The National Statement on Ethical Conduct in Human Research, 2007, Updated May 2015 (N.S.) classifies research according to the potential degree of risk involved. (N.S. 2.1).
Negligible Risk Research (N.S. 2.1.7)
Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than an inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.
Low Risk Research (N.S. 2.1.6)
Research is ‘low risk’ where 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.
If you believe that your research involves negligible/low risk quality assurance activities, audits, case studies or other potentially low risk activities, please refer to the LOW RISK HUMAN RESEARCH GUIDELINES.
The questions on the Low Risk_Audits Case_Studies Form have been designed for low risk Audits, Quality Assurance Activities and Case Studies using de-identified data where there has been no deviation from standard care. Any other study that might be considered to be low risk, including more complex evaluations, should be submitted on the full HREC application form to be considered through the Fast Track process.