Maestría en Bioética · 2026

Consideraciones éticas en la investigación con seres humanos: principios bioéticos en la recolección de datos clínicos retrospectivos

Resumen

Introduction: The collection of retrospective clinical data involves significant ethical challenges related to autonomy, privacy, and the protection of sensitive information, especially when explicit consent is not obtained. Although national and international regulations exist, their application is heterogeneous and limited, which may compromise patient dignity and rights. This study addressed these tensions to support an ethical model and an appropriate consent approach for retrospective research. Objective: To identify the key ethical considerations and bioethical principles that should guide the collection of retrospective clinical data in human research. Methodology: A multimethod approach was applied, integrating documentary analysis, literature review, qualitative study, and quantitative phase. Triangulation enabled the development of a consent model and a practical guide for the ethical collection of retrospective data. Results: Ethical, regulatory, and operational gaps were identified, along with tensions between autonomy and governance, knowledge gaps, and the absence of institutional guidelines—evidencing insufficient governance of clinical data.