- If you are only using your existing patient record base for the purpose of audit, you do not need to get patient consent since they have already given their consent to you creating and retaining their records. However, you must get patient consent if you are publishing any patient identifiable data.
- Clinical audit projects must conform to appropriate ethical standards. The Health Quality Improvement Partnership has produced a guide to managing ethical issues in clinical audit.303 Normally, audits can be undertaken without the requirement of ethical approval. However, there may be rare instances where the nature of the audit, or the local guidelines, make it necessary to get approval. The chart on Differentiating clinical audit, service evaluation, research and usual practice or surveillance work in public health gives some useful definitions of audit and research.304
- You should identify and agree with other practice staff, as appropriate, the audit:
- criteria or standards.
303 Health Quality Improvement Partnership Guide to managing ethical issues in quality improvement or clinical audit projects November 2017 [Accessed 20 Nov 2020]
304 Health Research Authority and Medical Research Council. Is my study research? Decision tool [Accessed 20 Nov 2020]