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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 Research Ethics Committee
- do not require approval from NHS R&D offices
- may require some other form of approval from the organisation(s) undertaking or hosting the project depending on local arrangements.
In the first instance, please refer to the HRA Decision Tool. http://www.hra-decisiontools.org.uk/research/
Further guidance:
- NHS Research and Development Forum guidance on categorising and managing research and related projects [External link; refer to section for “Deciding if a study is Research, Audit, Development or Service Evaluation”]
- HRA leaflet: Defining Research [pdf, 109KB] Published December 2009, revised 2013
If the project is audit, service evaluation or public health surveillance, or some other type of non-research activity, such as case study, system/equipment testing or satisfaction survey, you should contact the clinical governance office of your local NHS organisation to check what other review arrangements or sources of advice apply to the project. For example, there may be standard guidelines on the conduct of clinical audit. The Caldicott Guardian will be a source of advice on the use of patient data.