Section 1: Mandatory components for all ethics submissions

1a. Obtain a local HREC project number

Complete the following email template: research@mh.org.au.

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

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.

1e. Victorian Specific Module and other applicable state modules

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

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 CVsFolder@mh.org.au by the deadline date.

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

1g. REDCap survey to inform the project build in EMR

Complete the REDCap survey for all projects involving RMH as a site.

Provide evidence of completion of the survey with your application (for example, the email confirming you submitted the ‘Epic EMR Study Registration Survey’).

When completing the survey, note that:

• The survey consists of two parts, both of which must be completed: a Study Registration Form and an EMR Research Study Questionnaire
• Responses provided in the study questionnaire will determine if the study requires configuration to enable association and management of study participants in the Parkville Electronic Medical Record (EMR)
• You will need your 5-digit Ethical Review Manager (ERM) number to complete the survey. This is a unique 5-digit number generated by the ERM submission system (for example, HREC/XXXXX/RMH)

Questions? Email the EMR Research Liaison Coordinator

Why do you need to do this?

Completion of the survey is required for every project being conducted at the RMH regardless of whether your project will involve accessing and/or documenting in the Parkville EMR.

If you do not need to use or access Parkville EMR functionality the 'Research Study Questionnaire’ will confirm this by only asking key mandatory questions required to determine this.

If your project requires patient orders to be placed in the Parkville EMR you may require a Research SmartSet/Orderset to be configured. Based on your responses to the survey you may be requested to submit a SmartSet proforma in addition to completing the survey. The completed proforma will need to be returned to the central EMR team who will configure the order details. Timely return of the proforma is essential to ensure the build is completed and validated and ready for when Site Specific Authorisation is granted.

Please note that SmartSet build will take a minimum of two weeks post return of the SmartSet proforma and will depend on the workload of the build teams as well as the accuracy and completeness of the details provided.

Associate RMH clinical trial participants to your research record in the Parkville EMR

RMH requires that every clinical trial participant, enrolled or consented to an RMH trial (patients and healthy controls), is registered and associated to the trial in the Parkville EMR as a research participant. This must be done in real-time, regardless of where consenting takes place, to ensure the safety of every person enrolled in research at RMH.

The RMH Privacy brochure 'How the Royal Melbourne Hospital is Protecting Your Privacy' must be provided to all RMH patients being recruited to a research project that will access the patient’s medical record.

1h. 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.

1i. Fee payment

Complete the New submission 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.