It is not always clear whether a project is considered research or audit. Regardless of whether a project is considered audit or research, all new low risk or negligible risk projects must be registered with the Office of Research & Ethics (refer to the Eastern Health Research Policy, 2009).
Research projects or quality assurance activities that are considered low risk or negligible risk are not required a review by the full Human Research Ethics Committee. Such projects are reviewed and approved by the Ethics Chair, Ethics Sub-Committee or delegates.
Eastern Health aims to provide review and approval of low risk and negligible risk research and QA activities expeditiously and efficiently.
Do I need to complete the low risk & negligible risk form?
Complete the Quality Assurance and Level of Risk Checklist. If you are still unsure check with the Office of Research & Ethics, email: [email protected]
Ethical review acts in the interest of participants, whether patient, carer, health provider or institution.
Projects must not infringe ethical principles and the researcher must comply with the legislation.
Projects involving the following participant groups should not be submitted as low risk and will require review by the full Ethics Committee.
- Pregnant women & human foetus
- Children & young people (under 18)
- People in dependent or unequal relationships (i.e. doctors/patients, employers/employees)
- People highly dependent on medical care unable to give consent
- People with a cognitive impairment, intellectual disability or a mental illness
- People who may be involved in illegal activities
- Aboriginal & Torres Strait Islander People
- People in other countries
Risk Level
The following National Statement criteria is used for assessing risk level:
Negligible risk applies where:
- There is no foreseeable risk of harm or discomfort
- Any foreseeable risk is no more than inconvenience
The research is not negligible risk where the risk even if unlikely is more than inconvenience.
Low risk applies where the only foreseeable risk is discomfort.
The research is not low risk even if unlikely, is more serious than discomfort.
National Statement criteria for assessing risk level Chapter 2.1 (download)
The “Common Application Form” and the “National Ethics Application Form” are both acceptable for submission. Please see Application Guidelines and Forms.
If you are certain that your project will be considered as a low risk or negligible risk research or quality assurance activity, you can complete the Low Risk and Negligible Risk Research Application Form (download).
- One paper submission of all documents – fully signed
- Electronic submission of all documents
- There is no deadline
- Eastern Health departments impacted by your project should be notified
- A written confirmation from the head of departments is required confirming that the project can be supported
The same fee schedule is applicable to quality assurance, low risk and negligible risk projects