(L22) IMED2003 - Animal Ethics (ADD IMAGES)

What are the principal learning objectives of biomedical research involving animals?

1. Describe societal, scientific and regulatory grounds for animal use in health and medical research.

2. Explain considerations shaping ethical frameworks and guidelines.

3. Apply the 3Rs: Replacement, Reduction and Refinement to research and teaching examples.

4. Describe the Five Domains Model: nutrition, environment, health and behaviour contributing to mental state.

5. Recognise that behaviour and facial expression help assess pain and mental state.

6. Explain the Australian Code, Animal Ethics Committees (AECs), compliance and consequences of breaches.

The slide numbers its outcomes 1, 2, 4, 5, 6, 7.

What does a veterinary officer contribute to ethical animal research?

Support throughout a project:

- Planning and AEC applications.

- Choosing an appropriate animal model (e.g., sheep, pigs, mice, rats, rabbits or zebrafish).

- Performing procedures or training researchers.

- Anaesthesia and analgesia.

- Post-procedural monitoring and individual care.

- Quality control: ensuring animal health and fitness for the research.

Lecturer explanation:

The lecturer's PhD used preterm lambs to investigate ventilation of preterm babies. Her current work particularly supports invasive procedures, especially sheep and pigs.

How can veterinary research and professional organisations help refine animal models?

The lecturer's research includes refinement, particularly anaesthesia and analgesia for farm-animal husbandry such as Brahman cattle castration and lamb castration/tail docking.

Professional roles include AEC membership, the Australian and New Zealand College of Veterinary Scientists, scientific editing and peer review.

Laboratory-animal-science organisations pictured: ANZLAA, LASA (Laboratory Animal Science Association, UK), AALAS (American Association for Laboratory Animal Science) and FELASA (Federation of European Laboratory Animal Science Associations).

They involve veterinarians, researchers and technical animal-care staff.

What specialist journals illustrate the breadth of laboratory animal science?

Examples displayed:

- Laboratory Animals

- JAALAS (Journal of the American Association for Laboratory Animal Science)

- Journal of Medical Primatology

- Lab Animal / labanimal

- ATLA

- Animals

- ILAR Journal

- ALTEX (Alternatives to Animal Experimentation)

- Comparative Medicine.

Lecturer explanation:

The field includes work on replacement, refinement, primate research, animal models and welfare; collaborative teams span veterinary and biomedical disciplines.

What four themes frame the lecture on biomedical research involving animals?

1. Why animals are used in medical research.

2. Ethical concerns and the costs to animals.

3. The 3Rs.

4. The Australian Code.

The overarching purpose is to consider ethical, safety and professional issues in medical research.

What is the central moral justification offered for animal research?

Research is presented as an important human endeavour to prevent, alleviate and cure pain, suffering, distress, fear, anxiety, disability, infirmity and death associated with human disease.

Lecturer explanation:

The perceived duty to protect human health is a societal argument, not unlimited permission: the expected benefit must justify the harm and burden imposed on animals.

What position did Charles Darwin take on vivisection in 1875-76?

Darwin supported genuine physiological investigations but opposed experiments performed merely to satisfy curiosity.

He was distressed by animal suffering and argued for scientific justification.

The British Association for the Advancement of Science (BAAS) guidelines supported anaesthesia wherever possible and prohibited demonstrations with no intended scientific discovery.

Lecturer explanation:

Some historical experiments restrained conscious animals, including loyal dogs; Darwin's advocacy helped develop early animal-research rules.

DIAGRAM ON SLIDE 10

Which scientific, societal and regulatory roles explain why animals are used?

- Medical advances: cancer, preterm birth, transplantation, toxicity studies, brain trauma, glaucoma and hearing research.

- Translational/preclinical research before human clinical trials.

- Evidence supporting drug and medical-device registration (the lecturer cited the TGA and FDA).

- Other human activities, including food production.

Lecturer explanation:

The system and existing scientific literature have long incorporated animal models, so their use persists while these regulatory and scientific expectations remain.

DIAGRAM ON SLIDE 11

Where are animal studies positioned in the evidence pyramids, and why?

Displayed hierarchies place in-vitro/laboratory and animal studies toward the base, followed by ideas/opinions, case reports, case series, case-control and cohort studies, RCTs, and at the top systematic reviews and meta-analyses.

Some diagrams place cross-sectional studies and RCTs at slightly different levels.

Animal studies provide preclinical information rather than the same clinical evidence as trials involving people.

