AEC and the final guidelines will be approved by the DAF AEC. These guidelines are the standard which staff (and external registrants) must abide by when caring for and using animals for scientific purposes (clause 2.3.26).

The DAF AEC will also be required to provide comment and recommendations to the Department when the guidelines are updated.

6 Provide advice and recommendations to the Department

The DAF AEC will be required to provide advice and recommendations to the Department of Agriculture and Fisheries regarding:

(i) the care and use of animals for scientific purposes within the Department;

(ii) strategies required to ensure that the requirements of the Scientific Use Code are maintained; and

(iii) matters affecting animal wellbeing. (clause 2.3.27)

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7 Reporting to the Department

The DAF AEC must submit an annual written report on its operations to the Director- General (clause 2.3.28).

The annual report will include the following information:

(i) The numbers and types of project and activities assessed and approved or not approved;

(ii) The physical facilities for the care and use of animals;

(iii) Actions that have supported the educational and training needs of DAF AEC members and staff involved in the care and use of animals;

(iv) Any administrative or other difficulties experienced

(v) Any matters that may affect the Department’s ability to maintain compliance with the Scientific Use Code and any suitable recommendations, if appropriate.

8 The AEC will deal with situations in which a conflict of interest arises, including any situation where a member of an AEC has an interest that may be seen to influence the objectivity of a decision by:

a. Requiring the DAF AEC member to leave the meeting temporarily while the remaining DAF AEC members decide whether or not a conflict exists.

b. Requiring a member whose objectivity may be influenced by an interest (including consideration of an application submitted by that member) to leave the meeting at an appropriate time (certainly during the consideration and decision making process). The remaining members must still constitute a quorum (i.e. categories A, B, C & D

c. Recording the method of dealing with any conflict in the relevant meeting minutes (e.g. record when the member left and returned to the room or recording the basis on which it was decided that the member could participate in the item).

d. Considering and responding to any concern or claim raised by an activity leader or other party that an AEC member has a conflict of interest that may have influenced the objectivity of an AEC decision.

e. Advising complainants, in writing, of the AEC’s response to any concern or claim relating to conflict of interest.

f. If the complainant is not satisfied with the AEC’s response, a complaint/grievance may be lodged as per DAF policy (see Corporate Standard HR 4.2B “Grievances procedures”).

9 The AEC will examine and approve with or without conditions, defer subject to modification, or not approve written applications relevant to the use of animals for scientific purposes by:

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a. Considering new applications, modifications to existing activities and reviewing Executive decisions on minor modifications at quorate meetings.

b. Reviewing the relevant sections of a project application, modification or basis for an Executive decision against the ACPA, the Scientific Use Code and the Primary Industries Ministerial Council (PIMC) (previously Standing Committee on Agriculture and Resource Management [SCARM]) Codes of Practice. The AEC also may refer to other guidelines and standards developed for the ethical treatment of animals and that are considered acceptable by the AEC.

c. Inviting comment from a person(s) with specific technical expertise. The person may submit written comments or address the meeting, either in person or via a teleconferencing or videoconferencing link. The AEC should reach agreement on how it may seek advice, without breaching confidentiality.

d. Seeking clarification of and/or agreement to amendments to an application from the activity leader. The activity leader may be invited to address the AEC in person or via a teleconferencing or videoconferencing link.

e. Making decisions 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.

Note: The Chair should advise the activity leader of the AEC's decision using the approved form. The Chair must provide reasons to the activity leader if the application is not approved by the AEC.

The activity leader may seek clarification of the reasons for non-approval from the AEC and, subsequently, provide additional relevant information/comment from other parties (for example, persons with specialist expertise). The Chair may invite the activity leader to address the AEC at its next meeting.

If the matter is not resolved, the activity leader may lodge a grievance against the AEC decision.

10 The AEC will approve only those studies for which animals are essential and their use is justified and which conform to the requirements of the Scientific Use Code. This should take into consideration factors including ethics, the impact on the animal or animals and the anticipated scientific or educational value by:

a. Assessing applications for the use of animals for scientific purposes only after the committee receives a completed and signed application form that is completed to the Committee’s satisfaction.

b. Assessing whether the information provided by the Activity Leader adequately and concisely details appropriate justification of the proposed

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animal use, the impact on the animals of the proposed use and adequately shows the means by which it will be minimised, and that it complies with the principles of Replacement, Reduction and Refinement.

c. Insisting that all applications are written in language that can be understood by all members of the AEC.

d. Requesting, if necessary, advice or clarification from appropriately experienced people regarding the assessment of particular projects. The AEC should reach agreement on how advice can be sought from outside experts without breaching confidentiality.

e. Ensuring that, in addition to ethics approval, the Activity Leader is aware of the need to obtain all relevant permits for use of Genetically Modified Organisms, hazardous substances, and use of native wildlife, and bringing to the attention of the Activity Leader any perceived Work Place Health and Safety issues concerning the activity.

