El principio vulnerabilidad: definición y alcance en el ámbito de la investigación con personas

Sergio Ramos Pozón; Bernabé Robles del Olmo

Sergio Ramos Pozón Escola d’Infermeria. Universidad de Barcelona (Barcelona, España)
Bernabé Robles del Olmo Hospital de Sant Boi-Sant Joan de Déu (Sant Boi de Llobregat, Barcelona, España)

Palabras clave: Vulnerabilidad, Investigación, Salud mental, Bioética

Key-words: Vulnerability, Research, Mental health, Bioethics

Palavras chave: Vulnerabilidade, Pesquisar, Saúde mental, Bioética

Resumen

El principio de vulnerabilidad tiene un enfoque ontológico y otro circunstancial, aunque no está exento de críticas. Pese a ello, históricamente se ha ido reconociendo este principio en las distintas normas legales y deontológicas que orientan las investigaciones con personas. En salud mental, por la sus peculiariadades, adquiere un papel fundamental. Metodología: Reflexión teórica sobre la temática, utilizando la bibliografía relevante y actualizada extraída del buscador Pubmed. Se utilizan las siguientes palabras clave en inglés: Vulnerability, ethics, research, nursing, mental health, utilizando el opreador boleano “AND” para detectar cuáles son los problemas éticos subyacentes. Por otro lado, usamos los términos vulnerability, mental capacity, confidentiality, y research, junto con “AND”, para su análisis conceptual. Resultados: Aportamos un marco teórico antropoló-gico y ético para que el equipo de Enfermería sepa comprender y justificar con más rigor la temática de la vulnerabilidad cuando se investiga con personas con problemas de salud mental. Esto permite cuidados más apropiados a la naturaleza humana y a los condicionantes externos. Conclusiones: El principio de vulnerabilidad es clave en el ámbito de la investigación con personas. Un respeto por la vulnerabilidad cuando estas personas son incluidas en los experimentos, pasa necesariamente por hacer “trajes a medida” que garanticen una adecuada protección, que ha de hacerse siempre compatible con una libre participación y con el respeto a la intimidad y confidencialidad de las personas participante

Abstract

The principle of vulnerability has an ontological and a circumstantial approach, although it is not exempt from criticism. Despite this, historically this principle has been recognized in the different legal and ethical standards that guide research with people. In mental health, due to its peculiarities, it acquires a fundamental role. Methodology: we use a theoretical reflection on the subject, using the relevant and updated bibliography extracted from the Pubmed search engine. The following keywords are used in English: vulnerability, ethics, research, nursing, mental health, using the boolean operator “AND” to detect the underlying ethical problems. On the other hand, we use the terms vulnerability, mental capacity, confidentiality, and research, together with “AND”, for its conceptual analysis. Results: We provide an anthropological and ethical theoretical frame-work so that the Nursing team can more rigorously understand and justify the issue of vulnerability when researching people with mental health problems. This allows care that is more appropriate to human nature and external conditioning factors. Conclusions: The principle of vulnerability is key in the field of research with people. A respect for the vulnerability when these people are included in the experiments, necessarily goes through making "tailor-made suits" that guarantee adequate protection, which must always be made compatible with free participation and with respect for the privacy and confidentiality of the people. participant people

Resumo

O princípio da vulnerabilidade tem uma abordagem ontológica e circunstancial, embora não seja isento de críticas. Apesar disso, historicamente esse princípio tem sido reconhecido nas diferentes normas legais e éticas que orientam a pesquisa com pessoas. Na saúde mental, pelas suas peculiaridades, adquire um papel fundamental. Método: Reflexão teórica sobre o tema, utilizando a bibliografia relevante e atualizada extraída do motor de busca Pubmed. As seguintes palavras-chave são usadas em inglês: vulnerabilidade, ética, pesquisa, enfermagem, saúde mental, usando o operador booleano “AND” para detectar os problemas éticos subjacentes. Por outro lado, utilizamos os termos vulnerabilidade, capacidade mental, confidencialidade e pesquisa, juntamente com “AND”, para sua análise conceitual. Resultados: Fornecemos um referencial teórico antropológico e ético para que a equipe de Enfermagem possa compreender e justificar com mais rigor a questão da vulnerabilidade ao pesquisar pessoas com problemas de saúde mental. Isso permite um cuidado mais adequado à natureza humana e aos fatores condicionantes externos. Conclusões: O princípio da vulnerabilidade é fundamental no campo da pesquisa com pessoas. O respeito à vulnerabilidade quando essas pessoas são incluídas nos experimentos passa necessariamente pela confecção de "tra-jes sob medida" que garantam a proteção adequada, que deve ser sempre compatibilizada com a livre participação e com o respeito à privacidade e confidencialidade das pessoas. pessoas partici-pantes

