Protocol Amendments

HREC Amendments

Research Support Services Festive Closure – Research Support Services will be closed from 5:00pm on Thursday 22 December 2022 and will re-open at 8:30am on Tuesday 03 January 2023. In order for researchers to receive a response to items such as; post-approval amendments, project notifications, new governance applications/site authorisation applications, HREC conditions of approval or Quality Assurance applications, the item must be submitted no later 5:00pm on Thursday 15 December 2022. This enables time for the team to seek advice from HREC members (if required) and manage the high workload.

New applications for Low Risk Human Research Ethics Review or Full Human Research Ethics review for 2022 close at 5:00pm on Wednesday 23 November 2022. New Applications for 2023 are open from 03 January 2023 for consideration at the 02 February 2023 HREC meeting.

For urgent issues i.e. an issue involving patient safety, please contact the team by phone in the first instance Research Support Services Contact List.

Post-Approval Amendments are reviewed outside of the Human Research Ethics Meeting Schedule by an Authorised Representative of the Human Research Ethics Committee. Researchers can expect a response in approximately 3- 5 working days of submission. In the event that the amendment is deemed to warrant full Human Research Ethics Review, the researcher will be notifed 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)

Governance/Site Authorisation 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. Researchers can expect a response within 3 – 5 working days of submission.

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)

Electronic Submission

  • Researchers are asked to lodge amendments via ERM https://au.forms.ethicalreviewmanager.com/Account/Login
  • 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 enquires 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.

Documents