9 The AEC may withdraw approval for any project when:

a. An inspection detects activities that are non-compliant with the Scientific Use Code, the AEC could require that such activities cease immediately and remedial action is initiated.

b. An animal is used in a way other then as approved in the initial application or subsequent approved modification or amendment to an application.

c. It becomes aware that an activity or project is associated with a higher negative welfare impact than was approved or an unnecessary or unjustified welfare impact.

Note: If the AEC decides that approval for an activity should be withdrawn, the Chair must advise the activity leader.

The activity leader may seek clarification of the reasons for non-approval from the AEC and, subsequently, provide additional relevant information/comment from other parties (for example, persons with specialist expertise).

The AEC must consider any objection raised and additional relevant information provided by the activity leader. The Chair may invite the activity leader to address the AEC at a meeting.

If the matter is not resolved, the activity leader may lodge a grievance against the AEC decision.

10 The AEC will examine and comment on all DAF plans and policies that may affect the welfare of animals used for scientific purposes by:

a. Reviewing plans and policies provided by DAF units.

b. Considering information/comments provided by any person who has concerns regarding the care and use of animals by DAF staff and/or at DAF sites.

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c. Considering information/comments provided by delegates who conduct site and activity inspections on behalf of the AEC or in accord with the agreed monitoring strategy.

d. Discussing matters pertaining to plans and policies.

e. Making recommendations reflecting a consensus view of the Committee.

f. Making comments in its annual report to the Director-General.

11 The AEC will maintain a record of applications and projects by:

a. Authorising the Project Officer to retain, all documentation associated with AEC business (including minutes, applications, decisions, declarations and resolutions of conflicts of interests, inwards and copies of outwards correspondence, reports and comments provided by the AEC).

b. Authorising the Project Officer to maintain an electronic database (register) of all applications to the AEC (approved and not approved), including the outcomes of the committee’s deliberations.

Note: Records should be stored for the required time after which a disposal schedule is completed and permission may be sought from the Document Management Unit to destroy archived material.

12 The AEC will comply with the reporting requirements of DAF and the Scientific Use Code by:

a. Submitting an annual internal report as per section 2.2.40 of the Scientific Use Code on the activities of the AEC to the Director General through the Principal Project Officer (DAF Animal Ethics) each year. The details of the report are covered in section 7 of this document.

b. Promptly reporting to the Principal Project Officer (DAF Animal Ethics) any event or issue that may need to be referred to the Director-General, Assistant Director-General, Regional Delivery and/or other senior DAF managers.

c. Submitting any reports relating to use of animals for scientific purposes by DAF as required by law including the Annual Animal Use Statistics Report to the Department of Agriculture and Fisheries (DAF).

d. Submitting any other reports relating to the use of animals for scientific purposes by DAF as required (e.g. funding bodies, the NHMRC compliance report).

13 The AEC will perform all other duties required by the Scientific Use Code.

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Revision

The DAF AEC Terms of Reference will be reviewed as necessary in response to changes in legislation and departmental policy.

References:

Animal Care and Protection Act 2001

Australian code for the care and use of animals for scientific purposes

Contact

Principal Animal Ethics Officer

Department of Agriculture and Fisheries

Dutton Park Q 4001

Telephone: 07 3708 8507

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Chapter 2. Appointment, reappointment and retirement of Animal Ethics Committee (AEC) members

Governing principles and responsibilities

All appointments, reappointments and re tirements of AEC members of the Department of Agriculture and Fisheries (DAF) Animal Ethics Committees will be made in accord with the following procedures and the Australian code for the care and use of animals for scientific purposes.

PROCEDURES

1. The Principal Animal Ethics Officer (DAF Animal Ethics) will monitor the membership needs of departmental AECs.

2. If a new member is required, the Principal Animal Ethics Officer (DAF Animal Ethics) may call for ‘expressions of interest’, search the Queensland Register of Nominees to Government Bodies and/or make direct approaches to representative groups (for example, RSPCA and Animals Australia).

