Ethics, Bioethics, and Law: Legal Boundaries in Contemporary Medical Practice
DOI:
https://doi.org/10.63969/xv2mgq93Keywords:
Bioethics, Health law, Ethical governance, Informed consent, Data protection, Institutional accountabilityAbstract
The integration of ethics, bioethics, and law represents one of the most critical challenges facing modern healthcare systems, particularly in regions undergoing legal, technological, and social transitions. This study aimed to assess the degree of ethical and legal compliance within healthcare institutions in Ecuador, Mexico, and Colombia, focusing on informed consent, data protection, ethics committee functioning, and institutional accountability. A cross-sectional and descriptive design was conducted with 612 healthcare professionals and ethics committee members from the three countries. Data were collected through structured questionnaires addressing key domains of ethical governance, and statistical analyses included descriptive measures and cross-country comparisons to identify compliance patterns and institutional differences. The findings revealed moderate-to-high overall compliance (67%) with significant variability across domains. The strongest adherence was observed in ethics committee oversight and informed consent documentation, while internal auditing, transparency, and accountability mechanisms showed weaker implementation. Only 54% of institutions reported having formal corrective systems, and fewer than half published annual ethics or compliance reports. Despite the existence of advanced legal frameworks such as Ecuador’s Ley Orgánica de Protección de Datos Personales (2021), practical enforcement remains partial and inconsistent. These results indicate that formal ethical structures are in place but often operate reactively rather than proactively. True ethical maturity requires moving beyond procedural compliance toward sustained moral commitment, transparency, and continuous professional education. This study proposes the development of a regional model of integrated ethical governance that aligns law and moral philosophy to strengthen human dignity, professional accountability, and justice in healthcare practice across Latin America.
References
Asamblea Nacional del Ecuador. (2006). Ley Orgánica de Salud. Registro Oficial Suplemento No. 423. https://www.salud.gob.ec
Asamblea Nacional del Ecuador. (2021). Ley Orgánica de Protección de Datos Personales. Registro Oficial Suplemento No. 459. https://www.registroficial.gob.ec
Associated Press. (2024, febrero 7). Ecuador’s high court decriminalizes euthanasia, following a lawsuit by a terminally ill patient. https://apnews.com/article/7fff5e69f99ec573e13396a31b037d74
De Castro, P., & Garrafa, V. (2021). The negative impact of ad hoc committees for ethical evaluation in Latin America. Developing World Bioethics, 21(2), 89–96. https://doi.org/10.1111/dewb.12277
Floridi, L., Cowls, J., Beltrametti, M., Chatila, R., Chazerand, P., Dignum, V., … Vayena, E. (2018). AI4People—An ethical framework for a good AI society: Opportunities, risks, principles, and recommendations. Minds and Machines, 28(4), 689–707. https://doi.org/10.1007/s11023-018-9482-5
Fors, M., Falcón, K., Brandão, T., López, M., & Mena-Tudela, D. (2024). Investigating obstetric violence in Ecuador: A cross-sectional study spanning the last several years. Healthcare, 12(15), 1480. https://doi.org/10.3390/healthcare12151480
Gobierno del Ecuador / Ministerio de Salud Pública. (2015). Reglamento de los Comités de Ética de Investigación en Seres Humanos (Acuerdo Ministerial 4889). https://www.gob.ec/sites/default/files/regulations/2018-10/Documento_Reglamento%20Comit%C3%A9s%20%C3%89tica%20Investigaci%C3%B3n%20Seres%20Humanos.pdf
González, A. F. M., León Pineda, C. F., & León Martínez, F. M. (2024). Revisión bioética acerca de la legalidad de la muerte asistida en el Ecuador. Revista Bioética, 32, e3630ES. https://doi.org/10.1590/1983-803420243630ES
Hagendorff, T. (2020). The ethics of AI ethics: An evaluation of guidelines. Minds and Machines, 30(1), 99–120. https://doi.org/10.1007/s11023-020-09517-8
Human Rights Watch. (2020, septiembre 9). Ecuador’s Assembly approves bill furthering the right to health. https://www.hrw.org/news/2020/09/09/ecuadors-assembly-approves-bill-furthering-right-health
Instituto Nacional de Investigación en Salud Pública (INSPI). (2017). Reglamento interno del Comité de Ética de Investigación en Seres Humanos (CEISH). https://www.investigacionsalud.gob.ec/webs/ceish/wp-content/uploads/2017/05/Reglamento-CEISH.pdf
Jobin, A., Ienca, M., & Vayena, E. (2019). The global landscape of AI ethics guidelines. Nature Machine Intelligence, 1, 389–399. https://doi.org/10.1038/s42256-019-0088-2
Macpherson, C. (2022). Global bioethics: Its past and future. Global Bioethics, 33(1), 1–18. https://doi.org/10.1080/11287462.2021.2011009
Ministerio de Salud Pública del Ecuador. (2013). Acuerdo Ministerial 3557: Creación de la Comisión Nacional de Bioética en Salud (CNBS). https://www.controlsanitario.gob.ec/wp-content/uploads/downloads/2017/01/A.M.-3557-CREA-LA-COMISION-NACIONAL-DE-BIOETICA-EN-SALUD-CNBS.pdf
Ministerio de Salud Pública del Ecuador. (2014). Normativa nacional en relación a comités de bioética en Ecuador. https://www.salud.gob.ec/wp-content/uploads/2014/11/2.-CI-Comit-%C2%AEs-de-bio-%C2%AEtica.pdf
Mittelstadt, B. (2019). Principles alone cannot guarantee ethical AI. Nature Machine Intelligence, 1(11), 501–507. https://doi.org/10.1038/s42256-019-0114-4
Ortiz-Prado, E., Vásconez-González, J., & Izquierdo-Condoy, J. S. (2024). The difficult path to euthanasia in Ecuador: A call for actions for other nations. Developing World Bioethics, 24(2), e12449. https://doi.org/10.1111/dewb.12449
Peña, R. M. (2025). Argumentos bioéticos y jurídicos de la eutanasia como derecho a una muerte digna. Revista Médica Militar, 78(2), 45–58. https://doi.org/10.23857/pc.v8i6
Pratt, B., & Hyder, A. A. (2016). Twelve years of Fogarty-funded bioethics training in Latin America: Achievements and challenges. Journal of Empirical Research on Human Research Ethics, 11(5), 478–484. https://doi.org/10.1177/1556264616662060
Public Services International. (2025, abril 3). Ecuador approves law guaranteeing human right to care. https://publicservices.international/resources/news/ecuador-approves-law-guaranteeing-human-right-to-care?id=14010&lang=en
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Alfredo Mickael Espinoza Suco (Autor/a)
This work is licensed under a Creative Commons Attribution 4.0 International License.
Los artículos publicados en la revista se distribuyen bajo la licencia Creative Commons Atribución 4.0 Internacional (CC BY 4.0). Esta licencia permite a terceros descargar, copiar, distribuir, adaptar y reutilizar una obra, incluso con fines comerciales, siempre que se otorgue el crédito adecuado al autor original.
