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 private site governance amendments.
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.
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 level of review required.
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.
All governance amendments (including HREC approved general amendments, Change of CPI/PI, HREC Extension Approval, Change in Personnel and Contract changes/variations) to be implemented at either St Vincent's Hospital or St Joseph's Hospital 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.
All governance amendments to be implemented at either St Vincent's Private Hospital, the Mater Hospital or the Victor Chang Cardiac Research Institute must be submitted to the Research Office via email.
Mandatory ICH-GCP Training requirement:
- Please note that as of 31 January 2022, proof of current ICH-GCP training will be required for ALL study site team members named in an STE/SSA application.
- This applies to ALL research studies and NOT just to clinical trials
- This mandate applies to researchers based anywhere on the Darlinghurst Precinct including staff of St Vincent’s Private Hospital, St Vincent’s Clinic, and the Garvan and Victor Chang Institutes.
- Note that ICH GCP certificates must be renewed every 3 years
Please ensure that you have registered with REGIS (using a professional email address) and have an active account.
The following link can be used by St Vincent's Hospital staff members to access a variety of ICH-GCP training modules:
Clinical Trial Training and One Note Guidance
Non-St Vincent's Hospital staff members are required to seek training opportunities from their own institutions.
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.
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:
Tel: 02 8382 4960