Human-Interventional Research Studies/Clinical Trials
This site provides information and guidance of interest to researchers who lead or support health and social care human-interventional research studies which are sponsored by the University.
The University will not sponsor clinical trials of investigational medicinal products (IMP-trials) or clinical investigations of devices which fall under the UK Medical Devices Regulations. An alternative sponsor must therefore be sought for such studies (e.g. an NHS Trust, pharmaceutical company or device manufacturer). Further guidance on IMP trials or medical devices should be sought from the Health Research Authority and the Medicines and Healthcare Products Regulatory Agency. Other types of human-interventional study presenting significant risks may require specific approval before the University will agree to act as sponsor.
Definition of a Health or Social Care Human-Interventional Research Study
The University’s definition of a health or social care human-interventional research study is as follows (for the purposes of the University’s quality assurance procedure for human interventional studies which it sponsors – this forms part of the University’s Research Governance Procedure*):
‘Research studies designed to answer specific questions about health or social care intervention(s) in human participants, whose purpose is to investigate the effectiveness of the intervention(s). An ‘intervention’ may refer to a change in treatment, care or other services which is made as part of the research, or an activity/experiment which a participant is asked to engage in as part of the research, where measures are taken before and after the activity/experiment.'
- For a health intervention to come under this definition, effectiveness must be assessed via clinical or physiological outcomes. Studies which meet this definition AND which fall into one of the categories outlined at the end of this document* AND which are to be sponsored by the University will need to follow the Research Governance Procedure along with the additional quality assurance procedure.
[Studies involving health interventions for which effectiveness will be assessed via non-clinical or non-physiological outcomes (e.g. general well-being measures) will still need to follow the Research Governance Procedure if they fall into one of the categories outlined at the end of this document* but they will not need to follow the additional quality assurance procedure.]
- For social care interventions, effectiveness may be assessed via a range of potential outcomes, including those related to well-being, behaviour, education, or other social measures. Any studies involving a social care intervention which meet the above definition AND which fall into one of the categories outlined at the end of this document* AND which are to be sponsored by the University will need to follow the Research Governance Procedure along with the additional quality assurance procedure.
The University has developed the following list of examples of types of study considered to fall within this definition. The University will normally sponsor these studies (provided that there is not a more appropriate research governance sponsor) – NB. the University will not sponsor clinical trials of investigative medicinal products (CTIMPs) or medical devices, hence they are not included in the list of examples; in addition, certain types of interventional study require additional approval before the University will agree to accept sponsorship, these are outlined in the sponsorship flowchart.
- 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 or social care outcomes;
- Human-interventional studies which involve a form of therapy (e.g. physiotherapy, psychotherapy, Cognitive Behavioural Therapy, family therapy);
- Studies involving an experimental design in which measures are assessed pre- and post- intervention, such as evaluative conditioning.
The University will not confirm its sponsorship of a project until the appropriate steps of the Research Governance Procedure have been completed.
*Studies which fall into one or more of the following categories are required to follow the University’s Research Governance Procedure:
- Studies which involve the NHS/Department of Health (i.e. studies which require NHS Research Ethics Committee approval and/or HRA approval);
- Studies which involve social care services provided by a local authority (including organisations providing services under contract with a local authority) or prison health services;
- Studies which have been flagged by the University ethics reviewers as medium/high risk human-interventional studies NOT involving the NHS, social care services provided by a local authority, or prison health services.
Studies which fall into any of the above criteria AND which are sponsored by the University AND which meet the definition of a health and social care human interventional study (as outlined in this document) must follow an additional quality assurance procedure