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 Melbourne Health Human Research Ethics Committee 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.
Need help navigating your way through a research study?
The Path to Research Success provides an overview of the key elements and helpful tips that are crucial to conducting a successful research project.
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 Melbourne Health please visit our COVID-19 webpage.
For new COVID-19 related studies please also refer to information from the Coordinating Office for Clinical Research (DHHS). Visit the COVID-19 webpage and scroll down.
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, Melbourne Health–led research projects where Melbourne Health will formally act as the sponsor
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.
2. Local HREC Project Number
Contact the Office for Research on 9342 8530 to obtain a Local HREC Project Number (i.e. 2018.999).
The Local HREC Project Number, and for projects with a Melbourne Health site, the Electronic Medical Records (EMR) number (i.e. RMH12345), must be used on all forms and in all communications regarding the project.
NOTE: See Item 10 in this process where Melbourne Health is a site on the project. 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.
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.
4. Statistical Review of the project
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.
6. 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.
7. Project protocol and other project documents
Complete and submit a detailed project protocol in the application.
Researchers may elect to use the 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
8. 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
NOTE: The Melbourne Health HREC does not accept the LNR VIC form.
Help and support for use of ERM
|Infonetica Helpdesk||02 9037 firstname.lastname@example.org|
|DHHS Victoria||03 9096 email@example.com|
9. 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?
10. REDCap survey to inform the project build in EMR
For projects involving Melbourne Health 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: firstname.lastname@example.org.
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 Melbourne Health 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.
11. 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 Melbourne Health is the reviewing HREC
Reviewing HREC approving this research and HREC Executive Officer details
|Reviewing HREC name||Melbourne Health HREC|
|HREC Executive Officer||Manager HREC|
|Telephone||(03) 9342 8530|
For Melbourne Health site complaints
Complaints contact person
|Name||Director Research Governance and Ethics|
|Telephone||(03) 9342 8530|
12. Investigator's brochure
If conducting a drug, biologicals or device clinical trial, submit one copy of the investigator's brochure (IB).
13. Research involving ionising radiation
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).
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.
14. 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.
15. Electronic Submission **Hard copies of Ethics submissions no longer required**
Applicants must submit both the ethics application via ERM and email by the 11am deadline:
- Upload all application documents onto ERM and submit; and
- Email an electronic copy of the whole application (all documents) to HRECSubmissions@mh.org.au
- Ensure that the PICF is submitted in MSWord format (not PDF).
- Documents must include CPI/PI authorisation using one of the following three options:
- scanned copies of the original wet ink signatures; or
- HREA digital authorisation function via ERM; or
- an email from CPI/PI authorising the submission (must reference the project number in the email)
- The Local HREC Project Number and the Electronic Medical Records (EMR) number (i.e. RMH1111), must be included in both the email subject field and in the individual file names.
- Standard formats for naming files are outlined below.
File name convention
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted that do not follow these formats will not be considered and will be returned via email to sender.
Convention: [Project Number] [EMR number] [Document Name] [Version Number] [Date]
e.g. 2020.999 RMH11111 Protocol Version 1 29082017
16. Research Governance application
Complete an application for Research Governance where Melbourne Health is a participating site.
Note: Research governance applications for projects reviewed by the MH 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 will be withdrawn.
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.
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 under the heading NMA Research Governance/Site Specific Assessment (SSA) Application on the DHHS website at: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/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 Melbourne Health 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 Melbourne Health sponsored CTN clinical trials (ie investigator initiated trials where there is no external sponsor)
Upon receipt of governance approval letter from Melbourne Health, researchers must make an appointment with the Office for Research, Research Support Officer 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.
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