Investigate how research ethics and the role of regulatory bodies, including the NHMRC, shape what scientific research can be conducted

What this dot point is asking

NESA wants you to explain the ethical frameworks governing Australian research, identify the role of the NHMRC and ethics committees, and apply ethical reasoning to specific research scenarios. This dot point appears in 4-6 mark questions in most papers.

The answer

Australian scientific research is governed by overlapping ethical codes administered through the National Health and Medical Research Council (NHMRC) and other agencies. These rules determine which research can be conducted, how subjects must be treated, and what safeguards must be in place.

The historical roots

Modern research ethics emerged from a series of documented abuses.

Nuremberg Code (1947)

Following the Nazi medical experiments uncovered at the Nuremberg trials, this established the principle of voluntary informed consent.

Declaration of Helsinki (1964 onwards)

The World Medical Association extended the Nuremberg principles to all medical research, distinguishing therapeutic from non-therapeutic research.

Tuskegee Syphilis Study (1932 to 1972)

US Public Health Service withheld treatment from 600 African-American men with syphilis for 40 years. Exposed in 1972, this led to the 1979 Belmont Report and the modern US system of Institutional Review Boards.

Australian context

Australia introduced national ethical codes from the 1980s, consolidated in the National Statement of 1999.

The four main Australian codes

1. The National Statement on Ethical Conduct in Human Research (2007, updated 2018, 2023).

Joint statement of NHMRC, the Australian Research Council and Universities Australia. Governs all research involving human participants. Core principles:

• Research merit and integrity. Research must address a meaningful question with sound methodology.
• Justice. Burdens and benefits of research distributed fairly.
• Beneficence. Maximise benefit, minimise harm.
• Respect. Recognise the value and dignity of participants, including their autonomy to consent or refuse.

Specific provisions cover:

• Informed consent. Written, voluntary, fully informed, revocable.
• Privacy and confidentiality. Compliance with the Privacy Act 1988.
• Children. Both parental consent and child assent required.
• Aboriginal and Torres Strait Islander research. Additional cultural protocols.
• Pregnant women, prisoners, the mentally ill. Additional safeguards.

2. The Australian Code for the Care and Use of Animals for Scientific Purposes (2013, updated 2024).

Issued by NHMRC. Mandates the 3Rs principle:

• Replace. Use non-animal alternatives where possible (cell cultures, computer models).
• Reduce. Use the minimum number of animals required for valid science.
• Refine. Minimise pain, suffering and distress.

All institutions conducting animal research must operate an Animal Ethics Committee (AEC) with diverse membership (scientists, animal welfare representatives, lay members).

3. The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020).

Issued by the Australian Institute of Aboriginal and Torres Strait Islander Studies. Covers research touching on First Nations communities, knowledge or sites.

Principles:

• Indigenous self-determination. Communities decide which research proceeds.
• Cultural capability. Researchers demonstrate competence.
• Benefit-sharing. Communities receive tangible benefit from the research.
• Working with knowledge. Respect for traditional knowledge protocols.

4. The Australian Code for the Responsible Conduct of Research (2018).

Sets research integrity standards:

• Authorship and attribution.
• Data management and retention.
• Conflicts of interest declaration.
• Mentoring and supervision.
• Reporting research misconduct.

Ethics committees

The codes are implemented locally through committees.

Human Research Ethics Committees (HRECs)

Approximately 180 HRECs operate across Australia, accredited by NHMRC. Every research project involving humans must obtain HREC approval before any data collection begins.

Animal Ethics Committees (AECs)

Required at every institution using animals. Independent review of every proposed animal study.

Composition

Committees include scientists, ethicists, lay members, religious or cultural representatives and lawyers. Diversity is mandated to bring multiple perspectives.

The NHMRC's specific role

• Sets the rules. Develops the codes through expert panels and public consultation.
• Funds research. Largest single source of Australian biomedical research funding (over 1 billion AUD annually). Funded research must comply with the codes.
• Accredits and reviews HRECs.
• Audits. Periodic reviews of institutional compliance.
• Investigates misconduct. Through the Australian Research Integrity Committee (ARIC), which can recommend funding withdrawal.

