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 PUBLIC Hospital Sites (St Vincent’s Hospital Sydney, St Joseph’s Hospital):

  • 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):