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:

  • a framework through which institutions are accountable for the research they allow to be conducted under their auspices.
  • a way of thinking about and managing research and applies to all individuals involved in research – staff and students, in all professional groups, no matter how senior or junior
  • about how research is conducted and about facilitating good (ethical and worthwhile) research
  • about responsibility and about managing risk.

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 Where research governance applications have not been received in this time frame the ethical approval may be withdrawn.

COVID-19 Guidance for Research Studies including Clinical Trials

For updates on how COVID-19 impacts research at RMH visit the Office for Research COVID-19 webpage.

Apply for Research Governance (SSA) approval

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.

Essential Reading: Tips and FAQs for Governance Submission

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.

Remember to submit the complete application

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.

1. Investigator-initiated RMH-led research projects

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:

  • investigator-initiated drug and/or device clinical trials; or
  • all multi-site RMH-led research projects

This process needs to be completed before the application can be accepted for ethics and/or governance review.

2. Local HREC Project number and what is the EMR number?

Local HREC Project Number

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.

Label governance 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) codesElectronic Medical Record (EMR) number

HREC/12345/MH-2020
SSA/12345/MH-2020

Becomes the EMR number:
RMH12345

3. REDCap survey to inform the project study build in EMR

What project number do you need to use on the survey?

Use the Electronic Medical Records (EMR) number (e.g. RMH1111) to identify the project in the survey.

Instructions

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.

Why do you need to do this?

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.

Create a research record for every research participant

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.

4. Victorian Site-Specific Assessment form

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.

For investigators 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 Coordinating Office website.

Help and support

Infonetica Helpdesk02 9037 8404helpdesk@infonetica.net
General enquiries and ERM application advice0408 274 054multisite.ethics@ecode.vic.gov.au
5. Research Governance Checklist

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.

6. Statement of approval forms

Statement of Approval forms

  1. Complete a Statement of Approval (SoA) form for each RMH department used to conduct the project.
  2. Record both the local HREC Project Number and the EMR number on each SoA form.
  3. Email a copy of all documentation relevant to your research project including the protocol, SoA, associated study manuals and departmental forms (listed below) to the following contacts:
DepartmentContactEmailHard copies
CardiologyDianne ShelleyYesLevel 2SE, Main Building
Clinical Trials CentreJennifer HanYesNA
Dermatologydermatologyresearch@mh.org.auYesNA
Health Information ServicesVanessa Sagulo

Acting ECM Operations Manager
9342 7438

YesNA

Medical Photography Studio

Amanda Rebbechi
(back-up Joss Dimock)

YesNA
Nuclear Medicinenuclearmedicine@mh.org.auYesNA
OphthalmologyElizabeth DangYesNA
PathologyMaria BisignanoYesNA
PharmacyEmma Michael
Eugenie Hong
YesNA
RadiologyRae Clifton
Mary Lambert
rmh-radiologyadministrators@mh.org.au
YesRIS/PACS Office
Level 1, Radiology
Respiratory MedicineTim DimitriadisYesNA

Departmental Forms

As well as the SoA, also complete the departmental forms as they apply to your research project.

Department or ServiceInstruction
PathologyVisit the Pathology Clinical Trials web page for instructions
RadiologyReview the Trial Approval Process including the Radiology Research Internal Approval Form which must be completed for all studies
Clinical EngineeringContact Clinical Engineering to obtain necessary forms
Melbourne Private HospitalContact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements
7. Project Budget Review

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.

OR

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

  • Start the budget review process as early as possible as it can take some time to complete all required steps.
  • Allow 1-2 weeks for departments to return signed SoAs to you.
  • Provide as much information as possible for the full budget review.
  • Allow at least 3 weeks from the date of the meeting with the MAR for the budget approval notification.
  • Submit the budget review/approval (simple or full review documentation) with the Governance submission.
  • Include the local Project Number and the Electronic Medical Records (EMR) number on all forms and in the subject line of emails to allow our office to identify the project to which the submission relates.

