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Tesis Doctoral Presentada Por: Da UNIVERSIDAD CATÓLICA DE VALENCIA SAN VICENTE MÁRTIR ETHICAL ISSUES OF SYNTHETIC BIOLOGY: A PERSONALIST PERSPECTIVE Tesis doctoral Presentada por: Da. LUCÍA GÓMEZ TATAY Dirigida por: DR. D. JOSÉ MIGUEL HERNÁNDEZ ANDREU 2019 1 2 4 Agradecimientos Gracias A José Miguel, que es parte de esta tesis. A Samuel, que es parte de mí. A Justo, Nuria, Manuel, Ester y Cristina, que han sido parte de mi día a día en la realización de este trabajo. A Dios, por todo. 5 6 ABSTRACT Synthetic Biology is a scientific area that combines biology and engineering to build new biological systems that could provide solutions to a wide range of social needs. Multiple and promising applications are expected from this discipline. However, Synthetic Biology also raises several ethical concerns that need to be addressed, not only to protect those values that may be threatened by the different applications of this discipline, but also because failure to fully confront them could be, together with social rejection, an obstacle to the realization of these applications. This work has been carried out under the hypothesis that a detailed study of the current state of Synthetic Biology from a personalist perspective will highlight the main bioethical issues that could be a threat for a genuine development, respectful of human life and dignity, and provide solutions for it to become a reality. The main objective of this thesis is to assess the bioethical issues raised by Synthetic Biology from a specific bioethical approach, personalism, specifically ontological personalism, a philosophy that shows the objective value of the person on the basis of its ontological structure. The person, as a being endowed with reason, freedom and awareness, has a special value which is above that of other beings. This thesis has been divided into three main phases: contextualization (explanation of what Synthetic Biology is); identification and definition of the ethical issues raised by this discipline; and approach to bioethical issues from an ontological personalist framework. A literature search was therefore carried out to define the state of the question, covering the development of this discipline, the main advances achieved and the applications in this field, and to identify the ethical concerns that have been associated with Synthetic Biology. The bioethical principles derived from ontological personalism 7 (Sgreccia, 2012) have been applied to give an answer from this ethical framework to the different issues raised. From this critical analysis, different conclusions have been drawn regarding the questions raised, as well as proposals that are in accordance with the personalist framework. Thus, the implications of the personalist principles for each of the ethical issues identified have been discussed and then examined in more depth by evaluating the different branches of Synthetic Biology separately. Finally, directions for future research have been outlined. 8 RESUMEN INTRODUCCIÓN La Biología Sintética es un área científica que combina la biología y la ingeniería para construir nuevos sistemas biológicos que podrían brindar soluciones a una amplia gama de necesidades sociales. Se esperan múltiples y prometedoras aplicaciones de esta disciplina. Sin embargo, la Biología Sintética también plantea varias inquietudes éticas que deben abordarse, no solo para proteger los valores que pueden verse amenazados por las diferentes aplicaciones de esta disciplina, sino también porque un abordaje deficiente de estas cuestiones éticas puede ser, junto con el rechazo social. , un obstáculo para la realización de estas aplicaciones. HIPÓTESIS Este trabajo se ha llevado a cabo bajo la hipótesis de que un estudio detallado del estado actual de la Biología Sintética desde una perspectiva personalista sacará a relucir los principales problemas bioéticos que podrían ser una amenaza para un desarrollo genuino, respetuoso con la vida y la dignidad humana, y proporcionará soluciones para que se convierta en una realidad. OBJETIVOS El objetivo principal de este trabajo es evaluar las cuestiones bioéticas planteadas por la Biología Sintética desde un enfoque bioético específico, el personalismo, específicamente el personalismo ontológico, una filosofía que muestra el valor objetivo de la persona sobre la base de su estructura ontológica. METODOLOGÍA Se han realizado tres fases principales de trabajo: contextualización (definición de la Biología Sintética y del estado de la cuestión); identificación y definición de las cuestiones éticas planteadas por esta disciplina; y abordaje de las cuestiones bioéticas 9 desde un marco personalista ontológico. Así, se ha realizado una búsqueda en la literatura para definir el estado de la cuestión, abarcando el desarrollo de esta