​​​​​​​​​​​​​​​​​Annual Progress/ Final Reporting Submission Requirements for Low Risk/ QA Projects reviewed and approved by Western Health

A condition of authorisation of all projects authorised by the Western Health is that an annual progress report must be submitted by the Principal Investigator (PI) and Human Research Ethics Committees (HRECs)/Low Risk Ethics Panel (LREP) are required to monitor research in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2023).  A condition of approval and site authorisation of all projects approved by a HREC/LREP is that a report of project progress is submitted annually by the PI.

Click here for the Progress Report QA LR Summary Guide

Single submission date

The Office for Research has streamlined timeframes for submitting annual progress reports and self-audit forms with implementation of the same annual due date for all projects. This has been in effect since 2022. Progress reports for Low Risk and multi-site SSA projects are due on 01 May each year. Meaning, annual progress reports will no longer be due by the anniversary of HREC approval.

For Low Risk Research approved by Western Health Low Risk Ethics Panel, we also ask that investigators submit the final site report with the annual progress report to this deadline unless an acknowledgement is required earlier.

NOTE: Projects approved via the Quality Assurance/Minimal Risk/Evaluaion/Clinical Audit Project review pathway require ONLY a Final Report, and this should be proivded when the project is completed and certainly by the expiry of approval which is 2 years post approval date.

Why implement a single due date for progress reports?

The Office for Research envisages that a single due date for all progress reports will be easier for investigating teams to remember. In the past teams have forgotten to submit progress reports thus jeopardising the ethics status of their study. With this change we aim to avoid this confusion.

A single due date will also improve reconciliation and reporting by the Office for Research.

Reporting Period

The reporting period is for the twelve months preceding the annual due date which is 01 May i.e. May 2024 to May 2025.

Note: Annual Progress Reports for projects that have been approved in January – April in any year do not need to be submitted until 1 May the following year.

Annual Progress Reports

An annual progress report and self-audit should be submitted to the Office for Research by 01 May every year (Starting 2022). Continued ethical approval of a project is contingent upon the Office for Research receiving an annual progress report before the anniversary of LREP approval or as specified by the LREP. A failure to do so may result in withdrawal of ethical approval.

How to Submit an Annual Progress Report to WH

• The site Principal Investigator (PI) should create, complete and submit a  Site Notification Report Form sub form via Ethical Review Manager (ERM) where the main form is a VIC LR Form or VIC LNR form and select on the form that it is a 'progress report'.   For projects where the main form is an HREA form please create a Project Progress Report Form via Ethical Review Manager. 
  
• Complete all fields. If for your project a field is not applicable state “Not Applicable” or “(N/A)” Do not leave fields blank.  
• Ensure your summary of progress provides adequate details of the progress and status of the project at the time of completing the report. 
  Complete and upload the following documents on ERM (as supporting documents to the report):
  
• WH Self-Audit form (download this form on right hand side links)
•  If applicable, copies of any publication(s)
• Obtain signature(s) of Principal Investigator electronically via ERM
• Select Submit on ERM once you have obtained the required signature(s)
  
  

PLEASE NOTE: Failure to submit progress reports may result in suspension of the study and audit investigation from the Office for Research.

Acknowledgement of report and ongoing authorisation

• All Progress Report Acknowledgments from the Office for Research will be through an email generated in ERM with an Acknowledgement letter attachment.
• Research teams should file the acknowledgement email/s in the Investigator site file as evidence that the project has been approved for a further 12 months.