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A plain English summary of the National Statement

A quick way to understand and refer to the key document in ethical research and evaluation

Introduction

The National Statement on Ethical Conduct in Human Research 2025 is the most important document about ethics for researchers and evaluators in Australia. But it's a big document. It's not easy to understand if you aren't someone who works with ethics a lot of the time. But it's important to understand it if you want to do good research and evaluation.

So we thought we'd make a summary that is easier to understand. This guide gives you a plain English look at each of the sections of the National Statement, what's in them, and why it's important for evaluation and research. It's a starting point for you to read the full document in more detail. If there's enough interest, we may translate the full document into plain English, as well as create Easy Read or Easy English versions. Let us know if you would like to see this.

Summary of the National Statement

  • The document is called the National Statement on Ethical Conduct in Human Research (2025). It is called the National Statement for short. It was written by the National Health and Medical Research Council, who are part of the Australian Government. It explains how to plan, review and run research and evaluations that involve people, their data or their body parts ("biospecimens"). 
  • It has four main values (which are called "principles") that researchers must follow: 
    • respect for people; 
    • research merit & integrity (doing research for the right reasons, in the right way); 
    • justice (being fair); and, 
    • beneficence (which means to do good and avoid harm).  
  • The National Statement explains how to think about risk and benefit, and how to get people’s consent to take part. It explains when consent can be limited, and when consent may be waived.
  • It gives detailed rules for research and evaluation design, and how to manage data that people give. It also gives rules for working with groups such as: 
    • children; 
    • pregnant people; 
    • people with disability;
    • Aboriginal and Torres Strait Islander communities; 
    • people in natural disasters; and, 
    • doing research and evaluation with people overseas.
  • It explains how organisations and ethics committees must review and monitor research and manage conflicts, complaints and accountability.

The rest of this document looks at each of the sections of the National Statement, and why they are important to evaluators and researchers.

Preamble (the first part)

  • This part explains:
    • why ethics for human research matter; 
    • the history of ethical research including harms done in the past and the special harms to Aboriginal and Torres Strait Islander people; and, 
    • why public trust and responsibility are important.
  • For policy and program evaluators it is a strong reminder to consider historical harms and community trust when evaluating sensitive programs.
  • For social & market researchers it emphasises the importance of avoiding community harm and building trust by designing recruitment and communication to avoid repeat harms.

Purpose, scope and limits

  • This part: 
    • defines what is “human research” (people, their data or biospecimens); 
    • who must use the National Statement; 
    • when ethics review is needed; and, 
    • the relation of ethics to laws like privacy laws

Section 1: Values and principles of ethical conduct

  • This part sets the core ethics values (research merit & integrity; justice; beneficence; respect) and explains how to apply them when designing and reviewing research. 
  • Evaluators and researchers must use these values to justify methods, choose who to research with fairly, protect participants, and ensure results are credible (make sense and are believable).

Section 2: Themes in research ethics: risk and benefit, consent

Chapter 2.1: Risk and benefit 

  • This part defines risk as the likelihood and the severity of harm. 
  • It lists out types of harm that might happen to someone involved in research:
    • physical 
    • psychological 
    • social 
    • economic 
    • legal 
    • cultural (with a person's community)
  • It talks about the difference between discomfort, burden and harm. 
  • This part provides guidance on how to assess and manage risks and to think about if the benefits are bigger than the risks.
  • It also talks about the different types of review that might be needed:
    • Some research and evaluation needs to be reviewed by a Human Research Ethics Committee (HREC).  This is a group of people who know about risk and harm and work with researchers and evaluators to make sure that their work is safe as possible.
    • Some research and evaluation that has no risk of harm but might cause discomfort can be looked at by a smaller group or a single reviewer. These are called Lower Risk Reviews.
    • Some projects have almost no risk of harm, but sometimes need a letter to say that someone who is not the researcher/evaluator has looked at it and agreed. This is called a "Statement of Exemption".

