We've previously explored the overarching changes to Section 4 of the National Statement in the 2025 edition. This deep-dive focuses specifically on Chapter 4.5, which addresses research involving people experiencing physical or mental ill-health or disability. This chapter represents one of the most significant philosophical shifts in the 2025 update, moving away from a protectionist mindset toward genuine inclusion and self-determination.

You may be wondering why we’ve skipped over Chapters 4.2-4.4; don’t worry, these will be covered in future updates. However we wanted to prioritise the chapters that are most relevant to the kinds of work we receive as a committee. Moreover, as a disability-owned and led enterprise, the changes outlined in the updated National Statement are matters of significance to our executive and our HREC members, some of whom were involved in the consultation process that led to the current update, and who continue to be advocates for lived-experience representation in research and evaluation design and ethical review processes.

Introduction

Chapter 4.5 consolidates and updates what were previously two separate chapters in the 2023 edition:

• People highly dependent on medical care who may be unable to give consent
• People with cognitive impairment, an intellectual disability, or a mental illness

This consolidation is not merely administrative. It reflects a fundamental change in how we think about ill-health and disability in research and evaluation contexts, recognising that both exist on gradients of severity and can be permanent, chronic, episodic, or temporary conditions that fluctuate in both severity and expression.

What has changed?

The automatic HREC review requirement has been removed

Under the 2023 edition of the National Statement, any research or evaluation involving people with cognitive impairment, intellectual disability, mental illness, or who were highly dependent on medical care automatically required full HREC review, regardless of the actual risk level of the research activities.

This is no longer the case.

The 2025 edition removes this blanket requirement and instead applies the risk framework outlined in Chapter 2.1. As stated in guideline 4.5.9:

Some research involving people with ill-health or disability may be lower risk and should not automatically be deemed to require review by a Human Research Ethics Committee (HREC). The appropriate level of ethics review should be determined on a case-by-case basis.

This means that lower risk research involving people with disability or ill-health can now proceed through proportionate review pathways, rather than automatically requiring full HREC review.

From medical model to social model

Perhaps the most profound change in Chapter 4.5 is the shift from a medical model to a social model of disability and ill-health. The chapter explicitly acknowledges that:

• Impairments in autonomy may be perceived as well as real, placing responsibility on researchers to ensure there is not a gap between reality and perception
• Capacity to consent and participate may be dynamic and change over time or in different environments
• Barriers to participation are often contextual rather than inherent to the person

This is a significant departure from previous approaches that treated disability and ill-health as fixed deficits located within the individual. The updated guidance recognises that many barriers to participation are created by research design, recruitment processes, and environmental factors, all of which can be modified*.

From protection to inclusion

The 2025 edition explicitly names the historical problem:

“In the past, the design, review and conduct of research have directly or indirectly caused people experiencing physical or mental ill-health or disability to be disempowered or excluded from research due to assumptions about their ability to make decisions or provide consent, or due to misunderstandings of their ability to participate in research.”

The updated chapter changes this paradigm. Rather than starting from a position of exclusion for protection, it establishes an ethical imperative to include people with physical or mental ill-health or disability in research. As paragraph 4.5.2 states:

“Inclusion and the self-determination of people with ill-health or disability should be paramount in decision-making about research.”

Presumption of capacity

The chapter establishes a clear principle that mirrors disability policy approaches:

“The assumption should always be that adults are able to provide consent for themselves unless an assessment of their individual ability or the context of the research indicates otherwise.”

This presumption of capacity represents a fundamental shift from previous editions, which more readily assumed incapacity based on diagnostic labels or group membership.

Key provisions for different contexts

Chapter 4.5 provides tailored guidance for specific research contexts where additional considerations apply.

Research with people who are seriously ill or unconscious

The chapter maintains that the general principle of inclusiveness applies to people who are seriously ill or unconscious, while acknowledging that additional safeguards are necessary. Research may proceed where:

• It is likely to lead to increased understanding or improvements in care for this population
• Requirements of relevant jurisdictional legislation are met
• Either valid consent has been obtained (from the participant or an authorised person with appropriate risk-benefit considerations), or the participant has capacity and finds the risks acceptable

Importantly, the chapter recognises that people who are seriously ill may have impaired capacity for verbal or written communication, and provision should be made for them to receive information tailored to their abilities, such as Easy Read versions of information and consent forms.

