Welcome to the St Vincent’s Hospital Sydney Research Office Website.
This site explains the work of the Research Office and the processes a researcher must follow in order to undertake research on humans within SVHN. Useful links can be found on the right hand side of this page.
The policies and processes governing authorisation of human research have been developed in accordance with the National Health & Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research 2007 and NSW Health policy directives and guidelines.
The implementation of the REGIS platform for research across New South Wales and ACT is now complete. In an ongoing sense this web-based platform will be used to manage existing and new human research studies except for private site SSAs and governance amendments (please see below).
ALL new applications (single or multisite projects) to the SVH HREC (full Committee or HREC Executive Committee) must be submitted via REGIS.
ALL new amendment applications (including Change in CPI/PIs, site additions and documents for noting), Significant Safety Incidents (SSIs) and annual/final (milestone) reports to the St Vincent’s Hospital HREC must be submitted via REGIS.
Please note that no other form of processing is available.
GOVERNANCE REVIEW – PUBLIC SITES
- All new St Vincent’s Hospital SSA and LNR-SSA applications for studies which have HREC approval must be submitted via REGIS.
GOVERNANCE REVIEW – PRIVATE SITES
- If you are submitting an SSA for a private site for which the St Vincent’s Hospital Research Office provides governance review (including St Vincent’s Private Hospital, The Mater Hospital Sydney and the Victor Chang Cardiac Research Institute) and
- HREC Submission was completed via ‘Online forms’ (“OLD System”) or
- HREC submission was completed via REGIS (“NEW System - NSW”) or
- HREC Submission was completed via ERM (“NEW System - VIC and QLD”)
Please contact the SVH Research Office (SVHS.Research@svha.org.au ; 02 8382 4960) to obtain the SVH-unique SSA application form for PRIVATE SITES ONLY and for guidance on submission requirements. Note that SSAs for Private sites cannot be lodged via Online forms, REGIS or ERMs.
For guidance on how to submit governance amendments and other documents for RGO noting please see https://www.svhs.org.au/research-education/research-office/amendments-to-approved-research
- As per usual process, if you have a study that you think qualifies for review as LNR please submit the protocol to firstname.lastname@example.org and we will confirm the type of review required.
- Please ensure that you have registered with REGIS and have an active account.
- Please notify the Research Office immediately if you experience difficulties with selecting the appropriate Head of Department for your project as she/he is not appearing in the drop down menu.
- If you are submitting an SSA/LNRSSA for a study via REGIS, please contact directly the various Heads of Department or institutional service providers (which are providing a supporting role in or services for your study eg. Medical Records, Imaging, Pathology) outside of REGIS and prior to REGIS submission in order to brief them on the project and get their in principle support. Please advise them that they will receive a link or email from REGIS requesting sign off.
We have had instances whereby Heads of Department have received approval requests via REGIS without having any background on the study - this is not acceptable and will delay your approval. It remains the responsibility of the investigators and study coordinators to coordinate this prior to submission.
- A series of useful Quick Reference Guides (QRGs) as well as other useful information can be found on the REGIS website: https://regis.health.nsw.gov.au/
- REGIS updates will be made regularly to the Research Community.
Please feel free to contact the St Vincent’s Hospital Research Office directly with any questions: Email: email@example.com
Tel: 02 8382 4960