Levels of Ethical Review

Research projects with different levels of risk to research participants are subject to different requirements for review. References to 'NS' are to the National Statement on Ethical Conduct in Human Research (2007).

Guidance on different levels of risk, and the differences between ‘inconvenience’, ‘discomfort’ and risks that are ‘more serious than discomfort’ is contained in NS Chapter 2.1.

Exempt from review

Research that satisfies both of the following conditions is exempt from ethical review:

• It is ‘negligible risk’ research: there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
• It involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

Researchers should keep an auditable record of any research undertaken that is exempted from ethical review (NS 5.2.9).

Eligible for expedited review

Research may be eligible for expedited review if it satisfies both of the following conditions:

• It involves no more than low risk either to the research participant or researcher: 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.
• It does not involve:
  • clinical and other trials of therapeutic, preventive or diagnostic substances, devices or procedures (NS 3.3)
  • human genetic research (NS 3.5)
  • human stem cell research (NS 3.6)
  • research involving women who are pregnant and the human fetus (NS 4.1)
  • research participants whose ability to give informed consent is impaired (NS 4.4, 4.5)
  • research participants who may be involved in illegal activities (NS 4.6)
  • research with Aboriginal and Torres Strait Islander peoples (NS 4.7)
  • research involving young children
  • research being conducted overseas

Applications which are eligible for expedited review may be submitted to the HREC Secretary for executive approval by the HREC Convenor at any time. Please submit three copies of the application.

Psychology research applications in this category should be submitted to the School of Psychology Human Ethics Subcommittee.  

PLEASE NOTE:  Applicants’ research timetables should allow for the possibility that applications submitted for expedited review may be deemed to be of more than low risk, or to raise other issues, thereby necessitating full HREC review.

Subject to full review

Applications to conduct research involving more than low risk, or that fall into any of the catagories listed above, must be submitted for consideration by the full HREC, according to its annual schedule of meeting deadlines.

Guidance on the definition of ‘research’ is contained in NS pp.7-8.