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D/6.1 University research ethics |
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6.1.1 Background 6.1.1 BackgroundQUT is committed to the highest standard of integrity in research. The QUT Code of Conduct for Research, based on the Australian Code for the Responsible Conduct of Research, aims to embed ethical practice into research activities to enable quality research, ultimately contributing to the achievement of the University's stated ambitions in the QUT Blueprint, and to the national and global reputation of QUT. In order to undertake its research activities, QUT is accredited with various regulatory bodies. The Research Ethics Unit coordinates the reporting of compliance matters across the areas of human, animal and biosafety activities. This includes:
Full details of these obligations can be found on the Research Ethics website. 6.1.2 PrinciplesThe broad principles that guide the conduct of research at QUT are consistent with general codes of ethical conduct, including QUT's Code of Conduct ( B/8.1 ) and the QUT Code of Conduct for Research ( D/2.6 ). Central to these are the maintenance of high ethical standards, and validity and accuracy in the collection and reporting of research data. 6.1.3 DefinitionsMatters covered by ‘research ethics’ may also involve teaching activities, for example use of animals in teaching practicals or activities involving biosafety issues. The generic language of research has been used throughout this policy, for example ‘research project’, ‘researchers’, ‘ethical review’ or ‘ethics committee’ and, where relevant, these terms apply equally to teaching activities. 6.1.4 Roles and responsibilitiesDeputy Vice-Chancellor (Research and Commercialisation) The Deputy Vice-Chancellor (Research and Commercialisation) is the designated officer responsible for monitoring compliance in relation to research ethics matters. In matters relating to higher degree research students, the Deputy Vice-Chancellor (Research and Commercialisation) may delegate this responsibility to the Dean of Research and Research Training. Committees The following Vice-Chancellor’s committees are advisory committees established to assist in managing risk, ensuring compliance and reviewing applications to confirm they meet relevant requirements in their activity areas:
Faculty Research Ethics Advisors Each faculty must appoint a Faculty Research Ethics Advisor (FREA) to provide confidential advice to staff and students on integrity in research, research ethics, the responsibilities of postgraduate supervisors and students, and procedures for dealing with allegations of research misconduct within the University. FREAs are appointed by the executive dean of faculty and are normally drawn from the senior members of the faculty with a significant record of research experience. FREAs are expected to be familiar with the literature and guidelines on research integrity and research ethics and to provide advice on a University-wide basis where necessary. Individual staff and students Individual staff and students are responsible for the ethical conduct and integrity of their research and for complying with the QUT Code of Conduct for Research. 6.1.5 ProceduresA number of procedures have been developed (see below) to ensure compliance with the various regulatory frameworks and the QUT Code of Conduct for Research. QUT staff and students, and any external parties working through or in collaboration with QUT as approved by the Deputy Vice-Chancellor (Research and Commercialisation), must adhere to these procedures when engaged in any of the following:
The following policies are specific to each activity area:
All policy statements relating to research ethics should be read in conjunction with specific guidelines available on the Research Ethics website. 6.1.6 Ethical clearanceQUT has established a number of standard conditions of ethical clearance for research projects, and it is a strict condition of approval that researchers:
If the risks involved with a project are found to be higher than originally described, the project must be suspended and approval sought for a variation to the study. 6.1.7 Duration of approvalApplications for ethical clearance for research projects are normally approved for a period of three years. After three years, application may be made to extend approval to five years, provided there are no major changes to the conduct of the study from that originally approved. Researchers seeking to extend their research project beyond five years will normally need to submit a full new application for review by the relevant approving committee. This is in recognition that many factors may have changed since the original approval, including changes to the protocol for the study and/or changes to the external guidelines governing the study. 6.1.8 Variations to approved protocolsQUT understands that research occurs in a dynamic and constantly changing environment, and that it may be necessary for researchers to make variations to existing approved protocols. Variations may include adding or removing personnel from a project, additional cohorts to the study, or revised experimental protocols. Variations of a large scale, or that pose increased risks to those originally considered, may be subject to review by the relevant approving committee. Prior approval must be sought from the relevant approving committee, before any variations are implemented in the study. The University has established procedures for variations to be made to an approved project without the need to submit a new application for ethical clearance – see Research Ethics website. 6.1.9 Collaborative and/or multi-site researchQUT recognises that a great deal of research is conducted either in collaboration with other organisations, or through other organisations. In many cases, where these organisations have an ethics review committee, some form of review will be undertaken by all organisations. However, in keeping with national guidelines, QUT seeks to minimise duplication of review wherever possible. Where a project has been subject to a full review by a duly registered ethics review committee, QUT will seek to accept that review via an administrative review. All organisations need to be informed of who is responsible for:
For some types of collaborative work it is recommended that a formal agreement be drawn up between QUT and the host institution. For animal based research this agreement is a regulatory requirement which must be complied with. If a project requires review through multiple organisations, or is subject to audit or investigation / review by an external organisation, the Research Ethics Unit will determine the approach to be taken. 6.1.10 Concerns, complaints or unforeseen adverse eventsIn accordance with regulatory and National guidelines, QUT has established a set of procedures for responding to concerns, complaints or unforeseen adverse events. Allegations of research misconduct A complaint of suspected or alleged misconduct in research by a QUT-related research worker is responded to via the QUT Code of Conduct for Research, and in particular the procedures for dealing with allegations of research misconduct Unforeseen adverse events arising from research activities Any unforeseen adverse events arising from an approved activity must be reported to the relevant approving committee as soon as possible, and in the case of serious adverse events, immediately via the Research Ethics Unit. Projects approved by an external organisation Projects approved by an external organisation may be subject to the requirements of that organisation relating to concerns / complaints / adverse events. Researchers must immediately notify the Research Ethics Unit if their project is subject to such an investigation / review by an external organisation. Other concerns General feedback on the conduct of activities may be made by any person. Feedback should preferably be made in writing to the Research Ethics Coordinator. 6.1.11 ReviewsAny approved or ‘in progress’ research projects registered on the Research Ethics Unit database may be the subject of random review by the Research Ethics Unit, in conjunction with the relevant approving committee. A review panel, usually consisting of the Research Ethics Coordinator, FREA and any committee member wishing to participate, will meet with the research team's chief investigator to confirm that the project is being conducted in a manner consistent with University policy, relevant regulations and the approved protocol. The review panel will report its findings to the relevant approving committee, the head of school and the Deputy Vice-Chancellor (Research and Commercialisation) and make recommendations in relation to the continuation of the project. Projects approved through an external organisation may be subject to that organisation’s review arrangements. Researchers must immediately notify the Research Ethics Unit if their project is selected for investigation / review by an external organisation. QUT research projects may also be subject to review by the various regulatory agencies overseeing the activity areas. 6.1.12 Facility inspectionsIn accordance with external regulatory requirements and QUT’s research ethics procedures all laboratories, plant and animal containment facilities must be inspected and certified at least annually. The relevant approving committee will establish a panel drawn from its membership, and providing the relevant expertise to assess the facilities, and nominate a convenor to conduct the inspections. The panel will inspect the facilities and interview the officer in charge. The committee will consider all relevant information and make recommendations, as appropriate and required, to the external regulators and/or the University, via the Deputy Vice-Chancellor (Research and Commercialisation). 6.1.13 Progress reportsIt is a condition of approval of a research project that researchers submit a progress report on their activities at least annually, or as determined by the relevant approving committee. Failure to provide a progress report may result in:
Related DocumentsMOPP D/2.6 QUT Code of Conduct for Research Modification History
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