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[The "weak and sensitive elements" of the pediatric and adolescents' clinical trials]

Irene N Melamed

    Revista De Bioetica Y Derecho
    |August 1, 2017
    PubMed

    Insights

    Ethical review for pediatric clinical research must address child vulnerability. This study examines clinical research protocols for "fragile zones" to enhance ethical oversight in pediatric research.

    Area of Science:

    • Pediatric Ethics
    • Clinical Research Methodology
    • Vulnerability Studies

    Context:

    • Ethical review for pediatric research necessitates a focus on the inherent vulnerability of children and adolescents.
    • Vulnerability is influenced by biological, emotional, equity, and justice factors.
    • Existing ethical frameworks often address vulnerability broadly, but deeper protocol-specific analysis is needed.

    Purpose:

    • To identify specific "fragile zones" or weak spots within clinical research protocols involving children and adolescents.
    • To analyze how these identified weak spots impact the ethical review process.
    • To provide a more granular approach to ethical review by focusing on protocol content.

    Summary:

    • This research analyzes clinical research protocols for pediatric and adolescent subjects to pinpoint "fragile zones."
    • These zones represent areas within the protocol that may be underdeveloped or pose ethical risks.
    • Identifying these weak spots aims to improve the quality and rigor of ethical reviews.

    Impact:

    • Enhancing the ethical review process for research involving minors.
    • Improving the protection of vulnerable pediatric and adolescent populations in clinical studies.
    • Contributing to the development of more robust and ethically sound research protocols for children.

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