Research Office

Welcome to the St Vincent’s Hospital Sydney Research Office web site.

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.

REGIS Update – 18 February 2019

The platform for research across New South Wales and ACT has changed and we have been migrating to this new system (REGIS) over the past year.  

We are now in the final stages of the roll out and need to notify you of some crucial upcoming time points:

KEY DATES:

  • Data transfer into REGIS of already approved research studies will take place from 1 March 2019.Prior to that we recommend that researchers go into Online forms and take screen shots of all approved and active studies expected to be transferred into REGIS so data which is uploaded into REGIS can be cross checked.  All projects will be migrated to REGIS by 1 April 2019 and further information will be available closer to this date regarding how these studies are to be managed from there on.
  • In the meantime and until further notice please continue to submit any new Amendments, Site Additions, Change of CPI or PI, Change in Personnel Forms, SSIs, SUSARs etc. in the usual way (i.e., using the existing forms found on the St Vincent’s Hospital Research Office website and emailing them svhs.research@svha.org.au with hard copies where required).

ETHICS:

  • As of 1 February 2019 ALL new applications to the SVH HREC (full Committee or HREC Executive Committee) submitted to the St Vincent’s Hospital HREC (single or multisite projects) must be submitted via REGIS.   
  • From 1 February 2019 ONLY new HREC applications submitted via REGIS will be accepted. Documents submitted through ‘Online forms’ will not be accepted for public hospital sites.
  • For studies where the HREA has already been generated via ‘Online forms’ and the initial HREC application has been submitted to the Research Office and is not yet approved, please contact the Research Office for further instructions on how to proceed

    GOVERNANCE – PUBLIC SITES:

  • From 1 February 2019 all new St Vincent’s Hospital SSA and LNR-SSA applications for studies approved via REGIS by a NSW or ACT HREC must be submitted via REGIS.
  • Until 22 March 2019 all new St Vincent’s Hospital SSA and LNR-SSA applications for studies approved via ERM by a VIC/QLD HREC must be submitted via Online forms.
  • Until 22 March 2019 all new St Vincent’s Hospital SSA and LNR-SSA applications for studies approved via Online Forms by any NMA certified HREC must be submitted via Online forms.
    • The above listed governance applications must be submitted by the due date (22 March 2019) to avoid potential loss of data within Online Forms due to the closure of Online Forms portal.

  • After 22 March 2019 all SSAs and LNR-SSA applications must be managed through REGIS. Please contact the SVH Research Office for further information.

GOVERNANCE – 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.

**Due to the ongoing migration of existing data to the REGIS platform there can be no exceptions to these arrangements.

  • As per usual process, if you have a study that you think qualifies for review as LNR please submit the protocol to svhs.research@svha.org.au and we will confirm the type of review required.
  • As per usual process, if you are planning to submit a study for review by the full HREC please contact the Research Office in advance to book a slot.
  • Please ensure that you have registered with REGIS and have an active account.

Additional information can be found on the REGIS website: https://regis.health.nsw.gov.au/

and the Research Office website: https://www.svhs.org.au/research-education/research-office

Please feel free to contact the St Vincent’s Hospital Research Office directly with any questions: Email: svhs.research@svha.org.au

Tel: 02 8382 4960

We appreciate your support and patience during this time of change.

REGIS Submission Guidance:

  • To assist with REGIS submissions, please refer to the following Checklists:

    REGIS Checklist - LNR Submission

    REGIS Checklist - Full HREC Submission

    REGIS Checklist - SSA or LNRSSA Submission

  • REGIS Quick Tips
  • A series of useful Quick Reference Guides (QRGs) as well as other useful information can be found on the REGIS website
  • 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 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 coordinators to do this legwork behind the scenes prior to submission.
  • REGIS updates will be made regularly to the Research Community.

Additional information can be found on the REGIS website: https://regis.health.nsw.gov.au/

Please feel free to contact the St Vincent’s Hospital Research Office directly with any questions: Email: svhs.research@svha.org.au

Tel: 02 8382 4960