Managing Your Approved Human Research Ethics Protocol

Amending an approved Human Research Ethics protocol

If you need to amend your original research protocol (after approval has been given), you are required to submit an amendment.

The ANU does not grant retrospective approval for changes to research projects. You must gain approval before commencing with the varied protocol.

For amendments to projects with student (Honours, HDR, Masters) Principal Investigators (PIs), supervisor signoff is also required.

Amending legacy protocols 

Active applications that were transferred from ARIES are called 'Legacy' protocols within REMS.  Amendments to Legacy protocols are limited to minor amendments which may include changes to:

  • Participant numbers
  • Remuneration
  • Locations
  • Personnel

Changes to methods and or participant groups listed in the National Statement are subject to assessment by the HREC Chair.  

Amending HREA protocols

Applications to HREA protocols can be made by changing the areas of the form to reflect what is proposed. Please ensure that revised participant facing documentation is also uploaded in support of the changes requested.  

Please visit our Human Ethics Sharepoint page for guidance on submitting amendments.

 

Approval conditions - Submission of reports

Annual reports

Research projects that have received Human Ethics approval from ANU will need to provide a report annually until the project has been completed. You will receive a notification email from REMS when an annual report is due. Reports are submitted through REMS. Further information on how to do this is available on the Human Ethics Sharepoint page.

Expiry reports

As the expiry date of your protocol approaches you will receive a notification from REMS. This notification serves as both a reminder to initiate a new application if your work is continuing as well as to prompt you to submit an expiry report.   Reports are submitted through REMS. Further information on how to do this is available on the Human Ethics Sharepoint page.

Protocols do not need to remain open once data collection phase is complete. If you would like to close your project early please submit an expiry report within REMS. Should further data collection be required on closed protocols* they can be re-opened within REMS by contacting the Human Ethics Office.

*Projects closed prior to the use of REMS or on Legacy forms transferred from ARIES cannot be re-opened.

Please see this link for the REMS training video guidance for completing – an annual or expiry report for a Human Ethics protocol - How to submit and annual and expiry report.

 

 

Contact

  • Enquiries relating to Human Ethics
  • +61 2 6125 3427
  • Send email

Page Owner: Research Services