Bibliografía

Appelbaum, S., & Grisso, T. (2001). MacCAT-CR Mac Arthur Competence Assessment Tool for Clinical Research. Sarasota (FL – USA): Professional Resource Press.
Asociación Médica Mundial. (1964). Declaración de Helsinki. Recuperado de https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principios-eticos-para-las-investigaciones-medicas-en-seres-humanos/
Boldt, J. (2019). The concept of vulnerability in medical ethics and philosophy. Philosophy, Ethics, and Humanities in Medicine, 14,6.
Bracken D., Bell E., Ellen M., & Racine E. (2017). The concept of ‘vulnerability’ in Research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems, 15, 8. https://doi.org/10.1186/s12961-016-0164-6.
Bromwich D., y Rid A. (2015). Can informed consent to research be adapted to risk? J Med Ethics, 41:521–528. https://doi.org/10.1136/medethics-2013-101912. Bruce G. (2020). Vulnerability in Research: Basic Ethical Concepts and General Approach to Re-view. Ochsner Journal, 20, 34–38. Calvin W, Reis A., y Saxena A. (2015). Vulnerability in international policy discussion on research involving children. Asian Bioethics Review, 7(2), 230-249. OBEYD (1947). El Código de ética médica de Núremberg. Observatorio de Bioética y Derecho. Bar-celona: Universidad de Barcelona. Recuperado de https://web.ar-chive.org/web/20100602064823/http://www.pcb.ub.es/bioeticaidret/archivos/norm/ Consejo de Organizaciones Internacionales de las Ciencias Médicas (2016). Pautas éticas internacio-nales para la investigación relacionada con la salud con seres humanos. Recuperado de https://cioms.ch/wp-content/uploads/2017/12/CIOMS-EthicalGuideline_SP_INTERIOR-FINAL.pdf (Un.Org.). (2006). Convención sobre los derechos de las personas con discapacidad. Recuperado de https://www.un.org/esa/socdev/enable/documents/tccconvs.pdf Cunha, T., & Garrafa, V. (2016). Vulnerability. A Key Principle for Global Bioethics? Cambridge Quar-terly of Healthcare Ethics, 25,197 – 208. Dhai, A. (2014). The research ethics evolution: From Nuremberg to Helsinki. S Afr Med J, 104(3), 178-180. https://doi.org/10.7196/SAMJ.7864 Eustáquia, M., & Francini, D. (2018). The concept of vulnerability and its meanings for public poli-cies in health and social welfare. Cad. Saúde Pública, 34(3), e00101417. Fineman M. (2008). The Vulnerable Subject: Anchoring Equality in the Human Condition. Yale journal of law and feminism, 20(1):1-24. Henderson G., Davis A., y King A. (2004). Vulnerability to Influence: A Two-Way Street. American Journal of Bioethics , 4(3):50. Hurst, S. (2008). Vulnerability in research and health care; Describing the elephant in the room? Bioethics, 22(4), 191–202. Informe Belmont (1978). Disponible en: http://www.bioeticayderecho.ub.edu/archivos/norm/In-formeBelmont.pdf Jinbin, P. (2017). Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in the United States. Uisahak, 26(3), 545-578. https://doi.org/10.13081/kjmh.2017.26.545. Kipnis, K. (2001). “Vulnerability in research subjects: a bioethical taxonomy”. En National Bioethics Advisory Commission, editor. Ethical and policy issues in research involving human participants. Be-thesda: National Bioethics. Advisory Commission, G1–G13. Kottow, M. (2004). Vulnerability: What kind of principle is it? Medicine, Health Care and Philosophy, 7, 281–287.
