A condition of approval of all projects approved by the Melbourne Health Human Research Ethics Committee (HREC) is that an annual progress report must be submitted by the principal investigator.
In addition to submitting the progress reports, investigators are also required to submit a final report, due on completion of the study, or if the research is discontinued before the expected date of completion.
What does 'completion' of a project mean?
- For commercially sponsored clinical trials - a study is considered complete once the closeout visit has been completed.
- For investigator initiated clinical trials - a study is considered complete once the last patient has completed follow-up and the data have been analysed.
- For other research projects - a study is considered complete once data collection is complete and there is no further contact with patients or access to medical records or other sources of personal health or information and the data have been analysed.
Ongoing HREC approval
Continued ethical approval of a project is contingent upon the Office for Research receiving an annual progress report before the anniversary of HREC approval. A failure to do so may result in withdrawal of ethical approval.
The reporting period is for the twelve months preceding the anniversary of your approval date (the first report will be for 11 months, subsequent reports will be for 12 months).
For example, if your project was approved on 12th February 2011, the first year’s progress report period would be from February 2011 - January 2012, then January 2012 - January 2013. Note these dates at the top of your form.
For multi-site studies
- Where the Melbourne Health HREC is the reviewing HREC: Complete the HREC Progress Report – Site Report for your site and a completed HREC Progress Report CPI Cover Sheet to the Office for Research.
- Where the Melbourne Health HREC is NOT the reviewing HREC: Complete the HREC Progress Report – Site Report and submit a copy of the form to the Office for Research. Also forward a copy of the completed form to the Coordinating Principal Investigator of the project.
For all other studies
- Complete the HREC Progress Report – Site Report and submit a copy of the form electronically to the Office for Research.
If your project has finished, also submit a HREC Final Report and include it with the documents submitted.
- Reports must be submitted electronically to Progress Report Submissions.
- Progress Reports must be submitted one month prior to the anniversary of the HREC approval date. The Final Report form should be forwarded in a timely manner after the completion of the project.
- Use the appropriate text in the email subject line to allow us to match your project with our records by including the Local HREC Project Number:
- HREC project [Local HREC Number] [Reporting year/s] Progress Report e.g. HREC project 2014.322 2014-2015 Progress Report
- HREC project [Local HREC Number] [Reporting year] Final Report e.g. HREC project 2014.322 2015 Final Report
- Do not send other documents (such as amendment forms, insurance certificates, SAEs etc) to this email address, or they will be returned to you for submission to the appropriate email address.
Acknowledgement of submission and approval
Reports will be acknowledged via an automatic email response. File the automatic response in the project site files as evidence that the progress report has been received by the Office for Research and that ongoing HREC approval has been approved for a further 12 months.