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 CloseSubmissions Reopen
New Research Governance Submissions
(including Governance only)
16 December 20187 January 2019
New Quality Assurance Submissions28 November 20187 January 2019
New Research Ethics Submissions28 November 2018Deadline Dates

Budget review

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:

  • amendments,
  • safety reports,
  • progress and final reports
Note however that 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.
If you find that you require urgent research/ethics advice during the Office closure dates, please contact Dr Angela Watt (0411 510 494).

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.

Ethics Review Manager must now be used to submit new research ethics and governance applications

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) multisite.ethics@dhhs.vic.gov.au

Help and Support

Infonetica HelpdeskERM technical support including logins02 9037 8404helpdesk@infonetica.net
DHHSEthics enquiries relating to ERM03 9096 7394multisite.ethics@dhhs.vic.gov.au

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.

First GoToMeeting?

Perform a quick system check: https://link.gotomeeting.com/system-check.

Training Schedule

DateTime (AEST)Web Address or Dial inAccess Code
Thu 2 August2.00 pm to 4.00 pm

https://global.gotomeeting.com/join/375781285

Phone: 02 8355 1050

375-781-285
Thu 9 August10.00 am to 12.00 pm

https://global.gotomeeting.com/join/138312629

Phone: 02 9087 3604

138-312-629
Thu 16 August2.00 pm to 4.00 pm

https://global.gotomeeting.com/join/335409413

Phone: 02 8355 1038

335-409-413
Thu 30 August10.00 am to 12.00 pm

https://global.gotomeeting.com/join/986001989

Phone: 02 9087 3604

986-001-989
The sessions will cover:
  • 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)
Coordinating Office for Clinical Trial Research
Department of Health and Human Services, Victoria
Telephone: 03 9096 7394
Web: http://www2.health.vic.gov.au/about/clinical-trials-and-research
Updated 1 August 2018: Use of ERM suspended for Post Approval processes

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: helpdesk@infonetica.net 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.

Updated 8 June 2018: Peer Review and Statistical Review required for all projects

Effective 27 June 2018 deadline, all research protocols will require:

  1. 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
  2. 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.