disciplina, los principales avances logrados y las aplicaciones en este campo, y para identificar las cuestiones éticas asociadas con la Biología Sintética. Los principios bioéticos derivados del personalismo ontológico (Sgreccia, 2012) se han aplicado para dar una respuesta desde este marco ético a las diferentes cuestiones planteadas. A partir de este análisis crítico, se han extraído diferentes conclusiones sobre las cuestiones planteadas, así como propuestas de actuación acordes al marco personalista. RESULTADOS Y DISCUSIÓN Evaluación desde el personalismo de las cuestiones bioéticas planteadas por la Biología Sintética. La evaluación personalista de las cuestiones bioéticas planteadas por la Biología Sintética encuentra diferentes implicaciones para cada una de las cuestiones evaluadas: -Con respecto a la cuestión del impacto de la Biología Sintética en el concepto de vida y su creación, ninguna rama de esta disciplina se ha encontrado inevitablemente contraria a los principios personalistas. Sin embargo, las interpretaciones mecanicistas o reduccionistas del concepto de vida, que podrían derivarse de estos enfoques, podrían amenazar los valores defendidos por el principio de protección del ecosistema y el medio ambiente o incluso el principio de protección de la vida y la identidad genética de cada individuo humano. -Respecto al valor moral de los organismos sintéticos, sus intereses deben ser tenidos en cuenta. Se pueden derivar algunas conclusiones adicionales. En primer lugar, las consideraciones sobre el posible florecimiento dañado de los organismos sintéticos debido a su diseño no tienen relevancia moral desde nuestro punto de vista. En segundo lugar, deben observarse las características de los organismos sintéticos para determinar 10 sus intereses o requerimientos y preservarlos en la medida de lo posible. En tercer lugar, no existe un deber moral de salvaguardar la conservación de las especies sintéticas, ya que no forman parte de la biodiversidad que debe protegerse bajo el principio de protección del ecosistema y el medio ambiente. Finalmente, siempre se debe observar la primacía de la persona, teniendo en cuenta que, desde nuestro marco ético, los intereses humanos prevalecen sobre los intereses de los organismos vivos no humanos. Además, usar el término "máquina" para describir los organismos sintéticos puede ser peligroso. Si bien hoy en día los únicos organismos sintéticos que pueden producirse son microorganismos, cuyos requisitos de manipulación no tienen impacto a nivel moral, esto podría cambiar cuando se produzcan organismos más complejos. Nombrarlos adecuadamente desde el principio garantizaría que los intereses de los organismos sintéticos más complejos se respeten en el futuro. -Con respecto a los problemas de biosafety, hay algunas características de esta disciplina que justifican mejoras en las medidas de biosafety para salvaguardar los principios personalistas. Además, la legislación debe tener un papel en su regulación, incluidas las acciones de los biohackers, tanto a nivel nacional como internacional, teniendo en cuenta la naturaleza de los riesgos y los beneficios esperados. Se ha encontrado un punto débil en el desarrollo de los cinco principios personalistas aplicados en esta tesis. En consecuencia, parece que el principio de la competencia de la comunidad debería reformularse para incluir específicamente y describir el principio de libertad de investigación. Por lo tanto, el principio podría ser el principio de libertad de investigación y competencia de la comunidad. Su contenido debe incluir explícitamente el principio de libertad de investigación, su subordinación a los principios 1 y 2, de los cuales se deriva la investigación responsable, y la necesidad de tener en cuenta las opiniones de todos los interesados y la sociedad. 11 - También son necesarias mejoras en las medidas de biosecurity para responder a los riesgos, incluyendo el establecimiento de autoridades para la toma de decisiones y el desarrollo de normas, regulaciones y políticas de financiamiento para promover la seguridad, así como la implementación de formas eficientes y eficaces de controlar las secuencias genéticas distribuidas y las diseminación del conocimiento de alto riesgo, entre otras. - La posibilidad de aplicar la Biología Sintética a los seres humanos ha sido sugerida por importantes representantes en este campo, y podría servir para introducir grandes modificaciones en nuestro genoma (bioingeniería) o para sintetizarlo artificialmente (genómica sintética). Incluso bases no canónicas podrían introducirse en nuestro genoma (xenobiología). Según los principios empleados en este trabajo, la modificación del genoma humano es aceptable solo cuando es necesaria para el tratamiento de una enfermedad de otro modo incurable.
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