Ethical risks and ethics applications

Understanding ethical risks

All research involving people and their personal information has a level of risk involved. When considering ethical risks to participants, we are asked to think of all possible risks of harm or discomfort that a participant may be exposed to through the research. This may involve physical, psychological, economic, social, legal, and environmental harms, among others.

Risks may arise by virtue of participating in the research, or from the potential outcomes of the research. Discomfort or harm could arise because of a breach in research protocols, for example, if a participant’s personal information is shared without their consent. The research process itself may cause participants anything from minor inconvenience to discomfort or serious harm, for example, if the research questions ask participants to consider distressing issues or experiences.

Research may also involve burdens or inconvenience to the research participants. These must also be weighed against the potential benefits of the research to ensure they are not overly onerous.

Managing ethical risks

Ethical risk assessments require consideration of the likelihood of the risk occurring and the severity of the impact or consequence if the risk does occur.

Because the nature of research and data collection conducted for VLF grant projects varies, ethical considerations and requirements for specific projects also vary. As a general rule, the greater the potential for and impact of detrimental impacts on participants, the greater the efforts to try to mitigate that risk that are likely to be required.

While some level of risk will always remain, it is important to develop a risk management plan to reduce the likelihood of a risk event and the severity of its impact, should it occur.

Once a risk management plan has been developed, use a risk matrix such as the one below to assess the inherent risk before the implementation of any risk minimisation, mitigation, or management strategies, and the remaining risk after these strategies have been implemented. This remaining risk will determine the level of review required for the research project.

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For further support, see Key questions to support ethical risk identification and management.

Risk assessments and ethics approval

You will need to ensure that your project is approved by an appropriate review body before you begin your activities.

If your research project is classified as lower-risk research, the project may be approved by an internal committee or review body in accordance with Chapter Five of the National Statement. Higher risk research will need to be approved by an accredited Human Research Ethics Committee (HREC).

Use the following table to identify the required ethics process for your project, based on the overall risk rating.

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Ethics Exemptions

Research that may be eligible for exemption from ethics review includes research of ‘lower risk’ (highly unlikely to cause distress or harm to anyone involved), that does not involve the use of personal information without consent, without a specific focus on Aboriginal and Torres Strait Islander Peoples and communities, and that meets one or more of the following criteria:

• All personal identifiers have been removed prior to being analysed and that those conducting the activity agree:
  • not to attempt re-identification of the information.
  • to take all reasonable steps to prevent re-identification of the information or data for unauthorised purposes or access to the information or data by unauthorised parties, and
  • that any sharing of any research data during or after the project will not create any additional risks of re-identification of the information or data.

OR

• The research is restricted to surveys and observation of public behaviour using information that was or will be collected and recorded without personal identifiers and is highly unlikely to cause distress to anyone associated with the information or the outcomes of the research.

OR

• The research is conducted as part of an educational training program in which the research activity is for training purposes only and where any outcomes or documentation are for program use only.

OR

• The activity ONLY uses information that is publicly available as set out by legislation or regulation, such and data and reports published by the Australian Bureau of Statistics.