Fees for Clinical Trials
Research Ethics and Governance Review of Clinical Trials
In July 2023 NSW Health released an updated Policy Directive (PD2023_015 Fee Scheduled for Research Ethics and Governance Review of Clinical Trial Research) which describes the processes for the management of research ethics and governance review fees in NSW Public Health Organisations and sets out mandatory ethics and governance fees to be charged for processing research applications.
Research ethics and governance review fees described in this Policy Directive apply to external sponsored clinical trial research applications only.
Fees will be charged for both Commercial and Non-Commercial clinical trials with an external sponsor, with the exemption of non-standard contract review for Investigator Initiated trials, as per the associated Fee Schedule.
The HNELHD Research Office has designed a new form that will be mandatory for all new clinical trial ethics and site applications and amendments submitted with an external sponsor from 1st August 2023 (this includes any new clinical trial ethics applications submitted to HREC for consideration at the August HREC meeting).
Ethics and Governance Review Fees for Clinical Trials
For the Initial Ethics Review | Sponsor | Amount (Ex-GST) |
|---|---|---|
New Ethics Application | Commercial External Sponsor | $6,250 |
Non-Commercial External Sponsor | $1,000 | |
For the Ethics Review of Amendments | Sponsor | Amount (Ex-GST) |
General Amendments – Addition of site | Commercial External Sponsor | $1,500 |
Non-Commercial External Sponsor | $150 | |
General Amendments – Addition of a Sub-Study | Commercial External Sponsor | $2,500 |
Non-Commercial External Sponsor | $500 | |
General Amendments – Major Amendment | Commercial External Sponsor | $1,000 |
Non-Commercial External Sponsor | $250 | |
General Amendments – Minor Amendment | Commercial External Sponsor | $500 |
Non-Commercial External Sponsor | $150 | |
For the Initial Governance (SSA) Review | Sponsor | Amount (Ex-GST) |
New Site Application | Commercial External Sponsor | $4,500 |
Non-Commercial External Sponsor | $1,000 | |
For the Governance Review of Site Amendments | Sponsor | Amount (Ex-GST) |
Non-standard contract review | Commercial External Sponsor | $2,000 |
Non-Commercial External Sponsor | $500 | |
General Amendments – Major Amendment | Commercial External Sponsor | $750 |
Non-Commercial External Sponsor | $250 | |
General Amendments – Minor Amendment | Commercial External Sponsor | $325 |
Non-Commercial External Sponsor | $100 |
Definitions
Amendments: An amendment is considered as any change to a research project or an approved application that occurs after ethics approval or governance authorisation, respectively. Where an amendment is submitted as a single batch or documents containing several items for review (by either HREC or RGO), only a single amendment fee will be charged.
Addition of site: A fee for an additional site will be charged when a clinical trial adds a site to a clinical trial study after HREC approval has been granted.
Addition of Sub-study: A sub-study is a study performed a subgroup of the subjects included in the clinical trial. For example: a pharmacokinetics or pharmacogenetics sub-study may include a sample of the patients participating in the clinical trial. A fee for a sub-study will be charged when an already-approved clinical trial submits for approval a study related to the original clinical trial.
Clinical Trial: A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes. Clinical trials include but are not limited to: surgical and medical treatments and procedures; experimental drugs; biological products; medical devices; health-related service changes; health-related preventative strategies; health-related educational interventions.
Major Amendment: A major amendment is considered more than an administrative change and, in the case of an amendment submitted for Research Ethics Review, a full review by a HREC is required, examples include: protocol amendment; contract amendment, revision of study design due to safety issues; revisions of 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)
Minor Amendment: A minor amendment is defined as changes to the details of 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 include; Participant Information Sheet/Consent Form (PISCF) amendments with changes not required to be reviewed by the HREC Committee; investigator brochure updates where there is no change required to the Participant Information Sheet/Consent Form (PICF); change of PI/CPI; Minor updates to existing patient-facing documents, protocol clarification letters, advertising material and single-word changes.
Non-Standard Contract: The NSW Health 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.
Commercial External Sponsor: A commercial entity which is the sponsor of a clinical trial. For the purpose of PD2023_015 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include all pharmaceutical and medical device companies.
Non-Commercial External Sponsor: A non-commercial entity external to NSW Health which is the Sponsor of a Clinical Trial. For the purposes of PD2023_015 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include independent medical research institutes, collaborative or cooperative research groups and universities.
Institution Sponsor: A NSW Health Organisation which is the sponsor of a clinical trial. For the purposes of PD2023_015 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include those public health organisations from other Australian jurisdictions as well as other government agencies and departments.