All research studies must be submitted for ethical and research governance review before a study can be given approval to commence.
Submit an ethics application for approval
The Royal Melbourne Hospital (RMH) Human Research Ethics Committee (HREC) is constituted and operated in accordance with the National Statement on Ethical Conduct in Human Research 2007. Look in the website table of contents box located on the left hand side of the screen for more information on the RMH HREC, meeting dates and other useful information.
CPI, PI and Sponsor Guidance
The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the following documents.
The Principal Investigator at RMH must be a paid employee of the RMH.
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.
Complete and submit all items that apply to your study
- Pre-submission Action (Only for RMH–led, investigator-initiated clinical trials/studies requesting RMH to formally act as sponsor);
- Core elements (All studies)
- +/- Participant Information (for recruitment/participant facing documents)
- +/- Radiation and/or Genetically Modified elements
- +/- Clinical Trial elements (Drug and/or Device Clinical Trials)
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 order of items 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 requesting budget and departmental/service approvals as soon as possible after the protocol has been finalised to save you time preparing research governance applications
- Identify if you require an agreement early in the application preparation process and start drafting
Pre-submission Action - For RMH–led, investigator-initiated clinical trials/studies requesting RMH to formally act as sponsor
RMH Sponsorship review and approval is required for studies where RMH will formally act as sponsor of the research, including:
- RMH led investigator-initiated drug and/or device clinical trials (CTN/CTA clinical trials within the scope of the Therapeutic Goods Act); or
- Large/resource intensive multi-site RMH-led research studies
Process to request formal RMH sponsorship:
- 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.
- If a sponsorship meeting is required, our office will
- organise a meeting time
- forward sponsorship request forms to you complete and submit prior to the meeting.
- Complete the forms and submit prior to the meeting.
- The Principal Investigator must attend the sponsorship meeting. Other key research team members may attend the meeting if appropriate.
- The information will be reviewed, where required additional expert advice will be obtained.
- Decision on whether RMH will sponsor the clinical trail/study will be forwarded to the Principal Investigator and research team contact person.
This process must be completed before a trial/study application can be accepted for ethics and/or governance review.
Core Element 1 - Local HREC Project Number and the EMR Number
Obtain a Local HREC Project Number
To obtain a local HREC project number, open the following email template and provide requested details: firstname.lastname@example.org.
For commercially sponsored clinical trials, ensure that you obtain this number immediately upon confirmation of site selection by the sponsor.
Label ethics documentation and communications with the Local HREC Project Number (e.g. 2022.999) and the EMR number (e.g. RMH12345).
Using these numbers will assist our office to track, review and file you project documents.
What is the EPIC 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:|
Core Element 2 - Project protocol and data collection tools
Submit a detailed project protocol
Ensure that the protocol template is appropriate for the research to be conducted:
Researchers may elect to use one of the following protocol templates:
- General research project protocol RMH template for investigator initiated studies
- Qualitative project protocol RMH template for investigator initiated studies
- Databank/Tissue bank protocol RMH template
- Supporting documents for Databanks/Tissue banks
FAQ. Can I submit a grant application as a project protocol?
No. Abridged protocols included in a grant application, such as NHMRC ideas grants, do not usually contain the degree of detail that is required to review or conduct a research project.
Ensure the protocol includes the following information:
- Clear title
- List of authors and affiliated organisations
- A statement on ownership
- A statement of compliance (to applicable giuidelnes etc.)
- 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:
- Assessment tools
- 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.
Core Element 3 - Expert peer review of the project
Obtain an expert peer review of the project
Submit a completed Peer Review Proforma.
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.
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.
The Peer Review Proforma provides the required format for documentation of the reviewer’s comments on the protocol and contains all the required elements for the review.
For more information about this new process please refer to the Peer Review Process document.
Core Element 4 - Human Research Ethics Application (HREA)
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 Negligible Risk (LNR) VIC form.
Help and support for use of ERM
|Infonetica Helpdesk||(02) 9037 email@example.com|
0408 274 054
Core Element 5 - Victorian and other State Specific Modules
Core Element 6 - 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.
