The Western Health Low Risk Ethics Panel (LREP) is constituted according to the requirements of the National Health and Medical Research Council of Australia (NHMRC). The function of this panel is to consider the ethical implications of research applications submitted to the panel for review and to evaluate the ethical conduct of the research. The panel will be responsible for review of all quality assurance, negligible risk and low risk research from the Western Health Network.
Before submitting a new project, you will need to determine the level of risk and which criteria your project will fall under.
For the purpose of simplicity you should answer the following questions about your project:
Is this project undertaken for a valid purpose and does it aim to use the outcomes to improve delivery of health care?
Does this project seek to identify and/or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
Does this project seek to evaluate current health practices or to monitor the introduction of a new practice?
Could this project infringe on ethical principles that guide human research?
If you answer yes to questions 1 to 3 your project may fit the definition of a low risk QA project. To seek approval for a QA project, you need to complete the QA Application Form and if applicable, complete the QA Participant Information and Consent Form. QA projects are reviewed by one member of the WH Low Risk Ethics Panel.
If you answered yes to question 4 your project may warrant ethical review and need to be submitted to the WH Low Risk Ethics Panel as a research project. The following table may assist you in determining whether your project falls in the QA, low risk or high risk category, if unsure contact the Office for Research to clarify.
For High Risk projects that do not fit under the Multi-centre Streamlined Ethical Review/Interstate Mutual Acceptance Process are required to submit to Melbourne Health HREC for Ethical review and approval.
Retrospective medical audit of current practice
Prospective study comparing "standard of care"Impact on patients? If review will identify issues that will require patients to be contacted/treatment amended
Prospective study comparing "standard of care" vs intervention
Questionnaire based research
Questionnaires/survey of treatment group
Patients group - survey of patients outside "usual care"
5 years/ Clinical Trial 15 years
Consent or waiver of consent
Consent or waiver of consent (data use related to purpose of collection)
Participants able to consent for themselves
Patients unable to consent for themselves or waiver of consent (data use not related to purpose of collection)
Data re-identifiable or non-identifiable
Collect and use identifiable data
Collect, use and release of identifiable data. Databases. Tissues and Genetics Samples
Intervention & Impact risk to participants
Minimal or none
Participants - high impact, unable to consent and/or "vulnerable" group e.g. Children; Pregnant women; People with a cognitive impairment, an intellectual disability or a mental illness