Defining Low & Negligible Risk Applications:

The National Statement on Ethical Conduct in Human Research 2007 (N.S) provides a broad definition of low and negligible risk.

The threshold for low risk is ‘Research in which the only foreseeable risk is one of discomfort’ e.g. Measuring blood pressure or anxiety triggered by interview questions.

The threshold for negligible risk is ‘Research in which the only foreseeable risk is one of inconvenience’ e.g. completing a form or participating in a survey.

Identifying whether your study is low or negligible risk entails considering the position of the participant in your study and how they will be impacted by involvement in your research. The LNR Application form provides combined examples of both low and negligible risk research as outlined below. Delineation between the two thresholds will depend on the context of your study and again consideration as to whether there is a risk that the participant may experience ‘discomfort’ or merely ‘inconvenience’.

LNR Application Form states that ‘LNR is Research involving:

  • Only questionnaires and general surveys on non-controversial, non-personal issues, includes only basic demographic data & respondents are not identified.
  • Only the use and/or disclosure of information from existing data collections, where the identity of the person cannot reasonably be ascertained from the information to be disclosed to researchers.
  • Human tissue where consent is not required as broad consent has been provided for the use of the tissue in research & specific individuals cannot be identified from specimens used e.g. specimens have never been labelled with individual identifiers or these have been permanently removed.
  • Access to individual medical records or to information stored electronically, through the site’s medical records department or other department / specialty, but where participant consent is not required or where a waiver of consent requirement is being requested because, in all instances, individuals cannot be identified from data extracted or provided.’

An additional complexity to consider is the aspect of vulnerable populations.

The N.S outlines that any research specifically targeting Aboriginal or Torres Strait Islander peoples must be submitted on a NEAF application and ethically reviewed by the full Committee regardless of whether the research fulfills the LNR definitions outlined above.

Further to this, research involving the following areas and populations can only be submitted on an LNR application IFthe project uses collections of non-identifiable data and involves only negligible risk to the participants:

  1. Human Genetics
  2. Human stem cells;
  3. Women who are pregnant and the human foetus;
  4. People who are highly dependent on medical care who may be unable to give consent;
  5. People with a cognitive impairment;
  6. People with an intellectual disability or a mental illness; and,
  7. People who may be involved in illegal activities.

If your research meets the definitions above, refer to the LNR submission information located on the LNR webpage. If not, your study will be classified as a higher risk application and will be required to be submitted on a NEAF. Please refer to the NEAF: submission processes page located in the webpage navigation panel to access further information.

Furthermore, if your research fulfills the LNR definition outlined above however also involves sites spanning multiple states (i.e. NSW & VIC), you will need to submit your application on a NEAF. Please refer to the NEAF: submission processes page located in the webpage navigation panel to access further information.

Please note: If you are unsure as to the risk classification of your research, please contact the SCHN Ethics Team on (02) 984 51253 or at for guidance in this area.