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.

Process:

  1. Complete a Statement of Approval (SoA) form for each RMH department used to conduct the project.
  2. Submit SoA form to each relevant service department for review/approval. Allow 1-2 weeks for departments to return signed SoAs to you.
  3. Submit the completed simple budget template, all completed SoAs, protocol and any other documents required to the RMH Principal Investigators Head of Department (HOD) for review and approval.

Include the signed simple budget template and all service department SoAs in the research governance application

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 funds to an external organisation.

Submit the following documentation and information, as applicable to the project, by email to MAR@mh.org.au:

Required DocumentationDescription
Project protocol or proposalA 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 timeProvide 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 expensesConsider 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 numberProvide the RMH cost centre number from which the project will operate.
ParticipantsProvide 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.

Budget approval notification

The approval will be emailed to you either as:

  • A budget document prepared by the MAR; or
  • A confirmation by the MAR that the project's budget has been reviewed.

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.

8. HREC documentation where ethics review was not undertaken by RMH

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:

  • The HREC approval letter
  • All the approved HREC documents such as, but not limited to, the
    • Protocol
    • Investigator Brochure
    • Participant information and consent form
    • Approved HREA
    • Victorian Specific Module
    • Ionising radiation documentation
    • Questionnaires
9. RMH Participant Information and Consent Forms (PICFs)

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).

  • You must complete the site specific PICF based on the final Master PICF template approved by the reviewing HREC Committee - update only the RMH specific information.
  • Ensure the footer of site specific PICF references the final HREC approved Master version and the RMH site version number and date.
  • PICFs must be submitted in MSWord format - not PDF.

Contact details for PICFs at The Royal Melbourne Hospital

Complaints contact person

NameDirector Research Governance and Ethics
PositionComplaints Manager
Telephone(03) 9342 8530
Emailresearch@mh.org.au
10. Draft (unsigned) agreements where RMH and at least one other institution is involved in the study

Submit a draft copy of agreement as part of your governance application

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).

  • Use the RMH Guide to completing the MACH agreement with comments
  • The MACH template should also be used for interstate and overseas sites
  • If the collaborator does not have a suitable template, use the MACH template
  • Where the collaborating organisation wrote the protocol, RMH will consider the collaborator's agreement template.

RMH-specific information for agreements

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

11. Projects involving ionising radiation and/or MRI

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.

12. Site selection dates for externally sponsored clinical trials

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.

13. Drug and/or Device Clinical Trial Documentation

For all trials

For drug trials

Visit the Medicines Australia Clinical Trials website to download, complete and submit all the following:

  • A copy of the applicable Clinical Trial Research Agreement (CTRA) electronically signed by the sponsor and principal investigator; and
  • A copy of the Standard Medicines Australia Form of Indemnity for Clinical Trials; or
  • HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials (as applicable).

Find out more about financial information regarding invoicing and payment clauses to be included in the clinical trial research agreement.

For device trials

Visit the Medical Technology Association of Australia website to download, complete and submit the following documents:

  • A copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
  • A copy of the following documents:
    • MTAA Standard Indemnity Form for a clinical investigation
    • MTAA Standard Indemnity Form for HREC review only

Find out more about financial information regarding invoicing and payment clauses to be included in the agreement.

Clinical Trial/Investigator Research Agreements

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

Indemnity

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
14. Fee payment

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.

15. Submit your complete application via ERM and email
  1. Open the following email template and enter the local HREC Project number and EMR number in the subject line of the email: ResearchGovernance@mh.org.au and attach all the documents.

You may send more than one email if your files are too large for a single email

and

  1. Upload all application documents onto ERM and remember to hit Submit.
16. For CTN Submissions

For externally sponsored CTN clinical trials

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.

For RMH sponsored CTN clinical trials

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.

Downloads

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