Emergency care and intensive care research

One of the most detailed additions to the 2025 edition is the comprehensive guidance on emergency care and intensive care research (paragraphs 4.5.17 to 4.5.24). This guidance establishes a hierarchy of approaches:

1. Standard approach: Obtain valid consent from the participant (the standard for all research unless otherwise justified)
2. If participant consent is not possible: Seek consent from guardian (where a guardian is legally authorised to provide this) or other legally authorised person 
3. If neither is feasible: Consider obtaining a waiver of consent (there is more details on this at paragraphs 2.3.9 and 2.3.10 of the National Statement)
4. If waiver requirements cannot be met: Request approval from an HREC to proceed without consent, subject to specific conditions

The fourth option is noteworthy because it provides a pathway for genuinely urgent research where rapid recruitment is necessary and the waiver provisions cannot be satisfied. However, this pathway comes with stringent requirements, including that:

• There is no known reason to believe the participant would have withheld consent
• The research carries risk proportionate to the participant's underlying condition(s)
• Potential future benefits justify the risks**
• There is sufficient protection of privacy and confidentiality
• The participant is not deprived of financial benefits from commercial use of data collected
• Researchers comply with relevant legislation
• The participant and/or their family/authorised person are informed as soon as reasonably possible

Crucially, the chapter clarifies that should a participant gain the capacity to make decisions about participation, they should be informed of their involvement, their rights, and their ability to withdraw from the research/evaluation, noting that in some circumstances data already collected may need to be retained.

Research with terminally ill participants

The chapter provides specific guidance on research with terminally ill participants (guidelines 4.5.25 to 4.5.26), emphasising that:

• People who are terminally ill should not be routinely excluded from research
• Many terminally ill people value the opportunity to participate, even when there is no hope of cure or prospect of prolonging their own lives
• The distinguishing features are short remaining life expectancy and vulnerability to unrealistic expectations of benefits

Research should be designed to ensure benefits justify risks, prospects of benefit are not exaggerated, and participants' wishes to spend time as they choose (particularly with family) are respected and given priority.

Research with people with disability

The chapter provides extensive guidance on research with people with disability (guidelines 4.5.27 to 4.5.34), establishing that:

• Exclusion of people with disability from research is unethical unless adequately justified
• Researchers who explicitly exclude people with disability must disclose this to reviewers and disclose this exclusion in research outputs
• Research should be designed so people with disability can participate, including through adapted consent processes, accessible data collection methods and research spaces, and appropriate scheduling

The chapter emphasises the importance of consultation with potential participants, disability representative organisations, or supporting individuals during planning and in developing information materials.

Innovative approaches to consent

Chapter 4.5 introduces and expands several innovative approaches to consent that reflect the dynamic nature of capacity.

Advance directives

Paragraph 4.5.6 provides for the use of advance directives to record the views of potential participants about their participation when their ill-health or disability is fluctuating or when a decline in capacity is anticipated. Similar to the scope of consent discussed in Chapter 2.2, advance directives may be:

• Project-specific
• Applicable to related future research ('extended')
• Broadly applicable to future research activities ('unspecified')

This provision recognises that many people with progressive conditions or episodic ill-health may wish to participate in research but anticipate periods where they cannot provide consent. Advance directives enable them to exercise autonomy in advance. However, we note that advance directives come with a lot of legal nuance, and recommend that proposals seeking to use this mechanism obtain relevant advice to ensure that such directives are legally permissible.

Managing fluctuating capacity

The chapter acknowledges throughout that capacity may fluctuate and provides guidance on what should happen when capacity is regained after research has commenced. Guidelines 4.5.24 and 4.5.34 both establish that if a participant regains capacity to make decisions:

• Researchers should explain what ongoing participation involves
• Seek agreement that they are willing to continue and understand their right to withdraw
• Respect decisions to cease involvement
• Advise of potential retention of data already collected and reasons for retention

Understanding reluctance and distress

Paragraph 4.5.8 provides important nuance about interpreting signs of reluctance, discomfort, or distress from participants with ill-health or disability. Researchers should not assume these signs indicate a definitive desire to end participation. Instead, they must:

• Pause the research activity
• Explore the sources of reluctance, discomfort, or distress (potentially seeking advice from a guardian or relevant professional)
• If possible, address it using strategies to calm or re-orient the participant

However, if unwillingness to participate is sustained and unequivocal, any refusal must be respected, and withdrawal of consent is binding.

This provision recognises that people with disability or ill-health may experience discomfort for various reasons (environmental, communication-related, temporary physical discomfort) that do not necessarily reflect a desire to withdraw from research.

