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.
Office for Research News Update: Reduced Services over Christmas holiday period
The Melbourne Health Office for Research (OFR) will close over the Christmas holiday period from 12pm, Thursday 20th December 2018 inclusive and reopen on Monday 7th January 2019.
Leading up to this time, the OFR will be on reduced services. The OFR will continue to accept post approval items such as amendments/safety reports/breach reports/progress and final reports. However the review of these items will be deferred until mid-to-late January 2019.
Where there is a need for urgent review of an amendment or a safety report which may impact patient wellbeing, researchers are strongly advised to telephone the office on (03) 9342 8530 to ensure that the urgency of your correspondence is clearly understood so that review can occur in a timely manner.
Annual and Final Reports
In addition to submitting 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.
- For studies with a Melbourne Health site, complete a self-audit annually using the DHHS Self Audit Report for Research form and submit it with the Progress Report (see below for instructions). For further information regarding auditing of research at Melbourne Health refer to the Auditing research projects page of the website
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 February 2012 - January 2013. Note these dates at the top of your form.
Progress Reports must be submitted one month prior to the anniversary of the HREC approval date.
Forms for multi-site studies
- Where the Melbourne Health HREC is the reviewing HREC, submit the following:
- Progress Report – Site Form and
- Progress Report – Project Form (HREC).
- Where the Melbourne Health HREC is NOT the reviewing HREC,submit the following:
- Progress Report – Site Form. Also forward a copy of the completed form to the Coordinating Principal Investigator of the project.
For all other studies
- Complete the Progress Report – Site Form.
If your project has finished, submit a Project Final Report / Site Closure Report. The Final Report form should be submitted in a timely manner after the completion of the project.
Instructions: Submitting Progress/Final Reports
- Complete the relevant Progress Report/s or Final Report
- Email signed report/s to: ProgressReports@mh.org.au
Acknowledgement of submission and approval
- Reports will be acknowledged via an automated 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.