We've previously considered the principles of the National Statement and how each of these apply in the context of evaluation, social research, and market research. Our next deep-dive series looks at Section 4 of the National Statement, and in particular the 2025 edition. 

The 2025 update makes some significant changes to the way that researchers and evaluators should consider risks as it relates to stakeholders. The updated guidelines go into force across all HRECs from October 1st, but we're already applying them at Iris Ethics. That's why we want to have guidance for you on what this means for your practice.

Introduction

Section 4 of the National Statement is titled "Ethical considerations specific to participants in research"* and is designed to provide tailored guidance to researchers/evaluators, HRECs, organisations, and communities on how to approach ethical practice when working with particular groups or in certain scenarios where there are specific risks that can arise. 

Under the 2023 edition of the National Statement, these groups comprised:

• Women who are pregnant and the human fetus**
• Children and young people
• People in dependent or unequal relationships
• People highly dependent on medical care who may be unable to give consent
• People with cognitive impairment, an intellectual disability, or a mental illness
• People who may be involved in illegal activities
• Aboriginal and Torres Strait Islander Peoples
• People in other countries 

For the 2025 edition, these groups were reframed, with people highly dependent on medical care and people with cognitive impairment, an intellectual disability, or a mental illness generally combined as: "People experiencing physical or mental ill-health or disability." In addition, a new group was added to cover people involved in "research conducted during natural disasters, public health emergencies or other crises." 

Future deep-dives in this series will look closer at each of these groups and how evaluators and researchers can apply the principles of the National Statement effectively. This deep-dive looks at the section as a whole as well as the preamble to the section, which sets out the rationale upon which the rest of the section should be interpreted.

What has changed?

As well as the new groupings, a new preamble was created, as well as a new chapter looking broadly at "ethical issues in recruitment and involvement of research participants who may experience increased risk." 

The updated preamble to Section 4 marks a significant departure from previous practice. To quote the preamble to Section 4 in the 2023 and 2018 National Statements:

Ethics review by an HREC is required for any research that involves greater than low risk. It is also required for research discussed in the following chapters of this section [the groups identified above].

Under the 2023 edition, any human research that engaged with these groups required review by an HREC using the full review process, regardless of whether the activities would otherwise be considered low risk.

This is no longer the case.

The 2025 edition has replaced this blanket rule with a more purposive approach that considers contextual factors. The new preamble acknowledges this from the outset:

Anyone can be at increased risk of harm as a result of their participation in research, in different ways, at different times and to different degrees. However, some potential participants may be at increased risk of harm because of specific characteristics or circumstances, the nature of particular research projects and/or how these interact.

The inclusion or exclusion of individuals in research who may experience increased risk of harm from participating in the research project raises ethical issues about self-determination and agency, fairness, and the equitable distribution of benefits, risks and burdens. Assessment of the possible risk of their participation in research involves comparison with some implicit norm about ‘usual’ levels of risk. While this norm is difficult to quantify, the inclusion of some potential participants in research requires additional consideration arising from:

(a)  the nature, design or other contextual factors of the research

(b)  sources of risk of harm specific to potential participants as individuals or by virtue of their group membership or other circumstances

(c)  interaction between (a) and (b).

The updated preamble and Section also eschews the labelling of groups as "vulnerable" and conceives of risk to members of these groups as being separate in nature. It also reinforces the general principle from Section 2 that risk is a continuum, rather than a binary "low/high" construct.

As a result, research and evaluation done with members of a particular group no longer automatically requires full HREC review. Instead, researchers and evaluators need to consider risks to all stakeholders, taking into account that the context for some stakeholders (including membership of certain groups) may modify these risks. The later chapters are now framed as a resource to support the characterisation and management of risks for specific groups and scenarios.

Chapter 4.1: Ethical issues in recruitment and involvement of research participants who may experience increased risk

This chapter has been added to the 2025 edition, and goes into greater detail on the topics covered in the preamble. In addition, it provides a useful resource for researchers and evaluators to incorporate as part of project planning, and guidelines on how to broadly ensure that individual and contextual risks are considered in delivering activities.

The introductory section explores five topics, which are summarised here.

