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Is my project low or high risk?
This decision aid is intended to help researchers complete applications for the ethical and scientific review of research projects by a NSW Health Human Research Ethics Committee (HREC).
Please review this guidance, particularly Table 1. Discuss your proposed study with the Executive Officer of the Human Research Ethics Committee before completing an application form if unsure which pathway to select. If the Executive Officer considers that the appropriate risk pathway was not selected for a study submitted for ethics review, you may be required to re-submit the application to amend the pathway on the HREA. This will result in unnecessary delays.
The value of beneficence in the National Statement on Ethical Conduct in Human Research (2025) (the National Statement) requires that the risks and benefits of human research (to participants and to the wider community) be assessed and any risks effectively addressed The National Statement Chapter 2.1: Risk and Benefit describes the types and levels of risk that are relevant to research and the potential for harm, discomfort, burden or inconvenience to occur. Risk may be associated with research conduct and/or outcomes.
You should identify and assess risks in terms of their likelihood, severity and consequences and put measures in place to minimise, mitigate, and manage these risks. The National Statement recognises risks of physical harm, such as, death, and risks of psychological harm, such as, anxiety-related re-traumatisation. The National Statement (2025) introduced the concepts of cultural harm and social harm in research. The unauthorised disclosure of personal information is a social harm. There is recognition that some participants, by reason of the design study or their specific attributes, may be at higher risk of harm or discomfort from some types of research. Burden and inconvenience are not harms or discomforts and, therefore, are not viewed as “risks”. But researchers should recognise that research can impose non-trivial burdens or inconvenience on participants and the impacts of these should be balanced against the potential benefits of the research.
Earlier editions of the National Statement used a three-tier risk model: greater than low risk (harm), low risk (discomfort), and negligible risk (inconvenience). The 2023 National Statement replaced this with a continuum-based approach and only two broad categories: Higher Risk and Lower Risk. The term “Negligible Risk” was retired. All higher risk research requires full HREC review, while the low-risk review pathway may be used for lower risk research regardless of study type.
The 2025 National Statement also changed risk management by removing the automatic requirement for full HREC review of research involving participants covered by Section 4, “Ethical considerations specific to participants in research”. In earlier editions, any research involving these groups required full HREC review, even when the activities were otherwise low risk.
This is no longer the case.
The 2025 edition replaced the blanket rule with a more purposive approach that takes context into account. Researchers should assess risks for all stakeholders and recognise that, for some stakeholders, context—including membership of certain groups—may increase or change those risks. See the Iris Ethics blog Section 4 Deep-dive: The 2025 update to the National Statement.
1. Lower risk research
The National Statement defines research as “lower risk” when the only foreseeable risk is no more severe than discomfort or a minor burden or inconvenience. Examples include having blood pressure measured, feeling mildly anxious during an interview, completing a survey, or filling in a form. If there is any foreseeable risk of harm more serious than discomfort, even if unlikely, the research is not lower risk.
In Table 1, the Research Office has defined the study types that are suitable for low-risk review under the 2025 National Statement . This table takes the changes to Section 4 into account. Contact the Executive Officer for advice if your risk assessment suggests that your study is low risk, but the design you are using is not listed in Table 1.
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Table 1: Study Designs that may not require full HREC review
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1
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Retrospective medical record audits / data collection, from existing data sets with waiver of consent or participant consent for use of data for future research, i.e., extended consent. The waiver must meet the conditions in the National Statement.
Full HREC review should be sought if using:
- Large cohort [KF1] [KF2] (> 5k cases) of pre-existing data
- Artificial Intelligence
- Data linkage
- Commercial uses of data (e.g. pharmaceutical company/Phase 4 trials) or establishing a data registry/database
- High profile case series of rare condition or small number of records and identity cannot be adequately protected (particularly with a waiver of consent).
- Sensitive topics or polarising/controversial topics where there may be the potential to cause social harms or put participants in danger. These may include studies on gender reassignment, domestic violence, other physical violence, substance addiction and mental health. Consumer involvement is important for such topics to assess whether the study has a social license and is supported by people with lived experience.
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2
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Prospective medical record data collection, if a waiver of consent is sought for participants who will present in the future, the researchers should explain why it would be impracticable to obtain consent. The waiver meets the conditions in the National Statement.
