The Human Research Ethics Committee (HREC) and Human Research Advisory Panels (HREAPs) use the NHMRC Guidance to define quality assurance and evaluation activities and decide whether the ethical review and approval are required. If one or more of the following criteria apply to the activity that you are conducting, human ethics approval must be obtained:
- The data being collected and analysed is not coincidental to standard operating procedures with standard equipment or protocols;
- The data collected will not be used and analysed to maintain standards or identify areas for improvement in environments or settings where the data was obtained.
- The data collected, used or analysed will (or has the potential to) be linked to individuals or groups of individuals where their identity can be uncovered.
- The outcomes of analyses will ( or has the potential to) damage a person, provider or organisation's professional reputation.
- The data collected is beyond what is routinely collected in the environment or setting where it is to be obtained.
- The activity will involve implementing a non-standard, new or revised intervention, process, operational protocol or the use of equipment not used routinely.
- The analyses will draw comparisons between two cohorts, randomisation, or the use of control and intervention to establish outcomes.
- The activity will involve the targeted analysis of data involving minority/vulnerable groups whose data is separated from that data collected or analysed as part of the leading QA/evaluation activity.
- The data collected or analysed will be published.
The HRECs and HREAPs do not provide written advice to confirm that ethics approval is not required for this type of activity. Staff, students and researchers must assess whether any of the above criteria apply to the activity that you are conducting. If following assessment of the above criteria the HREC or HREAP is required to confirm that the activity that you are conducting does not require ethical approval it recommended that a form of approval is established.