Our orgnaisation, 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 closure December 2020 – January 2021
The Office will close for business from 11.00 am Wednesday, 23 December 2020 and reopen on Monday, 4 January 2021. Please see deadline dates below for submissions to the Office for Research and HREC:
- Closing date for new Quality Assurance applications: 4 December 2020.
- Closing date for new Governance applications: Monday 14 December 2020.
- Budget review services and invoice requests may be submitted at any time, however requests received after Monday14 December may not be actioned until early/mid-January 2021.
- The deadline for the February 2021 meeting of the HREC is 11.00 am, Wednesday 27 January 2021
- Other correspondence, including amendments, safety reports and replies to ethics and governance queries, can be submitted at any time but please note that reviews may take longer than usual.
Urgent matters, for example issues impacting patient safety and wellbeing, will be reviewed as soon as possible – researchers are asked to contact the Office for Research via telephone on (03) 9342 8530 to ensure that urgent matters are brought to the attention of the appropriate team member so they can be reviewed and actioned 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
Insurance certificates
Post approval submission of insurance certificates to the Office for Research is no longer a requirement.
Post Approval Management
- Post Approval Monitoring
- Amendments
- 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