Any new Standard Operating Procedure (SOP) which is to be used in an animal research project must be approved by the AEC before it is implemented. Any existing SOP referenced in a new application, regardless of whether it was developed for animal management purposes or for research, must have current AEC approval before the research application can be approved.
It may assist your research to have SOPs, however they are not applicable to all forms of animal research, nor are they a mandatory requirement for a research project's AEC approval. Researchers may also find that their research methods are constantly being updated and improved and in these cases it does not make sense logistically to use SOPs.
A SOP is approved by the AEC for three years and must be re-submitted to the AEC for review and approval for a further three years if it is being used in an animal research project.
There is a template available on the AEC website for researchers to use when preparing SOPs. Use of the template is not a requirement - it is intended to assist researchers who do not have a SOP template of their own. If you elect to use your own SOP template please refer to the checklist below in order to ensure you have covered everything in your SOP.
AEC SOP Template (64Kb)
All SOPs approved by the DPIPWE AEC are only approved with respect to their use in projects or research activities that are approved by the AEC in accordance with the requirements of the Tasmanian Animal Welfare Act 1993 (the Act) and the Australian Code for the care and use of animals for scientific purposes (the Code).
The approval of an SOP:
- Is not a determination with respect to whether activities undertaken using the SOP constitute 'Animal Research' within the meaning of the Act;
- Is not a determination with respect to whether activities undertaken
using the SOP constitute 'normal animal management operations' within the
meaning of the Act; and
- Does not exempt any person from any legal requirement or obligation that
applies, or may apply, to that person under the Act, and does not authorise the person to engage in any activity
that is prohibited by that Act
- .Title of the SOP eg. Procedure for trapping and handling wild frogs – 2014;
- Purpose of the SOP ie. A description of the procedures to be outlined in
the SOP and the reason for preparing the SOP, such as documented preferred
methods of handling animals, etc.
- Species of animals covered by the SOP;
- Equipment/materials to be used for the described procedures;
- Outline of procedures. If there are multiple procedures described in this SOP, please include sections that can be referred to (eg Section 2.1: Transportation of species x);
- Training/experience/qualifications required to undertake the procedures;
- Data management ie how data obtained from following the procedures will be
recorded, stored and distributed; and
- List of attachments.
Things to consider when outlining a procedure:
- How the animal is caught;
- How the animal is restrained;
- How the animal is monitored during a procedure including frequency of observation;
- The period of time the animal is restrained for;
- The duration of each procedure;
- Any determinants of procedural success;
- Any other protective measures undertaken to safeguard the animal's wellbeing; and
- Name of any pharmacological agent(s)
- Route of administration
- Dose rate (mg/kg)
- Duration of effect
- Frequency of administration
- Any further potential risks to the animal from this procedure
- Strategies to mitigate these risks
The Code provides for the submission and approval of SOPs as outlined in sections 2.2.33 to 2.2.36:
2.2.33 Institutions, in consultation with the AEC, may allow the AEC to
consider and approve standard operating procedures (SOPs) relating to the care
and use of animals. A SOP must only be
referenced in an application under the following conditions:
2.2.34 New SOPs must not be used until approved by the AEC
and may be included with an application for consideration by the AEC.
- the SOP must have current approval from the AEC;
- the SOP must include in its title the date of approval or last review by the AEC;
- investigators named in the application must be competent to implement the SOP; and
- any variation to a SOP must be described in the application and should be considered as a prompt for review of the SOP.
2.2.35 If an AEC-approved SOP is not reviewed by the AEC within three years of
its approval, approval for the SOP lapses, and the SOP cannot be used (as an
2.2.36 Approved SOPs must be made available to all relevant people, including
Australian code for the care and use of animals for scientific purposes, 8th Edition 2013 (the Code)