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

NHMRC is reviewing the 8th edition of Code (2013, updated 2021). The review commenced following NHMRC’s consultation with state and territory governments, relevant Commonwealth Departments, and the co-endorsers of the Code (Australian Research Council, Commonwealth Scientific and Industrial Research Organisation and Universities Australia).

The aim of the review is to ensure that the Code continues to provide guidance that is current, fit for purpose and reflects current scientific evidence and ethical and social views about the care and use of animals for scientific purposes.

NHMRC will be leading a review of the Code, with advice from the NHMRC’s Animal Welfare Committee. The review will also be informed by advice from an Interdepartmental Committee (IDC). (Further information about the advisory committees is available under the 'Committees' tab.) The process will be overseen by NHMRC’s Research Committee and Council, with the final Code being approved and issued by NHMRC’s Chief Executive Officer.

Further information

For further information about the review of the Code, contact code.review@nhmrc.gov.au.

Video: Review of the Code

NHMRC has produced a video that provides information about:

• the background to the Code
• the role of NHMRC and other parties, such as state and territory regulators, in the review of the Code
• how NHMRC is approaching the review
• the expected timeframes for the review.

Recorded on Thursday 22 January 2026.

Video transcript

Mary Bate 0:00
Hello everyone and welcome. My name is Mary Bate, and I am the Assistant Director in the Research Quality and Equity Section of the National Health and Medical Research Council, and I'm very pleased to be able to provide you with an update about the review of the 'Australian code for the care and use of animals for scientific purposes'.

Mary Bate 00:18
Before I begin, I would like to acknowledge the Ngunnawal people as the traditional custodians of the land from which I am presenting today. I would also like to extend this acknowledgement to the traditional owners of the land from wherever you may be joining this presentation, I pay my respects to their elders, both past and present, and acknowledge Aboriginal and Torres Strait Islander people who are joining this presentation.

Mary Bate 00:42
In this presentation, I'm going to give you a brief overview of the code review project, and I will focus on the background to the Code, the role of NHMRC, how we are going to approach the review, and the expected timeframes for the review.

Mary Bate 00:58
Although most of you are probably very familiar with the Code, I would like to give you a bit of history first to set the scene. The Code was first released by NHMRC in November 1969 and for almost 56 years, it has been guiding the ethical, humane and responsible use of animals. It has been reviewed and updated many times as our understanding of animals has evolved, techniques have improved, and public attitudes have changed. Over time, the scope of the Code has been expanded beyond health and medical research alone, so that it now applies to all areas of science, including teaching, field trials, environmental studies, research, diagnosis, product testing and the production of biological products. In 2004, the scope of the Code was also extended to add cephalopods to the formal definition of animal. The current edition, the eighth edition, was released in 2013. The approach taken for this edition was revised so that it provided governing principles that could be applied to all relevant species and to all situations. What you may not know is that this approach was taken to maximise the Code's effectiveness and longevity. To finish off this part of the story, a new section was added in 2021 about the use of animals for cosmetic testing.

Mary Bate 02:22
To put the Code in the context of the regulatory framework for animal welfare in Australia. State and territory legislation covers all uses of animals, including animals used for scientific purposes. Some aspects of animal use are also regulated under Commonwealth legislation, which applies to areas related to the import and export of animals to and from Australia and the international movements of animal species that are endangered.

Mary Bate 02:50
So where does the Code fit in? The Code applies to a subset of activities covered by state and territory legislation - animals used for scientific purposes. I want to highlight that the Code is a guidance document. It is not a legislative instrument. However, all state and territory governments have chosen to adopt the Code under their legislation. The use of animals for health and medical research is just one example of animal use for scientific purposes. This field is, of course, of interest to NHMRC as a funder for Health and Medical Research. NHMRC funding agreement requires NHMRC-funded research involving animals to comply with all relevant legislation and the Code.

Mary Bate 03:32
Given that NHMRC is involved in only one area covered by the Code, what is NHMRC s role in the Code review. NHMRC's core functions are set out in the National Health and Medical Research Act. You will see that, in addition to funding, NHMRC's core functions include the issuing of guidelines and advice on ethical issues related to health. NHMRC has a long-standing leadership role in animal welfare and ethics, primarily through the development and revision of the Code since 1969. However, I'd like to emphasise that, apart from requiring those we fund to comply with the code, NHMRC has no role or remit in the implementation of the Code. Nor does NHMRC have a role in the regulation or oversight of the use of animals for scientific purposes. This is important, as it explains why review of the Code is a collaborative effort between NHMRC and a team from all jurisdictions, working together with experts and community stakeholders.

Mary Bate 04:33
Now that the scene is set, why is the Code being reviewed now. In 2024, we consulted with Commonwealth and state and territory governments, as well as the Australian Research Council, CISRO and Universities Australia who are co-endorsers of the current edition of the Code. The aim of this consultation was to obtain feedback about the relevance and currency of the code. The feedback demonstrated strong support for review of all sections of the Code, apart from Section Seven about cosmetic testing, which was added in 2021.

