Governance approval process summary
(DOC,68.5 KB)
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.
LATEST ETHICS & GOVERNANCE NEWS - 10 July 2018
Sign up for training to the new ethics application platform, Ethics Review Manager
You are no longer able to create a HREA/SSA via Online Forms.
From Monday 16 July, you will need to log onto a new platform, Ethics Review Manager (ERM), to create new ethics and governance applications. It is essential that everyone who needs to complete research ethics and governance applications learns how to do this.
Online Training
The Department of Health and Human Services has arranged online training sessions for research applicants using the new ERM system details of which can be found on the Office for Research News page.
The sessions will cover:
- Getting started in ERM
- How to create and submit an ethics application
- How to transfer and accept an SSA
- Post approval
- Use of the minimal dataset form (MDF)
Apply for Research Governance (SSA) approval
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.
IMPORTANT: The Office for Research will only accept complete research governance applications
All Research Governance applications will only be accepted by the Office for Research as one complete package.
- Do not try to submit your governance application in multiple separate parts. This instruction applies to all governance applications, including those for commercially sponsored clinical trials.
- Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
Why are we enforcing this instruction?
Receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times. This promotes efficiency and will allow the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
1. For Investigator-initiated Melbourne Health-led research projects
For studies where Melbourne Health will formally act as sponsor of a research project, including:
- MH sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
- All MH-led multi-site studies
At least six (6) weeks before the intended submission deadline date call the Office for Research on 9342 8530 to confirm whether an MH Sponsorship Review Meeting is required for your project.
This process must be completed before a trial/study application can be accepted for ethics and/or governance review.
2. Obtain a local HREC Project Number
Prior to submitting your application, contact the Office for Research to obtain a Local HREC Project Number.
- If you have submitted an ethics application to the Melbourne Health HREC, you will already have this 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.
- If you have received ethical approval from an ethics committee other than the MH HREC you will still need a local HREC Project Number for your governance application.
The Local HREC Project Number must appear on all components of your governance application.
3. 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.
4. Complete the Research Governance Checklist
Download and complete the Research Governance Checklist from the Department of Health.
5. 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.
6. Submit a Victorian Site-Specific Assessment form
Submit a Victorian Site-Specific Assessment (SSA) Form via Ethics Review Manager (ERM), complete with e-signatures of all MH researchers.
The Online Forms site has transitioned to ERM in Victoria and Queensland effective 16 July 2018. Online Forms can no longer be used for ethics and research governance applications in these states.
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 under the heading NMA Research Governance/Site Specific Assessment (SSA) Application on the DHHS website at: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/national-mutual-acceptance.
Help and support
Infonetica Helpdesk | 02 9037 8404 | |
DHHS Victoria | 03 9096 7394 |
7. If your project involves ionising radiation
For all Melbourne Health governance involving ionising radiation:
- Complete and submit Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information.
- Provide a copy of the independent assessment report conducted by the RMH Medical Physicist. This applies to all research projects undertaken at Melbourne Health which involve radiation exposure.
Where radiation is not additional to standard care
If radiation exposure in a research project is not additional to standard clinical management/care at Melbourne Health the Principal Investigator must provide a copy of the confirmation letter reviewed by the HREC using the template available on the Department of Health's Clinical Trials and Research website and must have been included in the ethics application submitted to the reviewing HREC.
Where radiation is additional to standard care
If radiation exposure in a research project is additional to standard clinical management/care at Melbourne Health, please provide a copy of the independent assessment report conducted by a Medical Physicist.
8. 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.
9. 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.
10. Complete site specific PICFs
Complete a site specific Participant Information and Consent Form (PICF) for The Royal Melbourne Hospital if the study involves participants from whom you are obtaining consent.
- Complete the site specific PICF based on the final Master PICF template approved by the reviewing HREC Committee.
- Ensure the footer of site specific PICF references the final HREC approved Master version.
- PICFs must be submitted electronically in MSWord format - not PDF.
Contact details for the PICFs:
For Melbourne Health site complaints
Complaints contact person
Name | Director Research Governance and Ethics |
Position | Complaints Manager |
Telephone | (03) 9342 8530 |
| Research@mh.org.au |
11. 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 documentation | Description |
|---|---|
Clinical trial research agreement (CTRA); or | 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. |
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 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. |
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.
12. 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:
| Department | Contact | Hard copies | |
|---|---|---|---|
| Cardiology | Dianne Shelly | Yes | Level 2, Cardiology |
| Dermatology | Annette Phemister | Yes | NA |
| Health Information Services | Jasmine Souki | Yes | NA |
| Medical Illustration | Amanda Rebbechi (back-up Joss Dimock) | Yes | NA |
| Nuclear Medicine | nuclearmedicine@mh.org.au | Yes | NA |
| Ophthalmology | Elizabeth Dang | Yes | NA |
| Pathology | Maria Bisignano | Yes | NA |
| Pharmacy | Emma Michael Eugenia Hong | Yes | NA |
| Radiology | Ben O'Sullivan Mary Lambert rmh-radiologyadministrators@mh.org.au | Yes | RIS/PACS Office Level 1, Radiology |
| Respiratory Medicine | Tim Dimitriadis | Yes | NA |
Departmental Forms
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 |
| Office for Research | For 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 Hospital | Contact the MPH Research Governance Officer directly to determine specific requirements |
13. Complete documentation required for Clinical Trials (if applicable)
For all trials
- Insurance certificate: For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the requirements for clinical trials insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals. See Note below.
- One copy of the Investigator’s Brochure
Evidence of GCP training by Principal Investigator. Find out more about GCP training and certification.
For drug trials
Also submit the following:
- Three original copies of the applicable Clinical Trial Research Agreement (CTRA) signed by the sponsor and principal investigator.
- Indemnity: Two copies each of the Standard Medicines Australia Form of Indemnity for Clinical Trials and HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials as applicable.
- See Note below.
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:
- Three original copies of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
- Two copies each of the following documents:
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
14. Submit an unsigned draft of the 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 13 above.
For all other collaborations (non clinical/device trials) complete one of the following Research Agreements:
- MACH Research Collaboration Agreement: For all collaborative projects except where an Annexure A is used. Includes interstate and overseas sites.
- Annexure A: Master Collaboration Agreement 2015: For collaborative projects involving ONLY Melbourne Health and the University of Melbourne
Note: Researchers may use the template a collaborating partner if the protocol was written by the collaborator.
Melbourne Health Specific information for Agreements
| Legal entity for RMH, VIDRL & NWMH | Melbourne Health |
| ABN: | 73 802 706 972 |
| Address: | 300 Grattan Street, Parkville VIC 3050 |
Please enter details below for MH authorised person for signing research agreements:
Authorised Representative
Office for Research
Melbourne Health
300 Grattan Street Parkville VIC 3050
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.
Only after the agreement has been reviewed and approved by the Office for Research, organise for signatures as instructed below:
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).
15. Submit your application
- We only require hard copies of agreements and indemnities
- Note that digital signatures can be used in the SSA
Submit the original application to:
Manager, Research Governance
Office for Research
Level 2 South West, 300 Grattan Street
PARKVILLE VIC 3050
Electronic submission
- Upload all application documents onto ERM and submit; and
- Send an email with attached files (including the agreement, indemnity, insurance certificate, scanned copies of the original wet ink signatures, etc.) to ResearchGovernance@mh.org.au.
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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