Clinical Development

Institutional Review Board(IRB)

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

Usage Examples

The IRB approved the Phase 2 protocol with minor modifications.
IRB continuing review identified a protocol deviation.
The study requires central IRB approval for all sites.

What is IRB?

An Institutional Review Board (IRB) is a committee formally designated to approve, monitor, and review biomedical research involving humans. The IRB's primary purpose is to protect the rights and welfare of research subjects.

IRBs review research protocols, informed consent documents, investigator qualifications, and study procedures. They can approve, require modifications, or disapprove research activities. Continuing review is required at intervals no longer than one year.

IRBs must have at least five members with varying backgrounds, including at least one scientist, one non-scientist, and one member not affiliated with the institution.

Regulatory Context

This term appears most often in clinical development workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 56, 45 CFR 46.

FDAEMAPMDA

When This Matters

The IRB approved the Phase 2 protocol with minor modifications.
IRB continuing review identified a protocol deviation.
The study requires central IRB approval for all sites.

Common Mistakes

Applying one-region clinical assumptions to global submission strategies.
Missing protocol-to-regulation traceability for pivotal studies.
Underestimating how regional guidance updates impact trial documentation.

Related Regulations

21 CFR 5645 CFR 46

Frequently Asked Questions

IRB is the US term; Ethics Committee (EC) is used internationally. Both serve the same function of protecting human research subjects, though regulatory requirements may differ.

IRB approval is required before initiating any research involving human subjects. This includes clinical trials, observational studies, and even some retrospective chart reviews.