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Fees are charged by public health organisations for reviewing: research by their Human Research Ethics Committees, and research governance review of site specific assessments. The fees are charged in accordance with NSW Ministry of Health Policy Directive PD2023_015.

All figures are excluding GST.

Please note that the Ministry of Health (MoH) has recently updated the Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research. This MoH Policy Directive sets out the fees to be charged by NSW Public Health Organisations for processing clinical trial applications. The aim of the updated policy is to ensure consistency in the application of fees across NSW Public Health System.

The fee schedule is listed in the below links:

Policy Directive (PD2025_017, replacing PD2023_015 as of 30 June 2025) - Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (nsw.gov.au)

Information Bulletin (IB2025_014, replacing IB2023_026 as of 30 June 2025) - Fees for Research Ethics and Governance Review of Clinical Trial Research (nsw.gov.au)

The fee schedule is mandatory and the relevant items must be paid appropriately.

Please note that the SWSLHD Research Directorate has implemented the schedule from 1 September 2023. Please note that the Fee Policy applies to all new Clinical Trials submissions (including amendments to existing studies) received after 1 September 2023.

This current fee schedule is in effect until the 30 June 2025.

Table 1: FEE SCHEDULE FOR RESEARCH ETHICS REVIEW

Table 2: FEE SCHEDULE FOR RESEARCH GOVERNANCE REVIEW

*Non-Standard Contracts
While no fee may be charged for the presence of a non-standard contract for an institutionsponsored 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 (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 nonstandard 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.

Fee Policy Update for Research Ethics and Governance Review of Clinical Trial Research

Effective 1 July 2025, the classification of amendments into "Major" and "Minor" categories were discontinued. All amendments submitted for research ethics and governance review will be treated uniformly under the general term "Amendments." This change aims to streamline the review process, providing a more efficient framework that positively impacts non-commercial sponsors by reducing administrative complexity and potential delays. For commercial sponsors, this adjustment is not expected to significantly alter the review process, as the rigorous standards applied to their submissions will continue to be upheld.