Any proposed changes to an approved project must be submitted for HREC review prior to implementation of the amendment.
Sub-studies: sub-studies submitted subsequent to initial review and approval of the main study protocol cannot be submitted as amendments. Instead, these sub-studies must be submitted using the HREA Form for ethical review.
Submitting an amendment for SVH HREC review
Complete the Amendment to Approved Research application form which can be found under standard forms.
Submitting amendments and documents for review by the SVH RGO
All amendments and updates must be reviewed by the St Vincent’s Hospital Research Governance Officer prior to implementation on-site.
The Principal Investigator at the site is responsible for notifying the Research Governance Officer of all amendments (this includes updates to Investigator’s Brochures or equivalent) to a research project, and all amendments first must have HREC approval. Amendments must be submitted electronically via e-mail to SVHS.Research@svha.org.au in accordance with the ‘Instructions and template for submission of documents for RGO review.’
The following documents should accompany the e-mail:
- HREC Approval Letter listing all approved amended documents (mandatory)
- If applicable, Patient Information Sheet and Consent Forms - both master and site-specific versions (both 'clean' and 'tracked')
- If applicable, amendments to Clinical Trial Research Agreements on Australian sponsor letterhead (minimum 2 copies with sponsor signature)
Submissions which do not comply with the instructions will be rejected and a full resubmission required.