You must submit your application, using ONE of the following two types of application forms
(1) National Ethics Application Form
The NEAF has been adopted by most organisations in Australia and can be used for single site or multi-site research. Multi-site clinical trial research may be reviewed by central review processes. The NEAF has replaced the Victorian Specific Modules application form that was previously used.
In Victoria the NEAF application process consists of 3 components – all of which must be completed:
- National Ethics Application Form (on-line form)
- Site Specific Assessment (on-line form)
- Victorian Specific Module – download from the Department of Health’s Clinical Trials Research page under “How to make an application.”
Victorian Specific Module
The Victorian Specific Module addresses legislative requirements in undertaking human research in Victoria.
The Victorian Specific Module and the Victorian Specific Module Guidelines may be modified and updated from time to time.
The latest version of the Victoria Specific Module form in word document format as well as the guidelines may be downloaded from the Department of Health’s Clinical Trials Research webpage under “How to Make an Application.”
In addition to the Research Project Details there are 5 sections in total:
- Section 1 must be completed for projects involving Drugs & Therapeutic Devices
- Section 2 must be completed for projects involving the recruitment of adults who may be Incompetent to Consent
- Section 3 must be completed for projects involving the collection/use/disclosure of information
- Section 4 must be completed for projects involving the use of radiation
- Section 5 must be completed for projects involving the Use of Human Tissues or Blood, or Performance of Post Mortem
(2) Low Risk Application Form
This form can be used for all research projects or quality assurance activities that are considered of low risk or negligible risk are reviewed and approved by the Ethics Chair, Ethics Sub-Committee or Delegate (download).
Audit activities that are (i) conducted by Eastern Health employees (ii) within their area of employment (iii) for internal use only, are not required to have ethical approval.
Projects involving vulnerable population must NOT be submitted using the Low Risk Application Form.
Negligible risk applies where:
- There is no foreseeable risk of harm or discomfort
- Any foreseeable risk is no more than inconvenience
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 where the risk even if unlikely is more serious than discomfort.
Research falling within the category of “Observational studies and registries” should not be submitted as a low risk application.
This is because registries and observational studies often involve multiple jurisdictions and sites and will require review and approval by the full Human Research Ethics Committee.
These are documents that must be submitted with application forms. Click here for more details.
This must be submitted with application forms. Click here for more details.