Ethics and governance fees2024-10-14T12:24:45+10:00

Ethics and governance fees

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    Fee Template

    A completed and signed fee template must be provided with the relevant ethics/research governance submission via Ethical Review Manager (ERM). Failure to provide the form at time of submission will delay review and may result in the submission being withdrawn from review.

    Externally sponsored research fee template

    This template must be submitted for applications that are not sponsored or led by a Queensland Health Hospital and Health Service (HHS) 

    Internal Queensland Health research fee template

    This template must be submitted for applications that involve other Queensland Health HHS’ and require an inter-HHS Journal Transfer

    Submission type Amount
    Commercially Sponsored
    Ethics/SSA Review New Application – First in human studies/Phase 1 $8250
    Ethics/SSA Review New Application – All other $6050
    Ethics/SSA Review Major Amendment $880
    Ethics/SSA Review Minor Amendment $220
    Collaborative Research Group (CRG)
    Ethics/SSA Review New Application – First in human studies/Phase 1 $1100
    Ethics/SSA Review New Application – All other $770
    Ethics/SSA Review Major Amendment $220
    Ethics/SSA Review Minor Amendment Exempt
    Investigator-Initiated
    Ethics/SSA Review New Application – Investigator-Initiated Metro North led Exempt
    Ethics/SSA Review New Application – Investigator-Initiated Externally led $165
    Ethics/SSA Amendment Exempt
    Exempt from HREC Review
    Ethics New applications- Metro North HHS application Exempt
    Ethics New applications- Non-Metro North HHS application $55

    Amounts are inclusive of GST; Queensland Health Hospital and Health Services will not be charged GST.

    Contact the HREC Coordinator or Research Governance Officer for any queries.

    Frequently Asked Questions

    When do the new fees apply?

    New fees will only apply to new submissions post 1 May 2024, with the exception of commercially sponsored projects, whom the updated fee structure will apply to new and existing submissions.

    I have a Metro North Health staff member as part of the investigator team, do fees apply?

    Yes. Fees apply to the institution that is leading the research collaborative project.

    I am a Metro North employee and have an adjunct position with a university, do fees apply?

    Fees are applied to the institution leading the research project.  If a university is leading the project, then yes, fees will apply.

    I am a Metro North employee and doing a research higher degree, do these fees apply?

    No.  If you are Metro North Health employee and the research project is directly contributing to your research high degree, you are exempt from ethics and governance fees.

    What is an investigator-initiated study and when do fees apply?

    This is research that is initiated by a non-pharmaceutical company and led by the Chief/Coordinating Principal Investigators institution such as a university or hospital.  Fees apply for all investigator-initiated studies where the Coordinating Principal Investigator (CPI) is from an institution external to Metro North Health.

    A Metro North Health investigator-initiated/led study is one where the CPI is representing Metro North Health.  Fees do not apply if the study is led/sponsored by Metro North Health.

    I have a conjoint appointment with Metro North Health and the University, do fees apply?

    Fees apply for research that is not led by Metro North Health. Your application to the HREC or research governance should clearly detail which organisation is leading/sponsoring the research project.

    I am the Principal Investigator for an existing Collaborative Research Group (CRG) study do the new fees apply?

    No, fees will only apply for new CRG sponsored studies (and subsequent amendments) submitted post 1 May 2024.

    I am the Principal Investigator for an existing Investigator-Initiated study do the new fees apply?

    No, fees will only apply for new investigator-initiated sponsored studies (and subsequent amendments) submitted post 1 May 2024.

    Do fees apply for post approval amendments?

    Yes, fees apply for post approvals depending upon the research and submission type.  Please refer to the respective schedule of fees.

    What is defined as a major amendment?

    Major amendments include the following:

    • Changes to the protocol and/or Participant Information and Consent Form (PICF) beyond administrative changes
    • Changes that require review by the ethics committee, sub-committee or other expert/legal review
    • Review of a sub-study
    • Addition of a site
    • Changes to investigators that require study document and/or agreement/indemnity updates.
    • Other agreement/contract amendments/variations
    • Changes to procedures undertaken by participants.
    • Updates to Investigator’s Brochure.
    • Changes to procedures undertaken by participants or any amendments to patient facing material
    • Amended Radiation Dose and Risk Assessment Reports

    What is defined as a minor amendment?

    • Administrative changes e.g., typographical error correction, version control
    • Minor changes to the protocol or other study documentation e.g. correcting errors, minor clarification
    • Administrative changes e.g., typographical error correction or clarification to the research protocol or other research project documentation that does not impact the conduct of the study, version control
    • Updated Insurance Certificates
    • Updated eCTN
    • DSMB reports, or DSUR not submitted in conjunction with the Annual Safety Report. We highly encourage amendments to be consolidated as a major amendment, rather than submission of multiple minor amendments.
    • Please note the following are exempt from fees
      • HREC Annual/Final Reports submitted by the due date (30 April)
      • RGO external HREC Annual Report
      • DSMB reports and DSUR submitted with the Annual Safety Report
      • Annual Safety Report
      • SUSARs, Urgent Safety Measures and SSI
      • Temporary halt or early termination of a study.
      • Protocol deviation
      • Documents which only seek to update HREC/Governance contact details.

    Can I submit without the fee template?

    No, if fees apply to your submission, the completed and signed fee template must be provided. Failure to provide the form at time of submission will delay review and may result in your submission being withdrawn from review.

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