From time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes. 

Instructions for submitting amendments for ethics or governance projects

  1. Download and carefully review the Amendment Guidelines
  2. Complete and submit:
    • A signed Amendment Request Form
    • The signed Commercial Studies - Amendment Fee Payment Form or Investigator Initiated - Amendment Fee Payment Form, which is available on the Office for Research intranet page (access via RMH staff)
    • All documents required for review specific to your circumstance – see below for Documentation required for specific amendment types
  3. Open the email template for and enter all information as requested:
    • Important to include the local project number in the subject of the email
    • Once you have all the files that you want to submit, you need to compress them into a zipped folder. If using Windows: Select the files, right-click on them, and select Send to > Compressed (zipped) Folder.
  4. Submit your Amendment with the zipped folder. Ensure you receive the acknowledgment email from the Office for Research. If you do not get an acknowledgment email, it means that the Office has not received your email submission – contact the Office on (03) 9342 8530.

Documentation required for specific amendment types

Adding new research personnel
Adding a new study site
Changing sponsor or Coordinating Principal Investigator (CPI) or Principal Investigator (PI)
Adding a new recruitment site
Changing protocol
Updating the Investigator Brochure
New collaboration – samples/data sent off-site
Changes to an agreement, new agreement, indemnity, budget

Amendment review process

The majority of amendments are reviewed out of session and do not require review at the HREC meeting nor submission by a certain deadline. When deemed necessary, amendments are sent to the scientific and/or ethics spokespersons for the project, both of whom are members of the HREC.

They will determine whether the amendment can be approved by spokesperson review or whether more detailed consideration is required. If detailed consideration is required, the matter will be listed for discussion at the next HREC meeting.

Tips to avoid delays with the review of your amendment

For faster review and approval of your amendment request, detail all the requested changes on the Amendment Request form.

For example:

  • Where a PICF amendment is required, ensure the PICF is identified as an item on the Amendment Request Form
  • Specify if a Sponsor has requested the amendment to the PICF with an explanation for the change
  • Provide an explanation for the proposed change to the PICF especially relating to rewording previously approved standard clauses
  • Where the amendment impacts on an existing agreement (such as changes to sponsor name, payments made by sponsor to institution) state this in the Amendment Request form

By complying with the above you will ensure that the Ethics and Governance team will be able to review your submission quickly and reduce the time to approval.

Participant information & consent form guidelines (773KB - pdf document)
Guideline for writing PICFs using plain English
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