Effective 1 July 2025

There will be Drop-In Clinic presentations held to present the fee updates on:

Governance Drop-In clinic: Tuesday, 3 June 2025

Clinical Trials Drop-In clinic: Monday, 16 June 2025

The NSW Health Fee Schedule for Research Ethics and Governance Review of Clinical Trials has been updated and will apply to all submissions received by the Research Office on or after 1 July 2025.

Links to the policy and fee schedule can be found below:

·       Policy: Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research

·       Information Bulletin: Fees for Research Ethics and Governance Review of Clinical Trial Research

Amendment Classification Post 30 June 2025
Effective 1 July 2025, the classification of amendments into “Major” and “Minor” categories will be discontinued.  All amendments submitted for research ethics and governance review will be treated uniformly under the general term “Amendments.”

From 1 July 2025, the Amendment Fee applies to:
• Protocol amendment
• Revision of the study design due to safety issues
• Revisions in drug dosage, participant groups and numbers of study participants
• Investigator Brochure updates, where there are associated changes required to the Participant Information Sheet/Consent Form (PISCF).

Examples of amendments that do not require review by a full committee and do not attract a fee include:
• Participant Information Sheet/Consent Form amendments with changes not required to be reviewed by the Human Research Ethics Committee.
• Investigator brochure updates where there is no change required to the Participant Information Sheet/Consent Form.
• Change of Principal Investigator/Coordinating Principal Investigator.
• Minor updates to existing patient-facing documents, protocol clarification letters, advertising material and single-word changes

Site Specific Assessment Review
A fee for a Site Specific Assessment (SSA) Review is to be charged when a clinical trial application is submitted to a Research Office for governance review. The fee covers all components of the review

Non-Standard Contracts
While no fee may be charged for the presence of a non-standard contract for an institution-sponsored clinical trial, the costs of external legal review of the contract may be passed on to the study team or funder, at the discretion of the Research Office. This includes where an investigator-initiated clinical trial requires a ‘contract for support’ that is entered into with a funder or a provider of study product.

The NSW Health Policy Directive Research Agreements in NSW Health Organisations NSW Health Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (PD2023_017) outlines a series of standard contracts approved for use with both commercial and non-commercial clinical trials. Use of these standard contracts will not incur a on standard contract fee. However, should a non-standard contract be used by either a commercial or non-commercial sponsor, a non-standard contract fee will be applied.