This type of application is for when the Austin Health HREC is reviewing a project on behalf of Austin Health or Northern Health only.
Every research project at the Austin must undergo both an Ethics Review and a Site Specific Review (Governance). You are encouraged to submit BOTH your ethics and governance packages at the same time to ensure your project is reviewed in a timely fashion.
You must email the Office for Research as soon as possible to book a submission slot at your preferred meeting as numbers are limited. Your booking email should contain the following information: Protocol number and title, PI, preferred meeting date and Drug or non-drug study. The Office for Research will confirm your submission booking via email.
Please see the list below of required documents and refer to the instructions for submitting your Ethics Package and Governance Package.
For single site applications approval will be notified by an Ethics Approval letter and Site Specific Authorisation letter. Project Authorisation can be issued only once ethical approval is obtained AND all the site specific documents have been submitted and reviewed. A research project may not commence at Austin Health until an Ethics Approval letter and Project Authorisation letter has been received.
1. Book your submission slot with the Office for Research as soon as possible by calling (03) 9496 4090 or emailing the title of your study and the Principal Investigator's name to firstname.lastname@example.org (please note, there are limited submission slots so book early)
2. Log in to the Ethics Research Management website
3. Complete the HREA and SSA as appropriate.
4. Upload all supporting documentation (Note: scanning may be required)
5. Email an electronic copy of your submission to email@example.com.
(Please Note: Governance package will NOT be required to be submitted to Austin Health if Austin Health is not a participating site)
For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.
· HREA (Human Research Ethics Application Form; signed by PIs & Head of Department)
· Waiver of Consent Request Form - ONLY If a Waiver of Consent is being requested.
· Austin Health (AH) Site Specific PICF must include:
(a) the AH logo and barcode and place for a patient label sticker (HIS will only accept a PICF on the standard AH template. No deviations to this template will be accepted.)
(b) complaints section contact details guidelines
· For the Person Responsible Oral Information and Consent template, please see SOP 006
· Master Patient card/Diary/ Questionnaire/Survey/Flyer
· For information regarding Likert scales, see: http://www.cdc.gov/dhdsp/pubs/docs/cb_february_14_2012.pdf
· Fully signed (All Investigators & Head of Department) SSA (Site Specific Assessment Form; final version with submission code - no DRAFT watermark)
· GCP Certificate (http://www.austin.org.au/research/training-for-researchers/)
· Signed Medicine Australia Standard Indemnities (If applicable)
· Site Budget
· Austin Health Victorian Specific Medical Physicist Module and Medical Physicist Report
(If project involves radiation)
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