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    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. Under 21 CFR Part 56, an IRB must have at least five members with varied backgrounds, including one non-scientist and one member not affiliated with the institution. It approves, requires changes to, or disapproves studies, reviews informed consent, conducts continuing review, and for device studies decides whether a study is significant or non-significant risk. In the EU the equivalent body is an ethics committee.
    What the regulation says
    The FDA, under 21 CFR Part 56, mandates Institutional Review Board (IRB) review for clinical investigations involving human subjects to protect their rights, safety, and welfare. Similarly, clinical investigations conducted in the European Union must obtain a favorable opinion from an ethics committee, as outlined in the EU MDR 2017/745, Article 58. These regulatory requirements ensure that research protocols are ethically sound and scientifically valid.

    What this means in practice

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

    Examples

    • A MedTech company developing a new cardiac stent must submit its clinical investigation plan, including the informed consent form and patient recruitment materials, to an IRB for approval before enrolling any patients.
    • A medical device manufacturer conducting a post-market surveillance study involving patient surveys must obtain IRB clearance, even if the data collected is de-identified, to ensure ethical considerations are met.
    • A researcher modifying a previously approved study protocol to include a new patient population or a different data collection method must submit an amendment to the IRB for review and authorization prior to implementing the changes.
    Common pitfalls
    • •Failing to obtain IRB approval before initiating a clinical investigation can lead to regulatory non-compliance and invalidation of study data.
    • •Misinterpreting the scope of IRB review, assuming it only applies to interventional studies and not to observational studies or studies using existing de-identified data, is a common pitfall.
    • •Not ensuring that all investigators and research staff have completed appropriate human subjects protection training can result in IRB findings and study delays.
    • •Neglecting to submit modifications to an approved study protocol to the IRB for review and approval prior to implementation can be a serious regulatory violation.
    • •Assuming that an IRB approval from one institution is automatically transferable to another without formal review and acceptance by the second institution's IRB is incorrect and can lead to unapproved research activities.

    Frequently asked questions

    The primary role of an IRB is to review and approve research activities involving human subjects to ensure their rights, safety, and welfare are protected according to ethical principles and regulatory requirements.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1ICH·1ISO·1
    1. 1
      21 CFR Part 56
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      ICH Guidelines
      Tier 2 Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.