What is Animal Research?
In Tasmania, section 3 of the
Animal Welfare Act 1993
(the Act) defines animal research as a procedure, test, experiment, inquiry or study on an animal which:
- is undertaken to develop, demonstrate or acquire knowledge, or techniques, in an area of science or teaching; and
- is likely to have a significant adverse effect on the welfare of the animal.
The definition of 'animal' for the purpose of research is all live, non-human vertebrates and cephalopods. 'Animal' includes juvenile forms.
Animals that are killed expressly for the purpose of research or teaching are also included under the research provisions. Those that are not included are animals that have been killed for other purposes such as the use of abattoir specimens or carcases from routine vertebrate pest management programs.Significant adverse
effects are expected to render the animal less able to cope with its situation as evidenced by abnormal physiological or behavioural responses including death. The significance of the effect must be assessed in context taking the following into consideration:
- the environment in which the animal is being held, used and/or released into,
- the nature of the animal, and
- the physical and psychological state of the animal.
where the animals are not handled, tagged or otherwise interfered with and the animals' immediate environment is not entered or disturbed by that activity would not generally be considered to have a significant adverse impact on the animals.
Where clarification is required of whether an activity is animal research or not a determination can be made by an inspector authorised under the
Animal Welfare Act 1993
(see Determinations by an inspector below).
No activity is precluded by the Act from being submitted for AEC approval and monitoring as an animal research project in order to comply with institutional internal policies or funding and publishing requirements. This includes activities that have been determined not to be animal research or fall outside the definition or are exempt under section 27 of the Act from licensing.
Animal Research Decision Guide
Determinations by an inspector
A determination of whether an activity is animal research can be made by an inspector under the
Animal Welfare (General) Regulations 2013
. The determinations are based on an assessment of the risk of cruelty arising from the proposed research activity. Where it is apparent that there is insufficient information to adequately assess the risk, a precautionary approach is taken.
Where an activity is determined not to be animal research, it may be undertaken outside a licensed institution and without Animal Ethics Committee (AEC) approval, however is not required to be. Investigators may find value in submitting their project for AEC approval and monitoring, for instance to ensure protection from sections 8 and 9 of the Act and to comply with publishing rules for an increasingnumber of journals (see What is a licensed institution? below).
Examples of the areas in which determinations have been made are listed below:
Camera trapping with and without the use of lures in the terrestrial environment - use of camera traps fitted with infra-red flashes outside rookeries and nesting areas without lures or attractants of any kind does not constitute animal research in Tasmania.
The use of scent trails (where there is no visible accumulation of material or carcase remnants) for camera trapping purposes placed such that the target and non-target species are not attracted to areas where they are placed at high risk of injury or death does not constitute animal research.
The use of lures in association with camera traps constitutes animal research in the terrestrial environment. For this purpose, a lure is an attractant in volume sufficient to retain one or more animals at the site for sufficient time to engage in feeding type behaviour. Includes as examples, whole or part of a carcass or inaccessible bait.
Training in condition scoring of sheep - is not animal research in Tasmania if conducted by competent instructors and the sheep undergo no more than 5 assessments per session and the sessions are scheduled not to interfere with normal management regimes for the flock involved.
Use of juvenile animals - eggs and larvae - is not animal research in Tasmania where research is being applied to juveniles
less than halfway through their gestation, incubation or prior to feeding independently, and there is no potential for a deleterious effect on the sentient animal resulting from procedures applied prior to the onset of sentience.
Please note that a determination usually addresses a specific context and methodology.
Enquiries regarding existing determinations or requests for determinations should be directed to the inspector via the contacts listed below.
Requests for a determination should include detailed background information regarding the environmental context, methodology and the species involved - both subject and 'by-catch'.
What is a licensed institution?
The provisions of Part 4 of the Act govern the conduct of animal research in Tasmania.