Emerging issues

Some areas have outpaced existing guidance:

• Embryo gene editing. Heritable genome editing of human embryos is prohibited in Australia under the Prohibition of Human Cloning for Reproduction Act 2002.
• Artificial intelligence ethics. Research using AI in clinical decision making, predictive policing or surveillance. NHMRC is developing specific guidance.
• Synthetic biology. Engineered organisms and biosecurity concerns.
• Brain-computer interfaces. Implants like Neuralink raise novel consent and identity questions.

Australian examples of ethics in practice

The CRISPR moratorium

Following Chinese scientist He Jiankui's 2018 announcement of CRISPR-edited human embryos that led to live births, the international scientific community called for a moratorium. Australia's existing law was already restrictive; the NHMRC published clarifying guidance in 2020.

Indigenous genomic data

The National Centre for Indigenous Genomics, established at the Australian National University, holds genomic data with strict community consent and benefit-sharing arrangements, modelled on AIATSIS protocols.

COVID-19 research acceleration

During the pandemic, ethics review timelines were compressed (some reviews completed in days rather than months) while maintaining substantive standards. The experience showed that timely review is possible without weakening principles.

Limitations

The Australian system is one of the strongest globally but has limitations:

• Workload. HREC review can delay urgent research; some applications take 3 to 6 months.
• Self-regulation. Enforcement depends on institutions reporting their own misconduct.
• International collaboration. Multi-national studies face overlapping requirements.
• Emerging technologies. Codes lag behind technological change.

Examples in context

Example 1. Casgevy gene therapy ethics approval in Australia. The CRISPR-based gene therapy Casgevy (exa-cel), approved by the TGA in 2024 for sickle-cell disease and beta-thalassaemia, required staged ethical review: NHMRC ethics approval for early-phase trials at the Royal Children's Hospital Melbourne, HREC review at each participating hospital, parallel paediatric-specific safeguards (longer-term follow-up requirements, child-assent procedures), and a special review of germline-vs-somatic implications. The therapy edits somatic cells only and is not heritable, which simplified the ethical review compared to germline editing (which remains prohibited in Australia). The case shows how the layered NHMRC framework adapts to novel technology: existing principles (informed consent, harm minimisation, justice) apply, while novel issues (long-term gene-edit safety) trigger additional case-specific safeguards.

Example 2. Animal ethics committee oversight of CSIRO research. CSIRO operates multiple Animal Ethics Committees (one for each major research site) that approve every animal-use protocol, from sheep studies at FD McMaster Laboratory to insect studies at Black Mountain. Approval requires demonstration of the 3Rs: replacement (with in vitro or computational alternatives), reduction (sample size justified by power analysis), refinement (minimising distress and pain). Annual audits by the NHMRC verify compliance. A 2022 review of CSIRO sheep parasite studies illustrated the practical application: researchers used computer modelling first, then a reduced number of animals only for endpoints that could not be measured otherwise, and refined surgical procedures to reduce post-operative pain. The case shows the 3Rs as live institutional practice rather than abstract principles.

Try this

Q1. Outline the 3Rs of animal research ethics and give one practical example of each. [3 marks]

• Cue. Replace (use cell culture instead of mice); reduce (power analysis to minimise sample size); refine (humane endpoints, analgesia, environmental enrichment).

Q2. A university researcher proposes interviewing high-school students about cyberbullying. State three NHMRC requirements before the project can begin. [3 marks]

• Cue. HREC approval; written informed consent (parental for under-18); de-identified data storage; right to withdraw; safe-space disclosure protocol.

Q3. A clinical trial of a new diabetes drug recruits Aboriginal participants in the Northern Territory. (a) Identify one NHMRC code that applies. (b) Identify one AIATSIS-specific requirement. (c) Identify one practical safeguard. [2+2+2 marks]

• Cue. (a) National Statement on Ethical Conduct in Human Research. (b) Free prior and informed consent; community consultation; benefit-sharing of trial outcomes. (c) Indigenous-led research governance; trial design with community input; outcome reporting back to community.