Amendments to approved research

Amendments to approved research

Submitting an amendment for St Vincent’s Hospital HREC review

  • Any proposed changes (amendments) to an approved project must be submitted for HREC review prior to implementation

  • Simple amendments are routinely reviewed by the HREC Executive

  • More complex amendments are referred to the next Full HREC Meeting

  • All amendments for St Vincent’s Hospital HREC Review must be submitted via REGIS (https://regis.health.nsw.gov.au/how-to/ )

Submitting an amendment for St Vincent’s Hospital Governance review
  • All amendments must be reviewed by the St Vincent’s Hospital Research Governance Officer (SVH RGO) prior to implementation on-site

  • Evidence of relevant HREC amendment approval must be obtained prior to SVH RGO review

  • All other relevant governance implications affecting the site must be discussed with the SVH RGO and sign off may be required ( eg. variations to contractual arrangements or other study issues which impact the institution)

  • It is the responsibility of the local St Vincent’s Hospital Principal Investigator to notify the SVH RGO as required

  • Only one governance amendment can be submitted for each HREC amendment approval letter (multiple HREC approvals merged into one governance amendment will be rejected)

For St Vincent’s Hospital Sydney:

  • Submissions must be made via REGIS (https://regis.health.nsw.gov.au/how-to/ )
  • All Change in Personnel Forms must be submitted as site governance amendments via REGIS to allow for documents such as GCP certificates and CVs to be attached.
  • Due to current lack of  REGIS functionality, Change in Personnel Forms must not be submitted as “REGIS – Change in Personnel forms” and will these will be rejected.

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    For PRIVATE Hospital Sites (St Vincent’s Private Hospital, The Mater Hospital, Victor Chang Cardiac Research Institute):