In this Section:
Upcoming change of Victorian legislation and consent for research where the person may not have decision making capacity (formerly referred to as ‘incompetent to give consent’).
The Medical Treatment Planning and Decisions Act 2016 (the Act) will be implemented on 12 March 2018.
The Act is relevant to the Victorian Specific Module (VSM) and the Guidelines. The Coordinating Office is managing the changes to the VSM and Guidelines. There is minimal change but some additional questions will be required and the terminology has to align with the Act.
Any ethics approval relevant to this section of the VSM will still be valid after 12 March 2018 as the Act does not require any retrospective change. The standard Participant Information and Consent
Forms do not require change and will remain the same and available on the websites:
The - annotated with TGA comments, is now available on the TGA website.
All clinical trials conducted under the Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes, involving therapeutic goods that are not medical devices, must comply with the - annotated with TGA comments.
The Office for Research has updated their Ethics & Governance and AEC & IBC Fee Forms, the new forms and fees will be effective from the 1st of September 2016.
It is important to note the Ethics and Governance Fee form are now divided into two (New study and Amendments) for ease of processing and completion.
For clarification on the new fee structure or if you are unsure which fees should be submitted with your submission please feel free to contact the Office for Research firstname.lastname@example.org or (03) 9496 4090.
The Office for Research will commence from Friday 1st July a 'Drop In' Service for researchers seeking advice, clarification or assistance with ethics and governance.
Days: Tuesday and Friday
Time: 12pm to 1pm
Location: Harold Stokes Building
Office for Research
To serve you better and process your submissions in a timely manner, it is appreciated if all appointments outside this time be made via email@example.com
Contracts and all other documents can be submitted in the in-tray at the front desk outside these times following completion of the supplied cover sheet.
The Office for Research no longer issues project expiry dates for ethically approved projects. Continuation of ethics approval and/or governance authorisation is contingent on submission of an annual Progress Report before the anniversary of the HREC approval and/or governance authorisation, and any project specific conditions as listed in your ethics approval letter.
These changes took effect 1st January 2016 and apply to all submissions to extend ethics approval from that date.
There are new changes to the single ethical review for multi-centre health and medical research projects in addition to multi-centre clinical trials for Victoria only. This review process now includes low and negligible risk projects. The frameworks are similar and there is a new website with helpful information.
The health and medical research website has links to application forms, guidance, reporting forms and more at: www.health.vic.gov.au/healthandmedicalresearch
Please take the time to visit this page and add it to your favourites or bookmarks. The standard operating procedures are recommended reading with important information for those who have not used the streamlined system in Victoria.
In Victoria, single ethics review for all project applications will be conducted by seven reviewing ethics committees, including Austin Health’s HREC. See details at: www.health.vic.gov.au/healthandmedicalresearch/ethicalreview
Please phone the Central Allocation Service (CAS) to register HREC applications for multi-centre research projects and clinical trials. This should occur at least 2 weeks prior to the intended submission date. Please note, submission spots are limited.
For information about the submission process for new projects, see: http://www.austin.org.au/RE/NewProjects/
Online Forms has launched E-Submission which applies to all new applications submitted from the Online Forms website. This includes NEAF, SSA, LNR VIC and LNR VIC SSA applications for applications submitted to Victoria only.
If you have any questions, please contact the Infonetica Helpdesk (02 9037 8404).
While this new system is being rolled out the Office for Research will accept applications without signatures on initial submission.
As of 01 July 2015, the Therapeutic Goods Administration (TGA) no longer accepts the Clinical Trial Notification (CTN) Form in hard copy. The system is now solely online.
This is a welcome initiative and will enhance the efficiency of governance aspects of clinical trials in Australia. This is the first in a series of developments to improve and streamline the administrative processes of the clinical trials schemes. Guidance material for the online CTN form is available at: http://www.tga.gov.au/form/ctn-scheme-forms
Please note that Austin Health (AH) has adopted the following approach to the e-CTN online system.
For EXTERNALLY sponsored CTN clinical trials (NOTE: an external sponsor can be commercial, eg pharmaceutical company, or non-commercial, eg a collaborative group or another hospital)
Upon receipt of the Letter of Site Specific Authorisation (ie governance approval) from AH, the external sponsor will be able to lodge the CTN directly with the TGA, online.
It is requested that the AH principal investigator forward the email confirmation from the TGA and a PDF copy of the lodged CTN to the Office for Research (firstname.lastname@example.org) as soon as this is available (This should be provided to investigators by the sponsor). The Office for Research will audit its records regularly to verify compliance with this requirement.
Site details can be found here.
For Austin Health sponsored CTN clinical trials (ie Investigator initiated trials where there is no external sponsor)
Upon receipt of the Letter of Site Specific Authorisation (ie governance approval) from AH , researchers are asked to make an appointment for drug trials with HREC Manager - Drug Trials - Lisa Pedro , Lisa.Pedro@austin.org.au and for device trials with HREC Manager - Non-Drug Trials - Kristina Zlatic, Kristina.Zlatic@austin.org.au so that the online CTN application may be lodged by the investigator and HREC Manager together. We have made this arrangement to ensure that a consistent approach is used for trials where AH, through the investigator, assumes responsibility for the trial. This is an essential risk management activity and will ensure that our institution and our investigators are protected and fully compliant with TGA and insurance requirements. The fees associated with CTN submission for such trials will be processed by AH accounts payable with costs set against the applicable research cost centre.
Please direct any questions or concerns about the new e-CTN system to Lisa Pedro, HREC Manager - Drug Trials via email (Lisa.Pedro@austin.org.au) or call on 9496 4035.
If you wish to receive updates/newsletters via e-mail please send your full name and e-mail address to email@example.com
Any research involving collaboration between Austin Health and an external entity requires an agreement of some description. The nature of the research project will determine which type of agreement is required.
To assist in determining the type of agreement/s that may be required as part of your research project submission, the Office for Research have developed three flowcharts.
1. Contract/Agreement Flowchart
2. Material Transfer Agreement Flowchart
3. Service Level Agreement Flowchart
All three flowcharts can be found here. Please note this is as 3 step process. You MUST follow each step in the process.