Chapter 2.2: General requirements for consent

  • Consent is when someone gives permission for another person to do something. Here it means giving permission to be part of research or evaluation.
  • Consent must be voluntary, informed and understandable. 
  • The section lists information that should be given to participants. The information should have: 
    • the purpose of the research/evaluation; 
    • risks that might happen if a person chooses to take part;
    • how a person can withdraw consent (decide not to take part anymore);
    • how a person's data will be handled;
    • any conflicts that the researcher/evaluator might have that could make the research/evaluation be less believable;
    • any payments that might be made to the person; and, 
    • what will happen because of participating, including any reports that will be made.
  • It also discusses paying people to take part in research, when a person is allowed to give consent for another person, and consent for future use of a person's data/tissue. 

Chapter 2.3: Qualifying or waiving conditions for consent

  • Sometimes it is not possible to get people to give their consent, or a researcher/evaluator may not be able to give you all the information when they ask someone to take part. 
  • This part explains when they are allowed to do this.
  • It sets strict conditions for how these kinds of projects can be approved, and what laws have to be looked at, like privacy laws.
  • Usually this means that an HREC needs to look at the project first to make sure that it is safe.

Section 3: Ethical considerations in design, development, review and conduct of research

Chapter 3.1: The seven elements of research 

  • There are seven elements that need to be looked at to make sure research and evaluation projects are ethical: 
    • the aims & methods (why is the research/evaluation happening); 
    • how recruitment takes place; 
    • how people consent to take part; 
    • data collection/use/management; 
    • communicating findings to participants; 
    • how information on the research/evaluation results will be published; and,
    • what happens after the project (such as retention and disposal of data). 
  • This chapter talks about important issues with working with people's information, including data identifiability, data management plans, secondary use, and returning results when relevant.

Chapter 3.2: Human biospecimens in laboratory based research 

  • This part lists out rules for collecting, storing and using human biospecimens (like blood, tissue, and cell lines). 
  • It has special information about getting consent for "prospective" collection (this is where you collect information/specimens before you know what research you want to do with it), issues for stored/clinical samples, import/export of information and specimens, use of fetal tissue, and disclosure of clinically important findings. 
  • This part is less important for social research, market research, and evaluation, but because the National Statement is for many different types of research, it's included.

Chapter 3.3: Genomic research 

  • Genomic data are data about your DNA or your genes.
  • These types of data are: 
    • familial (they tell people about your family history); 
    • predictive (they can tell you about what diseases or conditions you might have in the future); and, 
    • potentially sensitive (it may have information that you may not know about but could be important, like if you have a disease).
  • This part provides guidance on consent, recruitment of relatives, data identifiability, return of findings, validation of results and genetic counselling. 
  • It sets out decision steps for whether to return genomic findings. 
  • Like the last part, this is less important for social research, market research, and evaluation, but it is still important to have in the National Statement. 

Chapter 3.4: Animal-to-human xenotransplantation

  • This part covers ethical review and consent for research transferring animal material to humans, which sometimes happens in medicine. 
  • It looks at things like infection risk ("xenozoonosis"), long-term monitoring, limits to withdrawal of consent, and community/public safety. 
  • This type of work always needs an HREC review.
  • Because this is mainly about biomedical research, it's not so important for program evaluation or market research except where public health or biosafety policy assessment is involved.

Section 4: Ethical considerations specific to participants in research

This section talks about things that are important when working with people with different backgrounds and in different places. Sometimes a person's background or where the research or evaluation is happening can make it more of a risk that someone is harmed. This section looks at how researchers and evaluators can manage this safely.

Chapter 4.1: Recruitment and involvement of participants who may experience increased risk

  • This chapter explains how a person's life stage (young or old), disability, social disadvantage, dependent relationships, or justice-involved status (such as being in jail) may increase risk. 
  • It recommends to include people as much as possible rather than exclude them, but gives advice on what to do, like:
    • including people where it is right to do so;
    • talking with communities to understand how to do evaluation/research well in that community; 
    • changing recruitment and consent processes; and, 
    • making sure people have protections such as advocates and support services so that they are safe.

Chapter 4.2: Pregnancy, the human fetus and human fetal tissue

  • This chapter explains the special rules that apply when participants are pregnant or when research involves fetal tissue (unborn babies). 
  • It recommends:
    • having different people doing care work and research work; 
    • getting consent at the right time (for example, do not approach a person when they are deciding to end a pregnancy); and, 
    • making sure that the pregnant person and their fetus are protected. 
  • This can be important in policy evaluations that relate to maternal health. 
  • Researchers and evaluators should avoid exposing pregnant participants to physical risk.

