Guide · checked October 2026
Clinical audit vs service evaluation vs research
Clinical audit measures care against a predetermined standard, service evaluation measures what a service achieves without a standard, and research generates new knowledge; in the HRA's table only research normally needs NHS Research Ethics Committee review.
The HRA's questions
The Health Research Authority's Defining research table (October 2022) frames each activity by the question it answers. Audit asks whether a service reaches a predetermined, recognised or pre-established standard, and measures against that standard. Service evaluation asks what standard a service achieves, measuring without reference to a standard.
In audit there is no allocation to an intervention: the clinician and patient chose the care before the audit. Randomisation is allowed only for sampling. The UK Policy Framework definition of research quoted in the table excludes audits of practice and service evaluations.
Ethics review
The table says service evaluation, audit and health surveillance do not require NHS Research Ethics Committee review, while research normally does, but not always. The HRA's online tool, Is my study research?, walks through a short set of yes or no questions, and a second tool asks whether you need NHS REC review.
HQIP's guide for clinical audit, research and service review covers the same ground from the audit side and describes service review as mostly using existing data.
Why it matters for audit leads
Getting the label right decides which approvals you need and how the work is registered locally. If a project starts testing a new intervention, comparing randomised groups or aiming for knowledge that applies beyond your service, check with your research office before it goes further.
No ethics review does not mean no governance. Audit still has to follow data protection law and your Trust's information governance rules.
Common misreadings
- "It's only audit, so information governance doesn't apply": it does.
- "Service evaluation is a lighter audit": it answers a different question.
- "Research always needs REC review": the HRA says normally, but not always.
Where Oriel fits
Oriel is built for audit: it checks records against a rule or a standard and asks a person to decide each finding. Its standards library also includes research governance checks such as consent dated before the first study procedure under ICH E6(R3) GCP, which a research office might audit.
Oriel does not decide whether your project is audit or research. Use the HRA tools and your local office for that. Oriel is a pilot on synthetic data only.
Questions
Does clinical audit need ethics approval?
In the HRA's Defining research table, audit does not require NHS Research Ethics Committee review. Local registration and information governance rules still apply.
Can an audit use randomisation?
Only for sampling, according to the HRA table. Randomly allocating people to care makes it research.
Sources
Official pages, checked October 2026. Guidance changes, so check the current version before you rely on it.
General information for healthcare managers and clinical teams, checked October 2026. It is not legal, regulatory or clinical advice; follow the current official guidance and your organisation's own policies. No patient data is used in these examples. Oriel is a working prototype shown on a fictional demo hospital with synthetic data only. It is not a medical device and is not for clinical use. It drafts and flags for people to decide; it does not diagnose or change clinical records. A clinical safety case and information-governance approval come before any use with real patient data. Oriel is a working name.