Skip to content
St Vincent's Centre for Applied Medical Research

New Submissions

In Research Ethics:

  • New Submissions
  • Post Approval
  • Authorised Prescriber

On This Page:

  • Low or Negligible risk (LNR) Submissions
  • Greater than Low Risk (GLR) Submissions
  • Use of Ionising Radiation for Research Purposes 

Low or Negligible Risk (LNR) Submissions

Research Office Review

Before you submit your LNR application, the Research Office must first confirm that the study is appropriate for review as LNR application.  To do that the study protocol must be submitted to the Research Office via email SVHS.Research@svha.org.au for initial review.

You will be informed of the decision as soon as possible and the confirmation email must be submitted with your study documents in REGIS. 

HREC Review

Low or negligible risk (LNR) studies are reviewed by the St Vincent’s Hospital Sydney HREC Executive Committee.

Meetings are held at least every two weeks and are subject to change at late notice. Submissions are reviewed in the order in which they are received.

LNR HREC Submission Requirements

ALL new applications (single or multisite projects) submitted to the St Vincent’s Hospital Sydney HREC Executive Committee:

  1. Must be submitted via REGIS
  2. Must be accompanied by the standard Cover Letter (link below)
  3. Must be accompanied by an email from the Research Office stating that the study is suitable for LNR review

Submission Resources for LNR HREC review:

Greater than Low Risk (GLR) Submissions

HREC Review

All greater than low risk (GLR) studies are reviewed by the full St Vincent’s Hospital Sydney HREC.

Meetings are held every month except January, and the strict submission deadline must be adhered to (link below)

GLR HREC Submission Requirements

ALL new applications (single or multisite projects) submitted to the St Vincent’s Hospital HREC:

  1. Must be submitted via REGIS
  2. Must be accompanied by the standard Cover Letter (link below)
  3. Must be received by the meeting submission deadline (HREC schedule link below)

Submission Resources for GLR HREC review:

Use of Ionising Radiation for Research Purposes 

Any research involving the exposure of humans to ionising radiation must follow the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) (ARPANSA Radiation Protection Series No. 8), which has been adopted by the New South Wales Radiation Control Act: https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-protection-series/codes-and-standards/rps8

An additional statement from ARPANSA containing important information about radiation assessments relating to clinical trials was released in February 2020: https://www.arpansa.gov.au/about-us/advisory-council-and-committees/radiation-health-committee/trials-statement 

Radiation Safety Report

A Radiation Safety Report is required in studies involving humans who are exposed to radiation which is in addition to that received as part of standard of care.

If you require a Radiation Safety Report please contact Medical Physics Specialists Partners at mps@med-phys.com 

A Radiation Safety Report is NOT required when the radiation administered is NOT in excess of standard of care. In these cases, a Letter of Declaration must be provided by the PI/CPI stating that there are no radiation procedures conducted in the study that are not standard of care (SOC), and it is the responsibility of the PI/CPI to ensure that this information is accurate. This letter must be signed by the PI/CPI.

Either the Radiation Safety Report, or a Letter of Declaration from PI/CPI stating that all radiation exposure falls within the site’s standard of care must be submitted to the St Vincent’s Hospital Sydney HREC and the Research Governance Officer prior to commencement of the study at a site.

Radiation Safety – Additional Resources

Please also refer to the following resources: