Governance review: How the process works
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Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they allow to be conducted under their auspices.
Good research governance is an essential component of the responsible conduct of research. It enhances ethical and scientific quality, promotes good research practice and accountability, reduces adverse incidents and ensures lessons are learned, thus reducing the likelihood of poor performance and research misconduct.
Research governance is:
Find out more about the essential governance elements for all research projects.
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 Where research governance applications have not been received in this time frame the ethical approval may be withdrawn.
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.
For updates on how COVID-19 impacts research at RMH visit the Office for Research COVID-19 webpage.
Click on each '+' in each section to view all the information related to that step.
The following information applies to all research projects conducted at or by RMH, including VIDRL and NWMH, irrespective of whether the RMH Human Research Ethics Committee (HREC) has provided ethical review for the project.
Download our "cheat sheet" - Essential Reading: RMH Tips & FAQs for Governance Submission.
This document is your guide through the most common Governance queries we receive and also contains helpful information addressing some of the most common errors we see in Governance applications.
Take the guess work out of your submission and use this document. The Office for Research also welcomes your input and any information you would like included.
Research Governance applications will only be accepted by the Office for Research as one complete submission. This instruction applies to all governance applications, including commercially sponsored clinical trials.
Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
Receiving a complete application in one package enables the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
For investigator-initiated studies where RMH will formally act as a sponsor, call the Office for Research six weeks before the intended submission deadline to confirm and, if determined that it is needed, to book in an RMH Sponsorship Review Meeting.
This RMH Sponsorship Review Meeting is required for studies that are:
This process needs to be completed before the application can be accepted for ethics and/or governance review.
To obtain a local HREC project number, open the following email template: research@mh.org.au and enter all information as requested.
Where you have ethical approval from a committee other than the RMH HREC you will need to obtain a local HREC Project Number for your governance application. If you submitted your ethics application to the RMH HREC, then you will already have this number.
For commercially sponsored clinical trials, ensure that you obtain this number immediately upon confirmation of site selection by the sponsor.
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.
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 | Becomes the EMR number: |
Use the Electronic Medical Records (EMR) number (e.g. RMH1111) to identify the project in the survey.
For projects where the RMH Local HREC Project Numbers starts with 2020 or later complete the REDCap survey for the project study build in EMR here: EMR (EPIC) REDCap survey.
OR
For projects where the RMH Local HREC Project Numbers start with 2019 or earlier email the EMR Research Team who will then confirm via return email once the REDCap survey has been completed for your project. Include this email in your submission.
Completion of the 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 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.
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 participant - patients and healthy controls - enrolled in a research project need to be registered in the 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.
Submit a Victorian Site-Specific Assessment (SSA) Form via Ethics Review Manager (ERM), complete with e-signatures of all RMH researchers.
For help using ERM, download a copy of the Applicant User Guide to ERM.
Instructions for investigators on how to create an SSA form for jurisdictions that do not use ERM can be found on Coordinating Office website.
Infonetica Helpdesk | (02) 9037 8404 | helpdesk@infonetica.net |
General enquiries and ERM application advice | 0408 274 054 | multisite.ethics@ecode.vic.gov.au |
Visit the Coordinating Office to download and complete the latest version of the Research Governance Checklist.
Record both the local HREC Project Number and the EMR number on the Research Governance Checklist.
Department | Contact | Hard copies | |
---|---|---|---|
Cardiology | Dianne Shelley | Yes | Level 2SE, Main Building |
Clinical Trials Centre | Jennifer Han | Yes | NA |
Dermatology | dermatologyresearch@mh.org.au | Yes | NA |
Health Information Services | Vanessa Sagulo Acting ECM Operations Manager | Yes | NA |
Medical Photography Studio | Amanda Rebbechi | Yes | NA |
Nuclear Medicine | nuclearmedicine@mh.org.au | Yes | NA |
Ophthalmology | Elizabeth Dang | Yes | NA |
Pathology | Maria Bisignano | Yes | NA |
Pharmacy | Emma Michael Eugenie Hong | Yes | NA |
Radiology | Rae Clifton Mary Lambert rmh-radiologyadministrators@mh.org.au | Yes | RIS/PACS Office Level 1, Radiology |
Respiratory Medicine | Tim Dimitriadis | Yes | NA |
As well as the SoA, also complete the departmental forms as they apply to your research project.
Department or Service | Instruction |
---|---|
Pathology | Visit the Pathology Clinical Trials web page for instructions |
Radiology | Review the Trial Approval Process including the Radiology Research Internal Approval Form which must be completed for all studies |
Clinical Engineering | Contact Clinical Engineering to obtain necessary forms |
Melbourne Private Hospital | Contact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements |
All research projects that use RMH resources including personnel, patients and data must include a completed budget as part of the research governance application.
There are two options for budget review depending on whether project funds are paid to/received from external sources.
Option 1: Simple Budget Review
The simple budget review template can only be used for projects where there are no funds (zero dollars) paid to - or received from - an external source. Internal transfers between RMH departments are permitted.
