Ethics

Local HREC Project Number

To obtain a local HREC project number, open the following email template and provide requested details: research@mh.org.au.

For commercially sponsored clinical trials, ensure that you obtain this number immediately upon confirmation of site selection by the sponsor.

Label ethics documentation with the Local HREC Project Number and the EMR number

Ensure that the Local HREC Project Number provided by the Office for Research (e.g. 2020.999) and the Electronic Medical Record (EMR) number (e.g. RMH1111) are used on all forms and communications regarding the project.

From where do I get the EMR number?

Use the five-digit number within the ERM code given during the creation of the ethics or SSA form in the HREA as your EMR number. Confused? See example below:

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 or the qualitative 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

Statistical Review

With the exception of commercially sponsored clinical trials, it is expected that researchers obtain appropriate statistical input into the development of a protocol.

The purpose of obtaining statistical input is to ensure that the proposed research is well designed and the methods can answer the research question.

Statistical input should be sought during the design stage of the project and prior to the submission of the project and will assist with development of the research question(s), selection of study design, sample size calculation and statistical analysis plan.

You may wish to seek statistical support. Further information can be found here.

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

Complete the Victorian Specific Module.

If the project application include a site in Western Australia, you must also complete and submit 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:

Reviewing HREC approving this research and HREC Executive Officer details

For Royal Melbourne Hospital site complaints

Complaints contact person

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

For RMH 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 RMH Medical Physicist must be included in the ethics application.

For non-RMH 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.

Submission is a two-step process

Each project needs to be submitted by Email and via ERM by 11:00 AM on the deadline day.

1. Upload all the application documents onto ERM and ensure you hit "submit";

and

2. Open the following email template and attach all the application documents:
   HRECSubmissions@mh.org.au. If you do not receive email confirmation that the Office for Research has received your ethics submission, contact the Office for Research directly on (03) 9342 8530 to confirm receipt.

Final checks when submitting your documents

Ensure that the following advice is adhered to:

• PICF is submitted in MSWord format and not in PDF;
• Submission must include CPI/PI authorisation using any one of three options below:
  • scanned copies of the original wet ink signatures; or
  • HREA digital authorisation function via ERM; or
  • an email from the CPI or PI, that references the Local HREC project number in the email, authorising the submission
• Use the file name convention outlined below for each document - this will allow HREC members to identify documents more easily.

File name convention

As shown in example below, include the following: [Local HREC Project Number] [EMR number] [Document Type] Version [Version Number] [Date]

Examples:

• 2020.999 RMH11111 Protocol Version 1 29082020
• 2020.999 RMH11111 PICF Version 3 30092020
• 2020.999 RMH11111 HREA Version 1 22102020

Projects submitted that do not follow these formats will be returned via email to sender and may not be considered for the meeting if not returned in correct format before the 11:00 AM deadline.

Criteria for Review at the next HREC meeting

Submission of a new research project must be received by the 11am deadline however this does not a guarantee that a project will be accepted for review by the HREC at its next meeting.

Following the submission deadline each month, all projects received will be carefully checked to ensure that projects meet the criteria required to allow a thorough review of the project. Projects not meeting these criteria in full will not be accepted for review and will be returned to the principal researcher for attention.