Research governance

Find information about health and medical research governance in Tasmania.

Research Governance Unit

The Research Governance Unit (RGU) provides policy advice and strategic leadership for health and medical research within Tasmania’s public health system to:

• ensure the conduct of high-quality research projects across all Tasmanian health services
• develop a centre of excellence, innovative health care and service delivery that improves the health and wellbeing of the Tasmanian community.

The RGU is a centralised coordination centre for all research-related enquires within Tasmania’s public health system for:

• HRECs
• public health institutions
• universities
• researchers
• sponsors
• health service staff
• broader Tasmanian community.

This approach aims to:

• improve efficiency and quality of governance reviews, especially for multi-site projects and clinical trials
• support local clinical researchers to understand and meet their regulatory obligations in accordance with Tasmania’s Research Governance Policy Framework (RGPF).

Research Governance Office

The Research Governance Office (RGO) is based within the Research Governance Unit and:

• coordinates governance review for all proposed research projects
• monitors all approved research projects. 

All proposed research projects to be conducted within Tasmania’s public health services must undergo a research governance review using either the:

• Site-Specific Assessment (SSA) form
• Access Request (AR) form

The research governance review includes the consideration of:

• the suitability of the site and the investigators to conduct the research
• the assessment and management of site risk
• the identification of actual and in-kind resources required to conduct the research
• scientific and ethical approval of the research project.

The RGO can help researchers with:

• Site-Specific Assessment (SSA) and Access Request (AR) forms
• supporting documents required for research governance review
• negotiation of research contracts, including obtaining legal review where required
• guidance regarding legislation, policies and standards relating to the conduct of research, including access to confidential health information
• education and training for new and experienced researchers to enhance the quality and conduct of research in accordance with good practice guidelines.
• monitoring of research, including responding to concerns about research conduct.

Research Governance Documents

In addition to Site-Specific Assessment (SSA) form or the Access Request (AR) form completed by the Principal Investigator (or delegate) at the site, used to complete the research governance review, the following Research Governance Documents are approved for use.

Pre-approval forms

• Checklist for New Submissions
• Site-Specific Assessment (SSA) Form
• Financial Analysis Form
• Supporting Department - Quotation Request
• Clinical Trial Research Agreements
• Patient Information and Consent Forms
• Access Request Form

Post-approval monitoring forms

• Amendment Form
• Site Progress Report
• Final Report
• Complaint Form

Research Governance Policy Framework

The Research Governance Policy Framework (RGPF) provides the governance framework to ensure that the conduct and management of all human and medical research activities comply with:

• applicable legal, regulatory, and institutional requirements
• appropriate ethical and scientific standards
• standards of quality, safety, privacy, risk management, financial management, audit and monitoring.

The RGPF applies to all staff, officers, volunteers, contractors, external individuals, organisations, entities, bodies, or institutions (for example, commercial, non-commercial sponsors, and tertiary institutes) that propose to conduct research within the Tasmanian public health system. The RGPF:

• promotes a whole of agency approach to the conduct of research
• introduces standardised processes promoting a systematic, streamlined approach to review, authorisation, conduct and monitoring
• fulfils one of three main project commitments under the Encouraging More Clinical Trials in Australia (EMCTIA) initiative, for which Tasmania received Commonwealth funding
• enables Tasmania to continue progressing national reform projects under the EMCTIA initiative, including an ICT system (a requirement to sign the National Mutual Acceptance (NMA) Memorandum of Understanding with other jurisdictions)
• assists hospital services to meet the Australian Commission on Safety and Quality in Health Care National Clinical Trial Governance Framework (National Standards) for accreditation.

Download the Research Governance Policy Framework

Research Governance submissions

Research Governance submissions must be submitted to the Research Governance Office along with any supporting documentation, for example:

• Protocol
• Participant Consent Form
• CTRA
• Investigator Brochure (where relevant)
• Investigator GCP Certificate (where relevant)
• CVs (where relevant)

Please email submissions to: [email protected]

Supporting Documents

Depending on the nature of the proposed research project, any of the following supporting documents may also be required to be submitted with the research governance submission to the Research Governance Office:

• Funding/Grant Agreement
• Medical Indemnity
• Certificate of Insurance/ policy wording
• eCTN/CTX
• ANZCTR Registration
• Radiological Council approval/Dosimetry assessment
• Declaration of Confidentiality
• Conflict of Interest declaration.

Research Governance resources

Costing and Budgets

The Independent Hospital Pricing Authority (IHPA) has developed a set of standard costs associated with conducting clinical trials in Australia. Learn more on the IHPA website.

Patient Information Sheets and Consent Forms

Standardised participant information and consent forms (PICFs) for interventional, non-interventional, health and social science, and genetic studies are available on the NHMRC website.

Where to get more information

Researchers, study coordinators, external researchers, and industry sponsors are encouraged to contact us as early as possible when planning a new research project or when considering adding a Tasmanian public health site to an existing project.

Email: [email protected]