The satirical science-versus-pseudoscience diagram contrasts evidence-based methods with intuition, unsupported internet claims, anecdotes and wishful thinking.

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What practical and historical factors perpetuate animal experimentation?

- Animals can be kept in captivity and physically restrained.

- Long histories using a particular species or strain provide comparable evidence; changing strains may introduce confounders.

- Animals are models for aspects of the human condition.

- Speciesism: privileging the human species over other species.

The historical confinement and vivisection drawings illustrate older practices and ethical concerns.

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Which five research organisms were highlighted as having made a major difference?

1. Fruit flies (Drosophila).

2. Genetically modified mice.

3. Zebrafish.

4. Dogs.

5. Non-human primates.

Lecturer explanation:

Fruit flies are animals biologically but are not covered by the specific definition of "animal" in the Australian Code discussed in this lecture.

DIAGRAM ON SLIDE 17

What is the central cost-benefit test for proposed animal research?

Compare:

- Cost to the animal(s): predicted pain, suffering, distress, restrictions, procedures and possible death.

- Potential benefit to society or science: useful knowledge or improved health.

An application must show that the prospective benefit justifies animal costs; benefit is uncertain even when costs are foreseeable.

Lecturer explanation:

Unexpected adverse events may increase actual cost and require reconsideration of approval.

DIAGRAM ON SLIDE 18

What are the three Rs of humane animal research, and who developed them?

1. Replacement.

2. Reduction.

3. Refinement.

William M. S. Russell and Rex L. Burch articulated them in The Principles of Humane Experimental Technique in the 1950s.

These differ from the familiar environmental "reduce, reuse, recycle" slogan shown on a slide.

The framework applies to both research and teaching.

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How do the standard and contemporary definitions of the 3Rs compare?

Replacement:

- Standard: methods that avoid or replace animal use.

- Contemporary: advance scientifically current models and tools to answer questions without animals.

Reduction:

- Standard: minimise animals used per experiment.

- Contemporary: robust, reproducible, well-designed and analysed experiments that genuinely add to knowledge.

Refinement:

- Standard: minimise suffering and improve welfare.

- Contemporary: use current in-vivo technologies and understand how welfare affects scientific outcomes.

Source displayed: NC3Rs.

DIAGRAM ON SLIDE 22

What is Replacement, and why must it be considered?

Using approaches that wholly or partially avoid animals where they would otherwise be used; favour less-sentient options and in-vitro methods wherever possible.

Addresses:

- Whether an animal model is relevant to human disease.

- Animal welfare costs.

- Time and monetary costs of breeding, keeping and using animals.

Researchers must justify why alternatives cannot adequately answer the question.

What distinguishes full Replacement from partial Replacement?

Full replacement: no animals used in the procedure, e.g. human volunteers, tissues/cells that do not require continuing animal use, established cell lines, mathematical/computer models.

Partial replacement: less-sentient organisms, certain immature vertebrates, primary cells and tissues harvested from animals.

Slide exclusions from some partial-replacement examples:

- Cephalopods (even though invertebrates).

- Mammalian, bird and reptile embryos/foetuses in the final third of gestation/incubation.

- Fish/amphibians capable of independent feeding.

- Hatched cephalopods.

- Earlier forms intended to survive beyond those developmental stages.

DIAGRAM ON SLIDE 24

How can realistic or simple training simulators replace animal use?

Examples pictured:

- Intubation/airway mannequins.

- Surgical/procedural training simulators.

- Computerised anaesthesia and physiological simulations.

- Simple balloon-and-foam models for veterinary castration or spaying skills.

Lecturer explanation:

Simulation quality and affordability have improved; simple and expensive high-fidelity models each have roles. Some later hands-on training may still benefit from living systems.

DIAGRAM ON SLIDE 25

What is Reduction, and why does it NOT simply mean using the fewest animals possible?

Use the minimum number consistent with answering the scientific question robustly.

Too few animals can produce inconclusive, statistically invalid results and waste those animals.

Other aims:

- Maximise information per animal.

- Share data, resources and tissues.

- Minimise avoidable repetition and waste.

- Design and analyse experiments so findings are reproducible.

How do study design and statistics support Reduction?

- Use power/sample-size analyses to avoid under- or over-sampling.

- Select appropriate controls and comparisons.

- Choose the correct design and statistical analyses.

- Consult a biostatistician from project planning onward.

Lecturer explanation:

AECs may require evidence of statistical consultation; scientific usefulness is part of the ethical justification for animal numbers.

