The ACU Human research Ethics Committee (HREC), Expedited Review Panel (ERP) and the School Advisory Panels (SAP), review research projects based on the application of the values and principles of research merit and integrity, justice, beneficence, and respect. The consideration of the risks and benefits of research and consent of participants require assessment as per Chapter 2.1 in the National Statement on Ethical Conduct in Human Research (2023), to ensure any risks are minimised, mitigated or managed.

Risk of harm or discomfort as stated in the National Statement are outlined below:

While no list of harms can be exhaustive, one helpful classification identifies the following types of potential harms in or from research:

• 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 in other ways treated disrespectfully or unjustly;
• 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.

Any of these types of harm can be experienced individually or collectively. Discomfort is considered less serious than harm. It can involve physical or psychological impacts, for example, minor side-effects of medication, discomfort related to non-invasive examinations or tests (such as measuring blood pressure), and mild anxiety associated with an interview. However, where a person's reactions might exceed discomfort and become distress, this should be viewed as the potential for harm.

Harm and discomfort to non-participants may also be relevant. Examples of risks to non-participants from research include the risk of distress for a participant's family member identified as having a serious genetic disorder, the possible impact of information in published research on family or friends, or the risks of biological research to the community. Some social research may carry wider social or economic risks; for example, research in a small community into attitudes to specific subpopulations may lead to unfair discrimination or have effects on social cohesion, property values or business investment. Research into the impact of public health policy on community well-being or into social determinants of health may also carry a risk of harm to participants or their communities.

Considering risk in your ethics application

Guidelines for minimising and managing risk when completing an online Orion application and Participant Information Letter and Consent Form (PICF):

• All projects have an element of risk involved e.g. risk of distress, to confidentiality, risk of time, social risk, physical etc. The HREC want to see that you have thought about what these risks might be, gauged their probability and severity, how they can be minimised and whether the risks are justified by the potential benefits. Detail how the risks can be suitably managed.
• Some participants may be at higher risk of harm or discomfort arising from research. The increased risk of harm or discomfort can express itself in different ways at different times and to different degrees and can arise from the nature, design or other contextual factors of the research, such as the setting in which the research will be conducted, the social or political implications of doing the research and cultural factors or some combination of these factors.
• If there is a likelihood of distress, contacts for support need to be provided. Supports suggested to participants if they experience distress or other adverse events need to be commensurate to the likelihood of the event and the likely severity. Referral to organisations like Lifeline and Beyond Blue are not blanket solutions. Think about what supports would be best for your research project. E.g. if the study is about mental health in men, a good support would be MensLine Australia.
• A project can have no benefits to participants, don't try to make them up. A catch all benefit could be that there are no immediate benefits but participants are contributing to a body of knowledge in the chosen area.
• Consider the risks to the researcher as well as the participants, especially if research is student led. Provide information on how the student will be supported and how any adverse events will be managed e.g. if a participant were to become distressed. Safety is also an issue. See also our policy on In-home Visits.
• For projects that are 'greater than low risk' a Risk Assessment and Management Plan (RAMP) must be attached. See information below.
• The risk of perceived coercion needs to be carefully considered:
  • If you are using participants where there is a power imbalance eg: staff/employee/colleague relationship you would tick yes to questions of conflict of interest and address how the conflict of interest will be managed e.g., it can sometimes be resolved through recruitment being handled by a third party.
  • The HREC prefers that all initial contact with potential participants is made either by a third party or at arm's length. This is a general rule, but of course does not fit the requirements of all projects.

Risk Assessment Management Plan (RAMP)

The HREC's assessment of ethical acceptability of risks is based on the researcher identifying any possible risks, the likelihood and severity of the risks, who the risks may affect and how the identified risks may be minimised. Where there is a higher than low risk or a number of risks that may require management, this template provides a structure which enables researchers and HREC members to easily identify the risk and their proposed management. Completion and submission of this form is considered essential when completing a clinical trial ethics application form.

Researchers should refer to the ACU Risk Management Policy and Risk Management Procedure for guidance when completing this form and in the management of any risks at ACU.

Determining the risk level

During the review, your application will be assigned with a letter that determines its risk level or type of application. Based on the type of risks associated with the proposed protocol, your application will be reviewed by either the Chair of the HREC, the Ethics Review Panel (ERP), the School Advisory Panel (SAP), or it will be referred to the full HREC to be considered at its next meeting.

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Accidents, Incidents or Adverse Events

It is a requirement of ethics approval that researchers inform the Ethics Committee of any accidents, incidents or adverse events that arise during the course of research as soon as possible. Such an incident might include an injury or accident resulting from the research, either to a person (who could be a participant, a member of the research team or a member of the public), a complaint, or involve some other harm such as inadvertent release of personal data.

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