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:

  2022 Submission Closing Dates for Early Phase Clinical Trials

SUBMISSION CLOSING DATE*
**12 noon SHARP**

Combined SAC and HREC meetings

Monday, 24 January 2022

Friday, 4 February 2022

Monday, 21 February 2022

Friday, 4 March 2022

Monday, 28 March 2022

Friday, 8 April 2022

Tuesday, 26 April 2022  

Friday, 6 May 2022

Monday, 23 May 2022

Friday, 3 June 2022

Monday, 20 June 2022

Friday, 1 July 2022

Monday, 25 July 2022

Friday, 5 August 2022

Monday, 22 August 2022

Friday, 2 September 2022

Monday, 26 September 2022

Friday, 7 October 2022

Monday, 24 October 2022

Friday, 4 November 2022

*Early Phase Clinical Trial applications have a mandatory pre-review process that must be initiated 4-6 weeks before the submission closing date. The submission of the "EPCT Intention to submit form" indicates the start of the review process.

Note: SAC = Statistical Advisory Committee; HREC = Human Research Ethics Committee

 Contact details:

Melinda Giles, EPCTs Research Ethics Officer

Email:SCHN-Ethics@health.nsw.gov.au

Phone: (02) 9845 3105 (Please note email is the preferred contact)

 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

  

2022 Submission Closing Dates for Greater than Low Risk Applications

SUBMISSION CLOSING DATE
**12 noon SHARP**

SAC MEETING

HREC MEETING

Monday, 31 January 2022

17 February 2022

18 February 2022

Monday, 28 February 2022

17 March 2022

18 March 2022

Monday, 11 April 2022

28 April 2022

29 April 2022

Monday, 2 May 2022

19 May 2022

20 May 2022

Monday, 6 June 2022

23 June 2022

24 June 2022

Monday, 4 July 2022

21 July 2022

22 July 2022

Monday, 1 August 2022

18 August 2022

19 August 2022

Monday, 29 August 2022

15 September 2022

16 September 2022

Tuesday, 4 October 2022

20 October 2022

21 October 2022

Monday, 31 October 2022

17 November 2022

18 November 2022

Note: These dates do not apply to Early Phase Clinical Trials. Please click on Early Phase Clinical trials to see submission closing dates and meeting dates. SAC = Statistical Advisory Committee; HREC = Human Research Ethics Committee 

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