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3
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Surveys or interviews/focus groups with staff on non-controversial or non-distressing topics, and the questions have been satisfactorily peer reviewed to ensure that the questionnaires are likely to achieve the intended outcomes. Time burden < 60 minutes and if participants have a pre-existing relationship with focus group participants clarify how researchers will manage group dynamics and confidentiality.
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4
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Interviews/focus groups with patients, including pregnant women, on non-controversial or non-distressing topics. Time burden < 60 minutes.
The Executive Officer will consider risks that may be posed by:
- Age-appropriate content/questions
- Topics such as sexual function, cancer treatment, life-threatening diagnoses, mental health,
- Financial stress or intrusive questions
- Use of validated questionnaires for children
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5
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One-off surveys with patients on non-personal, non-controversial, and non-distressing topics. Time burden < 15 minutes, and no additional visits are required.
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6
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Research involving human tissue:
- Where participant consent is not required because extended or unspecified consent has been provided for use of the tissue in research and the proposed use is consistent with the consent obtained from participants
- Held in a research tissue bank for which consent was obtained for its use in research at the time of its collection and storage and the proposed use is consistent with that consent
- That has been embedded in paraffin wax or stored on slides for which a waiver of consent is requested, and the waiver meets the conditions in the National Statement and the NSW Human Tissue Act (1983)
Full HREC review required if setting up a Biobank or doing genomic/genetic research where DNA is potentially identifiable or if human tissue will be transferred domestically or internationally.
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7
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Delphi studies, where participants are specialists in their fields and experts on the topic under investigation. Usually non sensitive surveys involving expert opinions and non-personal information, with minimal risk of harm.
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8
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Where Section 4 Ethical considerations specific to participants in research of the National Statement (2025) applies:
Section 4 addresses 1) individuals’ characteristics that may increase the risk of harm in research and 2) contexts that may increase the risk of harm (for all people concerned).
Where appropriate, the low-risk review pathway can be used for lower risk research with Section 4 participants and contexts.
There are nine chapters in Section 4:
- 4.1: Ethical issues in recruitment and involvement of research participants who may experience increased risk (applies to all studies involving Section 4)
- 4.2: Pregnancy, the human fetus and human fetal tissue
- 4.3: Children and young people
- 4.4: People in dependent or unequal relationships
- 4.5: People experiencing physical or mental ill-health or disability
- 4.6: Research conducted in other countries
- 4.7: Research with Aboriginal and Torres Strait Islander people and communities
- 4.8: Research conducted during natural disasters, public health emergencies or other crises
- 4.9: Research that may discover illegal activity.
This list is not exhaustive; reviewers should be aware of other characteristics and contexts that may increase the risk of harm in research. For example, people still suffer discrimination on the grounds of sexual orientation, gender identity and intersex status[1] and the legacy effects of past attitudes and behaviours[2] persist.
To assess the level of risk when Section 4 applies, researchers should apply the risk framework in Chapter 2.1 and the guidance in Chapter 4.1. Researchers should read:
- Chapter 2.1, on assessment of risk.
- Chapter 4.1 as well as the directly relevant chapter(s), e.g., on pregnancy; on research with Indigenous Australians, on research during natural disasters etc.
The Protocol should state the potential level of risk and outline how this was determined. Consumers should have the opportunity to engage with researchers from early in the research process to assist with identifying the likelihood of harms and their impacts on participants.
Note: The AH&MRC does not have a low-risk review pathway for research involving Indigenous Australians although these studies may still be eligible for low-risk review by the RPAH HREC.
Examples where full HREC review may not be required:
Pregnant women being interviewed on diet during pregnancy
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2. Higher risk research
Research projects where there is foreseeable risk of harm and/or burden is “higher risk”. Higher risk research requires full review by an HREC.
The following classifications may be helpful in determining the risk of harm:
- physical harm: including injury, illness, pain or death.
- psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease.
- devaluation of personal worth: including being humiliated, manipulated, or treated disrespectfully or unjustly in other ways.
- cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices.
- social harm: including damage to social networks or relationships with others, discrimination in access to benefits, services, employment or insurance, social stigmatisation, and unauthorised disclosure of personal information.
- economic harm: including the imposition of direct or indirect costs on participants.
- legal harm: including discovery and prosecution of criminal conduct.
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RPA
