Low/Negligible Risk Applications
Please read the National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research, 2007 before you begin a human ethics application.
The Human Research Ethics Committee (HREC) reviews low risk and negligible risk applications on a continuous basis.
Low risk research is defined as research in which the only foreseeable risk is one discomfort. Discomforts include, for example, minor side-effects of medication, the discomfort of associated with measuring blood pressure or the anxiety induced by an interview.
Negligible risk research is defined as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Examples of inconvenience may include filling in a form, participating in a survey, or giving up time to participate in research.
The following types of research cannot be granted expedited low or negligible risk and require a full Human Research Ethics Committee (HREC) review.
- All research that involves more than low risk
- Research falling under the following chapters of the National Statement:
- Chapter 3.2: Human biospecimens in laboratory based research;
- Chapter 3.3: Genomic research
- Chapter 3.4: Animal-to-human xenotransplantation
- Chapter 4.1: Women who are pregnant and the human foetus
- Chapter 4.4: People highly dependent on medical care who may be unable to give consent
- Chapter 4.5: People with a cognitive impairment, an intellectual disability or mental illness
- Chapter 4.6: People who may be involved in illegal activities (except for those projects that only involve the collect ion of non-identifiable data and involve negligible risk)
- Chapter 4.7: Aboriginal and Torres Strait Islander Peoples
- Chapter 4.8: People in other countries (except where the risk to participants is low/negligible risk and/or the project does not involve participants who could be considered a vulnerable group in the context of the project)
Click here requires a review by the HREC.