DIAGRAM ON SLIDE 27

What is the role of a pilot study in Reduction and Refinement?

A small initial feasibility study can test whether a proposed method works before committing many animals.

It helps identify unanticipated animal welfare impacts, guide staged assessment, improve procedures and avoid waste.

Code clause 2.3.14: pilot studies are integral to the overall project and need AEC assessment using project-approval criteria.

The accompanying Code criteria also require identifying potential harm, mitigation strategies, and regular competent monitoring.

DIAGRAM ON SLIDE 28

What is Refinement in animal-based research?

Methods that minimise pain, suffering, distress and lasting harm AND positively improve welfare.

Includes:

- Housing and husbandry enabling normal behaviour.

- Environmental enrichment.

- Appropriate procedures delivered by trained, skilled staff.

- Suitable anaesthesia and analgesia.

- Monitoring and supportive care before and after procedures.

A goal is more than simply avoiding harm: provide better quality of life where possible.

What refinement was achieved by delivering mouse analgesia in medicated gel?

The lecturer described disguising unpalatable pain-relief drugs in a jelly that could also serve as a water source.

After surgery, mice could take analgesia without repeated handling and injections two or three times daily.

Benefit: fewer stressful interventions while maintaining postoperative pain relief.

DIAGRAM ON SLIDE 30

Why did the rat functional-MRI study focus on standardising anaesthesia?

Anaesthetic drugs alter brain activity and thus functional-MRI measurements.

A rat pharmacokinetic/anaesthetic study aimed to give researchers standardised procedures, allowing more meaningful comparisons across studies of neurodegenerative conditions such as Alzheimer's disease.

DIAGRAM ON SLIDE 30

How did a mirror help refine the temporary isolation of sheep?

Sheep are social and generally dislike being alone. When brief separation is unavoidable (e.g., an hour or two), a mirror can simulate the presence of another sheep and reduce apparent distress.

Lecturer explanation:

Good welfare can also depend on simple husbandry strategies understood by experienced animal-care staff.

DIAGRAM ON SLIDE 30

How did bedding changes improve welfare in a long-term pig skin-injury model?

Pigs in the model could grow from ~20 kg to ~80-100 kg over about three months (approximately 5 kg/week).

Heavy pigs developed sore feet on harder pen floors around ~60 kg.

The team introduced thick hay bedding around ~50 kg or earlier, improving comfort and encouraging play, despite weekly replacement, labour and disposal costs.

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Why was recovery care particularly important after prolonged rabbit anaesthesia?

A rabbit in one model required about eight hours of anaesthesia.

The team designed care to encourage prompt recovery, drinking and resumption of normal behaviour.

Failure to recover appropriately could harm welfare and undermine the study.

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How have anaesthesia and analgesia historically changed animal experiments?

Anaesthesia permits unconsciousness and reduced responses during procedures; analgesia relieves pain during and after procedures.

Their development substantially reduced restraint-related suffering and increased capacity to perform reproducible procedures.

Historical methods included hypothermia, alcohol, then ether and chloroform; early human ether use was hazardous.

A cited 2020 review by R. Eddie Clutton discussed the history of anaesthetics and analgesics in the refinement of animal experiments.

DIAGRAM ON SLIDE 31

Which measures can be combined into an animal welfare monitoring score?

Examples:

- Eating and drinking.

- Gait, movement and activity.

- Demeanour/behaviour.

- Facial expression/grimace.

- Clinical condition and recovery.

A composite score often begins at 0 for normal and rises with severity; predetermined thresholds may trigger veterinary review, extra analgesia or humane euthanasia.

Monitor before, during and after procedures.

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How do grimace scales help assess animal pain?

Species-specific scales evaluate changes in facial expressions associated with discomfort or pain, complementing behaviour and other indicators.

Examples pictured/discussed include mice, rats, rabbits, sheep, piglets, horses and cats.

Lecturer explanation:

A general dog grimace scale was challenging due to marked facial variation across breeds.

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What should be recognised in the illustrated animal facial-expression poster?

Illustrated Irish setter expressions are labelled:

- Happy.

- Depressed.

- Angry.

- Pensive.

- Excited.

- Social.

It illustrates using faces to recognise possible emotional states, but is not presented as a validated dog pain scale.

DIAGRAM ON SLIDE 33

What is the Five Domains Model and how does it differ from the older freedoms concept?

The Five Domains Model is a structured way to assess and manage animal welfare including BOTH negative experiences and opportunities for positive welfare.

