Australia NHMRC National Statement on Ethical Conduct in Human Research
The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007, updated 2018) sets out the ethical framework for research involving humans. It covers consent, privacy, data management, governance, and the role of Human Research Ethics Committees (HRECs). Compliance is mandatory for NHMRC-funded research and widely adopted across Australian research institutions. Key principles: research merit, justice, beneficence, and respect for persons. Specifically addresses data governance, biobanks, genetic research, and Aboriginal and Torres Strait Islander research.
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Framework Domains (5)
Considerations Specific to Participants
Section 4: ethical considerations for specific participant groups.
| Code | Title |
|---|---|
| NHMRC-NS-4.1 | Women who are pregnant and the human fetus |
| NHMRC-NS-4.2 | Children and young people |
| NHMRC-NS-4.3 | People in dependent or unequal relationships |
| NHMRC-NS-4.4 | People highly dependent on medical care who may be unable to give consent |
| NHMRC-NS-4.5 | People with cognitive impairment, an intellectual disability, or a mental illness |
| NHMRC-NS-4.6 | People who may be involved in illegal activities |
| NHMRC-NS-4.7 | Aboriginal and Torres Strait Islander Peoples |
| NHMRC-NS-4.8 | People in other countries |
Design, Development, Review and Conduct
Section 3: ethical considerations in research elements, biospecimens, genomics and xenotransplantation.
| Code | Title |
|---|---|
| NHMRC-NS-3.1 | The elements of research |
| NHMRC-NS-3.2 | Human biospecimens in laboratory based research |
| NHMRC-NS-3.3 | Genomic research |
| NHMRC-NS-3.4 | Animal-to-human xenotransplantation |
Research Governance and Ethics Review
Section 5: governance, HREC review, researcher responsibilities, monitoring and accountability.
| Code | Title |
|---|---|
| NHMRC-NS-5.1 | Governance responsibilities of institutions |
| NHMRC-NS-5.2 | Responsibilities of HRECs and other ethics review bodies |
| NHMRC-NS-5.3 | Responsibilities of researchers |
| NHMRC-NS-5.4 | Monitoring |
| NHMRC-NS-5.5 | Minimising duplication of ethics review |
| NHMRC-NS-5.6 | Disclosure of interests and management of conflicts of interest |
| NHMRC-NS-5.7 | Complaints |
| NHMRC-NS-5.8 | Accountability |
Risk, Benefit and Consent
Section 2: themes of risk and benefit, and consent.
| Code | Title |
|---|---|
| NHMRC-NS-2.1 | Risk and benefit |
| NHMRC-NS-2.2 | General requirements for consent |
| NHMRC-NS-2.3 | Qualifying or waiving conditions for consent |
Values and Principles
Section 1: the values and principles underpinning ethical human research.
| Code | Title |
|---|---|
| NHMRC-NS-1.1 | Research merit and integrity |
| NHMRC-NS-1.2 | Justice |
| NHMRC-NS-1.3 | Beneficence |
| NHMRC-NS-1.4 | Respect |
Your Compliance Coverage
If you comply with Australia NHMRC National Statement on Ethical Conduct in Human Research, you already cover:
ICH E6(R3) - Good Clinical Practice
52%
14 controls mapped
Compare →ISO 13485:2016
7%
2 controls mapped
Compare →ISO 19011
4%
1 controls mapped
Compare →+ 11 more: ISO 13485 (4%), ISO 31000:2018 (4%)
See all 14 mapped frameworks ↓Maps to 14 other frameworks
Frequently Asked Questions
What is Australia NHMRC National Statement on Ethical Conduct in Human Research?
Australia NHMRC National Statement on Ethical Conduct in Human Research is a compliance framework from Australia (NHMRC) with 5 domains and 27 controls. The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007, updated 2018) sets out the ethical framework for research involving humans. It covers consent, privacy, data management, governance, and the role of Human Research Ethics Committees (HRECs). Compliance is mandatory for NHMRC-funded research and widely adopted across Australian research institutions. Key principles: research merit, justice, beneficence, and respect for persons. Specifically addresses data governance, biobanks, genetic research, and Aboriginal and Torres Strait Islander research. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does Australia NHMRC National Statement on Ethical Conduct in Human Research have?
Australia NHMRC National Statement on Ethical Conduct in Human Research has 27 controls organised across 5 domains. The largest domains are Considerations Specific to Participants (8 controls), Research Governance and Ethics Review (8 controls), Design, Development, Review and Conduct (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does Australia NHMRC National Statement on Ethical Conduct in Human Research map to?
Australia NHMRC National Statement on Ethical Conduct in Human Research maps to 14 other compliance frameworks. The top mapping partners are ICH E6(R3) - Good Clinical Practice (52% coverage), ISO 13485:2016 (7% coverage), ISO 19011 (4% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with Australia NHMRC National Statement on Ethical Conduct in Human Research compliance?
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