Research governance, including the ethical review of research, refers to the processes to ensure that research in Metro North Hospital and Health Service (HHS) is conducted according to the appropriate regulatory, ethical and scientific standards. The framework for research governance is relevant to all stages of the research process.
In order to conduct research in Metro North HHS, two main approvals must be obtained:
In some cases approval to use confidential information for the purposes of research must be obtained after ethics approval and prior to site authorisation.
The Metro North HHS research ethics committees and research governance officers are the contact point for obtaining relevant research approvals.
Key steps in the research approval process are shown in the diagram below.
The Australian Code for the Responsible Conduct of Research defines research as "original investigation undertaken to gain knowledge, understanding and insight". In terms of illustrating what the term 'research' can cover, the Code and the National Statement on Ethical Conduct in Human Research quote the following definition for research:
'Research'... includes work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artefacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction. It excludes routine testing and routine analysis of materials, components and processes such as for the maintenance of national standards, as distinct from the development of new analytical techniques. It also excludes the development of teaching materials that do not embody original research.
The National Statement defines human research as being "conducted with or about people, or their data or tissue":
Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:
- taking part in surveys, interviews or focus groups;
- undergoing psychological, physiological or medical testing or treatment;
- being observed by researchers;
- researchers having access to their personal documents or other materials;
- the collection and use of their body organs, tissues or fluids (eg: skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
- access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.
Multisite research is research that is conducted at more than one site or conducted by researchers who are affiliated with more than one institution (e.g. university and hospital), including student research. Student research includes undergraduate research projects and postgraduate research for the purpose of a higher degree (e.g. Master or PhD).
This is a common question for locally developed projects aimed at measuring patient outcomes and the impact of models of care. Quality assurance and research exist on a continuum of activity and sometimes expert advice is required to determine the appropriate approval pathway to follow. Key questions to ask are: What is the primary aim of my project? And: how will the results be used?
If the aim of your project is to evaluate and monitor local practice and your results will be used by local staff to inform and improve health care or service delivery, then (in most cases) you are undertaking a quality assurance activity rather than research. Ethical principles apply to both quality assurance and research; however, quality assurance requires institutional oversight (e.g. by a departmental director, executive director or the Safety and Quality Unit), while most research requires ethical review and site authorisation (see FAQ on Ethics approval page: 'Is my research exempt from ethics review?').
Research is defined in the Australian Code for the Responsible Conduct of Research as an original investigation undertaken to gain knowledge, understanding and insight. In contrast, quality assurance is an organised process that evaluates, assesses and seeks to improve health service delivery, including improvement of patient and population outcomes and health service efficiency.
For specific guidance, you should contact the HREC Coordinator/Chairperson or site Research Governance Officer. See also the National Health and Medical Research Council publication on Ethical Considerations in Quality Assurance and Evaluation Activities.
There are fees for ethics review and site authorisation of commercially sponsored research and research conducted by private institutions. The fee for submission of a research project with full industry sponsorship is $3300 and the fee for subsequent amendments is $550, excluding minor administrative changes. The Site Specific Assessment fee is $3300 per site for research projects with full industry sponsorship. HREC fees for the addition of sub-studies to research projects with full industry sponsorship will be determined on a case-by-case basis (typically $1665 or, in some cases, the full fee of $3300). All prices are inclusive of GST.
The benchmark for receipt of an ethical decision is 60 days from receipt of a valid ethics application. The benchmark for site authorisation is 25 days from receipt of a valid Site Specific Assessment form.
Low or negligible risk research studies are typically reviewed out of session of the HREC with a response received within 4 weeks of submission. For studies requiring HREC review, you should expect to receive a response within 2 weeks of the HREC meeting date. Site authorisation is typically received within 2 weeks of submission of a valid Site Specific Assessment form.
To reduce delays associated with incomplete Site Specific Assessment submissions, researchers are encouraged to make early contact with the relevant Research Governance Officer and undertake completion of the Site Specific Assessment form in parallel with ethical review.
Metro North HHS adhere to the guidelines for research set out in the Queensland Health Research Management Policy (PDF, 210KB), National Statement on Ethical Conduct in Human Research and Australian Code for the Responsible Conduct of Research, as well as the standard operating procedure for Queensland Health HREC Administrators and Research Governance Officers.