Sources of increased risk

The starting topic explores how a combination of a person's characteristics and life circumstances may present sources of increased risk for that person, as well as impact on that person's autonomy. The characteristics relate to a person's life stage, physical state, and cognitive state. The examples include age or developmental capacity to make decisions, as well as disability-related impacts on a person's autonomy. 

A key way in which this departs from previous statements is the recognition that the impact on a person's autonomy may be perceived as well as real, something that takes into account the responsibility of the researcher/evaluator to ensure that there is not a gap between reality and perception when making decisions around participation and consent. Similarly, the updated guidance recognises that impairments in autonomy may be dynamic and change over time or in different environments. This view is consistent with the social model of disability and marks a departure from the medical model that has dominated research ethics in the 20th century.

The life circumstances that play a role in a person's capacity and autonomy are also important to take into account, including a person's social and economic circumstances, their relationships with other stakeholders, and where that person is engaged in research and evaluation (e.g. in a hospital or prison). Importantly, the section notes that these circumstances may relate to past or future experiences and that this also impacts on the risk profile.

Later chapters of Section 4 look at four of these characteristics and circumstances in more detail, and provide insights on how to design and deliver ethical practice with stakeholders in these groups.

The context of the research

The second topic covered is the context of the research/evaluation, both in literal terms (the places where research and evaluation are conducted) as well in figurative terms (the social, cultural, and political context in which research and evaluation take place). Again, these can modify the risks to participants, and later chapters focus on specific cases where this takes place and how to approach design and delivery.

Risk mitigation

We noted earlier that unlike previous editions, in the 2025 edition of the National Statement the presence of stakeholders in a particular group no longer mandates the automatic use of the full HREC review pathway. This section provides guidance to support the effective assessment and mitigation of risks so that members of these groups can participate in the research and evaluation process. There are some key points from this section worth noting:

• Risk mitigation strategies should be considered in the design of projects.
• Inclusion should be the default objective for both researchers/evaluators and HRECs when working with participants and groups at increased risk.
• Meaningful consultation and engagement with groups (either directly or through representative bodies) should be considered at the design stage as a way to ensure that risks are identified and managed, and that objectives align with the goals and wants of these groups. Importantly, the NHMRC has noted that such pre-engagement does not typically require ethical review.
• The expertise and experience of the research/evaluation team plays a vital role in managing risks, and this needs to be taken into account in ethical review processes.

Inclusiveness in research

Building on the previous topic, this topic reinforces the idea that inclusion should be the default for researchers/evaluators and HRECs, and recognises the role that co-design and co-production can play in delivering meaningful and ethical engagement. This departs from the traditional notion that HRECs are there solely to protect "vulnerable" groups from harm, but places a responsibility on researchers and reviewers to ensure that barriers to inclusion are removed and that benefits are distributed equitably. It also highlights the role of lived-experience advice in identifying and mitigating risks to participants.

Review pathways

The introductory section closes by reiterating that the inclusion of participants who may be at increased risk does not automatically mean that a full HREC review is appropriate. Instead, assessments of risk should be considered under the risk framework outlined in Chapter 2.1. In practical terms, even if there are particpants at increased risk, if that increased risk does not meet the threshold for full HREC review (namely a non-negligible risk of harm), then a lower risk pathway can be appropriate and proportionate.

How do I apply this in my project? 

Given the above considerations, the NHMRC developed a useful set of questions for researchers and evaluators to consider when designing their projects:

• To which individuals or groups might our research be relevant?
• Who do we plan to include in our research?
• Who else is likely to be included in the pool of potential participants for our research?
• Even if not likely, who else might foreseeably be included in the pool of potential participants for our research?
• Is there an increased risk of harm to potential participants in this project? If so, what is the nature and extent of that risk?
• What is the foreseeable impact of the potential research findings on relevant individuals, groups or communities?
• How can we design, or modify the design of, and conduct our research so as to minimise, mitigate and manage the increased risk to potential participants (with consideration for recruitment, consent, ongoing participation and the potential outcomes of the research)?
• If we cannot reduce these risks to an acceptable level, are we justified in excluding these individuals from our research?
• In addition to reducing the risk to these potential participants, how can we accommodate the needs and interests of these participants and empower them as they consider participating in and as they participate in our research?

