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.

Submit a completed Statistical Review Proforma. This is the required format for documentation of statistical review. Statistical review of a project should be undertaken prior to submission of your project to the HREC.

• The investigators must allow sufficient time to find a reviewer, allow the reviewer/review body to conduct the statistical pre-review and to address any comments adequately, prior to submission to the HREC.

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

Complete an HREC Cover Letter and and submit with your application.

Complete the Ethics Checklist. This should be completed by the coordinating principal investigator (CPI).

The CPI is the person who will submit the research project to the HREC on behalf of other sites and coordinate the ethical submission.

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

For projects with a site(s) in NSW, also complete the NSW Department of Health Privacy Form.

For projects with a site(s) in WA, 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.

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.

Submit the signed, original application by 1 pm deadline day. No extra copies are required. Find our more about HREC submission dates and deadlines.

• submit the original documents complete with CPI/PI authorisation via one of these three options:
  • HREA digital authorisation function via ERM; or

  • scanned copies of the original wet ink signatures; or

  • an email from CPI/PI authorising the submission (must reference the project number in the email)

Submit the original application to:

Manager, Human Research Ethics Committee
Office for Research
Level 2 South West, 300 Grattan Street
PARKVILLE VIC 3050

Complete an application for Research Governance where Melbourne Health is a participating site.

It is strongly recommended that governance applications are submitted together with the ethics application on the HREC submission deadline day. This will ensure faster approval and earlier commencement of your project by allowing the Office for Research to review everyone’s project in the most efficient manner possible.

Concurrent submission of ethics and governance applications is strongly recommended where MH is providing ethical review and is also a participating site. ERM (effective 16 July 2018), the new online platform for ethics and governance applications, will allow ethics and governance applications to be generated and submitted concurrently. Governance applications for MH as a site where ethical review is undertaken by another HREC can be submitted at any time.