St Vincent's Hospital Sydney Ethics and Governance processes are independent of each other.
For an application to be reviewed at a given meeting, both the hard copy (with original signatures) and electronic copy submission must be received by the Research Office by the relevant submission deadline.
Process for submitting NEAF to the Full HREC
To submit a project for review by the Full HREC, follow the HREC Submission Checklist (Updated May 2016)
1. HREC Review of Phase ONE Clinical Trials
Phase One studies require specific review by a relevant expert in addition to the usual HREC review.
The type of expert review is based on the substantive issues in the study design and the drug, device, or procedure to be tested.
As of August 2016, the process for review of Phase One trials by the SVH HREC has been updated to expedite this required process.
For Phase I studies, Researchers are to notify the Research Office of Intent to submit a Phase One trial at least FOUR weeks prior to the submission deadline for a scheduled HREC meeting.
- Researchers are to submit the complete and signed set of study documents ONE week prior to the usual submission deadline for the scheduled HREC meeting.
- The Research Office will identify the appropriate expertise for the review and facilitate this review in the required timeframe. Please note that a $1000 fee will be applied for this service (payment to the expert).
- For further information please contact the Research Office directly on 8382 4960 or visit the Research Office website: https://svhs.org.au/home/research-education/research-office
2. For other studies to be submitted as a NEAF
The Research Office must be notified of an intention to submit to the Full HREC at least 1 week before the submission deadline for the meeting.
(Failure to notify the office may result in your application not being able to be accepted onto the agenda for your requested meeting)
Please see information sheets below on how to generate and lock a NEAF.
National Mutual Acceptance
- Currently, New South Wales, Queensland, South Australia, Victoria, and Australian Capital Territory participate in National Mutual Acceptance (NMA). Under NMA, from 14 December 2015, all NEW multi-centre Human Research Projects submitted on a NEAF conducted across public health sites in the participating jurisdictions are eligible for single ethical review. More information regarding NMA can be found on the NSW Health FAQ page or by contacting the Research Office.
Process for submitting Low/Negligible Risk (LNR) to HREC Executive
- Please submit a Protocol/Protocol summary to the Research Office SVHS.Research@svha.org.au to confirm LNR eligibility.
- Once confirmation has been received, please follow the submission instructions on the LNR Submission Checklist (Updated July 2016).
- Please see information sheets below on how to generate and lock an LNR.
Instructions for Managing Online Application Forms
- How to generate a NEAF or LNR PDF [85 KB]
- How to lock a NEAF or LNR PDF [255 KB] (the lock code is also known as the submission code - locking a form removes "DRAFT" from the pages. Without this code the submission is invalid)
- How to use ethics form Address Book PDF [357 KB] (this saves time for subsequent applications)
Please refer to the relevant submission checklist and contact online forms HELPDESK for technical issues or the Research Office if assistance is required.