While providing explicit answers to these questions is not a requirement in the ethics application process (and we don't want to make you fill out an extra form), researchers and evaluators should consider whether these questions are clearly answerable based on their application materials such as in their project plans and consent forms. 

Guidelines

Following the above questions is a set of formal guidelines for researchers/evaluators and reviewers to consider as part of their work. As for the above questions, addressing these should be something incorporated in the application.

What is our engagement strategy for key groups (s4.1.1)?

The first set of guidelines instructs researchers and evaluators on what they should do when planning to conduct activities with people who may be at increased risk because of their characteristics and context. That said, the advice is relevant to consider in the planning stage for all stakeholders, not least because there may be risks that are not understood until explicitly considered in the planning stage.

There are four key steps:

1. Developing processes for engaging lived-experience perspectives from relevant stakeholder groups.
2. Being inclusive in recruiting participants.
3. Providing adequate justification for exclusion of groups/individuals at increased risk, and considering the impact of this exclusion on the integrity of findings.
4. Where possible, engaging lived-experience advisors as a reference group and adopting genuine co-design and co-production.

Have we considered how risks of harm may vary by participant (s4.1.2)?

Building on the previous section, to ensure that risks are appropriately and ethically mitigated, researchers and evaluators should engage with participant groups during the design phase to understand:

• the characteristics and circumstances of participants;
• the nature of the proposed research/evaluation activities; and,
• how these may interact (i.e. whether the type of activity and its context influences risk to participants).

How are we handling situations where participants may have limited freedom (or they believe they have limited freedom) to make a decision on participation (s4.1.3)? 

While there are some situations where participants may not have the autonomy to decide on participation, autonomy should be presumed by default (in the disability policy space this is the principle of "presumption of competence"). Researchers and evaluators are also obligated where possible to support the individual in being able to provide free and informed decisions on participation. This includes strategies such as: 

• providing access to supports (or people who are authorised to consent on their behalf); 
• undertaking recruitment processes when the person is in the best position to make a free and informed decision (this is relevant for episodic and temporary impairment); and,
• where a person may be showing reluctance, discomfort, or distress, pausing the activity and identifying the source of this and managing this as reluctance, discomfort, or distress may not automatically mean a withdrawal of consent.

However, if unwillingness to participate is sustained and unequivocal, researchers and evaluators must respect this as a withdrawal of consent.

How are we managing risks around coercion (s4.1.4)?

Researchers and evaluators should be aware of the potential for actual or perceived coercion and situations where a person's freedom to consent is impaired. This is especially the case in projects in workplaces, commissioned evaluations by funding bodies, and where there are incentives to participation. It is not to say that such projects should not be conducted, but that there needs to be consideration of this in the design process, through:

• ensuring that decisions to participate are informed and voluntary (and if necessary, engaging a participant advocate to support this);
• documenting steps taken to minimise risks arising from stakeholder relationships; and,
• ensuring that the likely* benefits to participants and their communities justifies the risks of any harms or discomforts** and their impacts on participants and their communities.

How are we managing conflicts of interest (s4.1.5)?

While this is covered in other sections of the National Statement, the need to consider and manage conflicts of interest is reiterated here. This is because conflicts of interest, whether real or perceived, can influence the risks to participants, as well as play a role in coercion. Researchers and evaluators should have in place a conflict of interest management strategy so that risks are identified and managed appropriately.

Summary

Section 4 of the National Statement was the focus of the 2025 update, and while it appears at first glance to be similar to previous editions, it represents a fundamental shift in the conception of the participant. Rather than a one size fits all approach based on memberships of certain groups, researchers and evaluators are encouraged to think of risks as both individual and dynamic, and design their projects to reflect this. It also acknowledges the role that genuine collaboration with participants can have in designing and delivering ethical projects. 

What has not changed is the responsibility of the researcher and evaluator to think through how their activities may impact stakeholders, and ensure that there are appropriate mechanisms to ensure that positive impacts are magnified while minimising negative impacts.

*s4.1.4(c)(i) uses "potential", but as s1.6 ("Beneficence") uses "likely" we have chosen to use this term as this reflects the higher standard and precedence of s1.6.

**Similarly, s4.1.4(c)(ii) and (iii) use only "harms" while s1.6 includes discomfort, again setting a higher threshold which takes precedence over later guidelines.