All components in section 1 are mandatory and must be completed for all ethics submissions.

1a. Obtain a local HREC project number

Complete the email template for

The Office will provide you with a Local HREC Project Number number. Please label all your documentation and communications with this number (for example, 2022.999) and the EPIC EMR number (for example, RMH12345).

What is the EPIC EMR number?

RMH asks that you 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:

  • In Ethics Review Manager the code appears as follows (or similar to): HREC/12345/MH-2020 
  • The five digits, bolded in this example, form your EPIC EMR number: HREC/12345/MH-2020
  • Therefore using this example the EPIC EMR number is RMH12345

1b. Project protocol and data collection tools

Submit a detailed project protocol

Ensure that the protocol template is appropriate for the research to be conducted. For investigator initiated studies, researchers are encouraged to use the appropriate protocol templates for their project.

Ensure the protocol includes the following information:

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

Include data collection tools, such as:

  • Questionnaires
  • Assessment tools
  • Data collection sheets

Can I submit a grant application as a project protocol?

No. Research proposals included in grant applications, such as NHMRC Ideas Grants, typically do not contain the degree of detail that is required for ethical review of projects. Therefore we ask that you use a Project Protocol template.

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 before the submission of the project and will help with development of the research question(s), selection of study design, sample size calculation and statistical analysis plan.

Researchers may elect to seek statistical support.

1c. Obtain expert peer review of the project

Submit a completed Peer review proforma.

This proforma provides the HREC with specific consideration of the protocol by the reviewer and contains all the required elements for the review.

The investigators must allow sufficient time before submission to:

  • Find a reviewer
  • Allow the reviewer to conduct the peer review
  • Address the reviewer’s comments adequately

With the exception of commercially sponsored clinical trials, all applicants will need to obtain an expert peer review of the project. 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.

Learn more about the Peer review process.

1d. Human Research Ethics Application

Complete the Human Research Ethics Application (HREA) for all research projects via Ethics Review Manager (ERM).

Ensure the HREA has been authorised by:

  • The Chief Principal Investigator (CPI) for multi-site projects
  • Principal Investigators (PI) for single-site projects

The RMH HREC does not accept the Low Negligible Risk (LNR) VIC form.

Access Ethical Review Manager
A paperless information management system for the entire life cycle of a research project

1e. Victorian Specific Module and other applicable state modules

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

Sites in Western Australia?

If the project application includes a site in Western Australia, you must also complete and submit the Western Australian Specific Module (WASM).

1f. Investigator CVs

Provide a current copy of the Principal Investigator's Curriculum Vitae (CV) if one has not been submitted in the previous three years and email to by the deadline date.

Investigators who do not have a CV on hand may complete and submit an Investigator Curriculum Vitae form instead.

1g. Ethics checklist

Complete the Ethics checklist.

The Coordinating Principal Investigator (multi-site projects) or the Principal Investigator (single-site project) should complete the ethics checklist when preparing the ethics application.

1h. Fee payment

Complete the applicable fee payment form:

Fees are payable upfront, at the time of initial submission of a research project.

See Research fees & payment schedule for information on all ethics and governance fees.

Contact us
Office for Research: Ethics Office
The RMH Parkville
300 Grattan St, Parkville, Victoria
Diabetes and Endocrinology research nurse with patient in Clinical Trials Centre
About clinical trials

We need clinical trials to prove that new treatments are safe and effective for people to use. They are essential to the discovery of new medications and devices, neither of which can be approved for use in Australia without clinical trials.