Submission Details

All projects must be submitted to the Melbourne Health HREC both electronically and in hard-copy format. For details on HREC Project Numbers, number of copies, fees and other requirements, please read below.

HREC FEES
Projects will not be accepted without payment. For comprehensive information on HREC fees, please visit the Application Fees Web Page.

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HREC PROJECT NUMBERS
Prior to submitting your application, please contact the office of the Research Directorate on (03) 9342 8530 to obtain a HREC Project Number. The Project Numbers are given out during the week before the Submission Deadline.

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HARD COPIES
For each module completed, submit the original plus fifteen (x15) collated copies in numerical order of the modules. The original plus fifteen (x15) copies of the Protocol and Participant Information and Consent Form are also required. Please submit the original application single-sided and the fifteen copies double-sided.

Copies to be sent to:
     Manager Research Directorate
     6 East, Main Block
     The Royal Melbourne Hospital
     PARKVILLE VIC 3050

The HREC Project Number must appear in the top right-hand corner of all hard copies on each of the Modules.

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ELECTRONIC COPY
Researchers must also submit an electronic copy of all parts of their HREC submission. The HREC Project Number must be included in both the email subject field and in the individual file names. For further details, read the Electronic Submission Procedure.

Electronic Submission Procedure
An e-copy of all the documents, with the exception of Clinical Investigator Brochures, is mandatory. Applications which do not meet the submission requirements in full by 4.00pm on the HREC deadline day will not be accepted.

The address for electronic submissions is: hrecsubmissions@mh.org.au 

To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. Projects submitted that do not follow the format below will not be considered and will be returned via email to sender.

 Modules (Word Format Only)
Module One HREC YYYY.NNN
Module Two HREC YYYY.NNN
Module Three HREC YYYY.NNN
Module Four HREC YYYY.NNN
Module Six Form 1 HREC YYYY.NNN
Module Six Form 2 HREC YYYY.NNN
Module Six Form 3 HREC YYYY.NNN
Module Six Form 4 HREC YYYY.NNN
Module Six Form 5 HREC YYYY.NNN
Module Six Form 6a HREC YYYY.NNN
Module Six Form 6b HREC YYYY.NNN
Module Six Form 7a HREC YYYY.NNN
Module Six Form 7b HREC YYYY.NNN
Module Six Form 8a 8b HREC YYYY.NNN
Module Six Form 8c HREC YYYY.NNN
Module Six Form 9 HREC YYYY.NNN
Module Six Form 10 HREC YYYY.NNN
Module Six Form 11 HREC YYYY.NNN
Module Six Form 15 HREC YYYY.NNN

EXAMPLE: For instance, if your HREC project number is 2006.915, the file name for the first module will be: Module One HREC 2006.915

 Participation and Information Consent Form (Word Format Only)
PICF HREC YYYY.NNN
Third Party Information and Consent Form HREC YYYY.NNN

 Protocol (Word or PDF Format)
Protocol HREC YYYY.NNN

 Other Enclosures
If you have any other enclosures such as questionnaires, patient diary/card or advertisements, please clearly state what they are and then add HREC YYYY.NNN
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CLINICAL TRIALS
Further documentation is required for Clinical Trials. As well as submitting the original plus fifteen (x15) copies, you must also submit the following:

 Two (x2) copies of the Clinical Investigator's Brochure
 One (x1) copy of the CTN Form, signed by the sponsor, per each site
 Three (x3) indemnities, signed by the sponsor, per each site 
 One (x1) copy of the Insurance Certificate
 Three (x3) copies of the Clinical Trial Agreement, signed by the sponsor, per each site.