The Act provides that animal research (as defined above) can only be conducted by institutions licensed by the Minister for Primary Industries and Water. Research by unlicensed institutions (or researchers) is an offence for which substantial pecuniary and/or custodial penalties exist.
To be granted a licence, the institution must have its own or approved access to an Animal Ethics Committee that is constituted according to the approved research Code. (See Animal Ethics Committee below).
Animal research performed by a licensed institution is protected from the Cruelty (Section 8) and Aggravated cruelty (Section 9) provisions of the Act, provided it has Animal Ethics Committee approval and is conducted in accordance with the approved research Code of Practice.
An institution can be any entity that wishes to conduct research or teaching, for example a school, university, pharmaceutical company, ecological surveyor or private individual with a particular animal research interest. The person who signs the application (eg Vice Chancellor/Managing Director/CEO) is the person who is ultimately responsible for the activities of the institution. An additional person can be nominated for routine contact between the Department and the institution.
To be licensed, the institution must agree to comply with the approved research Code of Practice - currently the
Australian Code for the Care and Use of Animals for Scientific Purposes, 8th edition 2013 (the Code), published by the National Health and Medical Research Council.
Exemptions to licensing
There are three circumstances in which an animal research activity can be conducted outside a licensed institution (section 27 (2)). These are the observational study of one's own animal, administering veterinary treatment to an animal for the welfare of the animal, or a person conducting normal animal management operations. Please note that there is no protection from prosecution under the cruelty provisions applying in these circumstances as they have not been approved or monitored by an Animal Ethics Committee (AEC).
Administering veterinary treatment for the welfare of the animal implies there is a welfare issue such as a disease event to treat. In order to treat appropriately, diagnostic testing may be required and is considered to be included in this exemption.However, approval should be considered where wide scale surveillance for a disease is necessary subsequent to a disease event or suspect disease event,
and the surveillance involves procedures likely to cause significant impact on animals.
There are situations where there is an urgent need to use animals in the development of vaccines, treatments or tests. An example would be during the course of an emergency animal disease response. Specific arrangements need to be put in place by institutions with their AEC to ensure such projects are assessed as quickly as possible while maintaining compliance with the Code.
Normal animal management operations is considered to mean the use of established techniques, procedures and substances for the management of a known population of animals by competent persons as part of and directed by a management program of an appropriate authority be that the owner or manager of the animals.
Examples of situations where normal animal management operations may apply would be:
- the monitoring of the duck population by authorities for the hunting season, or
- routine health surveillance in livestock where those procedures are well established, industry-wide practices, or
- comparisons of different but well established and currently industry accepted management operations where nationally agreed codes of practice guide or regulations prescribe the application of the procedures and competency of the practitioner, and
- the operation of school farms.
Animal Ethics Committee (AEC)
Animal Ethics Committee
(AEC) (also referred to as an Animal Experimentation Ethics Committee) of or acting for an institution provides the assessment and monitoring service for individual projects. A properly constituted and functional AEC ensures that the use of animals for research and teaching purposes is justified and conducted in a way that minimises welfare compromise according to the principles of the '3R's':
- Replacement (use alternatives to animals whenever possible),
- Reduction (use the minimum number of animals required to achieve scientific and statistical validity without increasing pain and distress on individual animals), and
- Refinement (avoid or minimise welfare compromise to those animals you must use).
The formation and operation of the AEC must be in accordance with the Code no matter where the institution is resident.
Supply of animals
It is an offence to supply animals, to be used for animal research, to an unlicensed institution or in a manner that contravenes the Code.
Applying for an Animal Research Licence
Institutions should apply for an Animal Research Licence using the form below:
Animal Research Licence Application Form
Institutions must have their own AEC or approval from another institution to access their AEC - this approval must be in writing and a copy submitted with the licence application.
The application form includes a fee list. The appropriate licence application fee must accompany the completed form.
Note that interstate applicants who have access to an AEC in their own jurisdiction as an external institution are Category 4 institutions for the purposes of calculating licence fees.
