In plain English
Much of what is known about research peptides comes from studies in animals, usually rats and mice (preclinical studies) [2]. In Australia, that kind of research has to follow a national rulebook called the Australian code for the care and use of animals for scientific purposes (the Code) [1].
The Code says animals can be used only when it is justified. Each project must be checked and approved by an animal ethics committee (AEC), a group that includes a vet, a scientist, an animal welfare representative and a member of the public [1].
Researchers must also apply the “3Rs” [1]:
- Replace animals with other methods where possible.
- Reduce the number of animals to the minimum needed.
- Refine methods so animals experience as little pain and distress as possible.
The Code does not say whether a study’s findings apply to people. That is a separate question. Animal findings often do not carry over to humans [3]. Knowing how animal research is reviewed is useful when judging an animal study, but approval by an ethics committee is not evidence that a compound does anything in people.
What is the Australian code?
The Australian code for the care and use of animals for scientific purposes is published by the National Health and Medical Research Council (NHMRC). Its stated purpose is to promote the ethical, humane and responsible care and use of animals used for scientific purposes [1].
| Feature | What the Code says [1] |
|---|---|
| Current edition | 8th edition (2013), updated in 2021 to add Section 7 on cosmetic testing. The Code is currently under review. |
| Legal force | Adopted into legislation in all Australian states and territories |
| Endorsed by | NHMRC, the Australian Research Council, CSIRO and Universities Australia |
| Funding link | Compliance is a prerequisite for receiving NHMRC funding |
| Animals covered | All live non-human vertebrates (fish, amphibians, reptiles, birds and mammals) and cephalopods |
| Activities covered | Research, teaching, field trials, product testing, diagnosis, production of biological products and environmental studies |
The Code applies across an animal’s whole involvement: acquisition, transport, breeding, housing, husbandry, use in a project, and what happens to the animal at the end [1].
How the Code is organised
| Section | Topic [1] |
|---|---|
| 1 | Governing principles and ethical framework |
| 2 | Responsibilities of institutions, AECs, investigators and animal carers |
| 3 | Supporting and safeguarding animal wellbeing |
| 4 | Animals used in teaching |
| 5 | Complaints and non-compliance |
| 6 | Independent external review of institutions |
| 7 | Cosmetic testing |
The governing principles
Section 1 begins with respect for animals. The Code says this respect is shown by using animals only when justified, supporting their wellbeing, avoiding or minimising harm (including pain and distress), applying high standards of scientific integrity, and applying the 3Rs at all stages [1].
When is using animals justified?
The Code lists what an applicant must demonstrate [1]:
- the project has scientific or educational merit and potential value for humans, animals or the environment
- using animals is essential to achieve the stated aims, and suitable alternatives are not available
- the project uses the minimum number of animals needed to obtain valid data
- the project has the minimum adverse impact on the animals’ wellbeing.
The Code also ties ethics to scientific quality. Projects that are not scientifically valid must not be performed, “no matter how mild the impact” on the animals [1]. A badly designed study wastes animals as well as producing unreliable data.
Pain and distress
Unless there is evidence to the contrary, the Code requires researchers to assume that procedures causing pain and distress in humans also cause pain and distress in animals [1]. “Death as an endpoint” must be avoided unless it is essential to the project’s aims. If unanticipated pain or distress occurs, prompt action to relieve it takes precedence over completing the project [1].
The 3Rs: Replacement, Reduction and Refinement
The 3Rs were set out in 1959 by William Russell and Rex Burch in The Principles of Humane Experimental Technique, and are now built into legislation around the world [4]. The Australian Code defines each one [1]:
| R | Definition in the Code | Examples from the Code |
|---|---|---|
| Replacement | Methods that achieve a given purpose without using animals | Examining existing data and databases first; using in vitro systems, computer and mathematical models, simulations, non-sentient organisms, cadavers and clinical cases |
| Reduction | Methods that obtain comparable information from fewer animals, or more information from the same number | Using the minimum number needed for good statistical design; sharing tissue between investigators; avoiding unnecessary repetition |
| Refinement | Methods that alleviate or minimise pain and distress and enhance animal wellbeing | Competent handling, monitoring, intervention points and humane endpoints approved by the AEC |
Two points in the Code are easy to miss [1]:
- Too few animals is also a problem. Using too few animals may invalidate the experiment and waste the animals that were used.
