Direct comparison
IRB vs. Ethics Committee: What's the Difference?
IRB (US) and Ethics Committee (IEC/REC/REB/HREC) are functionally equivalent human-subjects review bodies — same mandate, different regional name.
Side-by-side comparison
| Dimension | IRB (US) | Ethics Committee (International / ICH GCP) |
|---|---|---|
| Full term | Institutional Review Board | Independent Ethics Committee (IEC) — ICH GCP umbrella term |
| Core mandate | Protect rights, safety, and well-being of human research subjects | Protect rights, safety, and well-being of human research subjects (same mandate) |
| Governing regulation | 21 CFR Part 56 (FDA-regulated trials); 45 CFR Part 46 "Common Rule" (federally funded research) | ICH E6 Good Clinical Practice (E6(R2) section 1.27); implemented via each country’s own national regulation |
| Jurisdiction | United States | Used internationally as the ICH GCP umbrella term; country-specific names apply locally (REC in UK, REB in Canada, HREC in Australia) |
| Legal standing of the term itself | A defined legal term under US federal regulation | A guideline-level umbrella term; the operative legal body is whatever each country names in its own law |
| Reviews before enrollment | Yes — protocol, informed consent materials, recruitment materials | Yes — same scope of pre-enrollment review |
| Ongoing oversight | Continuing review at least annually (or per local requirement); reviews amendments | Continuing/periodic review per local requirement; reviews amendments |
| Single/central review option | Single IRB (sIRB) for NIH-funded multi-site domestic research; commercial IRBs common | Country-specific coordinated review models exist (e.g., streamlined REB models in Canada) but are not a substitute for US sIRB review |
| Typical membership | Scientific, non-scientific, and unaffiliated community members, per 21 CFR 56.107 | Medical/scientific and non-scientific members per ICH E6 1.31-equivalent principles; exact composition set by local regulation |
Common questions
FAQ
Is an Ethics Committee the same thing as an IRB?+
Functionally, yes. Both are independent bodies that review, approve, and continue to monitor human-subjects research to protect participants’ rights, safety, and well-being. "IRB" is the specific US regulatory term; "Ethics Committee" (and its ICH GCP form, Independent Ethics Committee) is the broader international term for the equivalent body elsewhere.
Does a multinational trial need both an IRB and an Ethics Committee approval?+
Usually yes, if the trial runs sites in both the US and other countries — each participating country’s review body has jurisdiction over the sites and participants within its own borders, and one country’s approval does not substitute for another’s.
Why does ICH GCP write "IRB/IEC" instead of picking one term?+
Because ICH E6 was written as a single harmonized standard meant to apply across US and non-US trials alike, and the combined "IRB/IEC" form avoided rewriting the guideline per region — each country’s actual review body falls under one half of that combined term.
Is a Research Ethics Board (Canada) or HREC (Australia) a type of IRB?+
Not formally — each operates under its own national framework rather than US 21 CFR 56. They are the functional counterpart to a US IRB, not a subtype of one.
Going deeper