A licence may be issued for up to three years. Renewal is subject to satisfactory compliance with the Code and all reporting requirements having been met during the previous licensed period.
Note that there are specific additional requirements for those wishing to conduct wildlife or fisheries research - see the section on 'Additional Requirements for Wildlife and Fisheries Research' below.
Interstate Institutions' AEC Details
If an interstate institution's AEC has been constituted under the Code, an exemption to the requirement to submit individual details of AEC members may be made. Confirmation from the interstate Regulator that the institution's AEC is licensed in its jurisdiction may be adequate. The institution should contact the
Inspector of Animal Research about this issue prior to submitting an application.
Notification to the inspector of changes in membership is required within 28 days of the change. Where an exemption to listing individual members has been given, confirmation from the interstate Regulator that the AEC remains constituted according to the Code is required with the notification.
Interstate and Overseas Institutions Project Monitoring
The Code requires institutions' AECs to monitor approved research projects. As there are practical issues involved in complying with this aspect for AECs not resident in Tasmania, institutions must provide evidence that there are monitoring contingencies in place (such as a monitoring plan) from the nominated AEC for that institution's projects or parts of projects that are conducted in Tasmania. Institutions are encouraged to contact the
Inspector of Animal Research prior to submitting the application to discuss various options that may be available to ensure adequate project monitoring.
Research Licence conditions
Core conditions of the licence involve compliance with the approved Code and the
Animal Welfare Act 1993 at institutional, AEC and individual researcher levels. Reporting requirements and provision for inspection of the institution's research activities and the AEC are also included as a minimum.
Annual reporting of animal use statistics
The institution must report to the inspector on animal research conducted in Tasmania by 31 May for each calendar year during which the institution was licensed. This is referred to as the 'State report'. This report is in addition to any annual reporting required by AECs. The State report is in two parts:
Part 1 is a textual report on general research activities and provides an opportunity for institutions to notify changes in their areas of interest, operational procedures or facilities as they apply to animal use in Tasmania. The report should be submitted in the format shown in the document below (Part 1 Animal Use Activities). This document represents the minimum information required for Part 1.
Animal Use Activities
Part 2 must be submitted in an Animal Use Data Entry Excel file. It includes animal use data for individual approved projects as extracted by the licensed institution from annual project progress or final reports. Electronic submission of this data is mandatory. The file follows nationally agreed reporting areas. Some animal types have bene split to better describe the Tasmanian context. The exclusive use of camera traps has been included as a separate procedure for reporting for the 2013 calendar year.
Part 2 Animal Research Data Entry
Annual Reporting Instructions
DPIPWE AR Annual Report Instructions
The reports are collated and presented as a State report to Parliament as required by Section 35 (4) of the
Animal Welfare Act 1993.
Animal Research Statistics Tasmania Annual Report 23 (987Kb)
Animal Research Statistics Tasmania Annual Report 22 (1Mb)
Animal Research Statistics Tasmania Annual Report 21 (1Mb)
Additional Requirements for Wildlife and Fisheries Research
The DPIPWE's Biodiversity Conservation Branch (BCB), Wild Fisheries Management Branch and the Inland Fisheries Service have requirements for the use of Tasmanian wildlife including fish in research.
Investigators of licensed institutions are required to obtain a "Scientific Permit" before any wildlife is used for research. An Animal Ethics Committee approval of a project does not guarantee the receipt of the Scientific Permit. Permits are only issued after the BCB's special policy and procedural arrangements are met. The BCB's requirements are included in the Guidelines for Scientific Research
Scientific Permits (Wildlife).
For information about taking
marine fish under the
Living Marine Resources Management Act 1995 go to
About Permit Activities or contact the Wild Fisheries Management Branch.
Inland Fisheries Service for all permits to take
Scientific Research Permits (Fauna)
DPIPWE Animal Ethics Committee