Research amendments

COVID–19 - Advice to Researchers regarding Changed Data Access Arrangements

The PHSREC has become aware that researchers may be experiencing changes to working arrangements as a result of measures taken to combat the spread of the COVID–to19 virus.

Please consult the following advice if your access to NSW Health data is changing:

• For already-approved personnel who will exclusively access de-identified unit record data via SURE, or approved instances of eRICA, there is no need to seek an amendment.
• If access to de-identified unit record data is managed via a VPN service, and the data are not leaving the Institution’s IT infrastructure, then there is no need to seek an amendment.
• Where the approved study documentation explicitly states that unit record data will not be accessed remotely, and the Investigator team has been instructed to work remotely, please contact the Secretariat for further advice.
• For all other scenarios, please contact the Secretariat for further advice.

The PHSREC secretariat can be contacted on cinsw-ethics@health.nsw.gov.au . Please include your Project’s REGIS Reference number and CINSW Reference number in the Subject Line. We will endeavour to respond to your query as soon as possible.

Amendments

Please note that all requests for amendment and changes in personnel are to be submitted via REGIS, and that requests cannot be accepted via email. Please attach to your REGIS form the relevant Cancer Institute NSW request template as available here, along with all updated and associated documentation in clean and tracked forms. Find the guidelines on how to submit an amendment request in REGIS.. 

The PHSREC requires notification of any changes to personnel on the project if the personnel fall within the categories of Coordinating Principal Investigator, site Principal Investigator and/or persons that have access to identified or linked data. Please contact the CHeReL before submitting any amendment requests for studies that involve linked data at: moh-cherel@health.nsw.gov.au. 

• Researchers wishing to amend an ethically approved research project must complete a PHSREC Request for Amendment form (Word Doc) to be attached to the REGIS Amendment Form.
• All change in personnel requests must be submitted via REGIS under the "General Amendment" request type. Please attach a completed PHSREC Change in Personnel form (Word Doc), updated protocol in TRACKED changes, and CV(s) to your amendment in REGIS. 
• Researchers amending the addition of a new site and a new Principal Investigator at the site must complete a PHSREC Request for Amendment form (Word Doc) and PHSREC Change in Personnel form (Word Doc).

PHSREC Amendment forms

• Request for Amendment form (Word Doc) (updated 06/04/2020)
• Change in Personnel form (Word Doc) (updated 10/08/2023)