IRB / IEC
Institutional Review Board / Independent Ethics Committee
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
An IRB (US term) or IEC (ICH/EU term) is an independent body that reviews, approves, and provides ongoing oversight of a clinical trial to protect the rights, safety, and well-being of human participants. It reviews the protocol, informed consent materials, investigator qualifications, and recruitment methods before the trial begins, and conducts continuing review at intervals appropriate to risk. No participant may be enrolled before favorable opinion is granted.
The board's composition, quorum, and independence requirements are specified in regulation so that its judgment is not compromised by the interests of the sponsor or investigator. It must document its decisions and retain records.
The IRB/IEC and the regulatory authority are distinct gatekeepers: ethics approval addresses participant protection, while the competent authority addresses the scientific and regulatory acceptability of the trial — a trial generally needs both.
- —Independent review of protocol, consent, and investigator suitability
- —Approval required before any enrollment; continuing review thereafter
- —Composition, quorum, and independence are regulated
- —Separate from — and additional to — competent-authority authorization
ICH E6 GCP (IRB/IEC provisions); US 21 CFR Part 56 (IRBs) and 21 CFR Part 50 (protection of human subjects); EU Clinical Trials Regulation (EU) No 536/2014 ethics provisions.
Frequently asked questions
What does IRB / IEC stand for?
IRB / IEC stands for Institutional Review Board / Independent Ethics Committee.
What is IRB / IEC?
An IRB (US term) or IEC (ICH/EU term) is an independent body that reviews, approves, and provides ongoing oversight of a clinical trial to protect the rights, safety, and well-being of human participants. It reviews the protocol, informed consent materials, investigator qualifications, and recruitment methods before the trial begins, and conducts continuing review at intervals appropriate to risk. No participant may be enrolled before favorable opinion is granted.
Which regulations cover IRB / IEC?
ICH E6 GCP (IRB/IEC provisions); US 21 CFR Part 56 (IRBs) and 21 CFR Part 50 (protection of human subjects); EU Clinical Trials Regulation (EU) No 536/2014 ethics provisions.