How to make a HREC Application through the Streamlined Ethical Review Process (SERP) to the Melbourne Health Ethics Commitee

There are two (2) components of approval for all research projects -- both of these must be addressed in full before a project can be given approval to commence:

• HREC (ethics) approval; and 
• Research Governance (site-specific assessment) approval

Ethics approval requirements are outlined below. To access the requirements for Research Governance and Site-Specific Assessment, click here.

The introduction of a new system for streamlined ethical reivew of multi-site clinical trials has necessitated a separation of research ethics and research governance/site-specific assessment processes. At Melbourne Health, we have separated the application and review of ethics and research governance/site-specific assessment for all research projects, not just multi-site clinical trials.

These instructions apply to both the HREC and MHREC.  The Office for Research manages both committees and allocates new research projects to the appropriate Melbourne Health HREC for review. 

HREC Application Instructions for SERP Projects

1.	Call the Central Allocation System for your project to be allocated to a reviewing HREC. They will also provide you with a SERP HREC Number example - HREC/11/MH/7 which is different to a local MH HREC number example - 2011.001. Both these identifiers need to be documented on the submission. The central system for ethical and scientific review of multi-site research will apply to research involving interventional clinical trials. These will include drug and device trials that are conducted by: Commercial sponsors; Collaborative groups/Consortiums; Investigator initiated groups. However at this stage it excludes research such as supportive care and psycho-oncology and these areas may be considered at a later stage. Central Allocation System line: (61 3) 9092 1983, Monday to Friday 10am to 5pm EST. This phone call will involve answering questions about your research and you will be asked to provide relevant information.  The call will take approximately fifteen minutes. For more information visit the CCHRE website:  http://www.health.vic.gov.au/cchre/applications/applications_how_to.htm
2.	Complete the Ethics Checklist for Coordinating Principal Investigators - the Principal Investigator who will submitting the research project to the Melbourne Health HREC on behalf of other sites and coordinating the ethical submission is the Coordinating Principal Investigator.
3.	Complete the National Ethics Application Form (NEAF) from the online forms website. Please complete the NEAF for the following website: www.ethicsform.org/au and DO NOT USE the NEAF from the www.neaf.gov.au
4.	Completethe Victorian Specific Module.
5.	Fee payment - Please enclose the appropriate Research Governance/Site-Specific Assessment OR Ethics Fee with your application. Fees are payable up-front, at the time of initial submission of a research project.
6.	Submit a detailed Project Protocol and any other documentation such as: Documents to be given to participants, e.g. letters of invitation, transcripts for telephone contact, questionnaires, patient diaries, etc. Assessment tools Advertising Materials Data Collection Sheets
7.	Complete a Participant Information and Consent Form if the study involves participants for whom you are obtaining consent.
8.	For all Clinical Trials, please submit the following: An original CTN or CTX form - download the relevant form from TGA website. Two (2) copies of the Investigator's Brochure
9.	For all Research Involving the Use of Ionising Radiation at least one Radiation Safety Officer Report must be submitted with the HREC application.
10.	Complete a Melbourne Health Curriculum Vitae Form for all Investigators/Researchers involved in the Project.
11.	Complete a Melbourne Health Cover Letter for Ethics Submissions Template. Ensure this letter is submitted with your application and in the 15 copies.
12.	Before submitting your application, contact the Office for Research on (03) 9342 8530 to obtain a HREC Project Number. The HREC Project Number must appear in the top right-hand corner of all hard copies of each component of your application.
13.	Check the HREC Meeting Dates and Deadlines. Applications submitted after 1pm deadline will not be accepted.
14.	Submit the original plus fifteen (15) copies and send to: Ms Angela Gray, Manager, Human Research Ethics Committee Office for Research 6 East, Central Building The Royal Melbourne Hospital 300 Grattan Street PARKVILLE  VIC  3050 Please submit the original application single-sided and the 15 copies double-sided and collate each set of papers.    PLEASE MAKE SURE ALL DOCUMENTS PROVIDED IN THE ORIGINAL SUBMISSION ARE ALSO PROVIDED IN THE 15 COPIES.
15.	Submit an electronic copy. Ensure the hard copy and electronic copy are identical and that the electronic copy is labelled in the correct format as requested on the Submission Details web page.
16.	Complete the Research Governance/Site-Specific Assessment component of your application if Melbourne Health is a participating site. This includes the Site-Specific Assessment Form, the Budget, Clinical Trial Research Agreement (CTRA), Insurance, Indemnity, site-specific departmental approval forms, etc.

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