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    Informed Consent

    Voluntary, informed agreement to participate in research after disclosure of risks and benefits.

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

    Definition

    Per 21 CFR Part 50, informed consent is the legally effective agreement of a subject to participate in a clinical investigation, obtained under circumstances that minimize coercion and ensure understanding of risks, benefits, and alternatives.

    What this means in practice

    Informed consent documents are reviewed by IRBs. Pediatric, vulnerable population, and digital trial contexts have additional considerations.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1ICH·1ISO·1

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