Research within MIRI reflects the health concerns and needs of our communities, and is consistent with Mackay Hospital & Health Service values of:
‘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(in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.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.
This is a common question for locally developed projects aimed at measuring patient outcomes and the impact of models of care. Research and quality activity exist on a continuum and sometimes expert advice is required to determine the appropriate approval pathway to follow. Research is defined in the Australian Code for the Responsible Conduct of Research as an original investigation undertaken to gain new knowledge, understanding and insight.
In contrast, a quality activity is an organised process to evaluate current practice, intended to be used by local staff to inform and improve health care or service delivery. Key questions to ask in delineating are: What is the primary aim of my project? And: how will the results be used? The Health Research Authority (HRA) developed a Defining Research Table that may assist to delineate between research and quality activities as well as a tool called Is my Study Research?
Ethical principles apply to both quality activities and research; however, quality activities require institutional oversight (e.g. in Mackay Hospital and Health Service, this is the remit of Patient Safety & Quality Unit), while most research requires ethical review and site authorisation.
If you intend to disseminate the results of your quality activity beyond Queensland Health, you are required to obtain ethical review before it can be approved by the organisation.
The process locally for quality activity dissemination is to:
- Define your proposal, identify possible outcomes, and prepare a plan/protocol.
- Visit the Patient Safety & Quality intranet page for further pathways, tools and resources and to register your activity.
- Contact a relevant certified ethics committee such as Townsville, for advice and/or endorsement of your proposal.
For specific guidance, you should contact the MIRI RGO. See also the National Health and Medical Research Council publication on Ethical Considerations in Quality Assurance and Evaluation Activities.
Only for commercially sponsored research and research conducted by private institutions. If you have any queries regarding fees, please contact the MIRI RGO.
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 (SSA) 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 MIRI RGO and undertake completion of the Site Specific Assessment form in parallel with ethical review.
If you have any concerns or complaints about any aspect of a research project or the way it is being conducted then you should contact the MIRI RGO, who will initiate the appropriate follow-up and response.
MIRI adhere to the guidelines for research set out in the , 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 Research Governance Officers.
The Research Process
The below diagram provides a high level overview of the research process.
Image credit to Metro North Hospital & Health Service, used with permission.