Human-Interventional Studies/Clinical Trials
This site provides information and guidance of interest to researchers who lead or support human-interventional studies which are sponsored by the University.
The only type of study which the University will not sponsor are clinical trials of investigational medicinal products (IMP-trials), which are heavily regulated. The University will currently sponsor studies involving devices which may have a medical purpose, or may benefit healthcare provision; although please note that these also have additional regulatory requirements. Further guidance on IMP trials or medical devices should be sought from the Health Research Authority and the Medicines and Healthcare Products Regulatory Agency.
Definition of a Human-Interventional Study
The University's definition of a human-interventional study is, 'These are research studies designed to answer specific questions about intervention(s) in human participants, whose purpose is to investigate the effectiveness of the intervention(s) & to assess clinical or physiological outcomes.'
The University has developed the document, types of human-interventional studies, to provide examples of what is considered to fall within this definition and to clarify those studies which may, and which will not, be sponsored by the University.
The University will usually sponsor (provided that there is not a more appropriate research governance sponsor):
- Human-interventional studies involving surgery and other interventional procedures (i.e. trials that seek to improve surgical interventions (e.g. determining whether early surgery is more reliable than deferred surgery for a particular type of disease) & also studies such as those involving interventional radiology);
- Human-interventional studies of diagnostic tests (e.g. tests for tuberculosis);
- Human-interventional studies which are concerned with screening (e.g. checking for cancer when there are no symptoms);
- Human-interventional studies which involve the administration of human whole blood products (excludes studies involving a somatic cell therapy medicinal product – i.e. excludes trials involving living cells that have had their biological characteristics substantially altered as a result of manipulation);
- Human-interventional studies which involve the administration of a food product (this includes dietary supplements not presented as a medicine (any ingested product which is not a medicine is regarded as a food)- e.g. testing the health benefits of a particular margarine);
- Human-interventional studies which involve the administration of a cosmetic product (i.e. any substance or preparation intended for placing in contact with the various external parts of the human body with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours - e.g. a deodorant);
- Human-interventional studies that involve complementary therapies (e.g. aromatherapy, homeopathy, reflexology - examples: in the case of aromatherapy, a trial using a fragrant substance distilled from a plant (e.g. an essential oil from lavender), inhaled or applied during massage as a complementary treatment to reduce chronic pain and/or depression and/or stress);
- Human-interventional studies that involve behavioural and/ or educational interventions designed to affect health;
- Human-interventional studies which involve physiotherapy and/ or psychotherapy;
- Human-interventional studies that involve devices (devices may be medical (e.g. a tongue depressor) or assistive (e.g. a speech aid; home assistance technology).
The University will not confirm its sponsorship of a project until the initial quality assurance process for human-interventional studies has been completed.