Practical questions for researchers and evaluators

When designing research that may involve people experiencing physical or mental ill-health or disability, researchers and evaluators should consider:

Inclusion and design

• Have we designed our research to facilitate the participation of people with ill-health or disability?
• What recruitment strategies and models of consent will enable appropriate inclusion?
• Have we consulted with potential participants, disability representative organisations, or supporting individuals during the planning phase?
• If we are excluding people with ill-health or disability, what is our justification and have we disclosed this exclusion to reviewers?

Capacity and consent

• How will we determine the impact of a potential participant's ill-health or disability on their decision-making capacity, capacity to provide valid consent, and ability to participate?
• Who will make decisions about capacity to consent, and what criteria will be used?
• Have we considered whether additional measures to support the consent process are appropriate for specific participants?
• Is there a process for reviewing a participant's ability to continue participating during the research?

Fluctuating capacity

• Have we discussed with potential participants the possibility that their capacity may fluctuate or be lost during the research?
• Have we considered the use of advance directives where capacity decline is anticipated?
• What will happen if a participant regains capacity after research has commenced?
• Have we recorded participants' wishes about what should happen if their capacity changes?

Accessibility and accommodation

• Have we considered data collection methods, research spaces, and schedules that are accessible according to participants' needs?
• What adaptations to procedures might be necessary?
• Have we considered the timing of consent processes to accommodate any restrictions imposed by disability?
• Do we need to provide or facilitate transport to research sites?
• Do we need to provide supports for engagement (for example, Auslan interpretation, captioning, Easy Read versions)?

Managing distress and reluctance

• Do we have a protocol for managing situations where participants show reluctance, discomfort, or distress?
• Have we considered strategies to calm or re-orient participants?
• How will we distinguish between temporary discomfort and sustained, unequivocal unwillingness to participate?

For emergency and intensive care research and evaluation

• What model of consent will we use, or are we seeking a waiver or approval to proceed without consent?
• If proceeding without consent, have we met all the conditions in guideline 4.5.22?
• What is our plan for informing participants and/or their families as soon as reasonably possible?
• How will we seek agreement to continue participation if the participant regains capacity?

For research and evaluation with terminally ill participants

• How does the likely benefit of our research justify any risk, burden, discomfort, or inconvenience to participants?
• Have we been realistic about prospects of benefit to participants?
• How are we respecting and prioritising participants' wishes to spend time as they choose, particularly with family?

Ethics review pathway

• Given the nature and risk level of our research, what is the appropriate ethics review pathway? (See our flowchart and our resource on harm and discomfort) 
• If we are advocating for an alternative to full HREC review, what is our justification?

While providing explicit answers to these questions is not a requirement in ethics applications, researchers and evaluators should ensure these considerations are clearly addressed in their application materials, such as project plans, consent forms, and participant information sheets.

Summary

Chapter 4.5 represents a fundamental shift in how the National Statement approaches research involving people experiencing physical or mental ill-health or disability. The removal of the automatic full HREC review requirement is just one visible manifestation of a deeper philosophical change from a medical model that locates disability and incapacity within individuals to a social model that recognises capacity as dynamic and contextual.

The chapter establishes inclusion and self-determination as ethical imperatives, not optional aspirations. It challenges researchers and evaluators to design research that accommodates different abilities rather than excluding people who don't fit narrow participation criteria. It provides practical mechanisms for managing fluctuating capacity through advance directives and nuanced interpretation of distress signals. And it creates pathways for urgent research to proceed ethically when traditional consent processes are not feasible.

For researchers and evaluators working with people experiencing ill-health or disability, the message is clear: the burden is no longer on potential participants to prove they can participate in research. Instead, the burden is on researchers to design research that enables participation, and to justify any exclusions. This is not just about ethics compliance – it's about ensuring research is relevant, representative, and respectful of the diverse experiences and capabilities of all potential participants.

What has not changed is the core responsibility to think carefully about how research activities may impact stakeholders, and to ensure there are appropriate mechanisms to maximise positive impacts while minimising potential harms. The 2025 edition simply provides better tools and clearer guidance to fulfil this responsibility in ways that are genuinely inclusive.

 

*Our Managing Director has published an article on one approach to barrier removal, as part of his ongoing work applying Universal Design principles in research and evaluation contexts.

** We note that this language is a departure from other parts of the National Statement which apply the term “likely” instead of “potential”. We recommend that applicants interpret this condition as “likely” as this applies a higher but nonetheless proportionate threshold.

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