Chapter 4.3: Children and young people

  • Consent is when a person agrees to do something. 
  • Different children and young people have different abilities to consent to being involved in research and evaluation. 
  • This chapter provides guidance on how to ensure that children and young people can be part of research and evaluation and be safe.
  • It recommends: 
    • Researchers and evaluators should assess a child or young person's ability to give consent on a case-by-case basis.
    • Parental/guardian consent is usually required unless there is a good reason why not, and if this is the case, an HREC has to approve it. 
  • The chapter also provides guidance on child safety and mandatory reporting. 

Chapter 4.4: People in dependent or unequal relationships

  • This chapter covers research with people who are in relationships where one person (usually the researcher or evaluator) has more power than the other, which is called a "power imbalance". 
  • People who might have less power could be students, patients, employees, or prisoners. 
  • They may feel forced to take part because of having less power than the other person (we call this "coercion"). 
  • They might think that if they don't take part, it will lead to something bad happening to them.
  • The chapter provides steps to reduce coercion: 
    • Making sure that consent processes are done independently of the person with power. 
    • Having safeguards against coercion.
    • Making sure that researchers and evaluators are clear about any interests (such as jobs or relationships) that might lead to a power imbalance.     
  • Evaluators and researchers working inside service settings (hospitals, schools, workplaces) must ensure independent recruitment to avoid coercion. They must avoid recruiting via managers or authority figures without safeguards against coercion.

Chapter 4.5: People experiencing physical or mental ill‑health or disability 

  • This chapter has guidance on: 
    • assessing whether someone is able to take part in research; 
    • research in emergency or intensive care (at hospitals); 
    • research with terminally ill people; and 
    • how to include people with disabilities. 
  • Deferred consent (where a person might provide consent after you have done the research) is not allowed except in very specific emergency procedures, and there have to be a lot of safeguards to protect that person.
  • Evaluations and research in health and disability need: 
    • tailored consent procedures; 
    • accessible ways to collect information; 
    • advance planning; and, 
    • built-in safeguards. 

Chapter 4.6: Research conducted in other countries

  • Australian researchers working overseas must follow the National Statement and local expectations. 
  • They need: 
    • local engagement; 
    • awareness of local laws; and, 
    • they have to work with local ethics processes. 
  • Researchers and evaluators that do work in other countries must combine Australian ethical standards with local standards, and get local approvals. They should also make sure that their way of collecting research is safe and right for that local culture.

Chapter 4.7: Research with Aboriginal and Torres Strait Islander people and communities 

  • This chapter is very important for evaluators and researchers doing work with Aboriginal and Torres Strait Islander people communities.
  • There are special guidelines that need to be followed, including guidelines from the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS).
  • Ethics committees need to have certain skills to review research with Aboriginal and Torres Strait Islander people and communities.
  • Ethical research and evaluation should involve: 
    • meaningful consultation with communities including agreements from communities; 
    • working with communities to design the activities (co-design); 
    • making sure that researchers/evaluators have the cultural capability to do the work;
    • making sure that communities benefit from the activities; and, 
    • community agreements. 
  • This is essential for any evaluation, social or market research with Aboriginal and Torres Strait Islander communities, and requires partnership, benefit-sharing and local approvals. research

Chapter 4.8: Research during natural disasters, public health emergencies or crises

  • Research in crises must be timely and sensitive. 
  • Rapid ethical review processes are encouraged but not at the cost of participant safety. 
  • Researchers and evaluators should: 
    • coordinate with responders (like emergency services and aid organisations); and, 
    • ensure participant support is available especially if they have been directly impacted by a disaster or crisis.
  • Ethics review committees should have a process to get rapid ethics oversight. 
  • Evaluators and researchers working in crises must plan for fast but ethical review and community engagement and avoid exploitation of participants.  

