Ethics and governance
Metro North Hospital and Health Service (MNHHS) is committed to the highest standards of research integrity. Research governance, including the ethical review of research, refers to the processes to ensure that research in Metro North Hospital and Health Service 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.
Use of confidential health information
In some cases approval to use confidential information for the purposes of research must be obtained after ethics approval and prior to site authorisation.
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.
Metro North Research policy and procedures
The Metro North Research Policy and Procedures provide a framework to promote the responsible and ethical design, conduct and communication of research. Each is based on the principles of the National Statement on Ethical Conduct in Human Research (National Statement) and the Australian Code for the Responsible Conduct of Research (the Code), in the context of institutional policies, state and federal legislation and regulatory guidelines.
Frequently asked questions
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.
There are fees for ethics review and site authorisation of commercially sponsored research and research conducted by private institutions. As of 1st October 2017, the fee for the ethics review of a research project with full industry sponsorship is $4500. The Site Specific Assessment fee is $4500 per site for research projects with full industry sponsorship. The fee for subsequent major HREC or governance amendments is $650. The fees for the addition of sub-studies to research projects with full industry sponsorship will be determined on a case-by-case basis (typically $2000 or, in some cases, the full fee of $4500). All prices are inclusive of GST.
|Fee type||Fee schedule|
|HREC fees for application for research project with full industry sponsorship||$4500|
|HREC fees for major amendments to research projects with full industry sponsorships||$650|
|HREC fees for addition of sub-studies to research projects with full industry sponsorship||$2000|
|Site-Specific Assessment (SSA) Fee||$4500 per site|
|Research Governance fee for major amendments to research projects with full industry sponsorships||$650|
If you have any queries regarding fees, please contact the HREC Coordinator or Research Governance Officer.
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.
Key steps in the research approval process are shown in the diagram below.