PARTICIPACIÓN DE NIÑOS, NIÑAS Y ADOLESCENTES EN INVESTIGACIÓN BIOMÉDICA: CUESTIONES JURÍDICAS EN TORNO AL INTERÉS SUPERIOR DEL NIÑO/A

Objective: This article critically examines the participation of children and adolescents in biomedical research, considering the tension between their special protection, progressive autonomy, and right to participate in decisions affecting their health. It analyzes applicable international instruments and principles such as the best interests of the child, beneficence, non-maleficence, and justice. Method: A dogmatic review of international normative sources and specialized legal and bioethical scholarship is employed to identify the limits of traditional approaches to decisional capacity, particularly those based on age-based criteria or general notions of vulnerability. Results: The study shows that such approaches are insufficient when they fail to systematically incorporate the risk/benefit profile of the study, the child’s or adolescent’s level of development, and their specific healthcare context. As a specific contribution, the article proposes a model of proportionality-graded contextual decisional capacity, intended to guide consent, assent, and the resolution of potential disagreements between children or adolescents and their parents or reference caregivers. Conclusions: A situated and proportional assessment provides greater ethical and legal coherence to the participation of children and adolescents in biomedical research. This approach promotes decisions that are more respectful of their progressive autonomy, without weakening the reinforced protection required by their status as rights-holders.