All proposed changes to an HREC approved project must be submitted to the HREC and RGO for review prior to implementation of the amendment.

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Ethics

Amendments include changes to investigator brochures, protocol, consent forms, extension requests to ethical approval, addition of site requests and change in personnel requests (CPI/PI only).

Please note safety reports are submitted in the same way as amendments.

Please click here for further guidance on how to submit an amendment or safety report in REGIS.

Governance

The Principal Investigator at a site is responsible for notifying the Research Governance Officer of all HREC approved amendments to a research project.

HREC approved amendments must be submitted for governance review prior to implementation at the site. Note that amendments cannot be reviewed by the RGO without evidence of relevant HREC approval.

Please be advised governance do not require copies of tracked versions.

Please print the ethics amendment approval letter from REGIS and submit with a cover letter, via hard and soft copy to Research Governance at NSLHD-Research@health.nsw.gov.au and

NSLHD Research Office

Level 13, Kolling Building

Royal North Shore Hospital, Reserve Road

St Leonards, NSW, 2065