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Research Ethics Classification — FRCA Final MCQ

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ModerateMedicolegal & EthicsResearch Ethics ClassificationFRCA Final

An NHS anaesthetic department undertakes a project designed solely to assess current local practice and guide local service improvement, with no intention to generate generalisable new knowledge. It retrospectively compares outcomes from two established anaesthetic techniques selected during routine care, using anonymised routinely collected records. Which approval route is required in England?

Educational content. Not a substitute for clinical judgement or local policy.

Reveal the answer and explanation

Correct answer: E — Neither HRA Approval nor NHS Research Ethics Committee review; use the appropriate local service-evaluation governance process

Explanation lettering: B = shown as A · E = shown as B · D = shown as C · A = shown as D · C = shown as E

This is a service evaluation because its stated purpose is solely to assess current local care and inform local improvement, rather than to generate generalisable new knowledge. It therefore requires neither HRA Approval nor NHS Research Ethics Committee review, although it must follow the Trust's local registration, information-governance and service-evaluation procedures. Option B would apply to some genuine research confined to secondary analysis of previously collected routine anonymised data: such research may be exempt from REC review but still require HRA Approval. Options A and D incorrectly require REC review, while E wrongly treats the project as research requiring local R&D approval. Retrospective design, anonymisation and absence of treatment allocation do not alone distinguish research from service evaluation; the project's purpose is decisive.

Reference: University Hospitals Bristol and Weston NHS Foundation Trust. FAQs—Research Approvals and the Use of Secondary Data, section 3.1, 2022. https://www.uhbristol.nhs.uk/media/4210534/gd_035_faqs_research_approvals__use_of_secondary_data_v1.pdf