Does my project require Ethics review?

If your research project can be classified as a Clinical Audit or Service Evaluation, it will not need to be submitted to the Research Ethics Committee for review.

What is research and what is clinical audit?

Research is a structured activity which is intended to provide new knowledge which is generalisable (i.e. of value to others in a similar situation) and intended for wider dissemination (Department of Health, 2002). If your study involves Clinical Trial of an Investigational Medicinal Product, a Non CE marked medical device, ionising radiation or adults who lack capacity to be able to consent for themselves, this will need to be reviewed by the Research Ethics Committee.

Clinical Audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery. (Principles for Best Practice in Clinical Audit, NICE, 2002)

Both clinical audit and research:

  • Involve answering a specific question relating to quality of care
  • Can be carried out prospectively and retrospectively
  • Involve careful sampling, questionnaire design and analysis of findings
  • Should be professionally led

Differences between clinical audit and research:

Clinical Audit

  • Evaluates whether we are doing what we should be doing
  • Tells us if we are following best practice
  • Measures services against a set of standards
  • Never involves patients trying new methods of treatment or care
  • Only involves normal treatment
  • Does not involves allocating patients to different groups
  • Does not need a scientifically calculated sample size
  • Results are only applicable to local settings
  • Can only influence local clinical practice directly Rarely requires ethical approval

If you can answer yes to all of the statements above, please read through the Nottingham University Hospitals Clinical Audit Policy on the intranet (type clinical audit in the search function) and contact the relevant person in the Clinical Audit and Evaluation office

Research

  • Creates new knowledge
  • Tells us what is best
  • Is based on a hypotheses
  • Can involve untested methods or treatments
  • May involve experimentation
  • May involve allocating patients to different groups
  • Is based on a scientifically valid sample size
  • Results can be generalized to populations
  • Can have a wide influence on clinical practice
  • If the project involves NHS staff, patients, their tissue or data or NHS facilities, requires ethics committee approval and local NHS approval

To help you decide whether your project is classified as research you should refer to the HRA Decision Tool. For further information and more detailed guidance please refer to the Resources section on the HRA website.
If you have answered yes to any of the statements above, your project will need to go through the HRA Approval process.

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