The revised National Statement on Ethical Conduct in Human Research 2025 (National Statement) was published on 6 March 2025. The 2025 National Statement will take effect, and replace the 2023 National Statement, from 1 October 2025. Read more about the intended use of the National Statement.
Rare Voices Australia (RVA) would like to congratulate the National Health and Medical Research Council on their work to revise and strengthen the National Statement based on stakeholder feedback, including from RVA as the national peak body for Australians living with a rare disease.
Rare Voices Australia’s Input
In 2024, RVA provided a submission to the review of Section 4 of the National Statement that aligns with the Australian Government’s National Strategic Action Plan for Rare Diseases. We are pleased to see much of that feedback reflected in the changes. RVA welcomes the acknowledgement, in Section 2, that ‘those reviewing research should take into account any willingness by participant populations to assume greater risks or burdens because of their perception of the potential benefits to them, their families, or groups or communities to which they belong’. Given the inherent limitations in rare disease data and treatments, this is an important consideration for rare disease researchers.
RVA also welcomes the changes to Section 4, which was the focus of RVA’s submission. The changes include new and revised sections relevant to many Australians living with a rare disease highlighting recommendations for involving people experiencing physical or mental ill-health or disability, and for research conducted in other countries. Other important changes include explicit acknowledgement in the National Statement of:
- the complex, multifaceted and often changing circumstances impacting an individual’s risk of harm from participation in research and the need to consider modifications to the design of the research project to mitigate such risks and maximise inclusion; and
- the need to consult with relevant individuals, organisations and other relevant stakeholders to better understand participants’ risks
RVA encourages all Australian rare disease researchers, and any stakeholders involved in rare disease research, to familiarise themselves with the revised National Statement.
Why Is the National Statement on Ethical Conduct in Human Research 2025 Important?
The National Statement is intended for use by:
- any researcher conducting research with human participants
- any member of an ethics review body reviewing that research
- those involved in research governance
- potential research participants
