What the National Statement is
The National Statement is written jointly by three bodies: the National Health and Medical Research Council (NHMRC), Universities Australia and the Australian Research Council. It is written for researchers, ethics review bodies, people involved in research governance, and potential participants. Following it is a condition of receiving NHMRC funding.
The 2023 edition applied from 1 January 2024 to 22 June 2026. From 23 June 2026, institutions must follow the 2025 edition. If a consent form or a guide you are reading cites the 2023 edition, check it against the current one.
The Statement reads “human research” broadly. It includes taking part in surveys, interviews or focus groups, undergoing psychological or physiological testing, and being observed by researchers. Measuring how people respond to products and advertisements can fall within those words. Whether the Statement governs a particular project depends on who runs it and under which institution, which this page cannot settle. The NHMRC says it is reviewing selected provisions of the Statement on the definition of human research and on exempting research from ethics review, with a public consultation to come.
Risk decides who reviews
The Statement calls research low risk when the only foreseeable risk is no greater than discomfort. Research with a greater risk than that must be reviewed by a Human Research Ethics Committee (HREC); lower-risk research may go through other review processes the Statement describes.
Before, during and after
Enough information, in a usable form
People need an adequate understanding of the research’s purpose, methods, demands, risks and potential benefits, presented in a way that suits them, with the chance to ask questions and talk it over with others.
The Statement lists other matters to tell them as well. A selection: any alternatives to taking part; who to contact with a complaint; how privacy will be protected; the right to withdraw and whether data can be withdrawn; how much funding the research has and where it comes from; researchers’ and sponsors’ declarations of interests; any payments; and how results may be published.
Consent can be given verbally, in writing or by other means, such as returning a survey, depending on the research and the person.
No pressure, and no inducement to take risks
No one should be coerced or pressured into taking part. The Statement notes that even without open pressure, consent might reflect deference to a researcher’s perceived power.
Reimbursing costs such as travel and parking is generally appropriate, and people are sometimes paid for their time. Payment out of proportion to the time involved, or any inducement likely to encourage people to take risks, is ethically unacceptable.
People who decline need not give a reason, and researchers should do what they can to see they suffer no disadvantage.
Free to stop
Participants are entitled to withdraw at any stage, and should be told beforehand what withdrawing would mean. In complex or long-running projects, consent may need to be confirmed again, and people should be told if the terms they agreed to change.
An explanation, where something was held back
Where people were not told everything, the Statement expects that, whenever possible and appropriate, they are later told the real aims and why the omission was needed, and offered the chance to withdraw their data.
When the aim cannot be disclosed
Research on behaviour sometimes cannot work if people know exactly what is being studied. The Statement calls this limited disclosure, and describes it as a spectrum.
- LeastObserving everyday behaviour in public spaces
- FurtherCovert observation, such as of hospital staff washing their hands
- FurtherA researcher role-playing without saying so, to see how people respond
- MostTelling people the research is about one thing when it is about something quite different
For limited disclosure without active concealment or planned deception, an ethics review body may approve the research if the researchers show, in summary:
- there is no suitable way to reach the aims with fuller disclosure;
- the benefits justify the limited disclosure and any risk to the community’s trust in research;
- the research is no more than low risk, and the limited disclosure is unlikely to harm participants;
- exactly how much is withheld is defined; and
- people will be debriefed and offered the chance to withdraw their data, whenever possible and appropriate.
Where research involves active concealment or explicit deception, and does not aim to expose illegal activity, researchers should also show that participants face no increased risk of harm because of it, that a full explanation will be made available afterwards, and that there is no known or likely reason to think people would have refused had they known. Only an HREC can approve research involving active concealment or planned deception.
Opt-out, and where privacy law comes in
In an opt-out approach, people are told about the research and are included unless they act to decline. The Statement warns that this is unlikely to count as consent under Commonwealth privacy law when the information is sensitive, including health information. The privacy side is covered in biometric data and privacy.
When a scan finds something
Brain scans can turn up the unexpected. Ariely and Berns noted in 2010 that about 1% of people have an abnormality on an MRI scan, and that a written policy for handling such findings was standard practice.
The National Statement asks researchers whose work may yield findings significant to individuals to say in their consent strategy whether participants will receive them, or will be able to choose. Where information could matter to someone’s health, it expects an ethically defensible plan for disclosing or withholding it.
For how these rules sit beside the science, see what neuromarketing is.