Not all of the projects undertaken within the NHS are research. Under the Research Governance Framework, projects not classified as research are not managed as research within the NHS.
Projects not managed as research:
- do not require ethical review by a NHS Research Ethics Committee (NHS REC), but may require ethical review by the University's Biomedical & Scientific Research Ethics Committee (BSREC)
- do not require Health Research Authority (HRA) approval, but may require local approval by the Trust(s)*
- do not require a research sponsor
If your study is research, you will require HRA approval, but the following decision tool: Do I need NHS REC approval? will determine whether you require NHS REC review. Research studies that are exempt from NHS REC review will still require HRA approval and a research sponsor, but ethical review will be undertaken by BSREC. For more information on these types of study, please see the Research in the NHS page.
The following table, also taken from the NHS defining research leaflet, sets out the differences between the study types:
|RESEARCH||SERVICE EVALUATION**||CLINICAL AUDIT||SURVEILLANCE||USUAL PRACTICE
(in public health)
|The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.||Designed and conducted solely to define or judge current care.||Designed and conducted to produce information to inform delivery of best care.||Designed to manage outbreak and help the public by identifying and understanding risks associated.||Designed to investigate outbreak or incident to help in disease control and prevention.|
|Quantitative research – designed to test a hypothesis. Qualitative research – identifies/explores themes following established methodology.||Designed to answer: “What standard does this service achieve?”||Designed to answer: “Does this service reach a predetermined standard?”||Designed to answer: “What is the cause of this outbreak?”||Designed to answer: “What is the cause of this outbreak?” and treat.|
|Addresses clearly defined questions, aims and objectives.||Measures current service without reference to a standard.||Measures against a standard.||Systematic, statistical methods to allow timely public health action.||Systematic, statistical methods may be used.|
|Quantitative research – may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced.||Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.||Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.||May involve collecting personal data and samples with the intent
to manage the incident.
|Any choice of treatment is based on clinical best evidence or professional consensus.|
|Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care.||Usually involves analysis of existing data but may include administration of interview or questionnaire.||Usually involves analysis of existing data but may include administration of simple interview or questionnaire.||May involve analysis of existing data or administration of interview or questionnaire to those exposed.||May involve administration of interview or questionnaire to those exposed.|
|Quantitative research – study design may involve allocating patients to intervention groups. Qualitative research – uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications.||No allocation to intervention: the health professional and patient have chosen intervention before service evaluation.||No allocation to intervention: the health professional and patient have chosen intervention before audit.||Does not involve an intervention.||May involve allocation to control group to assess risk and identify source of incident but treatment unaffected.|
|May involve randomisation.||No randomisation.||No randomisation.||No randomisation.||May involve randomisation but not for treatment.|
|Requires HRA approval, may require NHS REC review||Does not require NHS REC review.Requires BSREC review||Does not require NHS REC review.Requires BSREC review||Does not require NHS REC review.||Does not require NHS REC review.|
*Service evaluations should be registered with the R+D department at the relevant NHS Trust(s) and Clinical audits should be registered with the Clinical audit department at the relevant NHS Trust(s). Contact details for all NHS Trusts can be found via the R+D forum.
**Service development and quality improvement may fall into this category.
Please see Approvals required when working in the NHS for a summary table on the types of approval required for each study type.
Research Passports, honorary contracts & letters of access
University staff who have no substantive NHS contract who wish to conduct a study within the NHS will need to contact the relevant NHS Trust with regards to obtaining research passports and honorary contracts, as appropriate.