Research governance and site authorisationDouglas2022-06-29T08:49:55+10:00
Research governance and site authorisation
Public health facilities use the Site-Specific Assessment Application (SSA) within Queensland Health to document all research governance arrangements for a study at a site. This involves assessing the legal, financial, regulatory, and contractual matters related to research. All applications are reviewed by the Research Governance Office. An SSA approval letter is required before a research study can commence at the site.
The Research Governance Office are able to help researchers with:
SSA forms and the application processes for site authorisation, including relevant site contacts such as Director of Finance and Heads of Department
Negotiation of research contracts, including obtaining Metro North legal review where required
Guidance regarding legislation, policies and standards relating to the conduct of research, including access to confidential health information under the Public Health Act 2005
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.
Study Budget Template – A budget of research costs associated, whether actual or in-kind, must be completed for all studies and signed-off by the relevant departmental Business Manager or hospital Director of Finance
Single SSA factsheet – describes the process for obtaining Research Governance approval for research projects being conducted at more than one Metro North facility or service
While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and Research Governance Officers to provide reporting and monitoring
Yes, all research projects need a study budget completed as part of the site specific assessment (SSA) submission. In-kind contributions should be quantified in order for the health service to calculate the actual cost of research. For example, if you anticipate spending 20 hours on a research project during work hours as a Principal Investigator and Metro North Hospital and Health Service employee, you need to quantify the in-kind contribution (e.g. 20 hours x hourly salary) for the SSA study budget. Facility and research business managers can assist with determining salary costs or with other queries relating to study budgets. Please discuss your research budget with the relevant departmental business manager or hospital director of finance.
All research projects that involve parties outside of Metro North require an agreement to cover matters such as confidentiality, intellectual property, ownership of data, insurance and indemnity. A suite of pre-agreed contracts for various projects, including non-commercial research agreements for higher degree students or university staff undertaking research involving resources from within Metro North, are available; contact the relevant Research Governance Officer early in the planning stage for advice and assistance. For sponsored studies, standard clinical trial research agreements are available at the Medicines Australia website. For projects involving two or more organisations which are part of the Brisbane Diamantina Health Partners, the BDHP Research Partner Agreement may be used.
All non-standard research agreements require review by Metro North legal services; queries should be directed via the relevant Research Governance Officer.
Intellectual Property consists of legal rights arising from the outcomes of intellectual and creative activity such as written papers, new inventions, some databases and new methods of treatment. Some Intellectual Property rights are automatic and some require confidential registration.
Advice should be sought from Metro North legal services (contactable via the Research Governance Officer) in relation to the protection of any such outcomes, particularly where there is a proposed or expected future use of those outcomes. Intellectual Property will also be relevant in collaboration agreements between Metro North and other parties where it is proposed to distribute or deal with the outcomes of collaborative activity. As a statutory body, Metro North Hospital and Health Service is expected to give due consideration to the outcomes of intellectual and creative activity and to use its best efforts to ensure the future use of such materials in the public health system in Queensland.
Consideration should be given to Intellectual Property issues when any existing materials, inventions or confidential information is intended to be supplied by Metro North to another party in the course of collaboration. Such “Background IP” must be checked for provenance to ensure that Metro North has title to grant a licence in such material. In this regard, please note that Intellectual Property created by Metro North Hospital and Health Service, including the past Metro North Health Service District, prior to 1 July 2014 vests in the Department of Health and not Metro North.
An indemnity consists of one party holding another party harmless for future or potential loss, damage, expense, cost or liability of another party. Indemnity can be a complex area of law and involve significant financial implications.
Employee indemnity arrangements
Employees of Metro North are generally covered by section 27C of the Public Service Act 2008 (Qld) in relation to acts and omissions made in the course of their employment. There are also indemnity and insurance arrangements that may apply to employees in specific instances, including Queensland Government Indemnity Guideline and HR Policy I2 Indemnity for Queensland Health Medical Practitioners. Generally, coverage of employees will require that the research activity is approved by Metro North, such as through the site authorisation process. For research involving parties external to Metro North, specific advice may need to be sought from Metro North legal services (contactable via the Research Governance Officers).
Under the Statutory Bodies Financial Arrangements Act 1982 (Qld), Metro North is limited from giving indemnities without undertaking certain steps which may include obtaining approval from the Queensland Treasury. As a general rule, Metro North seeks to remove all indemnities from research collaborations. Certain template agreements already include indemnities, such as the Medicines Australia Clinical Trial Research Agreement, and processes have been put in place to comply with legislative requirements. The Research Governance Officers are the initial contact point for queries in regard to indemnity considerations with research agreements.