Research governance and site authorisation

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).

Contractual Indemnity
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.