3. An interested person must complete an AEC membership application form to acknowledge their acceptance of the terms of reference of the AEC. An external applicant must also complete an Appointment to government body: Personal particulars form and an Application – Animal Ethics Committee (AEC) Member Details form. A curriculum vitae is also required.

4. The completed forms must be submitted to the Principal Animal Ethics Officer (DAF Animal Ethics).

5. Prospective members must declare their interests related to AEC membership and potential conflicts of interest of prospective members need to be managed in making appointments.

6. Unsolicited applications lodged periodically by departmental officers and external persons with an interest in serving on a departmental AEC may be considered also.

7. The Principal Animal Ethics Officer (DAF Animal Ethics) will confirm the availability of departmental officers with their supervisors.

8. The Principal Animal Ethics Officer (DAF Animal Ethics), will assess applications against the required criteria in the Code and make

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recommendations through the Director (R&D Policy and Partnerships) to the Director-General.

9. The Director-General may accept or reject recommended appointments.

10. The Principal Animal Ethics Officer (DAF Animal Ethics) will prepare a briefing note to the Minister and letter seeking the Premier’s approval for the proposed appointment.

11. The Principal Animal Ethics Officer (DAF Animal Ethics) will obtain a signed confidentiality agreement from each prospective new member before producing letters of appointment for the Director-General’s signature. Where the appointee is a departmental officer, a copy of the letter of appointment will be forwarded to the appointee’s supervisor.

12. The Principal Animal Ethics Officer (DAF Animal Ethics) will maintain a record of all appointments to DAF AECs and associated documents.

13. All new AEC members will complete the online learning course and have access to other educational programs and resources. New members will undergo an induction process that includes the education program.

14. A member may resign from the AEC at any time by advising the Principal Animal Ethics Officer (DAF Animal Ethics) in writing.

15. The Principal Animal Ethics Officer (DAF Animal Ethics) may ask a member to retire from the AEC if it is deemed to be in the best interests of the AEC. If the member does not accede to the request, the Principal Animal Ethics Officer (DAF Animal Ethics) may initiate action to retire the member by obtaining a retirement letter from the Executive Director.

16. The Director-General may retire members.

References:

Australian code for the care and use of animals for scientific purposes.

Clauses 2.2.2 to 2.2.12 (inclusive)

Cabinet Handbook 2017

Contact

Principal Animal Ethics Officer (DAF Animal Ethics)

Department of Agriculture and Fisheries

Ecosciences Precinct

41 Boggo Rd

Dutton Park Qld 4102

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Telephone: 07 3708 8507

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Chapter 3. Reporting any unexpected adverse event that may have a negative impact on the wellbeing of animals

PURPOSE AND SCOPE

The terms of reference for the DAF Animal Ethics Committee (AEC) include a requirement that the Committee must monitor the care and use of animals, including housing conditions, acquisition, transport, breeding, and practices and procedures involved in the care of animals in facilities.

The Australian code for the care and use of animals for scientific purposes (the Code) supports this requirement by adding that investigators or teachers must promptly notify the AEC of any unexpected adverse event which occurs during the period of the approved project and which may have a negative impact on the wellbeing of the animals used in project.

The Code also requires the manager of a breeding and holding facility to communicate with the AEC on management of the facility and any unexpected adverse events at that facility involving animals for which the facility manager is responsible.

Records of monitoring and assessment of animal wellbeing in projects and on facilities must be sufficient to allow review and critical investigation of unexpected adverse events.

Unexpected adverse event is defined in the Code as an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity.

An unexpected adverse event may result from different causes, including but not limited to:

death of an animal, or group of animals, that was not expected (e.g. during surgery or anaesthesia, or after a procedure or treatment)

adverse effects following a procedure or treatment that were not expected

adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study

a greater level of pain or distress than was predicted during the planning of the project or activity

power failures, inclement weather, emergency situations or other factors external to the project or activity that have a negative impact on the welfare of the animals.

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PROCEDURES

1. If an animal in an AEC approved project experiences any unexpected adverse event that does or may impact on its wellbeing during the period of that project (e.g. death or serious injury or illness not covered in the AEC approval), the event must be reported promptly to the AEC. This should be done by the investigator who is in charge of the project, other investigators involved in the project and/or the manager of the breeding or holding facility.

