Introduction to Ethics
The University has developed and implemented its Policy and Principles on the Ethical Approval of Research as it is concerned with the protection of the rights, dignity, health, safety, well-being and privacy of research participants, the welfare of animals and the protection of the environment. It is expected that all staff and research students working within or on behalf of the University, whether or not they are University employees, will adhere to the Policy.
From the outset of a study, researchers must give consideration to potential conflicts of interest that may arise given the source of funding and the nature of the research project.
When considering your research, use the Investigator’s Checklist (Gov 2 Form), to determine if your study requires consideration by an appropriate Research Ethics Committee.
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; non-animal techniques such as cell culture, molecular biology, computer modelling and the study of samples from human participants are used extensively.
Do I go to the School Research Ethics Committee or ORECNI?
Prior to any research involving human participants, their tissue or data, the research must be reviewed by an appropriate ethics committee. The University has defined four different categories of human participants and this determines the most appropriate place for the ethical consideration of the research.
Those being conducted by staff (or students under their supervision) involving human participants (their tissue or data, including commercially purchased human material), but excluding NHS/HSC patients, patient records and NI Prison Healthcare Service. Any clinical trials of medicinal products or devices are also excluded from this category.
Ethics/Regulatory Approval: School Research Ethics Committee; Trust R&D approval for research involving HSC Trust staff.
Those being conducted by staff (or students under their supervision) involving NHS/HSC patients and patient records, NI Prison Healthcare Service, nursing and/or residential homes, the use of previously collected data or tissue from which individual past or present users of NHS/HSC services could be identified, or exposure to ionising radiation. Category B research projects exclude Clinical Trials of Investigational Medicinal Products or clinical investigations of medical devices.
Ethics/Regulatory Approval: Office for Research Ethics Committees Northern Ireland.
Clinical Trials of Investigational Medicinal Products or clinical investigations of medical devices involving patients or healthy volunteers.
Ethics/Regulatory Approval: Office for Research Ethics Committees Northern Ireland; Medicines Healthcare (products) Regulatory Authority.
Those that involve the use of tissue or data from research tissue banks or research databases. In this context, a research database consists of a collection of personal data on human subjects with generic ethical approval from a recognised Research Ethics Committee (i.e. ORECNI or the equivalent) for use of the data for research purposes.
Ethics/Regulatory Approval: Office for Research Ethics Committees Northern Ireland; School Research Ethics Committee; Trust R&D approval for research involving HSC Trust staff.
What should I consider when completing my application?
The important thing about approaching your research is to consider it in terms of the lay reader. Ask yourself the following questions:
- Is it simply explained?
- Is the identification of the research participants being undertaken by someone other than me?
- Have I included all my documentation for review, such as letters of invitation, information sheets, consent forms, interview schedules, questionnaires, follow-up letters?
- Did I adapt the model information sheet and consent forms appropriately, or use the guidance available on the NRES site?
- Have I addressed the peer reviewer(s) comments, if necessary?
- Does my IRAS form match my protocol?
- Have I really completed all parts of the IRAS form comprehensively?
- Have I identified collaborators within Trusts?
- Did I complete an SSI for each Trust that is involved?
The Health Research Authority Decision Tools
The Health Research Authority has been working on the development of some decision tools that are intended to support researchers in finding the answers to some questions that they are frequently asked.
The first two of these tools are available through the National Research Ethics Service (NRES area) of the HRA website.