Earlier "freedoms" framing primarily stressed freedom from hunger, pain and other harms.

The Five Domains integrate four functional/physical domains to evaluate an animal's fifth domain, mental state.

Reference displayed: David J. Mellor, Animals (2017), Operational Details of the Five Domains Model.

DIAGRAM ON SLIDE 34

What are the Five Domains of animal welfare and their key indicators?

1. Nutrition — water intake, food intake, food quality.

2. Environment — temperature, confinement, shelter.

3. Health — disease and injury.

4. Behaviour — choices and limitations on normal behaviour.

5. Mental state — pain, thermal comfort, boredom, frustration and happiness.

Domains 1-4 influence Domain 5.

Lecturer example:

Pigs voluntarily sleeping piled together can be normal social comfort, rather than automatically an adverse sign.

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What Australian document governs the care and use of animals for scientific purposes?

Australian code for the care and use of animals for scientific purposes (8th edition, 2013), issued through the NHMRC/Australian Government framework.

Covers research AND teaching involving animals, with the purpose of minimising welfare harms and justifying expected benefits.

The lecturer noted related NHMRC guidance, including The Assessment and Alleviation of Pain and Distress in Research Animals.

DIAGRAM ON SLIDE 36

What counts as an "animal" under the Australian Code in this lecture?

Any live non-human vertebrate — fish, amphibians, reptiles, birds and mammals (domestic, purpose-bred, livestock or wildlife) — AND cephalopods.

Lecturer explanation:

The speaker contrasted this with the Western Australian Animal Welfare Act as described at the time, under which fish received different coverage. Fish in scientific research are covered by the Code.

Fruit flies are excluded by this particular Code definition.

How does the Code define "scientific purposes"?

Activities intended to acquire, develop or demonstrate knowledge or techniques across science, including:

- Research and teaching.

- Field trials and environmental studies.

- Animal breeding/new lines where welfare impact is unknown or uncertain.

- Diagnosis.

- Product testing and biological-product production.

Examples from lecturer: school egg-hatching exercises, clinical/surgical training and biomedical projects.

Who counts as an investigator and what counts as an activity under the Code?

Investigator: anyone using animals for scientific purposes, including teachers, researchers, undergraduate/postgraduate students, wildlife surveyors and people involved in environmental/product testing or biological-product production.

Activity: any action(s) involving animal care or use — acquisition, transport, breeding, housing, husbandry or procedures. Activities must be described to the AEC.

How does the Code define ethics and current best practice?

Ethics: a framework for judging actions as good/bad or right/wrong and deciding what should be done when animals are proposed for or involved in science.

Current best practice: effective ways to protect animal wellbeing that:

- Account for species-specific biology, physiology and behaviour.

- Follow best available evidence or accepted practice where evidence is lacking.

- Consider potential harms from conditions and procedures.

- Include strategies to minimise those harms.

DIAGRAM ON SLIDE 38

What additional animal-welfare guidance accompanies the Australian Code?

NHMRC Guidelines to Promote the Wellbeing of Animals Used for Scientific Purposes: The Assessment and Alleviation of Pain and Distress in Research Animals.

Lecturer explanation:

Guidance can specify practical parameters such as acceptable blood collection quantities per animal weight and sampling frequency.

DIAGRAM ON SLIDE 39

What do Code clauses 1.18-1.20 require for Replacement?

1.18: Investigate, consider and, where appropriate, implement methods that replace or partly replace animals.

1.19: Before proposing animal use, examine existing literature/databases and alternatives including epidemiology, physical/chemical analysis, computer/mathematical/synthetic models, simulations, in-vitro systems, non-sentient organisms, cadavers and clinical cases.

1.20: Continue reviewing alternatives throughout the project; implement relevant changes and use them when planning future studies.

DIAGRAM ON SLIDE 40

What do Code clauses 1.21-1.24 require for Reduction?

1.21: Use the minimum scientifically necessary animals consistent with sound statistical design; too few may invalidate results.

1.22: Reuse requires particular justification and specific AEC approval, considering the individual animal's lifetime experience and welfare cost.

1.23: Do not repeat animal activities unless scientifically essential (e.g., design, statistics or corroboration).

1.24: Reducing animal numbers must not increase pain, distress or other harms to remaining animals.

DIAGRAM ON SLIDE 41

What do Code clauses 1.25-1.27 require to minimise animal use and waste?

1.25: Control nonexperimental sources of variability; use animals of known genetic, biological and behavioural background where appropriate.

