Department of Psychiatry

Human Ethics in the Department of Psychiatry

Submission of Ethics applications

Using Themis

Melbourne University now requires all Human Ethics applications to be submitted electronically via Themis using the Human Ethics Workbench.

You can find more detailed information about this process at the Research Office Human Ethics website.

Submissions Procedure for the Department of Psychiatry

Human Ethics submissions within the Department of Psychiatry will be assessed initially by the Department HEAG. Once the HEAG has approved the application, it will be submitted to the Research Office for review by the relevant HESC.

At each stage of the process the researcher will be notified of any further requirements, and progress will be recorded in Themis by the HEAG Administrator.

Types of applications are:

Project and Minimal Risk

Submissions to the HEAG must be in the required format, complete and in their final form.

If no applications are received by the closing date then the HEAG meeting will be cancelled.

Once an application has been submitted in Themis, the following is required for the HEAG meeting:
A complete application includes the following:

It is also very helpful for the HEAG if you attach a separate listing of Attachments showing page numbering within the PDF document.

Printing the application

When combining these documents to create the PDF version, ensure that you insert page numbering so it is sequential for the PDF version. It is also helpful to insert a Table of Contents for the Attachments.

Version Identification

Each ethics application and each version of the application needs to be clearly identified.

This should be done in the following format:

Sending Project Applications to the Melbourne Research Office

The Dept has determined that it is the responsibility of the researcher to forward the Project application in its final form (single sided and signed) plus the 14 double sided copies which are required to the Melbourne Research Office by the HESC deadline.

The address is:

Human Research Ethics - HESC
Melbourne Research Office
Level 5, Alan Gilbert Building
161 Barry Street (corner of Grattan Street)
Carlton 3053

Please contact the HEAG Administrator if you have any queries re this process.

Amendment

Researchers need to record the Amendment in Themis, and attach all revised documents. Once this is completed, they need to submit a copy of the Amendment for sign off by the HEAG Chair. It does not need to be submitted to a HEAG meeting. The Amendment will then be forwarded to the Research Office for HESC review.

Once an Amendment has been submitted in Themis, the following is required for the HEAG Chair to sign off on:

  • one (1) original single-sided hard copy of the complete Amendment signed by the responsible researcher must be sent to the HEAG Administrator at the address given. Please DO NOT STAPLE - use paper clips.
    • A complete Amendment includes the following
  • A Request for Amendment form generated from Themis. To print this form, go to Reporting; select Request for Amendment; search by Project ID including Amendment extension; submit and ok; refresh and select icon to print. The Responsible Researcher needs to sign this form.
  • One (1) copy of each revised attachment
    • . Please note it is useful if the researcher can also include a listing of these revised attachments.

    Registration

    If a project needs to go to a teaching hospital or to an Area Health Service for approval, it does not need to come to a HEAG meeting for approval. However, it will need to be registered on Themis, and signed off by the researchers and the HEAG Chair. If a project has been approved by another HREC (properly constituted as per NHMRC guidelines) and the research is being carried out there, or that institution has been nominated as the central site for a study (where there might be more than one site), that project can be registered with the University without having to undergo full ethics review. This means that the other institution's ethics committee is the principal HREC responsible for that project. With regard to HEAG and HESC review, a copy of the approved project, approval letter and the registration cover sheet (available via Themis) has to be sent to the HEAG for sign off and then it is forwarded to the Research Office for notification to the HESC. The University always reserves the right to review a project even if it has been approved by another HREC and also reserves the right not to register a project.

    For further information regarding the process for the Department of Psychiatry, please contact Charlotte Henry.

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