Greater than Low Risk New Submissions

This page outlines the SCHN submission processes for Greater than Low Risk research ethics applications. Please carefully read the submission guidelines when preparing your ethics applications, and contact the Research Ethics Office if you have any questions.

Early Phase Clinical Trials 

The Sydney Children’s Hospitals Network HREC operates as the NSW Health’s statewide Early Phase Clinical Trials HREC for paediatrics.  

Age group within the scope of Sydney Children's Hospitals Network HREC

  • Trials involving only children and young people under the age of 18; and 
  • Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25. 

Definitions - Early Phase Clinical Trials 

Early phase clinical trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component. Please refer to the following Quick Reference Guide for a list of the types of clinical trials covered by this scheme: 

Submission Guidelines 

All applications must be submitted as per the following submission guidelines:

 2021 Submission Closing Dates for Early Phase Clinical Trials 

Submission Closing Date

 

12noon SHARP

Combined SAC and HREC meetings

Monday, 25 January 2021

Friday, 5 February 2021

Monday, 22 February 2021

Friday, 5 March 2021

Monday, 29 March 2021

Friday, 9 April 2021

Tuesday, 27 April 2021

Friday, 7 May 2021

Monday, 24 May 2021

Friday, 4 June 2021

Monday, 21 June 2021

Friday, 2 July 2021

Monday, 26 July 2021

Friday, 6 August 2021

Monday, 23 August 2021

Friday, 3 September 2021

Monday, 20 September 2021

Friday, 1 October 2021

Monday, 25 October 2021

Friday, 5 November 2021

Contact Details: 

Clare Bayram, EPCTs Research Ethics Officer

Phone: (02) 9845 3105

Email:SCHN-Ethics@health.nsw.gov.au 

Link to more information about the NSW Health Early Phase Clinical Trials HREC Scheme: https://www.medicalresearch.nsw.gov.au/early-phase-clinical-trials/

All Other Greater than Low Risk Applications 

All other greater than low risk applications must be submitted as per the following submission guidelines:

REGIS - Greater than Low Risk Submission Guideline

REGIS - Greater than Low Risk Submission Checklist

 2021 Submission Closing Dates for Greater than Low Risk Applications 

SUBMISSION CLOSING DATE

12pm SHARP

SAC MEETING

 

HREC MEETING

 

Monday 1 February 2021

18 February 2021

19 February 2021

Monday 1 March 2021

18 March 2021

19 March 2021

Tuesday 6 April 2021

22 April 2021

23 April 2021

Monday 3 May 2021

20 May 2021

21 May 2021

Monday 31 May 2021

17 June 2021

18 June 2021

Monday 28 June 2021

15 July 2021

16 July 2021

Monday 2 Aug 2021

19 August 2021

20 August 2021

Monday 30 August 2021

16 September 2021

17 September 2021

Monday 27 September 2021

14 October 2021

15 October 2021

Monday 1 November 2021

18 November 2021

19 November 2021

Contact Details: 

Email:SCHN-Ethics@health.nsw.gov.au 

Forms, Templates & Resources Specific to Greater than Low Risk Applications

SPIRIT Drug/device protocol template – mandatory for investigator initiated studies

SPIRIT Non drug device protocol – mandatory for investigator initiated studies

Peer Reviewer Report Form - V1 - August 2017

Booking an appointment with the CHW Biostatistician

CHW Radiation Safety Report Application Form

SCH Radiation Safety Report Application Form

Link to Consent Templates & Resources

Link to Invoicing Authorisation Forms

Link to other relevant resources and templates

Link to HREC Submission Closing Dates of other HRECs in Sydney Health Partners