Office for Research Closure Dates and Reduced Services
All allocations of ethics submissions to the MH HREC December meeting have been exhausted
The Melbourne Health HREC capped the number of submissions that were to be accepted for review to the December meeting to 25 (15 non-commercial studies; 10 commercial studies). In the first instance, places were allocated to people who had already obtained a HREC Project Number.
Q. I've missed out, what are my options?
A1. Submit to another reviewing NMA HREC
If you missed a spot for the December 2018 HREC meeting, we encourage you to contact another reviewing National Mutual Acceptance (NMA) Human Research Ethics Committee. Details can be found via the Victorian Department of Health webpage: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/hrec-applications-for-clinical-trials-and-research.
A2. Submit to a subsequent meeting in 2019
Alternatively, you can submit your project to a subsequent Melbourne Health HREC meeting in 2019. If you choose to do this, you will need to obtain a new “2019” Melbourne Health local reference number i.e. 2018.999. To obtain a 2019 MH local reference number, please contact the MH Research Office on: (03) 9342 7098.
For 2019 ethics submission deadline dates, please see: https://www.thermh.org.au/research/researchers/ethics/hrec-meeting-dates-deadlines.
Office for Research Closure Dates and Reduced Services
The Office for Research will close for business over the Christmas holiday period from 12pm, Thursday 20th December 2018 inclusive and reopen on Monday 7th January 2019. Note that leading up to this time, the Office for Research will be on reduced services.
Submission of New Projects
|Submissions Close||Submissions Reopen|
|New Research Governance Submissions|
(including Governance only)
|16 December 2018||7 January 2019|
|New Quality Assurance Submissions||28 November 2018||7 January 2019|
|New Research Ethics Submissions||28 November 2018||Deadline Dates|
Budget review services will be limited from 16 November 2018 until 15 January 2019.
Amendments and Other Correspondence
We will continue to accept other correspondence such as:
- safety reports,
- progress and final reports
Local HREC Project Numbers
If you are not submitting in 2018, call the Office for Research to obtain a new 2019 number
All researchers/research coordinators who have obtained a “2018” project number from the Office for Research and find that they will not be submitting their applications by the respective deadlines outlined below must call the Office for Research and obtain a “2019” Local HREC Project Number. Call 9342 8530 or email to Research@mh.org.au.
- Ethics application 2018 deadline: 1.00pm, 28 November 2018
- Governance only 2018 deadline: 16 December 2018
All new applications (Ethics or Governance only) submitted in the new year must obtain and use a “2019” Local HREC project number. This allows the office to track new applications quickly and efficiently.
Note that the Office for Research will not accept any new submissions during the Office Closure Dates listed above article.
Online Forms will no longer be accepted by Victorian and Queensland ethics committees. Researchers will need to log into Ethics Review Manager (ERM) to create new ethics and governance applications.
ERM is the new platform adopted by the DHHS for use by all hospital ethics committees in Victoria. All ethics and governance data has been migrated from Online Forms to ERM.
What does this mean for you?
- If you have submitted a VIC or QLD Online Forms application in the past, you will automatically have an ERM account. Your new ERM account will have the same log in details as your old Online Forms account. Contact the Infonetica Helpdesk if you have forgotten your log in details.
- The DHHS Victoria is providing support and training during and after the ERM roll-out and will provide information sessions for researchers, study coordinators, heads of departments (providing digital signature), sponsors, CROs etc.
All jurisdictions that participate in National Mutual Acceptance (NMA) are committed to working cooperatively. DHHS is working with other state/territory Departments of Health to ensure that there is minimal disruption for NMA applications. For help and support for National Mutual Acceptance, please contact DHHS, Victoria: (t) 03 9096 7394 (e) firstname.lastname@example.org
Help and Support
|Infonetica Helpdesk||ERM technical support including logins||02 9037 email@example.com|
|DHHS||Ethics enquiries relating to ERM||03 9096 firstname.lastname@example.org|
ERM training sessions for researchers/coordinators
It is essential that all staff involved in the application of ethics and governance approval learn how to use the new platform and are strongly encouraged to attend a training session.
The Department of Health and Human Services has arranged online training sessions for research applicants using the new ERM system. You can join the meeting from your computer, tablet or smartphone.
Perform a quick system check: https://link.gotomeeting.com/system-check.
|Date||Time (AEST)||Web Address or Dial in||Access Code|
|Thu 2 August||2.00 pm to 4.00 pm|
Phone: 02 8355 1050
|Thu 9 August||10.00 am to 12.00 pm|
Phone: 02 9087 3604
|Thu 16 August||2.00 pm to 4.00 pm|
Phone: 02 8355 1038
|Thu 30 August||10.00 am to 12.00 pm|
Phone: 02 9087 3604
- Getting started in ERM
- How to create and submit an ethics application
- How to transfer and accept an SSA
- Post approval
- Use of the minimal dataset form (MDF)
Department of Health and Human Services, Victoria
Telephone: 03 9096 7394
The new ethics and governance submission system, ERM, (Ethics Research Manager) went live last month and the system is mandatory for all new ethics and governance applications. While the platform was originally intended to include post approval submissions i.e. amendments, safety reports, breach reports , progress/final reports etc , the Melbourne Health Office for Research, together with other certified Victoria research offices, has decided not to use the system for review of post approval submissions until ERM is upgraded appropriately and tailored to manage site requirements.
Please note, the Office for Research intend's to use the ERM system for this purpose in the future provided that the system is fit for purpose in early 2019 – we will issue further advice about the actual start date for managing post approval submissions through ERM when a decision has been made. In the meantime, we strongly recommend researchers/coordinators ensure they have access to all of their projects via ERM in anticipation of the change. All existing Melbourne Health projects (ie projects originally submitted through Online Forms) have been migrated to the new ERM database and should be accessible to you. If you have trouble logging into ERM or cannot see the project listed under your log in or have any other difficulties using ERM – please contact the Infonetica Helpdesk directly by email: email@example.com or telephone: (02) 9037 8404.
In summary researchers and coordinators are asked to revert back to our original POST APPROVAL processes as per instructions on the RMH website.
Effective 27 June 2018 deadline, all research protocols will require:
- Peer review before submission to the Melbourne Health Human Research Ethics Committee (HREC), and evidence of this review must be submitted with the application using the Peer Review Proforma. Please refer to the Peer Review Process document
- Statistical review before submission to the Melbourne Health HREC, and evidence of this review must be submitted with the application using the Statistical Review Proforma. Please refer to the Statistical Review Process document.
Projects which have already had a rigorous independent review of the research protocol do not need to undergo additional peer or statistical review prior to submission. This applies to commercially sponsored research projects as well as a number of other exceptions – these are outlined in the Submission Process documents for the respective processes.