Examples
Worked examples
- Is an instance
A university researcher conducting interviews with prison leavers submits the protocol, participant information sheet, and topic guide to the university REC and receives a favourable opinion before recruitment.
- Is an instance
A multi-centre clinical trial obtains a single favourable REC opinion under the UK proportionate-review pathway covering all NHS sites.
Counter-examples
Looks similar, but isn't
- Not an instance
A literature review using only published anonymised aggregate data does not require REC opinion.
- Not an instance
Service evaluation projects that do not seek to derive generalisable knowledge are typically out of REC scope and routed instead to clinical-audit governance.
Editorial commentary
RECs are the European functional equivalent of US IRBs but operate under different statutory frameworks: in the UK, NHS Research Ethics Committees operate under the Health Research Authority and the Governance Arrangements for Research Ethics Committees, while university RECs review non-NHS research. RECs issue a favourable opinion, provisional opinion, or unfavourable opinion, and amendments must be re-reviewed. The committee considers participant welfare, scientific design, consent processes, recruitment, confidentiality, and the suitability of the investigator and site. Approval is study- and site-specific and must be in place before any participant is approached.
References
- UK Health Research Authority Governance Arrangements for Research Ethics Committees (GAfREC)
- EU Clinical Trials Regulation (EU) 536/2014 Article 4 (ethics committee opinion)
- Declaration of Helsinki (World Medical Association, 2013 revision)
Also known as
Research Ethics Committee · ethics committee (UK/EU) · NHS REC
Machine-readable encodings
Use in your systems
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