- Reduction must not increase harm. Using fewer animals should not mean greater pain or distress for each animal.
Animal ethics committees (AECs)
The primary responsibility of an AEC is to ensure, on behalf of its institution, that all activities involving the care and use of animals comply with the Code [1].
Who sits on an AEC?
Every AEC must include at least one person from each of four categories [1]:
| Category | Who |
|---|---|
| A | A person with veterinary qualifications recognised for registration as a veterinary surgeon in Australia |
| B | A suitably qualified person with substantial and recent experience in using animals for scientific purposes, including a higher research degree or equivalent experience |
| C | A person with demonstrable commitment to animal welfare, who is not employed by or associated with the institution and not currently involved in animal use for scientific purposes |
| D | A person not employed by or associated with the institution, who has never been involved in using animals in scientific or teaching activities (beyond undergraduate education), and who brings an independent community view |
For a meeting to make decisions, at least one member from each category must be present, and Categories C and D together must make up at least one-third of members present. Members with a conflict of interest must withdraw [1].
What does an AEC do?
- Reviews applications. The AEC must judge whether a proposed use of animals is ethically acceptable, weighing the potential effects on the animals against the project’s potential value [1].
- Approves only compliant projects. It may approve only projects that are ethically acceptable and conform to the Code [1].
- Assesses pilot studies like full projects. Pilot studies must be assessed against the same criteria as full projects [1].
- Monitors ongoing work. The AEC inspects animals, housing and procedures, or reviews records, on a regular basis. Inspections may be announced or unannounced [1].
- Receives reports. Investigators must submit annual reports, prompt notice of unexpected adverse events, and a final report [1].
Institutions, in turn, must arrange an independent external review of their compliance with the Code at least every four years [1].
Investigators’ responsibilities
Under the Code, investigators have personal responsibility for the wellbeing of the animals they use, from the start of the approved period until the animals’ fate at the end of the project is settled [1]. They must apply the Code’s principles at every stage, follow AEC-approved procedures, and seek expert advice (for example from veterinarians and animal care staff) where needed [1].
Research quality is an ethical issue
NHMRC’s 2017 guidance, Best practice methodology in the use of animals for scientific purposes (updated 2018), states that the ethical use of animals depends on how studies are planned, designed, conducted, analysed and reported. It describes common flaws in animal studies and practical ways to address them [5].
The concern is well documented. A 2009 survey of 271 publications using rats, mice and non-human primates found that most did not report randomisation (87%) or blinding (86%), and only 59% stated the study’s objective together with the number and characteristics of the animals used [6]. The ARRIVE 2.0 guidelines set out the minimum information an animal study should report, through an “Essential 10” checklist, so that readers can judge its rigour [2]. NHMRC lists ARRIVE among its recommended resources [5].
Reading animal studies of peptides
Much of the published research on peptides discussed in this library is preclinical. When reading any animal study, useful checks are:
- Ethics approval. Does the paper name the ethics committee that approved the work?
- Design. Were animals randomly allocated, and were outcomes assessed blind [2, 6]?
- Numbers. Is the number of animals stated and justified?
- Model. Which species, sex and age? How closely does the model resemble the question being asked?
- Reporting. Does the paper meet the ARRIVE “Essential 10” [2]?
Ethics approval shows that a study was reviewed for animal welfare and scientific justification. It does not show that the findings are correct or that they apply to humans. See How to Read Peptide Research for how animal evidence fits into the wider evidence hierarchy.
What this means in Australia
- The Code has legal force. It is adopted into legislation in all states and territories, so animal use for scientific purposes in Australia must be approved by an AEC and comply with the Code. State and territory laws set out the detail, and anyone involved must be aware of the relevant Commonwealth, state and territory legislation [1].
- Funding depends on it. Compliance with the Code is a prerequisite for NHMRC funding, and NHMRC requires the research it funds to comply with its best-practice methodology guidance as well [1, 5].
