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.