Ethics

For studies where Melbourne Health will formally act as sponsor of a research project, including:

• MH sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
• All MH-led multi-site studies

At least six (6) weeks before the intended submission deadline date call the Office for Research on 9342 8530 to confirm whether an MH Sponsorship Review Meeting is required for your project.

This process must be completed before a trial/study application can be accepted for ethics and/or governance review.

With the exception of commercially sponsored clinical trials, all applicants will need to submit a completed Peer Review Proforma.

This is the required format for documentation of the reviewer’s comments on the protocol and contains all the required elements for the review. Peer review of a project should be undertaken after the scientific protocol has been developed and must always occur before the application is submitted for HREC approval.

• The investigators must allow sufficient time to find a reviewer, allow the reviewer to conduct the peer review, and to address the reviewer’s comments adequately, prior to submission to the HREC.

For more information about this new process please refer to the Peer Review Process document.

Download and complete the New Submission Fee Payment Form. Fees are payable up-front, at the time of initial submission of a research project.

Visit the Research Fees page for detailed information on all ethics and governance fees.

Complete and submit a detailed project protocol in the application.

Researchers may elect to use the project protocol template for investigator initiated studies.

Ensure the protocol includes the following information:

• Clear title
• List of authors and affiliated organisations
• A statement on ownership
• A statement of compliance
• version number and date
• list of study sites and what aspects of the protocol that will be undertaken at those sites
• data management plan (may be a separate document)
• risk assessment (may be a separate document)

Include any other project documentation, such as:

• documents to be given to participants, such as letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
• assessment tools
• advertising materials
• data collection sheets

For all research projects with a site in Victoria, the Victorian Specific Module (VSM) is mandatory.

Complete the Victorian Specific Module.

Does the project application include sites in other states and territories?

• NSW site(s) - Also complete the NSW Department of Health Privacy Form.
• WA site(s) - Also complete the Western Australian Specific Module (WASM).

Complete a Participant Information and Consent Form (PICF) if the study involves participants from whom you are obtaining consent.

Note that PICFs must be submitted electronically in MSWord format - not PDF.

Different templates are available on the Department of Health website. Use the template(s) that are appropriate for the type of research you are conducting.

• Download a guide for writing PICFs.

Recruitment Tips

• Download a guide to Essential considerations for recruiting people into your research study.

Contact details for the PICFs:

Where Melbourne Health is the reviewing HREC

Reviewing HREC approving this research and HREC Executive Officer details

For Melbourne Health site complaints

Complaints contact person

Where radiation (including pre-MRI safety screening examinations) is not additional to standard care

For Melbourne Health sites: If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care, an independent assessment report by the Royal Melbourne Hospital Medical Physicist must be included in the ethics application.

For non-Melbourne Health sites: If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care at the site, the site Principal Investigator must provide a confirmation letter. The letter should be based on the template - available on the Department of Health Clinical Trials and Research website - and must be included in the ethics application submitted to the reviewing HREC.

Where radiation (including pre-MRI safety screening examinations) is additional to standard care

If radiation exposure (including pre-MRI safety screening examinations) in a research project is additional to standard clinical management/care, an independent assessment report by a Medical Physicist must be included in the ethics application (one report for each applicable site).

Special Consideration

Where the procedures in which exposure to ionising radiation are considered to be additional to standard care at some sites and standard care at other sites and/or the exposure dose is markedly different from site to site, the Coordinating Principal Investigator must investigate this difference with the respective site Principal Investigators and complete and submit the “Ionising Radiation Variation Form part A”. The Coordinating Principal Investigator must provide the reason for the variation and his/her opinion as to whether the differences are reasonable and acceptable.

Where the Research Protocol allows the Principal Investigator at each site to choose the modality of the investigations eg: CT scan or MRI; Echocardiogram or MUGA, CT scan or plain X-ray, the Coordinating Principal Investigator must complete the “Ionising Radiation Variation form Part B” for all sites where the ionising radiation modality is the chosen procedure and provide the rationale for this decision and his/her opinion as to whether this is reasonable and acceptable.

More information

Find out more about ethical review of research projects involving ionising radiation.

Applicants must submit both the ethics application via ERM and email by the 11am deadline:

1. Upload all application documents onto ERM and submit; and
2. Email an electronic copy of the whole application (all documents) to HRECSubmissions@mh.org.au

• Ensure that the PICF is submitted in MSWord format (not PDF).
• Documents must include CPI/PI authorisation using one of the following three options:
  • scanned copies of the original wet ink signatures; or
  • HREA digital authorisation function via ERM; or
  • an email from CPI/PI authorising the submission (must reference the project number in the email)
• The Local HREC Project Number and the Electronic Medical Records (EMR) number (i.e. RMH1111), must be included in both the email subject field and in the individual file names.
• Standard formats for naming files are outlined below.

File name convention

To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.

Projects submitted that do not follow these formats will not be considered and will be returned via email to sender.

Convention: [Project Number] [EMR number] [Document Name] [Version Number] [Date]
e.g. 2020.999 RMH11111 Protocol Version 1 29082017