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: 

•  Early Phase Clinical Trial HRECs Scheme Quick Reference Guide

Submission Guidelines 

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

• EPCT Submission Guideline
• EPCT Intention to Submit Form (non-Device)
• EPCT Intention to Submit Form (Device)
• EPCT Submission Checklist
• EPCT Invoicing Authorisation Form

  2022 Submission Closing Dates for Early Phase Clinical Trials

*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

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