All members of the study team must have sufficient and appropriate education, training, experience and resourcing to undertake their role on the study is a common requirement of:
- NHMRC National Statement on Ethical Conduct in Human Research (2007)
- The Good Clinical Practice Guideline (2016) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - Annotated with TGA comments
- National Clinical Trials Governance Framework (accreditation requirement for hospitals that conduct clinical trails)
Core Element 7 - REDCap survey to inform the project build in EMR
Complete the REDCap survey
Complete the REDCap survey for ALL projects involving RMH as a site.
Access the survey here: REDCap Survey
Provide evidence of completion of the survey with your application (Email for screening survey only or response from full survey).
- The survey is in two parts
- a short screening survey; and
- full survey.
- Responses provided in the short screening survey will confirm whether or not you will need to complete the full survey for the study. Examples of when a full survey will be required are if the study is a clinical trial, if the study require a study build manage the study/participants.
- Use the Electronic Medical Records (EPIC EMR) number (e.g. RMH12345) to identify the project in the survey.
Questions? Email the EMR Research Liaison Coordinator
Why do you need to do this?
Completion of the screening survey is required for every project being conducted at the Royal Melbourne Hospital regardless of whether or not your project will involve accessing and/or writing in the EPIC EMR.
If you do not need to access the EPIC EMR, or a SmartSet to be built within the EPIC EMR for your project, the screening survey will confirm this and you will not be directed to complete the full survey.
If your project requires a SmartSet to be built within the EPIC EMR, this early action will ensure that you can use the EPIC EMR as soon as possible once Site Specific approval has been issued.
It is important to take into consideration that 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.
Create a research record for every clinical trial participant
RMH requires that every clinical trial participant in a RMH trial (patients and healthy controls) is enrolled in a research project need to be registered in the EPIC EMR as a research participant at the time they are first enrolled or consented.
This must be done in real time regardless of where consenting takes place in order to ensure safety of every person enrolled in research at RMH.
Core Element 8 - 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.
Participant Information 1 - Participant Information and Consent Form / other consent forms
Submit applicable consent documents for ethical review in MS Word format only
Depending on the study these may include:
- Participant information and consent forms (PICF)
- Plain Language Statement (PLS)
- Opt-out information
- Transcripts for obtaining verbal consent
Participant information and consent forms (PICF)
Complete a Participant Information and Consent Form (PICF) if the study involves participants from whom you are obtaining consent.
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.
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 at RMH
|Name||Director Research Governance and Ethics|
|Telephone||(03) 9342 8530|
Download a guide to Essential considerations for recruiting people into your research study.
Participant Information 2 - All other participant facing documents
Submit all other documents requiring ethical review in MS Word format
Depending on the study the other documents may include:
- Letters of invitation
- Transcripts for telephone contact
- Wallet cards
- Participant diaries
- Questionnaires/self assessment tools
- Advertising materials
- Radio scripts
- Social Media text/scripts
Do not send PDFs.
Radiation and/or GMO elements 1 - 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.
Radiation and/or GMO elements 2 - Projects involving Genetically Modified Organisms
Requirements for projects involving GMOs
This information relates to clinical trials involving investigational products (IP) that are, or contains, a genetically modified organism (GMO).
In addition to the Therapeutic Goods Act (1989) and and Regulations (1990), trials involving GMOs are subject to the Gene Technology Act 2000 and Gene Technology Regulations 2001, which are administered by the Gene Technology Regulator (the Regulator), supported by the Office of the Gene Technology Regulator (OGTR) and Victorian state legislation that aligns with the federal legislation.
- TGA - the human safety and efficacy of investigational products
- OGTR - the health and safety of people and the environment from risks posed by gene technology
The type of OGTR regulatory approval required depends on the nature of the GMO and on its likely fate once introduced into the trial participant, specifically whether or not the GMOs is expected to be transmitted or shed by trial participants, thereby entering the environment.
For Investigator initiated trials request an appointment with the Office for Research to discuss the application.
- Download and read the following documents:
- The trial sponsor must advise the site that the IP is a GMO; the category of GMO and if it requires regulation by the OGTR.
