TranslateResearch governance
Each facility is responsible for research projects conducted on site. Research governance is the process of assessing and managing research activity such that it conforms with applicable national, state and institutional policies and legislation.
Guidelines for research governance
All research activities should be developed, reviewed, authorised, conducted and monitored in accordance with a research governance framework as described in the institution’s policy (National Statement, 2023).
The Research Governance Policy Framework (RGPF) is the principal Policy framework for the Tasmanian public health system, inclusive of the Tasmanian Department of Health (DoH), the Tasmania Health Services (THS) and the associated service delivery centres (e.g. Ambulance Tasmania).
The RGPF applies to all staff, officers, volunteers, contractors; external individuals, organisations, entities, bodies or institutions (e.g. commercial, non-commercial sponsors and tertiary institutes) that propose to conduct, manage, review and govern research that requires the use of Tasmanian public health system facilities, access to participants (patient and/or public health service employees) and/or their data (medical and personal records of information) and/or tissue collections held within the authority of the Tasmanian public health system.
Research Governance Office
The Research Governance team is responsible for ensuring that research conducted within the DoH and THS is compliant with all relevant local, state and national guidelines and legislation. The team coordinates governance review for all proposed research projects and monitors approved research projects for the entire life span of the project.
Research governance information:
Preparing a research governance application
All proposed research projects to be conducted within Tasmania’s public health services must undergo a research governance review by submitting an application through REGIS.
A 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.
Applications must be submitted through REGIS and incomplete applications will be returned to the applicant without review.
The documents required for a complete Research Governance application depend on the type of research project to be conducted and the reviewing ethics committee. Applications that have been submitted through the DoH Low Risk Ethics Committee will only need to complete the applicable governance documents. Where an ethics application has been reviewed and approved externally, all approved ethics documents will need to be submitted in conjunction with the required governance documents. Please review the Mandatory Documents Checklist to ensure that your application is complete. For further information and to access the HIMS Data Access and Request form, please contact us. All site investors are required to submit their current Good Clinical Practice (GCP) certificates. GCP is mandatory training for researchers in Tasmania’s public health service. The online training provided by A-CTEC is accessible free of charge.
Fees
All submission reviewed by the Research Governance Office will incur a fee.
REDCAP
Access to REDCAP for Medical/Health Research or Quality Improvement data collection will only be actioned by IT when DoH Research governance approvals have been provided. This means that research projects require evidence of project approval through the DoH Research Ethics and Governance Unit. Quality Improvement projects require evidence of approval through the Low Risk Ethics approval process. Please note that the data management section of your study protocol should reference the use of the DOH REDCAP licence. Contact [email protected] for Research or [email protected] (Quality Improvement) for guidance on approvals.
Contracts and research agreements
Types of agreements
All research conducted within the Tasmanian publicly funded health services that involves an external party requires a relevant research agreement. The DoH/THS/Ambulance Tasmania preferred agreements are:
Clinical trial research agreements | Clinical investigation research agreements | Non-clinical trial research agreements |
|---|---|---|
| Medicines Australia standard form | Medical Technology Association of Australia standard form | Multi-jurisdictional multi-party non-clinical trial collaborative research agreement |
| Contract research organisation acting as local sponsor | Contract research organisations acting as the local sponsor | - |
| Collaborative (or cooperative) research group studies | Post market (devices) | - |
| Phase 4 clinical trial (medicines) | Post market (devices)contract research organisations acting as the local sponsor | - |
| Phase 4 clnical trial (medicines)contract research organisations acting as the local sponsor | - | - |
The Research Governance Office will assist PIs to select the appropriate research agreement for a study and will also arrange DoH/THS signatures at the time of site authorisation to ensure execution of the contact/research agreement is coordinated with site authorisation.
Research agreement templates
- Medicines Australia Clinical Trial Research Agreements
- Medical Technology Association of Australia Clinical Investigation Research Agreements
- Multi-Jurisdictional Multi Party Non-Clinical Trial Collaborative Research Agreement
Non-standard research agreements
Non-standard research agreements are not recommended for use within the Tasmanian public health services. If a Sponsor does not agree to use a standardised Medicines Australia CTRA or Medical Technology Association of Australia CIRA, or multijurisdictional then the non-standard CTRA/CIRA must be forwarded to RGO for review. If required, the RGO will seek further legal advice. The RGO will liaise with the Sponsor and Legal Services until an agreement between the parties is reached.
If a data sharing agreement is required, please contact the Research Governance Office.
Tasmanian-specific clauses
The CTRAs/CIRA must include the Tasmanian Specific Clauses, which are inserted at ‘Special Conditions’ (either Schedule 4 or Schedule 7 depending upon the contract type) to ensure full compliance with Treasurer’s Instruction, ‘Contracts – Disclosure and Confidentiality in Government Contracting’.
Medicines Australia Clinical Trial Research Agreement
Medicines Australia Multi-Jurisdictional Multi-Party non-clinical trial collaborative research agreement
Treasurer's Instruction, Contracts – Disclosure and Confidentiality in Government Contracting
The Tasmanian Treasurer’s Instruction, Contracts – Disclosure and Confidentiality in Government Contracting, issued under the Financial Management Act 2016 (Tas) (“TI C-1”) prohibits the inclusion of confidentiality provisions in contracts where the Tasmanian Crown is a party unless the Head of Agency (Secretary) grants approval.
