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The proxy dilemma: Informed consent in paediatric clinical research - a case study of Thailand

Sheila Varadan, Salin Sirinam, Kriengsak Limkittikul

    Developing World Bioethics
    |January 25, 2022
    PubMed

    Insights

    Navigating legal uncertainty in pediatric research is crucial for ethical and lawful informed consent. International frameworks can help ensure children access clinical trials when national laws are unclear.

    Area of Science:

    • Medical Law
    • Bioethics
    • Pediatric Research

    Background:

    • Informed consent is a cornerstone of ethical and legal research involving human subjects.
    • Paediatric research requires authorization from a legal representative due to children's presumed lack of competence.
    • Legal uncertainty in determining who can provide consent can hinder children's participation in clinical research.

    Purpose of the Study:

    • To explore how international legal frameworks can address legal uncertainty in informed consent for paediatric research.
    • To examine the implications of lacking or inadequate national laws on children's enrollment in clinical research.
    • To propose solutions for enabling greater child participation in paediatric clinical research, using Thailand as a case study.

    Main Methods:

    • Analysis of international legal frameworks, specifically the UN Convention on the Rights of the Child.
    • Case study approach focusing on Thailand's legal and socio-cultural context regarding informed consent in paediatric research.
    • Examination of legal uncertainty and its impact on the informed consent process.

    Main Results:

    • National laws may not always align with socio-cultural realities, creating legal ambiguity.
    • International conventions offer a potential basis for resolving legal uncertainties in informed consent.
    • Thailand's context highlights challenges in applying legal frameworks to paediatric research.

    Conclusions:

    • Leveraging international legal frameworks can help navigate ambiguities in informed consent for paediatric clinical research.
    • Addressing legal uncertainty is vital for ensuring children can access and benefit from clinical research participation.
    • A harmonized approach considering both international law and local realities is needed to facilitate ethical paediatric research.

    Keywords:
    children's rightsinformed consentlegally authorised representativepediatric clinical trialsproxyresearch ethics

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