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This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

- England


- Health Research Authority (HRA)

Page last reviewed: 15 Jan 2023

Understanding the difference between research and non-research activities

Reviewed by: Health and Care IG Panel

It can be difficult to decide whether an activity is research or not. You might intend the activity to be service evaluation, service improvement, service development or audit. The main distinctions are:

  • research is designed to generate generalisable or transferable new knowledge (that is, produce results to be extrapolated or applied to a different setting). That may or may not involve new interventions. Treatment allocation using randomisation may only be done in research
  • service evaluation is designed to answer the question ‘what standard does this service achieve?’. It only involves interventions that are well established within a service. Choice of treatment is decided between the patient and clinician. Service improvement or development seeks to find out what improvements could be made to the quality of a service
  • audits are designed to find out whether the quality of the service meets a defined standard

To help you assess whether an activity is considered research, use the HRA’s decision tool ‘Is my study research?

You should pay particular attention to your underlying intentions in carrying out the activity and remember that intentions can change over time. What started as service evaluation may later become a research activity, for example, which may require approvals.

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