Human Research Ethics Review

The Monash Health Human Research Ethics Committees (HRECs) are certified under the National Mutual Acceptance (NMA) Scheme and the NHMRC National Certification Scheme to review:

• Clinical trials phase 0, I, II, III, IV
• Clinical trials drugs and devices
• Clinical interventional research other than clinical trials
• Population health and/or public health
• Mental health
• Paediatric research

Researchers seeking HREC review from the Monash Health HRECs, please check:

• HREC meeting availability
• HREC booking instructions
• HREC submission process 

Researchers are strongly encouraged to plan ahead and book their applications well in advance, as available booking slots typically fill up 3 months before the meeting. For HREC meetings marked as fully booked, unfortunately there is no capacity to accept additional booking requests.

If these timelines are not suitable, you may wish to approach another NMA-certified HREC that can accommodate review of your application sooner.

If a researcher has obtained HREC approval from another NMA-certified HREC, Monash Health will not duplicate HREC review and will only require an application for Site Specific Authorisation (SSA) prior to commencing the project at Monash Health.

Looking for HREC Composition Letter? Click here.

HREC meeting availability and Submission Deadlines 2025/2026

*Please note, early phase trials and GMO/gene therapy trials have different submission deadlines and additional steps involved. For more information, please refer to the Monash Health Early Phase Clinical Trials Policy & Procedure and Monash Health GMO and Gene Therapy Trials Policy & Procedure.

2026

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Booking Instructions

To request a booking, please email research@monashhealth.org with the following information:

• Project Title
• Brief Lay Summary of the Project
• Name and Contact Details of Principal Investigator (including email address)
• ERM Project ID (even if not submitted yet, ERM will have automatically created this)
• Proposed HREC Meeting Date
• List of proposed Participating Sites (e.g. Monash Health, Eastern Health, Peninsula Health, etc.)
• If known, a list of the documents that will be submitted

A booking is only required for new applications. A booking is not required for responses to HREC Outcome Letters. If the letter indicates that the revised application requires review by the full Committee, the applicant must follow the advertised submission deadlines.

Please note: If your application is not booked in advance, the Research Support Services cannot guarantee it will be included in the agenda. If the cap has been reached, the application will be allocated to the next available meeting, or you may choose to submit it to another HREC.

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Submission Process

Step 1
Researchers are asked to lodge a Human Research Ethics Application (HREA) form via ERM https://au.forms.ethicalreviewmanager.com/Account/Login

Step 2
Please ensure that all study documents for ethical review are attached to the application. This includes Victorian Specific Module (VSM), Protocol, Participant Information and Consent Forms and other patient-facing materials, Waiver of Consent letter etc.

Step 3
The complete application must be submitted in ERM by the submission deadline, and an email advising of the ERM submission sent to research@monashhealth.org.

The email must include the following:

• Study Title
• ERM Project ID
• Monash Health Reference (provided to researchers when a booking is made)
• A list of all the documents being submitted (including the document title, version, and date)
• Monash Health New Project Fee Form (if applicable)

The only documents submitted in hard copy will be legal documents, such as the HREC Review Only Form of Indemnity, if commercial sponsors prefer a wet ink signature.

Need further information
Email us at research@monashhealth.org. Please note, that whilst our staff are able to meet with researchers prior to a submission, we strongly suggest making an appointment first and sharing a list of your queries.

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