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Is it research?

The first question to ask when setting up a study is 'Is it research?'.  

NRES (National Research Ethics Service) and the NHS R&D Forum have issued guidance on the categorising of research, clinical audit and service evaluation. Whilst all three types of study require the approval of host Trusts, systems for approval for each type of study vary and only research requires REC (Research Ethics Committee) review.

  • Research - is designed and conducted to generate new knowledge and should follow the systems for approval of NHS Research.
  • Audit - is designed to answer the question "Does this service reach a predetermined standard?"
  • Service evaluation - is designed to answer the question "What standard does this service achieve?"

Gathering the views of service users (patients and their relatives and/or carers) is an increasingly important feature of planning and delivering NHS services. Questionnaires and other types of survey (eg interviews and focus groups) are commonly used methods of seeking such views. Surveys can be used in a number of ways, for example in research, as part of a clinical audit, or as a dedicated patient involvement activity.

Surveys can provide valuable insights into the experiences and preferences of service users, but they need to be well designed and fit for purpose. UH Bristol has therefore established a questionnaire, interview and survey group which can advise on the draft design and format of surveys (ie questionnaires, interview schedules) and their appropriateness in the context and conditions in which they will be used.

More information is availble on the Trust's Questionnaire Interview and Survey Group (QIS).

Once it is clear that the study is research a number of factors, such as protocol design, sponsorship and funding need to be taken into consideration.