Option 2: Full Budget Review
A full budget review by the Management Accountant Research (MAR) is required for all projects for which RMH will receive or pay any funding to an external organisation
IMPORTANT tips for budget reviews
The simple budget review template can only be used for projects where there are no funds (zero dollars) paid to, or received from, an external source.
Process:
Include the signed simple budget template and all service department SoAs in the research governance application
A full budget review by the Management Accountant Research (MAR) is required for all projects for which RMH will receive or pay funds to an external organisation.
Submit the following documentation and information, as applicable to the project, by email to MAR@mh.org.au:
Required Documentation | Description |
---|---|
Project protocol or proposal | A project protocol is the document that describes the objective(s), design, methodology, statistics and organisation of a project. |
Statement of approval form (SoA) | An SoA must be completed and signed by the head of department for each RMH department used to conduct the project. This includes, but is not limited to, departments that will be used for services, staff, infrastructure or recruitment purposes. |
Estimated labour time | Provide details of the estimated time that all RMH staff members will contribute to the conduct of the study using the Estimated Labour Time Template. |
Details of other project expenses | Consider any other project expenses. These expenses may include, for example, archiving costs, capital equipment, ethics fees, meal allowances, postage, printing & stationery, statistical analysis, software, travel allowances, etc. |
RMH cost centre number | Provide the RMH cost centre number from which the project will operate. |
Participants | Provide details of the anticipated number of participants to be recruited at each site and the anticipated recruitment period. |
Agreement or funding letter i.e.Clinical trial research agreement (CTRA); Research Collaboration agreement (RCA), or Funding agreement (e.g. MIA) / Letter of offer; or Details of how resources that will be used to conduct the project will be funded i.e. departmental funding | The CTRA, RCA, funding agreement or letter of offer should detail the source of external funding for the project. A completed draft version of the relevant agreement for preliminary review is sufficient. A finalised version of the agreement will then be required for final budget approval. |
The approval will be emailed to you either as:
Allow at least 3 weeks from the date of the meeting with the MAR for the budget approval notification. The budget approval must then be submitted to the Office for Research as part of the Governance submission.
Find out more information about the financial documentation and information required by the MAR.
If RMH is only responsible for the review of the Research Governance application - HREC approval was granted by another institution), provide an electronic copy of the following:
Where Master versions of consent forms were approved in the ethics application, complete site specific Participant Information and Consent Form (PICF/s) for RMH (RMH or NWMH).
Complaints contact person
Name | Director Research Governance and Ethics |
Position | Complaints Manager |
Telephone | (03) 9342 8530 |
research@mh.org.au |
Submit the unsigned draft agreement in MSWord format for review and comment to the Office for Research as part of your Governance Application. Include as much information as possible in the agreement template.
All research involving RMH and at least one other institution requires a written agreement even if there is no funding provided for the project.
Note: For drug and/or device clinical trials, agreements are covered in Drug and/or Device Clinical Trial Documentation on this web page.
For all other collaborations where RMH initiates the project complete the Research Collaboration Agreement (MACH template).
Legal Entity for RMH, NWMH or VIDRL: | Melbourne Health |
ABN: | 73 802 706 972 |
Address: | 300 Grattan Street, The Royal Melbourne Hospital, Parkville VIC 3050 |
Enter the following details for RMH authorised signatory for signing research agreements:
Director Research Governance and Ethics
Office for Research
Melbourne Health
300 Grattan Street
The Royal Melbourne Hospital
Parkville VIC 3050
All RMH projects involving ionising radiation require written advice from the RMH Medical Physicist regardless of whether the procedures are additional to standard of care or not.
This applies to all research projects undertaken at RMH which involve radiation exposure (including pre-MRI safety screening examinations) .
RMH Medical Physicist and Radiation Safety Officer:
Record both the local HREC Project Number EMR number on all documents.
For externally sponsored clinical trials, enclose a copy of the correspondence from the sponsor confirming selection of RMH as a participating site in the trial - include the corresponding Project number.
Visit the Medicines Australia Clinical Trials website to download, complete and submit all the following:
Find out more about financial information regarding invoicing and payment clauses to be included in the clinical trial research agreement.
Visit the Medical Technology Association of Australia website to download, complete and submit the following documents:
Find out more about financial information regarding invoicing and payment clauses to be included in the agreement.
For all Research Agreements where Royal Melbourne Hospital is a party, complete the “Institution” details as per below:
Name: | Melbourne Health |
ABN: | 73 802 706 972 |
Address: | The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050 |
Contact for Notices: | Director of Research |
Fax for Notices: | (03) 9342 8548 |
Phone Number: | (03) 9342 8530 |
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 |
ABN: | 73 802 706 972 |
Address: | The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050 |
Download and complete the New Submission Fee Payment Form. Fees are payable up-front, at the time of initial submission of your Research Governance application.
Record the local HREC Project Number and the EMR number on the fee form.
Find out more about research fees and payment.
You may send more than one email if your files are too large for a single email
External sponsors may be commercial, a collaborative group or another hospital.
Upon receipt of the HREC 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.
These are investigator initiated trials where there is no external sponsor
Upon receipt of governance approval letter from RMH, researchers need to make an appointment with the 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.