This does not apply to adverse events that are expected and included in the AEC approval. The AEC may apply or approve a specific notification threshold and/or interval to a project and/or facility. For example, the AEC may accept that it is reasonable to anticipate an attrition rate of x% of fingerlings during a specified period of a project.

2. The reports must be submitted promptly and preferably by email to the AEC Chair. It must describe the timing, nature and extent of the event, any remedial action taken, prevention plans and, in the case of a project, the probable impact on project outcomes. Remedial action should include prompt alleviation of pain and distress if applicable.

3. Any animal that dies unexpectedly or is euthanased due to unforeseen complications or unknown circumstances should be subjected to autopsy by a competent person (where practical) and the results forwarded to the AEC. Laboratory diagnostic services should be used when a diagnosis has not been achieved or needs to be confirmed.

4. When an unexpected adverse event involving an animal in an AEC approved project is reported, the Chair, in consultation with the AEC Executive, must:

consider the circumstances associated with the event, the project approval, and the action taken by the investigator or teacher or manager of the breeding and holding facility

specify any emergent additional or alternative action required to ensure the wellbeing of the animals are not further compromised

withdraw or suspend the AEC approval immediately, if necessary to protect the wellbeing of the animals

inform the Principal Animal Ethics Officer (Animal Ethics)

inform the responsible General Manager of events when DAF investigators are involved in the project and

advise the AEC of all events reported 'out of session' and associated actions at the next AEC meeting. The AEC may specify additional or alternative action required.

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5. The applicant and/or manager of the breeding and holding facility must comply with any additional or alternative action specified by the Chair and/or AEC.

6. The applicant must report unexpected adverse events and remedial actions undertaken in the next annual progress report/project completion return.

References:

Australian code for the care and use of animals for scientific purposes

Clauses 2.1.5 [v] [d], 2.3.2 (v), 2.3.24, 2.4.18 (ix), 2.4.34, 2.5.15, 3.1.22, 3.1.24

Contact

Principal Animal Ethics Officer (DAF Animal Ethics)

Agri-Science Queensland

Department of Agriculture and Fisheries

Ecosciences Precinct

41 Boggo Rd

Dutton Park Qld 4102

Telephone: 07 3708 8507

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Chapter 4. Complaints and appeals

Governing principles and responsibilities

The Australian code for the use of animals for scientific purposes (the Code) specifies that 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 (Section 2), and act in accordance with the Code (Clause 1.31).

It is anticipated that most enquiries and complaints will be dealt with at the AEC level. Where appropriate, the management of complaints will follow the current DAF Complaints Management Policy.

Complaints may concern the care and use of animals by the department or others, including conscientious objection in the case of teaching activities. Complaints may concern the AEC process of review of an application or report, or may concern disagreements between AEC members or between the AEC and investigators, or between the AEC and the department. Complaints may concern the process for independent external review or may relate to governance officials.

Procedures

1. Any staff member or member of the public who has a concern regarding the care and use of animals within DAF or with animals used in an external project that has been approved by a departmental AEC (Clauses 2.6.3 and 2.6.6) may raise their concern with the responsible AEC, any member of that Committee, the Principal Animal Ethics Officer or any senior departmental officer. Alternatively, a member of the public may lodge a complaint with the department by telephoning the DAF Business Information Centre on 13 25 23.

2. All complaints concerning the care and use of animals overseen by departmental AECs must be referred promptly to the Chair of the responsible AEC. Complaints should be documented (email is preferred) and include detail of the concern, place, date, time and perceived urgency of the situation. All information received should be stored in accordance with departmental administrative records requirements.

Note: A complainant may request that their name is not revealed to other parties. However, an anonymous complaint may limit the processes able to be undertaken.

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3. The Chair must assess the urgency and seriousness of the situation as soon as possible following the receipt of the inquiry or complaint. When making these assessments, the Chair should consult the AEC (quorate meeting or Executive), applicant and/or the person-in-charge of the animals at the site where relevant.

4. Urgent issues (for example, events that have or are likely to have a significant or severe impact on the welfare of an animal) must be addressed immediately by the Chair/AEC and should precede a response to the complainant.

Note: Executive decisions must be reviewed by the next quorate meeting of the AEC.

5. Other issues (for example, events that have a minor impact on the welfare of an animal or where the main issue is related to financial or administrative considerations) should be addressed by the Chair.