- Cosmetic testing is banned. The use of animals for cosmetic testing is banned in Australia, and an AEC must not approve testing of finished cosmetic products [1].
- Ethics approval is not regulatory approval. An AEC approves a research project. It does not approve a substance for supply. Peptide products remain regulated as therapeutic goods, and the TGA states that a “research use only” disclaimer does not make supply lawful, change a product’s regulatory status, permit importation, or remove advertising or supply obligations [7]. Many peptides are also scheduled in the Poisons Standard, which is a separate set of controls [8]. See Are Peptides Legal in Australia?.
This is general information, not legal advice. Laws change; check the current Poisons Standard and TGA guidance.
Frequently asked questions
What is the Australian code for the care and use of animals for scientific purposes?
It is the NHMRC’s national code setting out the ethical framework and responsibilities for anyone using animals for scientific purposes. It is adopted into legislation in all Australian states and territories [1].
What are the 3Rs in animal research?
Replacement (using methods that avoid animals), Reduction (using the fewest animals needed for valid data) and Refinement (minimising pain and distress and supporting wellbeing). The Code requires all three at every stage [1].
Who sits on an animal ethics committee in Australia?
At least one member from each of four categories: a veterinarian (A), an experienced animal researcher (B), an independent animal welfare representative (C) and an independent community member with no involvement in animal research (D) [1].
Which animals does the Code cover?
All live non-human vertebrates, including fish, amphibians, reptiles, birds and mammals, plus cephalopods such as octopus and squid [1].
Does ethics approval mean a study’s findings apply to humans?
No. Ethics approval concerns animal welfare and scientific justification. Whether animal findings translate to people is a separate question, and they often do not [3].
References
- National Health and Medical Research Council. Australian code for the care and use of animals for scientific purposes, 8th edition (2013, updated 2021). nhmrc.gov.au. Accessed 11 October 2026.
- Percie du Sert N, Hurst V, Ahluwalia A, et al. The ARRIVE guidelines 2.0: updated guidelines for reporting animal research. PLoS Biol. 2020;18(7):e3000410. doi:10.1371/journal.pbio.3000410. PMID: 32663219
- Ineichen BV, Furrer E, Grüninger SL, Zürrer WE, Macleod MR. Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications. PLoS Biol. 2024;22(6):e3002667. doi:10.1371/journal.pbio.3002667. PMID: 38870090
- Hubrecht RC, Carter E. The 3Rs and humane experimental technique: implementing change. Animals (Basel). 2019;9(10):754. doi:10.3390/ani9100754. PMID: 31575048
- National Health and Medical Research Council. Best practice methodology in the use of animals for scientific purposes (2017, updated July 2018). nhmrc.gov.au. Accessed 11 October 2026.
- Kilkenny C, Parsons N, Kadyszewski E, et al. Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PLoS One. 2009;4(11):e7824. doi:10.1371/journal.pone.0007824. PMID: 19956596
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. tga.gov.au. Accessed 11 October 2026.
- Commonwealth of Australia. Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327). Federal Register of Legislation. legislation.gov.au/F2026L01327/latest/text. Accessed 11 October 2026.
Important information and disclaimer
General information only. This article is published for general educational and informational purposes. It summarises published scientific literature and public regulatory information as at the “last reviewed” date shown above. It is not medical, health, pharmaceutical, veterinary or legal advice, and it must not be relied on as a substitute for advice from a qualified professional about your circumstances.
Not for human or animal use. Nothing in this article recommends, endorses or describes the use of any substance in humans or animals. Findings from cell, animal or early human studies cannot be assumed to apply to people. The compounds discussed have not been evaluated by the Therapeutic Goods Administration (TGA) for safety, quality or efficacy unless the article expressly states otherwise. Any research materials offered by Iconic Peptides are supplied solely for in vitro and laboratory research.
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Regulatory status. Many peptides are scheduled substances under the Poisons Standard. Some are prescription-only (Schedule 4), and some may not be possessed without authority (Appendix D). The TGA has stated that a “research use only” label does not make supply lawful, change a product’s regulatory status, or remove advertising or supply obligations. State and territory laws may also apply. You are responsible for knowing and complying with all laws that apply to you. Regulatory information in this article may change after the review date.
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