← Module 8: Science and Society

NSWInvestigating ScienceSyllabus dot point

Inquiry Question 2: Are there limits or boundaries to scientific research, and how are these determined?

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

A focused answer to the HSC Investigating Science Module 8 dot point on research ethics. Covers the NHMRC National Statement, human research ethics committees, the 3Rs animal code, the Australian Code for Responsible Research, and worked HSC past exam questions.

Generated by Claude OpusReviewed by Better Tuition Academy5 min answer

Have a quick question? Jump to the Q&A page

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.

Past exam questions, worked

Real questions from past NESA papers on this dot point, with our answer explainer.

2023 HSC6 marksOutline the main ethical considerations that govern Australian scientific research, and evaluate the role of the NHMRC in enforcing them.
Show worked answer →

A 6-mark answer needs the main ethical frameworks, the NHMRC role and a clear judgement.

Australian ethical frameworks.

  1. The National Statement on Ethical Conduct in Human Research (2007, updated 2018). Jointly issued by NHMRC, ARC and Universities Australia. Covers informed consent, privacy, justice, minimising harm and special protections for vulnerable groups.

  2. The Australian Code for the Care and Use of Animals for Scientific Purposes (2013, updated 2024). Applies the 3Rs: replace, reduce, refine. Requires Animal Ethics Committee approval before any animal research.

  3. The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020). Requires community consent, benefit-sharing and respect for cultural protocols.

  4. The Australian Code for the Responsible Conduct of Research (2018). Sets standards for research integrity, including authorship, conflicts of interest and misconduct investigations.

NHMRC role.

  • Sets the framework. Develops and updates ethical codes through expert committees.
  • Funds research. Major federal funder of biomedical research; funding requires ethics compliance.
  • Accredits committees. Reviews and accredits Human Research Ethics Committees (HRECs) nationally.
  • Audits compliance. Periodic reviews of institutional adherence.
  • Investigates misconduct. Through the Australian Research Integrity Committee.

Evaluation. The NHMRC system is one of the strongest in the world, with multiple complementary codes covering most research scenarios. Limitations: enforcement relies on institutions self-reporting, ethics committee workloads can slow research, and emerging fields (AI ethics, gene editing in embryos) have outpaced specific guidance.

Markers reward multiple frameworks, the explicit NHMRC functions and a balanced judgement.

2021 HSC4 marksWhy are ethics committees required for research involving human or animal subjects?
Show worked answer →

A 4-mark answer needs the historical reason, the modern function and the consequence of absence.

Historical reason. Modern research ethics emerged after the Nuremberg trials (1947) documented Nazi medical experiments on prisoners. The Nuremberg Code established informed consent as fundamental. The 1932 to 1972 Tuskegee Syphilis Study in the United States revealed continued exploitation, leading to the 1979 Belmont Report and subsequent codifications. Australia's National Statement followed in 1999.

Modern function of ethics committees. Human Research Ethics Committees (HRECs) and Animal Ethics Committees (AECs) review every proposed research protocol involving humans or animals before research begins. They assess:

  • Informed consent processes.
  • Risk-benefit balance.
  • Methodology and statistical power (to ensure animal use is justified).
  • Vulnerable population protections.
  • Privacy and data protection.

Consequence of absence. Without prior independent review, researchers may proceed with protocols that exploit subjects, cause unnecessary harm or violate confidentiality. Subjects cannot reliably evaluate research risks on their own; the committee provides expert oversight.

In Australia. Universities, hospitals and research institutes all operate accredited HRECs and AECs. Federal funding (NHMRC, ARC) requires demonstrated ethics approval. Refusal to obtain approval can void publication and end careers.

Markers reward the historical context, the modern function and the protection role.

Related dot points