6. When determining the appropriate action needed to address the issue, the Chair/AEC members should consider the following:

Is due consideration being given to the welfare of the animal? (Additional advice may be sought from a veterinarian who can inspect/examine the animals)

Is the Applicant acting in accordance with the requirements of the Animal Care and Protection Act 2001 and the Code?

Is the project being conducted in accordance with the AEC approval?

Any reasonable explanation and/or additional information obtained from the Applicant, the person-in-charge of the animals at the site, the responsible program leader, other AEC members and, if appropriate, the person making the complaint.

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7. Where complaints raise the possibility of ‘research misconduct’, as described in the Australian code for the responsible conduct of research, the complaint will be handled in accordance with procedures specified in that document.

8. Where complaints allege misconduct that falls outside the range of ‘research misconduct’, as described in the Australian code for the responsible conduct of research, the complaint will be handled in accordance with processes outlined in this document for dealing with other forms of misconduct.

9. The AEC may decide that:

The project may continue

Modifications to a project or activity are required or

Approval for a project or activity is suspended or withdrawn.

Where activities are not conducted in accordance with AEC approval, the matter will be referred to the relevant groups in DAF for action.

10. The Chair will coordinate a respectful, documented and timely (within appropriate timeframes) response to the complainant. The response (email is preferred) should cover any progress and outcomes as appropriate and confidentiality and privacy of personal information should be maintained throughout the process.

11. The Principal Animal Ethics Officer will provide details of all complaints to the appropriate departmental management personnel. Any suspected breach of the Act or suspected non-compliance of the Code will be referred for investigation and possible disciplinary action.

12. For projects involving more than one institution and/or AEC (Clauses 2.6.4–2.6.7), reporting between the relevant institutions and AECs on complaints should follow the relevant formal agreement.

13. All complaints must be included in the AEC annual report.

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14. Complaints should be considered fairly and should follow the principles of natural justice and protection of whistleblowers. Where the substance matter of the complaint is deemed to be frivolous or vexatious, the complaint may not be pursued further.

Complaints concerning the animal ethics committee process:

1. The complainant and the AEC that is the subject of the complaint should negotiate to resolve any complaint. If the complaint appears to be related to a lack of knowledge of the process or the relevant legislation on behalf of the complainant, the departmental educational material should be provided to the complainant for review by the complainant before negotiations continue.

2. If negotiations do not resolve the complainants concerns, a person external to the AEC will be identified to review of the process followed by the AEC. This person may be from within DAF. 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.

3. The ultimate decision regarding the ethical acceptability of an activity lies with the AEC and must not be overridden (Clause 5.6).

Complaints concerning the process for independent external review:

1. DAF must conduct an independent external review as required in the Code.

2. Any appeal against the process of the review is to be negotiated between the external review panel and the Departmental AEC representative (Clause 6.5).

3. If negotiations are not successful, an alternative external reviewer should be employed.

Referral to a person or agency external to the institution:

A person external to the AEC will be identified and be the contact to whom a person can take a complaint concerning the AEC process of review of an application or report that cannot be resolved by communication between the complainant and the AEC (Clauses 5.1–5.7)

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References:

Complaints Management Policy (version 1.01) for DAF staff

Australian code for the care and use of animals for scientific purposes.

Section 5, Clauses 2.1.7 (ii), 2.1.9 (iii), 2.2.20, 2.2.29, 2.6.3, 2.6.6 and 6.5.

Contact

Principal Animal Ethics Officer (DAF Animal Ethics)

Department of Agriculture and Fisheries

Ecosciences Precinct

41 Boggo Rd

Dutton Park Qld 4102

Telephone: 07 3708 8507

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Chapter 5. Conducting a necropsy and access to diagnostic services

Governing principles and responsibilities

The Australian code for the use of animals for scientific purposes (the Code) specifies that institutions, Animal Ethics Committees (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 (Section 2), and act in accordance with the Code (Clause 1.31).

To be compliant with the Code, institutions must ensure facility managers follow institutional and AEC policies and procedures regarding the conduct of a necropsy and access to diagnostic services for animals that die unexpectedly on the facility. In addition, each person involved in the care and use of animals for scientific purposes must ensure a necropsy is performed by a competent person on an animal that dies unexpectedly during a project.

