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 (GAfREC), 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.
REC, IRB, and REB — the same function, different names
“Research Ethics Committee” is the standard UK/EU/Ireland term; the US uses “Institutional Review Board” (IRB) under the Common Rule (45 CFR 46) and FDA regulations; Canada uses “Research Ethics Board” (REB) under the Tri-Council Policy Statement (TCPS2). The three perform the same core review function — independent prospective assessment of risk, consent, and scientific justification before human-subjects research begins — but sit inside different legal frameworks, so a multinational study cannot simply carry one country’s approval into another; each jurisdiction’s committee must review under its own rules.
Composition and independence
A defining structural feature of a properly constituted REC, distinguishing it from an internal management sign-off, is mixed membership: both scientific/clinical expert members and lay members with no professional stake in the research, and a quorum requirement that cannot be met by expert members alone. This mirrors the US Common Rule’s own IRB membership rule at 45 CFR 46.107, which requires at least one member whose primary concerns are non-scientific and at least one member not otherwise affiliated with the institution — the specific mechanism differs by jurisdiction, but the underlying principle (no committee reviewing solely from within its own research community) is shared.
How REC review fits into the wider approvals process
In the UK, REC review is one part of a combined approvals process coordinated by the Health Research Authority and typically submitted through the Integrated Research Application System (IRAS); a favourable REC opinion is necessary but not by itself sufficient to start recruitment — site-level research and development (R&D) capacity-and-capability confirmation is also required before the first participant can be approached, and both must be in place. For multi-site UK studies, a single national REC opinion generally applies across all participating sites, avoiding the need for separate local ethics review, though local site sign-off is still required.
Amendments
Substantial amendments — changes materially affecting participant safety, wellbeing, scientific value, or study conduct — require REC re-review and a new opinion before being implemented. Non-substantial or purely administrative amendments (e.g. a change of contact phone number) can typically proceed with notification only, without triggering a full re-review cycle.
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)
- US Common Rule, 45 CFR 46.107 (IRB membership)
Related: IRB (Institutional Review Board) · Common Rule (45 CFR 46) · TCPS2 (Tri-Council Policy Statement) · ICH GCP · IRB/REC Approval Process guide.
Also known as
Research Ethics Committee · ethics committee (UK/EU) · NHS REC
Machine-readable encodings
Use in your systems
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