Ethics Review Process at RMH
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All research studies must be submitted for ethical and research governance review before a study can be given approval to commence.
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.
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.
Hints for completing the Ethics Application Process
RMH Sponsorship review and approval is required for studies where RMH will formally act as sponsor of the research, including:
Process to request formal RMH sponsorship:
This process must be completed before a trial/study application can be accepted for ethics and/or governance review.
To obtain a local HREC project number, open the following email template and provide requested details: research@mh.org.au.
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.
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: RMH12345 |
Ensure that the protocol template is appropriate for the research to be conducted:
Researchers may elect to use one of the following protocol templates:
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:
Include data collection tools, such as:
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.
Submit a completed Peer Review Proforma.
The investigators must allow sufficient time to:
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.
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:
Important: The RMH HREC will not accept the Low Negligible Risk (LNR) VIC form.
Infonetica Helpdesk | (02) 9037 8404 | helpdesk@infonetica.net |
Coordinating Office | 0408 274 054 | multisite.ethics@ecodev.vic.gov.au |
For all research projects with a site in Victoria, the Victorian Specific Module (VSM) is mandatory.
Complete the Victorian Specific Module.
If the project application include a site in Western Australia, you must also complete and submit the Western Australian Specific Module (WASM).
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:
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).
Notes:
Questions? Email the EMR Research Liaison Coordinator
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.
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.
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.
Download and complete the New Submission Fee Payment Form. Fees are payable up-front, at the time of initial submission of a research project.
Visit the Research Fees page for detailed information on all ethics and governance fees.
Depending on the study these may include:
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.
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 |
Research@mh.org.au |
For Royal Melbourne Hospital site complaints
Complaints contact person at RMH
Name | Director Research Governance and Ethics |
Position | Complaints Manager |
Telephone | (03) 9342 8530 |
Research@mh.org.au |
Download a guide to Essential considerations for recruiting people into your research study.
Depending on the study the other documents may include:
Do not send PDFs.
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.
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.
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.
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.
The OGTR guidance document Requirements under the Gene Technology Act 2000 for clinical trials in humans involving GMOs –Guidance for clinical trial sponsors
Guidance for conducting clinical trials involving GMOs at the RMH
Where regulation is required, the trial sponsor must also:
Refer to 'Guidance for conducting clinical trials involving GMOs at the RMH' for details of information required and timeframes for submission
The RMH does not run an IBC. Access to IBC review managed by the RMH site is via the PMCC Clinical Trials IBC.
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:
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 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 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.
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 |
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.
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.
Each project needs to be submitted by Email and via ERM by 11:00 AM on the deadline day.
and
Ensure that the following advice is adhered to:
As shown in example below, include the following: [Local HREC Project Number] [EMR number] [Document Type] Version [Version Number] [Date]
Examples:
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.
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 (research governance application) where RMH is a participating site.
Note:
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).