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    Clinical & TrialsClinical EvidenceIRB

    Institutional Review Board

    Board that reviews and approves human-subjects research at an institution.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    An IRB is a committee that reviews biomedical research involving human subjects to ensure their rights and welfare are protected, per 21 CFR Part 56.

    What this means in practice

    Both SR and NSR device studies require IRB approval. Non-U.S. trials use equivalent ethics committees.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1ICH·1ISO·1
    1. 1
      21 CFR Part 56
      Verified
      eCFRecfr.gov
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

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