Chapter 4.9: Research that may discover illegal activity

  • This chapter looks at projects where there is a risk that as part of the project, it might discover illegal activities that have happened, or discover that illegal activities might take place. An example of this is where someone is interviewed and they admit to committing a crime.
  • If a research or evaluation project may find illegal behaviour, researchers and evaluators must: 
    • warn participants where possible that this might happen; 
    • consider confidentiality and legal disclosure obligations (and tell participants about these obligations); and, 
    • get HREC approval when the study aims to expose illegal activity or is likely to discover it (unless the study uses collections of data where it is not possible to identify people). 
  • Researchers and evaluators studying unlawful behaviours (e.g. drug markets) must plan for and understand legal reporting obligations and be clear to participants about limits to confidentiality.  

Section 5: Research governance and ethics review

This section is about how ethics review should take place, the different requirements needed to do certain types of ethical review, and the complaints process for ethical reviews.

Chapter 5.1: Governance responsibilities of institutions

  • Organisations ("institutions") must have policies and governance for ethics review. 
  • Organisations can have their own ethical review processes, or use another organisation's review process. Iris Ethics is an example of an organisation that other organisations can go to if they do not have their own process.
  • The section sets out that research or evaluation that is more than "lower risk" must be reviewed by an HREC.
  • Lower risk research or evaluation can be reviewed using other processes, and this chapter provides information on what needs to be part of those processes.
  • The chapter also talks about the kinds of research and evaluations that don't need ethical review and can receive a "grant of exemption".
  • Organisations that do ethics reviews need to make sure that:

Chapter 5.2: Responsibilities of HRECs and other ethics review bodies 

  • This chapter talks about how HRECs should operate: 
    • procedures; 
    • how meetings are run; 
    • how decisions are made; 
    • how records of decisions are kept; 
    • the duties of members; 
    • confidentiality of information; and, 
    • how they interact with applicants. 

Chapter 5.3: Responsibilities of researchers and evaluators

  • Researchers and evaluators must design ethically sound proposals that follow the principles of the National Statement. 
  • They must also follow standards for their industry, disclose sources of funding and conflicts of interest, and submit appropriate documentation.
  • Researchers and evaluators should present information about their work to participants in ways that help them make informed decisions about whether they take part, and support them. This includes:
    • putting information in a form that is appropriate and if needed, in the right language; and,
    • thinking about how a person's culture, language, education, age, and ability may change how they can take part.

Chapter 5.4: Monitoring

  • Organisations must monitor their research and evaluation projects. 
  • This chapter talks about how organisations can do this, and what is the best approach for different types of projects.
  • Higher risk projects require more monitoring.
  • The chapter also talks about when a project may need to be stopped, or where ethical approval needs to be taken away.
  • This might happen because of something discovered in the project, or because the project is doing something different to what was planned.
  • Organisations and HRECs have to have processes for stopping projects and ethical approval, and they also need processes for starting projects again once changes have been made to make sure that everyone is protected.
  • The chapter finishes by talking about what happens if an organisation or an HREC closes down.

Chapter 5.5: Minimising duplication of ethics review

  • This chapter has guidance to avoid multiple ethical reviews, which may happen if: 
    • a project is happening at multiple places ("multi-site"); 
    • a project has parts that need a special ethics review panel; or,
    • a project is being done by two or more organisations ("cross-institution").
  • Multiple ethical reviews take extra time and money, and this may mean that research or evaluation projects do not get done well or at all.
  • However, there are times when more than one ethical review is needed.
  • Where possible, organisations should try not to have multiple reviews, and be clear about when a review by another organisation can be used instead of doing it themselves.
  • Researchers and evaluators should try and plan their projects to account for possibly needing multiple reviews.

Chapter 5.6: Disclosure of interests and management of conflicts of interest

  • Organisations, HRECs and project teams must disclose and manage conflicts of interest (both financial and non‑financial).  
  • The chapter provides advice on how to manage these conflicts, like:
    • Telling participants about the conflict;
    • Putting details about the conflict in any reports;
    • Having project members with conflicts be removed from important decisions;
    • Having an independent team to oversee the project; and,
    • Removing the conflict of interest.
  • Sometimes the conflict of interest is so large that the project cannot be conducted.

Chapter 5.7: Complaints

  • Institutions must have clear, public complaint procedures about research or review bodies and must handle complaints promptly and sensitively. 
  • Iris Ethics has a complaints process here.

Summary 

This resource provides a quick overview of the National Statement in plain English. It doesn't have all the detail, so you should always refer to the National Statement when making decisions or get advice from people who understand the National Statement.