Procedures

Necropsy

Necropsies are to be performed by a competent person. Where registered veterinary surgeons are not available, other competent people may perform the necropsy. Specific post mortem guides are available electronically:

https://www.agric.wa.gov.au/livestock-biosecurity/ruminant-animal-post-mortem-guide

https://www.agric.wa.gov.au/livestock-biosecurity/chicken-necropsy-guide

https://www.agric.wa.gov.au/livestock-biosecurity/sampling-and-post-mortem-resources-veterinarians

Submitting samples to the Department of Agriculture and Fisheries’ Biosecurity Sciences Laboratory at Coopers Plains

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The Biosecurity Sciences Laboratory's activities include, but are not limited to:

Identifying and investigating new and emerging animal diseases across Queensland

monitoring and diagnosing diseases

o in Queensland's livestock industries (e.g. Hendra virus, bovine infertility)

o of aquatic animals farmed in the tropics and subtropics (e.g. barramundi, prawns, oysters, crabs, scallops)

o of wildlife in cases of mass mortality, unusual mortality or suspicion of a potential public health problem.

screening for mad cow disease

testing cattle ticks for resistance to chemicals used for control

maintaining a database of plants toxic to animals.

Samples may be submitted by:

private or industry veterinarians

Biosecurity Queensland staff (veterinarians, biosecurity inspectors, researchers)

some farmer groups (such as fish or prawn farmers).

Guidelines and forms for sample submission

Email bslclo@daf.qld.gov.au to request a copy of the Biosecurity Laboratory user's guide for advice on submitting samples to the laboratory.

General guidelines for submitting samples

Veterinary samples should be sent chilled, not frozen. The exceptions are smears, ticks and culture media for campylobacter and tritrichomonas, which should be kept at ambient temperature

a completed specimen advice sheet: Form A (PDF, 80KB) has to accompany all specimens

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use a separate specimen advice sheet per animal species/property/reason for testing

complete ALL sections; print clearly and sign and date in the place provided at the bottom of the form

number animals and corresponding samples sequentially from 1

attach a separate necropsy findings form (PDF, 110KB), if required

provide an after-hours phone contact for urgent cases.

Submitting aquaculture samples

You can read more about managing disease in aquaculture farms and submitting samples for laboratory examination, including pearl oysters, fin fish, crayfish and prawns.

When preparing aquatic disease investigation cases please phone the laboratory to assist you with the initial preparation before sending samples to the Biosecurity Sciences Laboratory for testing.

Other information regarding the use of the DAF laboratory system

Forms, documents, laboratory contact details (postal address, delivery address and normal laboratory hours) are all available on the website: https://www.business.qld.gov.au/industries/farms-fishing-forestry/agriculture/land-management/health-pests-weeds-diseases/sample-testing/submitting

For samples not eligible to be processed by DAF laboratories

Necropsy or other samples are to be submitted to private veterinary pathology laboratories if they are not eligible to be processed at the DAF laboratory. The laboratories should be contacted to confirm sample collection and transport details.

References:

Australian code for the care and use of animals for scientific purposes.

Clauses 2.1.5, 2.1.8, 2.5.17, 3.1.25,

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Contact

Principal Animal Ethics Officer (DAF Animal Ethics)

Department of Agriculture and Fisheries

Ecosciences Precinct

41 Boggo Rd

Dutton Park Qld 4102

Telephone: 07 3708 8507

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Chapter 6. Administrative processes (including communication and documentation/records)

Governing principles and responsibilities

The Australian code for the use of animals for scientific purposes (the Code) specifies that 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 (Section 2), and act in accordance with the Code (Chapter 1.31).

Institutions must establish procedures for the effective governance and operation of the AEC that enable the AEC to comply with the Code and relevant institutional policies, and promote competent and timely ethical review of animal care and use (Clause 2.2.20).

Procedures for administrative processes

General

Each meeting is to be quorate and meet the minimum requirements for the proportion of C and D members attending (Clause 2.2.25). The meeting is to remain quorate for all decisions including those where members leave the room for potential conflicts of interest. Circumstances where face-to-face meetings are not possible, meetings can utilise videoconferencing and web-conferencing or, in special circumstances, teleconferencing. These meetings are also to be quorate and meet minimum membership requirements.

Each DAF AEC meets approximately once a month (except around the end of the year) to provide an efficient service to the customers (Clause 2.2.26). An agenda including all issues for discussion is provided on the AEC agenda form. The meeting room, catering and parking are booked in advance.

