Governance approval process summary
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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.
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, VIDRL and NWMH, irrespective of whether the Melbourne Health Human Research Ethics Committee (HREC) has provided ethical review for the project.
Research governance applications for projects reviewed by the MH 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 Where research governance applications have not been received in this time frame the ethical approval may be withdrawn.
Need help navigating your way through a research study?
The Path to Research Success provides an overview of the key elements and helpful tips that are crucial to conducting a successful research project.
Tips for completing Research Governance Applications
- Read all of the points in the process (including information drop-downs) before commencing with your application
- Note that the numbering system is arbitrary and that multiple steps can be undertaken in parallel to save you time
You can start preparing the application along side the ethics application
You can submit the research governance application at the same time as the ethics application or even before you receive ethical approval
Start obtaining departmental/service approvals as soon as possible after the protocol has been finalised
Identify if you require an agreement early in the application preparation process and start drafting it
- Governance approval can only be be issued after ethical approval has been obtained
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 requesting formal MH sponsorship
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 (i.e. 2020.999) and the Electronic Medical Records (EMR) number (i.e. RMH1111), must be used on all forms and in all communications regarding the project.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site EMR number RMH11111.
3. Complete the 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 (i.e. RMH1111) to identify the project in the survey.
The EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 in ERM becomes the site EMR number RMH11111.
Instructions
- For projects that have Melbourne Health research project numbers starting with 2020.XXX or greater (i.e., 2020.999, 2021.999) complete the REDCap survey for the project study build in EMR here: EMR (EPIC) REDCap survey.
OR
- For older studies - those projects starting 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 Melbourne Health 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. Complete 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.
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 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 |
5. Complete the Research Governance Checklist
Download and complete the Research Governance Checklist from the Department of Health.
Record the local HREC Project Number (i.e. 2020.999) and the Electronic Medical Records (EMR) number (i.e. RMH1111) into the checklist.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site EMR number RMH11111.
6. 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.
IMPORTANT - Record the local HREC Project Number and the Electronic Medical Records (EMR) number (i.e. RMH1111) on the stetement of approval form.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site code RMH11111 in the EMR.
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 |
| Clinical Trials Centre | Jennifer Han | Yes | NA |
| Dermatology | Annette Phemister | Yes | NA |
| Health Information Services | Vanessa Sagulo Acting ECM Operations Manager | Yes | NA |
| Medical Photography Studio (formerly 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 | Rae Clifton 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 |
7. Submit a project budget for review
Reduced services over Christmas holiday period
Update: The Office for Research will close over December-January holiday period. Consequently budget review services and invoice requests may be submitted during this period however requests received after Monday 14 December may not be actioned until early/mid-January 2021.
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
Record the local HREC Project Number (i.e. 2020.999) and the Electronic Medical Records (EMR) number (i.e. RMH1111) in the subject line of emails.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site EMR number RMH11111.
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 |
|---|---|
|
|
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. |
Agreement or funding letter i.e.Clinical trial research agreement (CTRA); Research Collaboration agreement ((RCA), or | 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. 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 an 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.
9. Complete site specific PICFs
Where Master versions of consent forms were approved in the ethics application - complete site specific Participant Information and Consent Form (PICF)/s for MH site (The Royal Melbourne Hospital, NWMH etc.).
NOTE:
- Complete the site specific PICF based on the final Master PICF template approved by the reviewing HREC Committee - update only MH specific information.
- Ensure the footer of site specific PICF references the final HREC approved Master version AND the MH site version number and date.
- 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 |
10. Complete a draft (unsigned) agreement - where MH and at least one other institution is involved in the study
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) where MH initiates the project complete the:
Note:
- MH Guide to completing the MACH agreement with comments
- This template should also be used for interstate and overseas sites.
- Researchers may use the template a collaborating partner if the protocol was written by the collaborator if the collaborator does not have a suitable template.
- Where the collaborating organisation wrote th protocol, MH will consider the collaborators template agreement.
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:
Director Research Governance and Ethics
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:
Melbourne Health prefers the use of electronic signatures for agreements and indemnities.
11. If your project involves ionising radiation and/or MRI
All Melbourne Health 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.
- 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 (including pre-MRI safety screening examinations) .
RMH Medical Physicist and Radiation Safety Officer:
- email: paul.einsiedel@mh.org.au
- phone: (03) 9342 8378
Include the local HREC Project Number (i.e. 2020.999) and the Electronic Medical Records (EMR) number (i.e. RMH1111) into the documents.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site EMR number RMH11111.
12. Confirm date of site selection for externally sponsored clinical trials
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.
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:
- A copy of the applicable Clinical Trial Research Agreement (CTRA) electronically signed by the sponsor and principal investigator.
- A copy 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:
- A copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
- A copy 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. Complete fee payment form
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 (i.e. 2020.999) and the Electronic Medical Records (EMR) number (i.e. RMH1111) on the fee form.
NOTE: the EMR number is derived from Ethics Review Manager (ERM) code given during the creation of the project application i.e. HREC/11111/MH-2020 or SSA/11111/MH-2020 in ERM becomes the site code RMH11111 in the EMR.
Find out more about research fees and payment.
15. Submit your application
- We only require hard copies of agreements and indemnities
- Note that digital signatures can be used in the SSA
Electronic submission
- Upload all application documents onto ERM and submit; and
- Send an email with ALL application documents as attached files (including the agreement, scanned copies of the original wet ink signatures etc.) to ResearchGovernance@mh.org.au and include both the local and EMR project numbers in the subject line.
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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