Where regulation is required, the trial sponsor must also:
- Apply to the OGTR for a licence or exemption documentation
- Confirm who is responsible for organising Institutional Biosafety Committee (IBC) review of the trial (sponsor or site)
- Provide the licence or exemption documentation to:
- the site
- the responsible IBC
- Provide information to the study site in a timely manner to allow site to conduct feasibility review, obtain departmental and service approvals, and submit applications for ethical and research governance approval
Refer to 'Guidance for conducting clinical trials involving GMOs at the RMH' for details of information required and timeframes for submission
- The study site staff should:
- Request confirmation from the Sponsor on whether the IP is a GMO that requires regulation early in feasibility discussions
- Undertake a feasibility assessment for trials using a GMO as there may be extra costs and procedures involved
- Request the following information from the sponsor for inclusion in the application:
- Product information
- Classification of the GMO
- GMO Licence issued by the OGTR (if this has been issued)
- Questions and answers on licence decision (if licence issued)
- Summary of Risk Assessment and Risk Management Plan (if Licence has been issued)
- Full Risk Assessment and Risk Management Plan prepared by the OGTR (if licence issued)
- All GMO specific information to be provided to participant
- Name of the iBC that will review the GMO application
- IBC approval letter
- IBC review correspondence - queries and replies
- Confirmation the sponsor will provide GMO/study specific training for the site
- Update SOPs/prepare additional site SOPS to cover trial GMO processes.
- Inform service departments that he study involves a GMO and any special conditions and/or procedures that will be involved in handling, transport, storing or disposal of the GMO.
- Include as much of the above information in the ethics application as possible
- Ensure that the HREA flags that the IP is a GMO
- Ensure that the protocol and information to participants describes the IP as a GMO and includes requirements identified as per:
- The Licence
- The Risk Assessment and Risk Management Plan
- Any other requirement
The RMH does not run an IBC. Access to IBC review managed by the RMH site is via the PMCC Clinical Trials IBC.
Clinical Trial element 1 - Drug and/or Device Clinical Trial Documentation
Submit the following documents
Investigator's brochure (IB) - if conducting a drug, biologicals or device clinical trial, submit one copy of the IB.
Data Safety Monitoring Board (DSMB) or other safety monitoring processes- For randomised controlled trials, the protocol or ethics application should enable the HREC to determine the following:
- If a DSMB is to be convened, what its main role and function will be and provide (or confirm if it is provided in the protocol or other documents):
- The DSMB is constituted and functions in line with the NHMRC Data Safety Monitoring Boards (DSMBs) guidance
- Provide the Terms of reference
- List of DSMB members, role and affiliations
- If a DSMB is not to be convened, confirm the alternative mechanism for monitoring trial safety and whether this is justified given the nature of the trial (refer to Section 10 of NHMRC Data Safety Monitoring Boards (DSMBs) guidance)
- That appropriate (risk‑based) processes for monitoring trial safety and data integrity are planned.
Note: if the DSMB has not been established by the submission of the HREC application please confirm this in the cover letter and provide the information in the research governance application.
For drug trials
For multi-site commercially sponsored clinical trials - visit the Medicines Australia (MA) Clinical Trials website to complete and submit the MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials.
For device trials
For multi-site commercially sponsored clinical trials - visit the Medical Technology Association of Australia (MTAA) website to complete and submit MTAA Standard Indemnity Form for HREC review only.
RMH information for Indemnity forms
For all indemnities given by sponsors to RMH, please complete the “To” or (“the Indemnified Party”) section on page one as follows:
|Name:||Melbourne Health trading as the Royal Melbourne Hospital|
|ABN:||73 802 706 972|
|Address:||The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050|
Clinical Trial element 2 - 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
i.e. 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.
SUBMISSION PROCESS - Submit your complete application via ERM and email
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.
- 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.
- Upload all the application documents onto ERM and ensure you hit "submit";
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]
- 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.
Complete a Site Specific Assessment application if the research will be conducted at the RMH
Site Specific Application
Complete a Site Specific Assessment application (research governance application) where RMH is a participating site.
- Concurrent submission of ethics and site specific applications is especially recommended where RMH is providing ethical review and is also a participating site.
- ERM allows ethics and site specific applications to be generated and submitted concurrently.
- There are no deadlines for submission of site specific applications.
- However site specific applications for projects reviewed by the RMH HREC must be submitted within 12 months of obtaining ethical approval. Where research site specific applications have not been received in this time frame the ethical approval may be withdrawn.
- Where ethical review is undertaken by another HREC, site specific applications for RMH as a site can be submitted at any time.
Where investigators are submitting SSA applications in states other than Victoria and Queensland
Follow the instructions available on the Coordinating Office website on how to create an SSA form for jurisdictions that do not use Ethics Review Manager (ERM).
Contact us if you need an accessible version of a download.