Levine. C., Faden, R., Grady Ch., Hammerschmidt, D., Eckenwiler, L., & Sugarman J. (2004). The Limitations of “Vulnerability” as a Protection for Human Research Participants. The American Jour-nal of Bioethics, 4(3), 44–49.
Lozano, J. (2022). El sentimiento kantiano de respeto como núcleo normativo en investigaciones sociales en contextos de vulnerabilidad. Recerca. Revista de Pensament i Anàlisi, 27(2),1-22. http://dx.doi.org/10.6035/recerca.6119
Luna, F. (2009). Elucidating the concept of vulnerability: layers not labels. Int J Fem Approaches Bioeth, 2(1),121-139.
Mergen, M., & Akpınar, A. (2021) Vulnerability: An integrative bioethics review and a proposed taxonomy. Nursing Ethics, 28(5), 750–765.
Moreno, A. (2013). La ética de la vulnerabilidad de Corine Pelluchon. Daimon Revista Internacional de Filosofia, (58), 171–178.
Palmer, B., Harmell, A., Pinto, L., Dunn, L., Kim, S., Golshan, S., & Jeste, D. (2017). Determinants of capacity to consent to research on Alzheimer’s disease. Clinical Gerontologist, 40, 24–34.
Rendtorff, D., & Kemp, P. (2000) Basic Ethical Principles. In European Bioethics and Biolaw. Auton-omy, Dignity, Integrity and Vulnerability (I), y Partners' Research (II), Barcelona: Institut Borja de Bioética.
Rogers, W., & Meek, M. (2013) Rethinking the vulnerability of minority populations in Research. Am J Public Health, 103(12), 2141-6. http://dx.doi.org/ 10.2105/AJPH.2012.301200.
Stienstra, D., & Chochinov, H. (2006). Vulnerability, Disability, and Palliative End-of-Life Care. Jour-nal of Palliative Care, 22(3),166-74.
Taua, C., Christine, N., & Hepworth, J. (2014). Research participation by people with intellectual disability and mental health issues: An examination of the processes of consent. International Jour-nal of Mental Health Nursing, 23, 513–524.
Ten Have H. (2015). Respect for Human Vulnerability: The Emergence of a New Principle in Bio-ethics. Bioethical Inquiry, 12, 395–408. http://dx.doi.org/ 10.1007/s11673-015-9641-9.
Ten Have, H., & Gordijn, B. (2021). Vulnerability in light of the COVID‑19 crisis. Medicine, Health Care and Philosophy, 24, 153–154.
UNESCO (2022). Declaración Universal de Bioética y Derechos Humanos (1948). Madrid: Editorial Letra Minúscula. Recuperado de https://unesdoc.unesco.org/ark:/48223/pf0000146180_spa
Van der Zande, I., Van der Graaf, R., Oudijk, M.A., & Van Delden, J.J.M. (2017). Vulnerability of pregnant women in clinical Research. J Med Ethics, 43(10),657-663. http://dx.doi.org/ 10.1136/me-dethics-2016-103955.
Vicens, E., Calcedo, A., Hastings, J., Männikkö, M., & Silvia P. (2021). What Is the Capacity of Indi-viduals with Schizophrenia and Bipolar Disorder to Make Healthcare Decisions? An Exploratory Study of the Views of Patients, Psychiatrists, and Family Caregivers—A Survey on Decisional Ca-pacity in Mental Health. Psychiatry Int, 2, 127–144.
Wrigley, A. (2015). An eliminativist approach to vulnerability. Bioethics, 29(4), 478–487

El principio vulnerabilidad: definición y alcance en el ámbito de la investigación con personas

The principle of vulnerability: definition and scope in the field of research with people

O princípio da vulnerabilidade: definição e alcance no campo da pesquisa com pessoas

Resumen

Abstract

Resumo

Bibliografía