Clinical Audits
Clinical audits investigate the care received by a patient (includes all aspects, from procedures used for diagnosis, treatment received and the outcome on their quality of life), and evaluates this against the current recommended guidelines for practice.

General Medical Council (UK): 'You must work with colleagues and patients to maintain and improve the quality of your work and promote patient safety. In particular, you must take part in regular and systematic audit(s)'. 3

Clinical Audits are important to optimise current knowledge and literature, in order to improve the quality of practice and outcomes for patients.

Clinical Audits require access to medical records of patients. Patient records may be used for an audit by the medical team caring for the patient, and:

  • Consent:
  • Consent from the patient is not required
  • Patient consent is implied as long as the patient is 'aware that the audit may exist'. 4
  • Additionally, audits may be carried out by people outside of the care team if the data is anonymised, and consent is still not needed).
  • Consent is needed if a researcher, who is not part of the medical care team, wished to use non-anonymised data. However, Health and Social Care Act 2001 recognises that this may be quite difficult if large numbers of records are being used, and makes allowances for research to proceed in such circumstances, strictly only if it is in the wider public interest.

  • Ethical Review
  • Does not require ethical review or approval from the NHS research ethics service (NRES).
  • However, the NRES may be consulted for advice if there is some confusion over what defines an audit. (Guidance on what is an audit or research is available at http://www.nres.npsa.nhs.uk/applications/is-your-project-research/)
  • If the NRES determines that no approval is necessary, the research and development offices, at the NHS site where the research is carried out, still need to be notified.
References