AEC members are contacted prior to each meeting to determine who will be attending each AEC meeting so the Departmental Domestic “Prior Approval to Travel” Form can be completed. The director signs the approval and any required changes also need Director approval. These are required to allow payment of members for their travel expenses. All expenses are recorded in the payment system.

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All attending members are to be provided with the required meeting material approximately a week in advance of the meeting so they have adequate time to be fully informed for the meeting (Clause 2.2.26).

When received, submitted applications are given an individual reference number and an assessment date and filed in the appropriate meeting folder. The number and date are to be entered in the ‘AEC use only’ section on the front page of the application. Currently the individual reference number includes the year and month that the application was first presented to the AEC. Each application is to be signed in the appropriate sections of the application. Submission of word versions of applications and reports are currently required for AEC processing. Electronic or scanned signatures are accepted and are required in the relevant sections on the application and on the reports. All other meeting material is to be included in the appropriate meeting folders for each meeting (Clause 2.2.24) and stored in the AEC files.

Minutes are recorded for each meeting on the minutes form. The minutes will record outcomes and decisions. Any perceived conflicts of interest will also be recorded in the minutes.

Online training for investigators and other relevant staff is available. The AEC requires investigators to complete this course as training of investigators is a responsibility of the department (Clause 2.1.8).

Procedures for communication (including AEC decisions)

The decisions of the AEC for new applications should be promptly sent by email to the applicants on the Decision of AEC form (Form AE 07 – in the forms folder). The Decision of AEC form is provided to clearly communicate reasons for decisions and any conditions associated with AEC decisions. When making decisions in the AEC meeting, contact by phone or face to face interaction with the applicants may be required and should be used when appropriate to resolve issues (Clauses 2.2.27 and 2.2.28).

The decisions for annual reports and amendments should be included on the forms, and the forms signed, dated, and returned. Site inspection forms are to be completed after each inspection and should be signed, dated and returned to the relevant people when accepted by the AEC. The relevant people may include the site manager, any applicants identified in the report, and supervisors of any applicants. Where possible these are to be sent to the applicant within two days of the meeting.

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Procedures for complaints and non-compliance (in the terms of reference) have been developed and are included in the AEC terms of reference. 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 department should ensure that the complainant has access to a person or agency external to the AEC for review of the process followed by the AEC. This person should be identified by the AEC when required.

Reminders to review projects

To assist applicants to meet their annual reporting and their project completion reporting obligations, reminders are sent to the applicants when appropriate.

Reminders that approvals are due to expire are sent between two and three months before expiry dates so applicants can prepare for project completion reporting obligations and submit new applications or amendments if the project is to continue. This is to reduce the risk that applicants continue work after their AEC approvals have expired.

Reminders that project completion reports are required are also sent between two and three months after the expiry of projects if project completion reports have not been received by this time. Monthly reminders are sent until the completed forms are received. These reminders can be phone calls to check why the forms are not being received. Company and staff changes can then be clarified so annual reporting can be completed by the required time.

Communication and agreements with other AEC’s

Projects involving investigators from other institutions, or projects involving the care and use of animals at other institutions, are to be approved and monitored by the responsible AECs (Clause 2.6.4). A formal agreement will be signed so that each institutions’ AEC so all investigators clearly understand their responsibilities including reporting responsibilities.

Communication and agreements with outside investigators

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When an investigator or institution external to DAF uses the DAF AEC, a formal agreement must be signed which documents procedures for communication between the AEC and the investigator and an undertaking by the investigator that they will abide by the directions of the AEC (Clauses 2.6.2 and 2.6.3). When the formal agreement is with another institution it will clearly include governance and reporting responsibilities of each institution.

Procedures for documentation and records

Application form

Investigators and those involved in the care and management of animals in facilities must obtain written approval from an AEC before commencing a project that involves the use of animals. The application is to be written in plain English with sufficient information provided to the AEC members.

The application form has been developed to address the governing principles of the Code. The form clearly identifies people responsible for the wellbeing of the animals in the project in sections 6.1 and 6.2. Section 6.2 documents the competency of the animal carers and animal monitoring.

Section 4.7 documents the frequency and details of monitoring and how these details will be communicated to all responsible parties. Section 4.4.2 requires the applicant to document the details for contacting competent and authorised staff who can treat/withdraw animals in an emergency. The form also documents what is expected when there are any unexpected adverse events. The application form and the associated teaching activity forms (when required) are available on the DAF website and on request.

