Research governance

Research governance ensures that the principles, requirements and standards of research are upheld.

It enables the protection of research participants, the safety and quality of research, privacy and confidentiality, legal and regulatory matters, risk management, and monitoring arrangements. Effective research governance promotes a positive research culture and sustainable practices that facilitate the conduct of high-quality research.

The University's Legal Compliance Framework ensures all legal obligations are identified, risk assessed and managed appropriately and that non compliances are reported and used to inform continuous improvement. The Research Governance Model and Process Frameworks have been developed based on the Legal Compliance Framework with a focus on research related obligations.

The Research Governance Office aims to work collaboratively with risk owners to develop, maintain and monitor standardised and functional frameworks to meet legal obligations.

    Specialist advice, guidance, and training in safe and compliant management is provided at Research and Research Training Portfolio - Research Governance (Staff intranet) for:

    • hazardous biological materials;
    • gene technologies;
    • clinical trials; and
    • defence export controls

    For specialist advice on research governance considerations in the following areas, please contact:

    Clinical trial governance

    Applying for University of Tasmania Clinical Trial Governance Authorisation

    If your project is a clinical trial, the next step is to determine what role the University is playing.

    A clinical trial sponsor is defined as the organisation that takes responsibility for the initiation, management and/or financing of a clinical trial.

    The University can play one of four roles in a clinical trial:

    In this scenario the University’s only involvement is in the ethical review of the project. The trial is being conducted by an external group, at a trial site that is not the University.

    University of Tasmania Clinical Trial Governance application process: No application required.

    Other requirements: See the Health and Medical Research Human Research Ethics Committee (HREC) submission requirements. A HREC review only indemnity will be required for commercially sponsored clinical trials. If the trial involves the use of an unapproved therapeutic good, a Clinical Trial Notification (CTN) will need to be submitted to the Therapeutic Goods Administration.

    Examples:

    1. A pharmaceutical company is sponsoring a clinical trial which is to be conducted at the Launceston General Hospital.
    2. Royal Hobart Hospital Research Foundation grant awarded to a Royal Hobart Hospital employee, administered at the Hospital and trial to be conducted at the hospital

    The University is the sponsor of the clinical trial, but is not involved in the conduct of the trial (i.e. is not a trial site). As sponsor the University takes responsibility for the initiation, management, provision of insurance and indemnity, and/or financing of the clinical trial. Further information about clinical trial sponsors is available at the Australian clinical trials website.

    University of Tasmania Clinical Trial Governance application process: A Sponsor Only Governance Application Form (DOCX 179.4 KB) must be completed at or before the time of ethics submission. The Governance Application Form includes details of all governance requirements, including any legal and regulatory requirements.

    Other requirements: See the Health and Medical Research Human Research Ethics Committee (HREC) submission requirements.

    If the trial involves the use of an unapproved therapeutic good, a Clinical Trial Notification (CTN) or Clinical Trial Authorisation (CTA) will need to be submitted to the Therapeutic Goods Administration. Complete the application form (DOCX 174.8 KB) and submit this alongside your Governance Application Form.

    Examples:

    1. An NHMRC grant is awarded to a clinician holding a conjoint appointment at the University and Royal Hobart Hospital. The grant is administered by the University, and the University takes on the role of sponsor, but trial is conducted at the Royal Hobart Hospital.
    2. A University of Tasmania employee designs a new medical device that requires testing in patients. Hospitals around Australia conduct the trial, with the University of Tasmania responsible for the overall conduct of the trial as sponsor.

    The University of Tasmania is conducting the trial by recruiting and treating participants, but is not taking overall responsibility for trial oversight.

    University of Tasmania Clinical Trial Governance application process: A Site Only Governance Application Form (DOCX 178.6 KB) must be completed at or before the time of ethics submission. The Governance Application Form includes details of all governance requirements, including any legal requirements.

    Other requirements: See the Health and Medical Research Human Research Ethics Committee (HREC) submission requirements.

    If the trial involves the use of an unapproved therapeutic good, a Clinical Trial Notification (CTN) or Clinical Trial Authorisation (CTA) will need to be submitted by the sponsor to the Therapeutic Goods Administration. Please provide a copy of the sponsor's CTN or CTA form (can be a draft) when you submit your Governance Application Form for review. The trial cannot commence at the University of Tasmania site until the sponsor has submitted the CTN or CTA to the TGA and the TGA has acknowledged receipt.

    Examples:

    1. A pharmaceutical company is conducting a clinical trial at sites all around the world, the University of Tasmania is one of these site. The company has provided the protocol, funding and the investigational product, the University of Tasmania recruits and treats the participants and collects the data on behalf of the company.
    2. University of Tasmania employees have collaborated with employees of another University to design a clinical trial of a device. The other University is the administrating institution for the NHMRC grant, and has entered into a collaborative clinical trial agreement with the University of Tasmania. The other University takes overall responsibility for the clinical trial, however the collaborative agreement specifies that some sponsor responsibilities have been delegated to, or shared with the University of Tasmania.

    The University of Tasmania is responsible for all aspects of the clinical trial, including design, conduct and oversight. The trial may or may not be conducted at other sites in addition to the University.

    University of Tasmania Clinical Trial Governance application process: A Site and Sponsor Governance Application Form (DOCX 181.3 KB) must be completed at or before the time of ethics submission. The Governance Application Form includes details of all governance requirements, including any legal and regulatory requirements.

    Other requirements: See the Health and Medical Research Human Research Ethics Committee (HREC) submission requirements. If the trial involves the use of an unapproved therapeutic good, a Clinical Trial Notification (CTN) or Clinical Trial Authorisation (CTA) will need to be submitted to the Therapeutic Goods Administration. Complete the application form (DOCX 174.8 KB) and submit this alongside your Governance Application Form.

    Examples:

    1. A University employee designs a clinical trial to test a medicine in a population of the community, and the participants are seen at the Menzies Clinical Research Facility. Funding for the trial has been received from the Bill and Melinda Gates Foundation and the drug manufacturer is supplying the medicine.
    2. A clinical trial has been designed by a University PhD student to test the usefulness of an online maths training game. Participants are recruited through local primary schools and they undertake the training at home on their family computer. Funding for the project has been provided through Faculty funds. Even though the ‘site’ of the clinical trial is the family home, the University takes responsibility for this.
    3. A pharmaceutical provides the University with a medicinal product to be used in a clinical trial but has no other involvement in the conduct of the trial. The University takes responsibly for the oversight and conduct of the trial.