Research and Ethics Office

Fees

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 new fee schedule is listed in the below links:

Updated Policy Directive (PD2023_015) - Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (nsw.gov.au)

Information Bulletin (IB2023_026) - Fees for Research Ethics and Governance Review of Clinical Trial Research (nsw.gov.au)

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

Please note that the SWSLHD Research Directorate has implemented the new 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.

Table 1: FEE SCHEDULE FOR RESEARCH ETHICS REVIEW

ITEM INSTITUTION SPONSORED CLINICAL TRIALS NON-COMMERCIAL EXTERNAL SPONSOR COMMERCIAL EXTERNAL SPONSOR
HREC Review $0 $1000 $6250
Additional site $0 $150 $1500
Addition of a sub-study $0 $500 $2500
Major* Amendment $0 $250 $1000
Minor* Amendment $0 $150 $500

Table 2: FEE SCHEDULE FOR RESEARCH GOVERNANCE REVIEW

ITEM INSTITUTION SPONSORED CLINICAL TRIALS NON-COMMERCIAL EXTERNAL SPONSOR COMMERCIAL EXTERNAL SPONSOR
SSA Review $0 $1000 $4500
Non-standard contract-review See below** $500 $2000
Major* Amendment $0 $250 $750
Minor* Amendment $0 $100 $325

*Please refer to the Policy Directive for information on the definitions of Major and Minor amendments.

**Non-Standard Contracts
While no fee may be charged for the presence of a non-standard contract for an institution-sponsored clinical trial, if a review of that contract by an external legal provider is required, research support offices may pass that cost on to the study team/ funder. 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 Clinical Trial Research Agreements for Use in NSW Public Health Organisations sets out a series of standard contracts approved for use with both commercial and non-commercial clinical trials. Use of these contracts will not attract a non-standard contract fee. Should a non-standard contract be used by either a commercial or non-commercial sponsor, a non-standard contract fee will be charged.

 

 


 

 

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Last Updated: 22 February, 2024
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