Amendments

From time to time, Amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors.

Notifications of protocol Amendments must be made in writing and addressed to:

The Manager
Human Research Ethics Committee
Melbourne Health Research Directorate
Post Office
The Royal Melbourne Hospital
Parkville Victoria 3050

Requirements

Two hard copies of Form13 Request for Approval of Amendments explaining the background of the amendment should be accompanied by two copies of the original and amended sections of the protocol, and any other relevant documentation. Changes should be highlighted for ease of review.

If the Patient Information and Consent Form (PICF) is to be amended, please underline all additions and changes to the text and strikethrough any deleted original text. Two (2) copies are to be provided, along with two final 'clean' copies. A new version number and date is required in the footer of each page of the PICF. If new researchers are to be included, their names and contact details are required on the PICF.

Investigator Brochures

In order to be able to review and 'approve' a new updated Investigator's Brochure, the Human Research Ethics Committee (HREC) requires a brief, clear and simple explanation from the Principal Investigator as to what the changes are, what they mean, why they have occurred and whether they impinge in any way on the conduct of trial at our site and/or on our patients.

Accordingly, you are requested to complete a Request for Approval of Amendments (Form 13) to accompany your submission of a new Investigator Brochure.  Please note that a comment directing the HREC to a summary provided by the trial Sponsor and located within the updated document is NOT ACCEPTABLE. Please submit only one copy of the updated Investigator Brochure.

Review process

Copies of the material submitted will be sent to both the scientific and ethics spokespersons for the project, both of whom are members of the HREC. They will determine whether the amendment should be approved without further assessment or whether a detailed examination is required. If a detailed examination is required, the matter will be listed for discussion at the next HREC meeting.

Review fee

Please refer to the Fees web page on the Research Directorate website.