RMH, the ethics committee and investigators must ensure that the research continues to conform to approved ethical standards, and in accordance with the Melbourne Health Research Policy.
Office for Research 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.
I have Ethics and Governance approval, what now?
- Register participants on iPM as a research participant at the time they are first enrolled or consented.
- Ensure that participants (including health volunteers) are registered with HIS and have a UR number. Visit the HIS webpage for more information.
- Notify the Office for Research of the actual start date of the project at Melbourne Health
- Submit updated insurance certificates to: InsuranceCertificates@mh.org.au. Include the project number in the subject line of the email.
Post Approval Management
- Post Approval Monitoring
- Adverse Events involving patients of Melbourne Health.
- Serious Breaches (Previously Protocol Deviation and Violation)
- Progress Report every 12 months
- Final Report upon completion of the project
- Correspondence which may include:
- Unforeseen events
- Any matters not covered elsewhere which may impact on the conduct of the project at Melbourne Health.
- Amendments to the project approved by another Ethics Committee