Research must be conducted according to ethical principles, guidelines for responsible research conduct, legislation and regulations. Research governance is about responsibility and about managing risk. 

Research governance is a framework through which institutions are accountable for the research they allow to be conducted under their auspices. 

The following information applies to all research projects conducted at or by Melbourne Health, including RMH and NWMH, irrespective of whether the Melbourne Health Human Research Ethics Committee (HREC) has provided ethical review for the project. 

Complete the following steps to apply for Research Governance (SSA) approval.

1. Obtain a HREC Project Number

Prior to submitting your application, contact the Office for Research to obtain a Local HREC Project Number. If your research project is a commercially sponsored clinical trial, please ensure that you obtain this number immediately upon confirmation of site selection by the sponsor.

The Local HREC Project Number must appear on all components of your governance application.

If you have submitted an ethics application to the Melbourne Health HREC, you will already have this number.

2. Confirm date of site selection (if applicable)

For externally sponsored clinical trials, enclose a copy of the correspondence from the sponsor confirming selection of Melbourne Health as a participating site in the trial - include the corresponding project number.

3. Complete the Research Governance Checklist

Download and complete the Research Governance Checklist from the Department of Health.

4. Complete the Governance Cover Letter

Download and complete the Research Governance Cover Letter from the Department of Health

Address the cover letter to Dr Angela Watt - Research Governance & Ethics.

5. Submit a Victorian Site-Specific Assessment form

Submit a Victorian Site-Specific Assessment (SSA) Form complete with signatures of all MH researchers. 

Hint: An SSA Form can be generated after the NEAF Application form has been created as part of the Ethics Review Process for the project.

The Coordinating Office for Clinical Trial Research have released an Online Forms Handbook. Download a copy of the Online Forms Handbook to assist you with creating, completing and submitting ethics and research governance applications. 

6. Complete fee payment form

Download and complete the Application and Amendment Payment Form. Fees are payable up-front, at the time of initial submission of your Research Governance application.

Find out more about research fees and payment.

7. Provide a copy of all HREC documentation where ethics review was not undertaken by Melbourne Health

If Melbourne Health is only responsible for the review of the research governance application (i.e., HREC approval was granted by another institution), provide 1 hardcopy and 1 electronic copy of the following:

  • The HREC approval letter
  • All the approved HREC documents such as the protocol, IB, participant information and consent form, the signed NEAF, the signed VSM, ionising radiation documentation, etc. 
8. Submit a project budget for review

All researchers who are planning to undertake a research project at MH or who are planning to use MH resources to undertake a research project must email the Management Accountant – Research (MAR) at MAR@mh.org.au

Budget Review Submission

Where applicable, the following documentation and information is required for the budget review and should be emailed to MAR@mh.org.au:

Required documentationDescription

Clinical trial research agreement (CTRA); or
Funding agreement / Letter of offer;
or 
Details of how resources that will be used to conduct the project will be funded 

The CTRA, 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.

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, statistial analysis, software, travel allowances, etc.

Internal cost centre numberProvide 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.

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.

9. Complete statement of approval and departmental forms

Statement of Approval Forms

Complete a Statement of Approval (SOA) form for each MH department used to conduct the project.

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 ShellyYesLevel 2, Cardiology
DermatologyAnnette PhemisterYesNA
Health Information ServicesKrissy Zamora 
(back-up Trudi Dundas)
YesNA
Medical IllustrationAmanda Rebbechi
(back-up Joss Dimock)
YesNA
Nuclear Medicinenuclearmedicine@mh.org.auYesNA
OphthalmologyElizabeth DangYesNA
PathologyMaria BisignanoYesNA
PharmacyEmma Michael
Eugenia Hong
YesNA
RadiologyPeter Nuttman
Irene Ngui
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
Pathology Visit 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
Office for ResearchFor any person who will access Melbourne Health patient records and who is not an employee of Melbourne Health, e.g. trial monitor or external researcher, complete an Approval to Examine Records for the Purposes of Research form
Melbourne Private HospitalContact the MPH Research Governance Officer directly to determine specific requirements
10. Complete documentation required for Clinical Trials (if applicable)

For all trials

For drug trials

Also submit the following:

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

For device trials

Also submit the following:

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

Note

CTRAs and CIRAs

For all CTRAs and CIRAs to which MH is a party, complete the “Institution” details on page one as follows:  

Name: Melbourne Health
Address: The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050
ABN: 73 802 706 972
Contact for Notices: Executive Director of Research
Fax for Notices: (03) 9342 8548
Phone Number: (03) 9342 8530

Indemnity

For all indemnities given by sponsors to Melbourne Health, 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

11. Complete an agreement where MH and at least one other institution is involved in the study

In accordance with the Australian Code for the Responsible Conduct of Research, all research involving Melbourne Health and at least one other institution requires a written agreement. This is required even if there is no funding provided for the project.

Note: For clinical trials, agreements are covered in point 10 above. 

For all other collaborations (non clinical/device trials) complete one of the following Research Agreements:

Note: Researchers may use the template a collaborating partner if the protocol was written by the collaborator.

Agreement review process

  • Submit the unsigned draft agreement in MSWord format for review and comment by the Office for Research.
  • Agreements will not be signed until all collaborators of have agreed on the content in the agreement.

Signing of agreements

For original ink signatures

  • Once all collaborators have agreed in the content of the agreement, forward copies of the agreement (one for each collaborator) to the Office for Research to arrange appropriate sign-off.
  • An original copy of the fully signed agreement will be returned to you. Make a copy of the document to keep in your records and forward the signed original agreement to the collaborating organisation(s) for their records.

For scanned signatures

  • Melbourne Health prefers original ink signatures for agreements. However where a scanned signature is used then it must be a scan of an original ink signature (not a pdf signature).
12. Submit your application

Submit the hard copy original application and a soft copy to the Office for Research.

  • Mail or deliver your hard copy original application to the Office for Research.
  • Send an email with attached files (including the agreement, indemnity, insurance certificate, etc) to ResearchGovernance@mh.org.au.

Ensure that the hard copy original contains original signatures

Note: Governance applications can be done at any time and do not have to be submitted on the HREC submission deadline day. However, early completion and submission of both HREC and Research Governance will ensure faster approval and earlier commencement of your project.

NOTE: 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 Melbourne Health Principal Investigator with a copy of the TGA's confimration/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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