Risk assessment

Risk assessment

A risk is a potential for harm, discomfort or inconvenience (National Statement, page 15). It involves:

  • the likelihood that harm, discomfort or inconvenience will occur
  • the severity of the harm, including its consequences.

Researchers should do their own risk assessment when thinking about ethical clearance. This shall provide an indication of how long review of the application shall take. Please refer to the National Statement on Ethical Conduct in Human Research (2007) for more detail.

Low risk research

Low risk research describes research in which the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

High risk research

High risk research is research which involves more than low risk. The following types of research will, in most circumstances, require review by the full Human Research Ethics Committee which includes all research that involves (National Statement, page 78) :

  • more than low risk
  • Aboriginal and Torres Strait Islander Peoples
  • people with a cognitive impairment, an intellectual disability, or a mental illness
  • people in dependent or unequal relationships
  • people highly dependent on medical care, who may be unable to give consent
  • people who may be involved in illegal activities
  • woman who are pregnant and the human foetus
  • interventions and therapies, including clinical and non-clinical trials, and innovations
  • human genetics
  • human stem cells