All research projects must be submitted for ethical and research governance review before a project can be given approval to commence.
Submit an ethics application for approval
The Royal Melbourne Hospital Human Research Ethics Committee (HREC) is constituted and operated in accordance with the National Statement on Ethical Conduct in Human Research 2007.
CPI, PI and Sponsor Guidance
The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the following documents.
COVID-19 Guidance for Research Studies including Clinical Trials
- For updates on how COVID-19 impacts research (including ethical review of studies) and updated requirements at RMH please visit our COVID-19 webpage.
- For new COVID-19 related studies please also refer to information from the Coordinating Office for Clinical Research. Visit the COVID-19 webpage.
Hints for completing the Ethics Application Process
- Prior to commencing your application review all of the items noted in the process below
- Note that the numbering system is arbitrary and that multiple items can be undertaken in parallel to save you time
- You can submit the research governance application at the same time as the ethics application
- We recommend obtaining departmental/service approvals as soon as possible after the protocol has been finalised
- Identify if you require an agreement early in the application preparation process and start drafting
Complete all items below to apply for HREC ethical review.
1. For Investigator-initiated, RMH–led research projects where RMH will formally act as the sponsor
For studies where RMH will formally act as sponsor of a research project, including:
- RMH sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
- All RMH-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 RMH 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.
2. Local HREC Project Number and the EMR Number
Local HREC Project Number
To obtain a local HREC project number, open the following email template and provide requested details: email@example.com.
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:
|Ethics Review Manager (ERM) Codes||Electronic Medical Record (EMR) number|
|HREC/12345/MH-2020 in ERM||Becomes the EMR number:|
3. Expert peer review of the project
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.
5. 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.
6. Project protocol and other project documents
Complete and submit a detailed project protocol in the application
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
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.
7. Human Research Ethics Application (HREA)
Applicants must complete the HREA Form for all Research projects including Low Risk Research via Ethics Review Manager (ERM).
For help, download the ERM Applicant User Guide.
Ensure the HREA has been authorised by:
- The Chief Principal Investigator (CPI) for multi-site projects
- Principal Investigators (PI) for single-site projects
Important: The RMH HREC will not accept the Low Negilible Risk (LNR) VIC form.
Help and support for use of ERM
|Infonetica Helpdesk||02 9037 firstname.lastname@example.org|
0408 274 054
8. Victorian and other State Specific Modules
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?
9. REDCap survey to inform the project build in EMR
For projects involving RMH as a site and have a local project number starting with 2020.XXX complete the REDCap survey for the project study build in EMR here: EMR (EPIC) REDCap survey .
For older projects, please contact the EMR Research Team by email: email@example.com.
As part of your ethics submission you must Include a copy of the email you received from the epic.research team as confirmation that the REDCap survey has been completed for your project.
What project number do you need to use on the survey?
- use the Electronic Medical Records (EMR) number (i.e. RMH12345), to identify the project in the survey.
The Electronic Medical Records (EMR) number is derived from Ethics Review Manager code given during the creation of the project application, i.e. HREC/12345/MH-2020 in ERM becomes EMR site code RMH12345.
Why do you need to do this?
Completion of the survey is required for every project being conducted at RMH with a project number starting from 2020.001, regardless of whether or not your project will involve accessing and/or writing in the EMR.
If you do not need to access the EMR, or a SmartSet to be built within the EMR, for your project, the email you receive from the Epic Research team will serve as confirmation of this.
If your project requires a SmartSet to be built within the EMR, this early action will ensure that you can use the EMR as soon as possible once governance approval has been issued.
NOTE: the SmartSet build may take up to 4 weeks from completion of your REDCap survey so it is essential you complete the survey as early as possible.
10. Participant information and consent forms
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 to Essential considerations for recruiting people into your research study.
Contact details for the PICFs:
Where Royal Melbourne Hospital is the reviewing HREC
Reviewing HREC approving this research and HREC Executive Officer details
|Reviewing HREC name||Royal Melbourne Hospital HREC|
|HREC Executive Officer||Manager HREC|
|Telephone||(03) 9342 8530|
For Royal Melbourne Hospital site complaints
Complaints contact person
|Name||Director Research Governance and Ethics|
|Telephone||(03) 9342 8530|
11. Investigator's brochure
If conducting a drug, biologicals or device clinical trial, submit one copy of the investigator's brochure (IB).
12. Research involving ionising radiation
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).
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.
Find out more about ethical review of research projects involving ionising radiation.
13. Investigator CVs
Provide a current copy of the Principal Investigator's Curriculum Vitae (CV) if one has not been submitted in the previous 3 years and email to CVsFolder@mh.org.au by the deadline date.
For Investigators who do not have a CV handy you can complete and submit an Investigator Curriculum Vitae Form instead.
14. Submit your complete application via ERM and email
Submission is a two-step process
Email and ERM submission must be complete by 11:00 AM on the deadline day.
- Upload all application documents onto ERM and don't forget to hit "submit";
- Open the following email template and attach all the application documents:
- the PICF is submitted in MSWord format (not PDF);
- submission must include CPI/PI authorisation using any one of three options:
- 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
- the file name convention as outlined below is used for each document so that documents are easily identifiable
File name convention
As shown in example below, include the following:
[Local HREC Project Number] [EMR number] [Document Type] Version [Version Number] [Date]
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.
15. Research Governance application
Complete an application for Research Governance where RMH is a participating site.
Research governance applications for projects reviewed by the RMH HREC must be submitted within 12 months of obtaining ethical approval. Where research governance applications have not been received in this time frame the ethical approval may be withdrawn.
Concurrent submission of ethics and governance applications is especially recommended where RMH is providing ethical review and is also a participating site.
It is strongly recommended that governance applications are submitted together with the ethics application on the HREC submission deadline day to ensure faster approval and earlier commencement of your project.
ERM allows ethics and governance applications to be generated and submitted concurrently.
Governance applications for RMH as a site - where ethical review is undertaken by another HREC - can be submitted at any time.
For investigators submitting SSA applications in states other than Victoria and Queensland
Instructions for investigators on how to create an SSA form for jurisdictions that do not use ERM can be found on the Coordinating Office website at: https://www.clinicaltrialsandresearch.vic.gov.au/national-mutual-acceptance
NOTE: For CTN Submissions
For externally sponsored CTN clinical trials (external sponsors may be commercial, a collaborative group or another hospital, etc)
Upon receipt of the HREC ethics approval from the reviewing HREC, external sponsors can lodge the CTN directly with the Therapeutic Goods Administration (TGA), online.
Sponsors are asked to provide the RMH Principal Investigator with a copy of the TGA's confirmation/acknowledgement of the CTN together with a PDF copy of the lodged CTN application to forward to HrecCorrespondence@mh.org.au as soon as this is available.
For RMH sponsored CTN clinical trials (ie investigator initiated trials where there is no external sponsor)
Upon receipt of governance approval letter from RMH, researchers must make an appointment with the Office for Research to lodge the CTN application online together.
The fees associated with the CTN submission will be set against the applicable research cost centre.
Direct any questions about the CTN submission scheme to the Research Support Officer.
Contact us if you need an accessible version of a download.