Note - Please be aware that as per DHHS Vic Health reporting guidelines, unless valid reasons are given, trials must commence within 12 months of approval.
If the project is not commenced within 12 months of approval then the approval becomes void and a new proposal will need to be submitted.
In all cases sufficient detail should be given to allow a valid assessment of the ethical issues involved.
All research studies, including low and negligible risk studies, require a protocol. It is also advisable that all clinical audits should have a formal written project plan.
The Avenue's Research Ethics Committee will accept research applications submitted on the latest HREA version which is available through the Ethical Review Manager (ERM) website (https://au.forms.ethicalreviewmanager.com) which is an online system that enables users to complete their research ethics applications for research electronically. The website hosts a licensed copy of the NHMRC's Human Research Ethics Application Form (HREA) and the Victorian Specific Module (VSM).
Or - (www.health.vic.gov.au/clinicaltrials/application-instructions.htm).
The application should also include the Victorian Specific Module – (https://au.forms.ethicalreviewmanager.com)
Please read the Guidelines for the Victorian Specific Module to assist in completing the form.
LOW AND NEGLIGIBLE RISK APPLICATION
For Low & Negligible Risk applications the standard forms and guidelines are available from Ethical Review Manager (ERM) (https://au.forms.ethicalreviewmanager.com). Please email a copy of the completed LNR VIC as a pdf file, together with all other supporting documentation, to The Avenue Ethics Coordinator.
PARTICIPANT INFORMATION SHEET AND CONSENT FORMS
A Patient information sheet must accompany each consent form. It must be written in simple language and contain minimal or neither technical terms nor jargon. It is also to be given to, and remain the property of, the patient or volunteer. A copy of the Patient Information Sheet should accompany the proposal when it is submitted to the Committee. The Committee also requires the Patient Information Sheet to include the version number and the date it was prepared/amended.
An adequate consent procedure is necessary to ensure that the interests of the subjects, the researcher and the institution are properly protected. The Ethics Committee requires all applicants to submit for approval a consent form for each study or else to justify why this is considered unnecessary. The Committee also requires the consent form to include the version number and the date it was prepared/amended.
Participant Information and Consent Forms (PICF) are available via –