Research Governance
The Research Policy Office is responsible for issues relating to research governance. This includes matters relating to research ethics, sponsorship and misconduct in research. The purpose of research governance is to ensure that all research, undertaken by both staff and students, is carried out to the highest standards of integrity.
1. University Research Governance Framework: Regulations Relating to Research Involving Human Participants
Research involving human participants falls into a different category from other research carried out within the University. The University’s Regulations Relating to Research Involving Human Participants, implemented 1 July 2007, outlines the governance requirements of research involving human participants. Some of these requirements have a legal status.
For all research involving human participants, the University is responsible for ensuring that before the research commences:
- That all staff are aware of their responsibilities, especially the Chief Investigator, and of the need for appropriate training.
- That all necessary regulatory and ethical requirements are in place.
- The appropriate indemnity provision is in place.
The appropriate monitoring and reporting will take place.
2. Code of Good Conduct in Research
The Code of Good Conduct in Research addresses the issues involved in the proper conduct of all research, and provides guidance on the expected standards. All those involved in the research process should exhibit impeccable integrity and follow the principles of good research practice.
Researchers who are involved in medicinal products, must comply with Good Clinical Practice (GCP) and must have received GCP training.
3. Governance Components
3.1 Ethics
Prior to the commencement of research projects involving human participants, material or data, carried out under the auspices of the University, researchers must undergo ethical scrutiny to ensure that the rights, safety and wellbeing of all those involved are protected. The degree of scrutiny will be proportionate to the amount of risk of harm entailed. The Policy on the Ethical Approval of Research requires the Chief Investigator to indicate on the Research Grant Application Summary Form (RGAS) if there are likely to ethical implications associated with the research proposal. The Research Support Office will not proceed with setting up the research project on Qfis until confirmation of ethical approval is received.
The investigator’s checklist for research ethics review (Gov 2) form should held with deciding whether the most appropriate place to seek ethical approval is the School Research Ethics Committee or ORECNI. Alternatively, look at the Frequently Asked Question’s section to assist with any queries. It is also important to ensure that researchers adhere to the requirements of the individual School within which the research is being undertaken.
All research projects involving human participants must have a Research Sponsor. The Research Sponsor takes on the prime responsibility for the initiation and management of the research and is responsible for the assessment of the scientific quality of the proposed research. The role of Sponsor is outlined in the University’s Research Governance Framework: Regulations Relating to Research Involving Human Participants and anyone who wants the University to sponsor their research must complete a Request for sponsorship of a research project (Gov 3c) form.
3.3 Indemnity
All research involving human subjects must appear in the University Human Subjects Research Database that is found on Queen’s On-line under the section ‘My Research’. It is the responsibility of the main Queen’s investigator to ensure this is entered. Consideration needs to be given as to whether the project involves research that may be an exclusion of the insurance company. In this case the insurer will individually scrutinize the project. Further advice can be sought from the Financial Services Insurance Office (Ext 3058).
3.4 Compliance with the Human Tissue Act 2004
The Human Tissue Act 2004 regulates the removal, storage and use of human tissue – defined as “relevant material” and consists of, or includes, human cells. All stored “relevant material” from 1st September 2006 must be recorded monthly on the Queen’s On-line Human Tissue database. This is found on Queen’s On-line under the section ‘Other’. Further information can be sought from the Human Tissue Administrator , based in the Dean’s office, Faculty of Medicine, Health and Life Sciences.
3.5 Animal Use Policy
The University is actively involved in world-leading research into areas such as the treatment and cure of cancer, cardiovascular disease and blindness. In doing so, our researchers work to the highest standards and use the most relevant research models available. This may involve work on animals, which is only part of any appropriate research programme, and non-animal techniques such as cell culture, molecular biology, computer modelling and the study of samples from human patients are used extensively.
3.6 Monitoring of Research
As part of its sponsorship responsibilities, the University must satisfy itself that appropriate checks have been undertaken to ensure that research studies meet the relevant standards. One aspect of sponsorship responsibilities includes both the monitoring and reporting of research. The Research Governance Officer will be undertaking audits and monitoring of research in order to ensure the University complies with its duties as sponsor.
The University expects that the standards outlined in Research Governance Framework, the Code of Good Conduct in Research and the Policy on the Ethical Approval of Research to be adhered to all University staff. This includes academic and support staff, as defined by Statute 1, honorary staff, visitors and external collaborators that are conducting research within or on behalf of the University. Any allegation of Misconduct in Research is thoroughly and expeditiously investigated under the auspices of the Regulations Governing Investigations into Allegations of Research Misconduct to determine whether Misconduct in Research has been committed.
4. University Committees
The Research Governance Steering Group, chaired by the Dean of the Faculty of Medicine, Health and Life Sciences is responsible for ensuring that the University complies with the requirements of the Research Governance Framework for Health and Social Care, February 2007 , the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Human Tissue Act 2004 . The Terms of Reference and Membership can found by following the link.
The University Research Ethics Committee is charged with developing appropriate ethical policies and guidelines for and with the Schools, and for monitoring adherence to ethical policies and procedures within the University. The Terms of Reference and Membership can found by following the link.
5. Useful links
The following list provides links to a range of relevant legislation and to a number of useful websites:
Office for Research Ethics Committees in Northern Ireland (ORECNI)
Central Office for Research Ethics Committees (COREC)
Research & Development Office, HPSS
Economic and Social Research Council (ESRC)
Medical Research Council (good research practice guidelines) Department of Health
Human Organs and Tissue (QUB only)
Queen's Child Protection Policy
Human Tissue Act
Data Protection Act
Freedom of Information Act
British Psychological Society's Code of Conduct
The Psychological Society of Ireland Code of Professional Ethics
British Educational Research Association Ethical Guidelines
British Sociological Association Statement of Ethical Practice
