This information is in accordance with the NSW Health Information Bulletin ‘Fees for Research Ethics and Governance Review of Clinical Trial Research’ () and the NSW Health Policy Directive Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (PD2023_015)
Researchers should be aware of the fees applicable to their submissions and provide correct details for invoices to be raised and ensure payment. Researchers must make themselves aware of all research review fees as outlined below prior to submitting a research ethics or governance application or amendment.
The study team must provide appropriate invoicing details when submitting their research applications. The sponsor, principal investigator and/or relevant research project contact person is responsible for ensuring the invoice is paid in accordance with details included.
Table 1: FEE SCHEDULE FOR RESEARCH ETHICS REVIEW
Table 2: FEE SCHEDULE FOR RESEARCH GOVERNANCE 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.
The NSW Health Policy Directive Clinical Trial Research Agreements for Use in NSW Public Health Organisations (PD2011_028) sets out a series of standard contracts approved for use with both commercial and non-commercial clinical trials.
* A major amendment is considered more than an administrative change and, in the case of an amendment submitted for Research Ethics Review under Table 1 above, a full review by a Human Research Ethics Committee is required. Examples of major amendments include:
· protocol amendment
· contract 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).
** A minor amendment is defined as changes to the details of a research project that have no significant implications for the safety of participants or for the conduct, management, or scientific value of the research project. Examples of minor amendments 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.
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 (PD2011_028) 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.
The CRGH Pharmacy Department levies fees for the conduct of clinical trials in line with the “Schedule of Fees for Clinical Drug Trials NSW Teaching Hospitals Pharmacy Departments”.
Please contact the Clinical Trials Pharmacist on (02) 9767 7035 for further information on fees.
CRGH CLINICAL TRIALS SERVICE FEE (CTSF)
All clinical trials that are fully sponsored by an industry sponsor will be subject to a clinical trials service fee of 7.5% (plus GST) of the total funding.
This fee will be levied on the amount of funding after payment of the Ethics Filing Fee (and pharmacy fee if paid separately). If the pharmacy fees are not separated but included in the total trial budget the service fee will apply to the total budget.
The CTSF will be administered by the Concord Hospital Finance Department and will be automatically deducted from each payment made by the sponsoring company to the investigator’s nominated cost centre for that particular trial. If exemption from payment is granted (e.g. in the case of a partially funded trial) this transfer will be reversed.
For more information (including requests for a waiver or reduction) please contact the Research Office on SLHD-ConcordEthics@health.nsw.gov.au.