- This prohibition applies only to the terms and conditions of the contract itself.
- The purpose of this policy is to not unduly fetter public scrutiny of contracts.
- Pursuant to Section 1.2 of TI C-1 a confidentiality provision may be sought by the Sponsor.
The Sponsor must make the application in writing to the Department of Health (Tasmania) requesting:
- the contract be confidential
- outline the sections of the contract that are to be made confidential
- or demonstrating that disclosure is commercially sensitive to the contracting party.
The request must be sent to the Deputy Chief Medical Officer via the Research Governance email: [email protected].
National Clinical Trials Agreement Panel (NaCTA, formerly SEBS)
The National Clinical Trials Agreement Panel (NaCTA, formerly Southern Eastern Border States (SEBS) has representatives from the health department of each jurisdiction.
NaCTA works to standardise (as far as possible) the terms and conditions of the Medicines Australia Clinical Trial Research Agreement (CTRAs) and Medical Technology Association of Australia Clinical Intervention Research Agreements (CIRA) to streamline the administrative management of contracts for Sponsors and public health service organisations who are parties to the agreements.
The NaCTA panel also considers proposed amendments and variations that are intended to accommodate, as far as possible, company-specific clauses that clarify or add to the CTRAs or CIRAs.
The CTRAs or CIRAs can then be executed without the need for any amendments via Schedule 7 (or Schedule 4 in the case of the CRG, Phase IV CRO and Phase IV templates). This ensures national consistency and improves efficiencies on contract amendment negotiations.
For further information or to submit an application for amendment, please visit the Medicines Australia website.
Initial Contact Point for Submissions:
- Phone – (08) 7117 2225
- SEBS email address – [email protected]
Insurance & Indemnity Procedure
The DoH is self-insured through the Tasmanian Risk Management Fund. The Medicines Australia template is preferred for Clinical Trials and other research types where indemnity is provided. Further information on insurance and indemnity can be found on the NHMRC website.
Confidential Disclosure Agreements (CDA)
Sponsors may require the DoH/THS to enter into a confidentiality agreement prior to releasing the study protocol to the DoH/THS for feasibility assessment. The DoH/THS preferred agreement template is a Deed of Confidentiality. If a Sponsor does not accept the DoH standard Deed, a non-standard CDA should be referred to the Research Governance Office for review. If necessary, the Research Governance Office will seek legal advice and will support the PI in negotiating the agreement with the Sponsor.
Approval process
The table below provides an overview of the roles and steps of approvals in REGIS. Further information about roles and their associated responsibilities can be found in the Research Governance Framework Policy and the Research Governance Handbook (2011).
Area | Actions |
|---|---|
| Site PI |
|
| Ethics committee |
|
| Business managers |
|
| Head(s) of department |
|
| Research governance office |
|
| Chief Executive/Deputy Secretary |
|
Once approved, researchers will receive an email indicating that the research can commence at site, noting the Conditions of Site Authorisation.
Post approval activities - Ethics and Governance
A research project should continue to comply with ethics and governance standards throughout the lifetime of the project. Post-approval activities are submitted to both the Ethics committee and Governance Office.
Amendments
Researchers may make changes to their study documentation after approvals have been granted. These changes are called amendments and may be classified as major or minor.
- Amendments to projects that are already in REGIS must be made through the REGIS platform.
- Amendments to paper-based project applications may continue to be submitted via email to the Research Governance email.
- Amendment Form
Safety reports
Monitoring and reporting of research-related adverse events and safety information ensures compliance with the National Statement.
The Research Governance Office needs to be notified of safety events via email.
Annual Site Progress Reports
Annual site progress reports are due on 1 August 2024 and then on 1 May each subsequent year for the duration for which the project is authorised.
A single due date for all progress reports is easier for investigating teams to remember and easier for the Research Governance Office to track.
- Annual site progress reports for projects that are already in REGIS must be made through the REGIS platform. Please review the instructions for submitting an annual site progress report below.
- Annual site progress reports for paper-based project applications may continue to be submitted via email to the Research Governance email.
- Research Governance Annual Site Progress Report
- Annual Site Progress Report Submission Instructions
Close out procedure
Upon completion of a research project, researchers are required to submit a final report and ensure that the close out procedure is followed.
- Final reports for projects that are already in REGIS must be made through the REGIS platform.
- Final reports for paper-based project applications may continue to be submitted via email to the Research Governance email.
- Research Governance Final Report
Research ethics and governance information system (REGIS)
The Research Ethics and Governance Information System (REGIS) is the online portal for the submission, approval, monitoring and management of human research projects.
REGIS is a system for investigators, project members, sponsors, site administrators, Human Research Ethics Committees and Research Governance Offices. REGIS enables the application and submission of projects for ethical and governance review by incorporating the National Health and Medical Research Council’s, Human Research Ethics Application (HREA) ethics form and the Site-Specific Assessment (SSA) governance form. Additionally, REGIS hosts post-approval monitoring forms online.
All health and medical research projects that seek to use Tasmanian publicly funded health system facilities and resources, including consumers and staff as participants, biospecimen and/or health information and data, must be submitted for review through REGIS.
REGIS FAQs and Resources
There are a number of resources available for help with REGIS. The Research Ethics and Governance Office has collated Tasmania-specific FAQ’s which are available for download:
REGIS also provides a number of role-specific training sessions and reference guides on the REGIS website