Mary Bate 05:09
How are we approaching the review? First, some of the key considerations that will inform the review include the need for the Code to accord with current and emerging scientific evidence in relevant fields, such as animal welfare science, veterinary science and medicine. The review will also take into account international standards and approaches and advances in technologies, including non-animal technologies. Public attitudes have also changed since the Code was last reviewed. We will also need to look at any changes in ethical views about the use of animals. The Code will still need to provide guidance for the varying circumstances where animals are used. This is particularly important if the scope of the Code changes. We will also need to ensure that the language used in the Code minimises subjective interpretation and hence promotes consistent implementation across all jurisdictions. This will include reviewing the 'should' and 'must' statements in the Code.

Mary Bate 06:11
Our approach will include consideration of issues that have been identified in international literature and by stakeholders. I am going to give you some examples, but I also wish to stress that this list is not exhaustive, and it is in no particular order of importance. So, let us go through some of the issues: review of the definitions, such as whether the definition of animals should be expanded to include decapods; how animal sentience should be taken into account; whether there should be more guidance about the nature and depth of the ethical judgement that needs to be made. This point also goes to whether there should be more guidance about the harm-benefit analysis, animal welfare impact and its assessment, and the scientific validity of the proposed animal use. We will also look at whether there should be stronger guidance about the consideration and the use of non-animal methods. Improving the quality of animal-based studies is another issue, and I will talk a little bit more about this shortly. The matter of retrospective assessment at the end of a project, and how better to incorporate the principles of transparency and accountability will also be considered.

Mary Bate 07:27
Some additional matters that will be considered include whether AEC membership categories should be expanded to include, for example, a biostatistician, and whether training of AEC members should be mandatory; whether there should be more guidance about the assessment of competence for the conduct of procedures, including the qualifications of the assessor and renewal of competency. The inclusion of guidance on information to be reported about animal use has also been suggested as a mechanism for promoting national consistency and to inform the development of a national data set. There are calls for clarification about the application of the Code in teaching, particularly in primary and secondary schools. We will also be looking at whether there should be additional or stronger guidance for particular situations. Some examples are unexpected adverse events, what they are and how they should be managed; the assessment of studies involving a high impact on animal wellbeing; the use of non-human primates; studies involving wildlife research and field studies and the techniques used with wildlife; rehoming of animals particularly dogs and cats, at the end of a project; and animal-based studies in Aboriginal and Torres Strait Islander communities.

Mary Bate 08:49
Now to focus on improving the quality of animal-based studies that I mentioned earlier. I would like you to think about this diagram of the classic research cycle, from the inception of the work and the development of the research question, through to the design and conduct of the project, analysis and reporting, and then the translation of the research discovery and informing new studies. The use of responsible research practices is essential at all stages to ensure that the studies are rigorous, transparent and reproducible, and ultimately to minimise the wastage of animals used and the unnecessary use of animals. The Code applies throughout this research cycle, including during the early stages, when the research question is being developed and during the design of the project. I make this point because applying the Code during these early stages may often be overlooked. Examples of where information in the Code about responsible research practices could be strengthened are guidance about the inclusion of both male and female animals in the research design, and the importance of full reporting of research, including negative or neutral results. Many of these matters are outlined in NHMRC's 2017 document about best practice methodology, and the 2024 statement about sex and gender in health and medical research. So, incorporation of some of the guidance in these two documents could be considered.

Mary Bate 10:18
The review of the Code will be led by NHMRC, with advice from NHMRC's Animal Welfare Committee. If required, we may also seek additional advice on specific issues. We have also set up an Interdepartmental Committee that will provide advice to the Animal Welfare Committee. This committee has representatives from the Commonwealth and state and territory government departments and agencies that have responsibility for regulation, policy and funding related to the use of animals. The process will be overseen by NHMRC's Research Committee and Council, with the final Code being approved and issued by NHMRC's Chief Executive Officer.

Mary Bate 11:00
The Animal Welfare Committee includes people with experience and expertise relevant to the scope of the Code, as well as representatives from animal welfare advocacy groups and the community. Most members have experience and expertise in multiple areas. However, we will not be restricted to this group of people. Where necessary, we will seek advice from additional experts and groups about particular issues. We will also consult widely through a public consultation process to ensure that all interested people and groups have the opportunity for input.

Mary Bate 11:34
Finally, some words about the anticipated timeframe for the Code Review project. I wish to highlight that this is an anticipated time frame at this point, and that there are many factors that can influence how the project progresses. The first phase, which is now complete, included planning and committee establishment, as well as seeking initial advice. Reviewing the eighth edition of the Code and developing a draft document for consultation will take us up to about midway through 2026. We expect the public consultation about the draft ninth edition to occur in the latter half of 2026. We will then revise the draft document in response to the consultation feedback. The timeframe for this work will depend, of course, on how much feedback we do receive. The last phase will be finalisation and release of the ninth edition by NHMRC's Chief Executive Officer. We expect this phase to be completed by the end of 2027.

Mary Bate 12:38
If you would like more information about the Code Review project, please have a look at our website. The website includes advice about how you can subscribe to a code review contact list. We will use this contact list during the review to provide updates on the work. We will also use the NHMRC Tracker newsletter and social media channels to alert stakeholders to consultation processes as they arise. And of course, you can contact us directly via email.

Mary Bate 13:04
Thank you so much for your attention. And goodbye for now.
 

End of transcript