After the application has been discussed at an AEC meeting and a decision has been achieved, a copy of the application must be signed by all AEC members involved in the decision. The AEC may decide that an application is:

Approved,

Approved with conditions,

Deferred subject to modification, or

Not approved.

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The decision form is promptly sent to the applicant or applicant contact person.

Amendments (Clause 2.7.6)

All responsible investigators are to obtain written approval from an AEC before commencing an amendment to an approved project.

Amendment request forms and the associated S6.1 and S6.2 forms are available on the DAF website and on request. The S6.1 and S6.2 forms are to be used when the amendment request is to add personnel to the project or activity.

The AEC may decide that an amendment is:

Approved,

Approved with conditions,

Deferred subject to modification, or

Not approved.

These options are provided on the amendment request form which is to be signed and returned by the AEC.

An executive may be delegated to approve minor amendments to approved projects or activities, for ratification at the next AEC meeting. The structure of the executive is to follow the Code guidelines.

Review annuals

Annual progress report forms are provided and available on the DAF website and on request. The current animal types list is also available on the site. This list is to be used in conjunction with the annual progress report form as it is provided to suit the Biosecurity Queensland annual reporting requirements. Annual reports are required from all projects that are active at the end of the calendar year. Each report is discussed at the next AEC meeting and the decision is made to approve the project to continue or not. It is then signed by the AEC Chair and returned to the investigator. The AEC can allow the project or activity to continue or to be suspended, modified or discontinued. The options are included on the form.

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Completions

Project completion forms have been developed and are available on the DAF website and on request. DAF staff and external customers are to provide completed project completion forms to the AEC as soon as practicable after completion or discontinuation of a project. If the completed form is accepted by the AEC, the form is then signed by the AEC Chair and filed.

Unexpected adverse events

Adverse event report forms have been developed to allow prompt reporting of adverse events to the AEC and are available on the DAF website and on request. The form has been developed to cover the aspects of unexpected adverse events that are required so the AEC can be adequately informed. Adverse event reports are promptly sent to the AEC members for any immediate discussion or action. The issues is also included on the agenda for discussion at the next AEC meeting.

Documentation of inspections

Inspections of projects and sites will be recorded (Clause 2.3.22) using the DAF ‘Site Inspection’ form. This form includes the names of attendees, observations, any identified problems, recommended actions, ongoing or outstanding issues, and outcomes (Clause 2.2.30).

Database

An access database is maintained. Data entry guidelines are included as Appendix 1. The data entry guidelines covers the process for data entry for each stage of the application process:

Pre AEC Meeting,

Post AEC Meeting,

Application – Activity Leader details,

Annual Report,

Completion Advice, and

Annual Report.

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Breaches recorded

Any possible non-compliance with the Code will be reported and recorded electronically in the AEC folders (Chapter 5.10) on the DAF intranet. The DAF non-compliance issues will also be recorded in the annual AEC report to the department. The process to be followed for non-compliance is contained in the AEC Terms of Reference.

Operating procedures

Standard operating procedures (SOP) should be developed by staff responsible for the care and use of animals to provide detailed descriptions of standardised procedures or processes relating to the care and use of animals. These SOPs are to be reviewed and approved by the AEC every three years or should not be used as a reference. These site operating procedures should include actions required in the event of disease outbreaks and emergencies, such as fire, power failure and biosafety issues.

References:

Australian code for the care and use of animals for scientific purposes.

Clauses 2.1.7, 2.1.8, 2.2.20, 2.2.23, 2.2.24, 2.2.25, 2.2.26, 2.2.27, 2.2.28. 2.2.30, 2.2.32, 2.2.33, 2.3.9, 2.3.22, 2.4.4, 2.4.34, 2.5.15, 2.6.2, 2.6.3, 2.6.4, 2.7.1, 2.7.6 and Chapters 2.7, 5.6 and 5.10

Contact

Principal Animal Ethics Officer (DAF Animal Ethics)

Department of Agriculture and Fisheries

Ecosciences Precinct

41 Boggo Rd

Dutton Park Qld 4102

Telephone: 07 3708 8507

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General references

Animal Care and Protection Act 2001 (ACPA)

Australian code for the care and use of animals for scientific purposes (8th edition, 2013) (Scientific Use Code).

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