Amendment Submission and Review
HREC (Ethics) Amendments
Post-Approval Amendments are reviewed outside of the Human Research Ethics Meeting Schedule by an Authorised Representative of the Human Research Ethics Committee. In the event that the amendment is deemed to warrant full Human Research Ethics Review, the researcher will be notified via email as soon as possible and the amendment will be included in the next Human Research Ethics Committee agenda.
The required submission documents for a post-approval amendment:
- Amendment Form summarising the amendments and commenting on the implications of the amendment to the project and whether the changes warrant any revisions to the Participant Information and Consent Form.
- All of the revised documents with track changes (eg. Protocol, Participant Information and Consent Form, Investigator’s Brochure etc)
Site Specific (Governance) Amendments
Post-Approval amendments that have received Human Research Ethics Approval, require Site Authorisation/Governance approval prior to the amendment being implemented at Monash Health. The Site Authorisation of Amendments are reviewed by a member of the Research Support Services Team.
The required submission documents for a post-approval amendment:
- Amendment Form summarising the amendments and commenting on the implications of the amendment to the project and whether the changes warrant any revisions to the Participant Information and Consent Form.
- A copy of the reviewing HREC approval correspondence for the post-approval amendment
- All of the revised documents with track changes (eg. Protocol, Participant Information and Consent Form, Investigator’s Brochure etc)
How do I Submit the Amendment?
- Researchers are asked to lodge amendments via Ethical Review Manager (ERM).
- Following lodging the submission please send an email to research@monashhealth.org informing the team of the amendment.
- In the email please advise of the ERM Review Reference and Monash Health Reference along with the study title. Please list the documents including their versions and dates in the body of the email.
- Please attach the amendment request form and all of the revised documents with track changes (eg. Protocol, Participant Information and Consent Form, Investigator’s Brochure etc)
- Attach the fee form (if applicable) to the email.
- The only documents required in hard copy, will be the HREC Review Form of Indemnity/Standard Indemnity or Agreement as many commercial sponsors prefer a wet ink signature.
For further information please refer to the Research Support Services contact list for the person/people able to assist with submission enquiries and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.
Memo HREC and Gov Fees – December 2021
PDF document