Research Governance

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Research Governance

The Tasmanian public health service has a centralised approach to research governance, through the Research Governance Office. The aim of a centralised approach is to improve the efficiency and quality of governance reviews, especially for multi-site projects and clinical trials, and to support local clinical researchers to understand and meet their regulatory obligations in accordance with Tasmania’s Research Governance Policy Framework (RGPF).

The Research Governance Office coordinates the governance review for all proposed research projects within the Tasmanian public health service. 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 or the 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 is able to help researchers with

  • Site-Specific Assessment (SSA) forms or 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

Researchers, study coordinators, external researchers, and industry sponsors are encouraged to contact Research Governance Office, research.governance@health.tas.gov.au as early as possible when planning a new research project or when considering adding a Tasmanian public health site to an existing project.

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. The Research Governance Documents include: research agreements templates, participant consent forms templates, protocol templates, and the monitoring forms used post-approval.

Pre-Approval Forms
Post-Approval Monitoring Forms
  • Amendment Form
  • Complaint Form
  • Safety Event Report Form
  • Progress /Final Report

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, and 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 (eg commercial, non-commercial sponsors, and tertiary institutes) that propose to conduct research within the Tasmanian public health system. The RGPF is supported by the suite of Research Governance Documents.

The RGPF:

  • Promotes a whole of agency approach to the conduct of research, introducing standardised processes that promote a systematic, streamlined approach to review, authorisation, conduct and monitoring;
  • Fulfills one of three main project commitments under the Encouraging More Clinical Trials in Australia initiative, for which Tasmania received Commonwealth funding;
  • Enables Tasmania to continue progressing national reform projects under the Encouraging More Clinical Trials in Australia initiativeincluding an ICT system, which is 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 (ACSQHC) National Clinical Trial Governance Framework (National Standards) for accreditation.

Research Governance Submissions 

Research governance submissions, plus any supporting documentation e.g. Protocol, Participant Consent Form, CTRA, and where relevant the Investigator Brochure, Investigator GCP Certificate, CVs must be submitted to the Research Governance Office, research.governance@health.tas.gov.au

Supporting Documents

Depending on the nature of the proposed research project, any of the following supporting documents amy 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: https://www.ihpa.gov.au/publications/development-table-standard-costs-conducting-clinical-trials-australia

Patient Information Sheets and Consent Forms

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