1.26: Share biological materials from animals being killed, or bank tissue, when practical.

1.27: Manage breeding to avoid surplus; do not create a new line if a suitable line exists; share new colonies with other investigators where appropriate.

DIAGRAM ON SLIDE 41

What do Code clauses 1.28-1.30 require for Refinement?

1.28: Continually safeguard wellbeing; review methods throughout activities, implement improvements and use learning in later projects.

1.29: People performing procedures must be competent or directly supervised by a competent person.

1.30: Keep activities no longer than necessary, consistent with wellbeing; do not retain animals for prolonged pre-use periods without AEC approval.

DIAGRAM ON SLIDE 42

Why assess an animal's lifetime rather than only its daily welfare scores?

A cumulative/lifetime assessment records an animal's experiences across days, weeks, months or even years — not only one day's condition.

The lecturer cited Wolfensohn and colleagues (Animal Welfare, 2015, 24:139-149), describing a quantitative framework that can help assess changes in cumulative harm and the need for intervention.

DIAGRAM ON SLIDE 43

What four axes and scoring anchors are shown on the lifetime welfare-assessment grid?

- Procedural/clinical events: direct suffering/concurrent illness; score 1 = mild, 10 = severe.

- Clinical condition/physical wellbeing: 1 = normal, 10 = grossly abnormal.

- Behavioural deviations/psychological wellbeing: 1 = normal, 10 = grossly abnormal.

- Environmental quality/husbandry: 1 = enriched, 10 = barren.

The axes address physical, psychological, procedural-event and environmental impacts; a larger plotted area reflects higher cumulative welfare burden and greater need for management.

DIAGRAM ON SLIDE 44

What is an Animal Ethics Committee (AEC), and why is its approval important?

An AEC is a committee constituted under the Code to consider animal research/teaching proposals and whether expected scientific or social benefit justifies animal cost.

Institutions working with animals require access to appropriate AEC oversight; applications cover housing, procedures, welfare safeguards and justification.

The committee assesses, approves and monitors the ethical acceptability of proposed work.

What are the four required AEC membership categories?

A — Veterinarian qualified for registration in Australia with relevant experience or ability to acquire it.

B — Qualified researcher with substantial, recent scientific animal-use experience; generally higher research degree or equivalent (or an experienced teacher for teaching-only AEC work).

C — Independent animal-welfare advocate with demonstrated welfare commitment and experience, not presently engaged in institutional animal research.

D — Independent layperson without professional involvement in animal research/teaching, and meeting none of the other categories.

At least one of each category is required; the range of perspectives supports balanced ethical review.

DIAGRAM ON SLIDE 45

What main ethical and practical challenges remain in animal research?

- Animal welfare cost is relatively certain while benefit is uncertain.

- Animals may react unpredictably and experience adverse events not anticipated in the protocol.

- Many biomedical-study animals are euthanased at study end (not every study, e.g. observational wildlife research).

- Public openness/transparency about species, numbers and purposes of use.

- Sensitive language, including saying "work with" rather than "use" animals.

Unexpected harms can alter cost-benefit judgements and require AEC review.

DIAGRAM ON SLIDE 46

What institutional transparency agreements were listed in the lecture?

Countries, year and signing institutions on the slide:

- UK 2014: 127.

- Spain 2016: 147.

- Portugal 2018: 18.

- Belgium 2019: 19.

- France 2021: 30.

- Germany 2021: 54.

- New Zealand 2021: 21.

Total shown: 416.

Lecturer explanation:

Public reporting of which species are used, how many, and for what reasons may build trust and address misconceptions about secrecy.

DIAGRAM ON SLIDE 47

What central ethical question does the lecture's closing balance-scale image ask?

Does the anticipated societal/scientific benefit justify the real welfare cost to animals?

The benefit is not guaranteed, so assessment requires scientific rigour, 3Rs, welfare monitoring, transparent oversight and ongoing reassessment.

DIAGRAM ON SLIDE 48

What uncertainty did the lecturer discuss about pain perception in fish and invertebrates?

Lecturer explanation:

Evidence of fish neurophysiological capacity for pain/suffering has become much stronger, although assessment and management continue to develop.

Cephalopods have neural pathways supporting potential pain perception and are covered by the Code.

The capacity of other invertebrates to experience pain was described as uncertain; lack of complete evidence should not be treated as proof that they cannot suffer.

The lecturer did not claim the question had been definitively resolved.