Governance Review: HREA used for ethical review

Human Research Ethics Application

Preparing your governance application

Governance Application Forms

The following documents are required for multi-site ethical review projects only:

Site specific documents based on the ethically approved master documents e.g. site-specific Participant Information and Consent Form (PICF) on Peter Mac letterhead (if you are a Peter Mac employee, access vis the intranet. For outside access please contact the ethics secretariat) . Find Peter Mac details for use in PICFs.

NOTE: Site specific project documents must have a version/date inserted in the footer of all pages. An example for a site specific PICF is: PMCC PICF version X dated day month year based on master PICF version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.

If Peter Mac Ethics Committee is the reviewing HREC:
All documents already submitted to the Peter Mac Ethics Committee for ethical review and all correspondence issued by/on behalf of the Peter Mac Ethics Committee are available to the Peter Mac Ethics Secretariat staff and the Peter Mac Research Governance Officer and do not need to be submitted again.

If the reviewing HREC is an external Ethics Committee, please also include the following additional documents:

  • Ethical Approval(s) from the external Ethics Committee. The Ethics Approval(s) should list most recent approved documents and list Peter Mac as a site included under the approval
  • A copy of the ethics application forms as reviewed by the external Ethics Committee e.g. HREA and VSM
  • Ethically-approved project documentation (e.g. Protocol, Investigator Brochure, master PICF/s and any other master documents)
  • Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) for unapproved therapeutic goods, if required. The CTN is an online form. Please include a PDF of the filled in CTN for review (Peter Mac as sponsor projects please contact the Office of Cancer Research to fill out a CTN form [email protected]). Find Peter Mac contact details for use in CTNs here.

Submitting your governance application

  1. Please ensure that all required documents are completed and that the electronic files are clearly labelled
  2. Submit the SSA and upload all other forms and project documents on the Online Forms site.  Electronic signatures or scanned copies of signed application form pages are accepted. Find link here for HREA SSA completion and submission
  3. The Standard Indemnity is the only document required in hard copy, please deliver or post as per the below:

Hand delivery address:

Ethics Committee Secretariat

Peter MacCallum Cancer Centre

Level 4, 305 Grattan Street

Melbourne VIC 3000

Postal address:

Ethics Committee Secretariat

Peter MacCallum Cancer Centre

Locked Bag 1 A'Beckett St

Melbourne, VIC 8006

The Principal Investigator will be advised of the outcome of the review and any further queries or requirements.