Terms of reference and operating procedures for animal ethics committees
The Australian code for the care and use of animals for scientific purposes, known as the scientific use code, states that all animal ethics committees (AECs) must have terms of reference that are publicly available. The Animal Care and Protection Act 2001 (ACPA) requires that these are submitted to Biosecurity Queensland as part of the application for registering as a user of animals for scientific purposes.
The terms of reference must include the following provisions:
- the scope of responsibilities for ethical review, approval and monitoring of animal care and use (see clauses 2.3.1 and 2.3.2 of the scientific use code)
- its institutional accountability
- its mechanisms of reporting
- the way in which it meets the requirements for categories of minimum membership.
The AEC must:
- review applications for projects and approve only those projects that are ethically acceptable (see clause 1.3) 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 follow-up review of approved projects and activities (see clause 2.2.32 [ii]), and allow the continuation of approval for only those 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
- report on its operations to the institution.
Read the example of a terms of reference.
The institution must establish and document procedures for the effective governance and operation of the AEC. These must enable the AEC to comply with the scientific use code and relevant institutional policies and promote competent and timely ethical review of animal care and use.
The procedures should include:
- declaration of interests and management of conflicts of interest
- appointment of and delegation of functions to an AEC Executive
- administrative processes
- meeting procedures
- complaints and non-compliance
- records and documentation.
A quorum must be present when making decisions about proposals.
There are different categories of membership outlined in clause 2.2.4 of the scientific use code. A quorum of at least one person from each of categories A, B, C and D must attend each meeting of an AEC. There may be more than one member in any of these categories, though to maintain a balance members from categories C and D must represent no less than one third of the members. If possible, it is advisable to appoint at least 2 members of each membership category to ensure a quorum can be reached if some members are absent.
The scientific use code provides for a quorate meeting of a properly established AEC to consider and make ethical/values-based decisions in relation to animals being cared for and used for scientific purposes. Quorate meetings require the 'presence at meetings' (face-to-face) 'of at least one member for each of categories A, B, C and D'. The meeting procedures should also include the use of videoconferencing and web-conferencing where a face to face meeting is not possible. Teleconferencing is only possible in special circumstances (clause 2.2.26 (ii)).
New approvals, the review of Annual Progress Reports and approval of modifications to projects that are not minor must only be considered at a quorate AEC meeting. Decisions/approval of these matters must not be made 'out-of-session'. Where a decision on these matters is required before the next scheduled meeting, the AEC must be convened to meet and consider the matter.
An institution may appoint an AEC Executive which must include the Chair and at least one Category C or D member. The AEC Executive may be delegated to approve minor amendments to approved projects or activities. The AEC Executive must not approve new applications. All decisions made by the AEC Executive must be ratified at the next quorate meeting of the AEC (clause 2.2.23).
The AEC Executive can make 'out-of sessions' decisions using any means the AEC considers appropriate, including by email, phone, etc.
In deciding whether an amendment must be considered by the AEC at a quorate meeting or can be considered by the Executive 'out-of-session', the question becomes 'what is minor?'
The code advises that '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 Chair alone must not decide or approve any new or modified animal use, as clause 2.2.23 clearly requires ethical/value-based decisions on even 'minor amendments to approved projects or activities' to also involve at least a Category C or D member. The AEC or AEC Executive cannot delegate their decision-making responsibilities to the Chair alone. The Chair may not decide whether details of a procedure submitted to them alone are appropriate.
It is proposed that for administrative purposes the Chair (or anyone else) could 'confirm' finalisation of AEC approval by confirming that requirements, concerns or modifications 'approved' by the quorate AEC meeting or AEC Executive have/or will be met (e.g. confirming other permits have been received or confirming use of procedures will be done as approved by the AEC).
'Out-of-session' confirmations by the Chair alone must not be discretionary - the Chair alone must not make ethical, scientific or value-based decisions/approvals about what can or cannot be done with animals. Discretionary decisions must be made by either the AEC Executive (if minor) or the AEC at a quorate meeting.
Complaints, grievances and non-compliance
Institutions must have procedures for dealing with complaints and non-compliance with the code, complaints related to the AEC process, and irreconcilable differences between the AEC and an investigator (see Section 5 of the scientific use code).
If any person, whether a member of the public or staff of the institution, has concerns regarding the care and treatment of any animal on the institutional property (whether or not they are part of an AEC project), or at any other site as part of a AEC approved project, they may report the matter to the institution or any member of the appropriate AEC. The operating procedures must include or refer to procedures for recording and responding to concerns and complaints.
Holding an AEC meeting (checklist)
The following checklist can be used to plan the meeting:
- Is there a quorum of AEC members present i.e. at least one A, B, C and D? The meeting cannot proceed without a quorum.
- Will proposals from any of the A or B members present be assessed at this meeting? If so will there still be a quorum when they leave the room during the discussion and decision making regarding their proposal?
- Do the number of C and D members comprise not less than one-third of the members present? This ratio must be met.
- Have any absent members provided comments on the proposals? These comments can be tabled but the members cannot be part of the consensus process.
- Is the Chair also taking the role of another category of member? The Chair must clarify their role at all stages of the meeting.
- Have all the proposals to be assessed and the documents to be discussed been circulated well before the meeting? The procedures should cover this event if this is not the case.