Is my project high or low risk?

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Is my project high or low risk?

Research projects can be classified as Negligible, Low or High Risk.

Negligible Risk
Research where there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.

  • Basic, simple research that does not require an extensive scientific review
  • Example - aim to establish new knowledge by what has already been collected and stored by the establishment only
  • Requires ethical approval via the LNREC process

The National Statement states that research which is no more than low risk research (including QA and negligible risk research):

  • Must be reviewed by people who are familiar with the NS and have an understanding of the ethical issues that can arise; and
  • Have due regard to privacy regulations (laws) and is reviewed to ensure that it does not require review by the Human Research Ethics Committee.

Low Risk
Research where the only foreseeable risk is one of discomfort.

This research involves more risk than just inconvenience:

  • Physical, eg: injury, illness, pain
  • Psychological eg: distress, guilt, anger or fear related
  • Information and/or privacy risks, eg: collection of personal or health information

To be eligible for Low Risk Review, the project must not include:

  • Women who are pregnant
  • Children or young people under the age of 18
  • Persons with an intellectual disability or severe mental impairment
  • Persons highly dependent on medical care
  • Persons incompetent to provide informed consent
  • People involved in illegal activities
  • Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project
  • Additional clinical interventions and/or therapies (e.g. Application of a drug or device)
  • Human genetic research or gene technology or use of human stem cells
  • Deception of participants, concealment or covert observation
  • Exposure to ionizing radiation e.g. X-rays, DEXA
  • Invasive procedure that is outside of standard care e.g. blood samples or obtaining biopsies
     

Where the risk, even if unlikely, is more serious than discomfort the research is not low risk.

In general any research involving a physical intervention is considered above low risk.

Examples of Low & Negligible Risk Research Projects

  • Social science questionnaires on non-controversial, non-personal issues; anonymous questionnaires may explore more personal matters;
  • Observational studies in public situations which focus on non-sensitive issues;
  • Studies of existing non-identified data, documents, records, pathological or diagnostic specimens;
  • Studies that do not involve an intervention that could result in significant harm to participants. This would include non-invasive procedures and blood sampling (standard care) but exclude exposure to radiation.

Audits
Audits will require review and approval by the LNREC.

An audit is defined as an activity instigated by a Northern Health principal investigator involving a prospective or retrospective review of information that has been or will be collected for clinical purposes (e.g. a review of medical records).

High Risk (Full HREC review)
Research where the risk is more serious than discomfort and may involve persons from the groups listed above.

Generally, projects involving any intervention or risk ≥ a blood test (above standard care) is required to undergo full HREC review.

The process for ethical approval for the three levels of risk is different. Refer to ‘Research Applications for Approval’ in PROMPT once you have determined which category your research project falls into.

Go through the checklist attached and if you answer ‘Yes’ to any of the questions, then your research project will be classified as high risk and will require review and approval by a high risk Human Research Ethics Committee. If you answer ‘No’ to the questions below, then your research project will be classified as low risk or quality assurance.

If further clarification is required, email your query and protocol to ethics | at | nh.org.au  or contact the Ethics Office on ph: 8405 2918

To download a checklist to assist you with determining if your project is high or low risk, please click here.