Clasificación del sujeto de derecho frente al avance de la genómica y la procreática / Subjects of rights classification facing genomic and proteomic development / Classificação do sujeito de direito contra o avanço da genômica e da procriativa

Resumen: El Derecho cataloga la vida humana de acuerdo al estado con el cual se presenta en sociedad con la finalidad de darle una adecuada seguridad. La teoría del sujeto de derecho se sustenta en la conceptualización jurídica de la vida humana. Como teoría, fue creada para reconocer una real y efectiva regulación jurídica a las relaciones que lleve a cabo el hombre en la sociedad, tomando en cuenta que la vida humana tiene numerosas formas de presentarse en sociedad. La vida es una, pero -sea biológica o social- adopta diversos estadios que merecen una regulación acorde con su estatus. Es esta esencia y forma como la vida se presenta en sociedad lo que permite categorizarla jurídicamente y de esto se encarga la teoría del sujeto de derecho. De esta forma se regula la vida humana en su verdadera esencia y dimensión; sin embargo, la biotecnología procreática y genómica vienen alterando su clásica taxonomía, variándolo, al presentar nuevos actores en un mundo de relación.

Abstract: Law categorizes human life according to its situation in society with the goal to provide adequate safety. The theory of the subject of rights is based on the juridical conceptualization of human life. As theory, it was created to recognize a real and effective legal regulation to human relations in society, taking into account that human life has many ways to appear in society. Life is one, but -be biological or social- it adopts diverse stages which deserves regulation according to their status. This essence and way in which life is presented allows its juridical categorization by the subject of rights theory. In this way, human life is regulated in its true essence and dimension; nevertheless, genomic and proteomic biotechnology have being altering their classic taxonomy, changing it when presenting new actors in a world of relations.

Resumo: O Direto cataloga a vida humana de acordo com o estado com a qual se apresenta na sociedade com a finalidade de dá-la um nível adequado de segurança. A teoria do sujeito de direito é baseada no conceito jurídico de vida humana. Como teoria, foi criada para reconhecer uma real e efetiva regulação jurídica das relações realizadas pelo homem na sociedade, tendo em conta que a vida humana tem inúmeras maneiras de se apresentar na sociedade. A vida é uma, embora -seja biológica ou social- adota diferentes fases que merecem uma regulação em conformidade com o seu estatuto. É essa essência e forma como a vida surge na sociedade é o que permite categorizá-la juridicamente e disso se encarga a teoria do sujeito do direito. Assim, regula a vida humana na sua verdadeira essência e dimensão; no entanto, a biotecnología procriativa e genômica vem alterando sua taxonomia clássica, variando-a, introduzindo novos atores em um mundo de relações.

Genomic sovereignty or the enemy within / Soberanía genómica o el enemigo interior / Soberania genômica ou o inimigo interior

Genomic sovereignty is a concept that has become very popular among developing countries such as India, China, South Africa and Mexico. This concept is a response to developed countries that have taken advantage of those countries and researchers who don't have the means for protecting their own biogenetic resources. In this article we argue that genomic sovereignty is not about the “others” extracting and exploiting local “human genetic resources”, but developing and implementing the ethical, legal and administrative tools, based on transparency, openness and equal access to biological material, in order to build up a robust research networks. Being biological samples a scarce and valuable good, we conclude that controlling the access to this resource by means of the law, without a well implemented biobanking system and a clear scientific policy may lead to a situation where asymmetric relations are generated among research groups of the very same developing country. We would advice to those countries pretending to protect their biological samples and data from the outside, before developing laws against possible “intrusions”, they need to design strategies to promote equal and fair access to both resources paramount to biomedical research.

“Soberanía genómica” es un concepto que se ha hecho muy popular entre los países en desarrollo, como India, China, Sudáfrica y México. Este concepto es una respuesta a los países desarrollados que han tomado ventaja, aprovechándose de aquellos países y de los investigadores que no tienen los medios para proteger sus propios recursos biogenéticos. En este artículo argumentamos que la soberanía genética no se trata de impedir que “otros” extraigan y exploten “los recursos genéticos humanos” locales, sino del desarrollo y de la aplicación de las herramientas éticas, jurídicas y administrativas basadas en la transparencia, la apertura e igualdad en el acceso al material biológico, con el fin de construir redes de investigación sólidas. Al ser las muestras biológicas un bien escaso y valioso, concluimos que el control del acceso a este recurso, por medio de la ley, sin un sistema de biobancos bien implementado y sin una política científica clara, puede llevar a una relación asimétrica entre los grupos de investigación del mismo país en desarrollo. Nos gustaría advertir a los países que pretenden proteger sus muestras biológicas y datos asociados que, antes que elaborar leyes contra posibles intrusiones, es necesario diseñar estrategias para promover el acceso justo y equitativo a los recursos primordiales para la investigación biomédica.

“Soberania genômica” é um conceito que se fez muito popular entre os países em desenvolvimento, como Índia, China, África do Sul e México. Este conceito é uma resposta aos países desenvolvidos que obtiveram vantagem, aproveitando-se daqueles países e dos investigadores que não têm meios para proteger os seus próprios recursos biogenéticos. Neste artigo argumentamos que a soberania genética não trata de impedir que “outros” extraiam e explorem “os recursos genéticos humanos” locais, senão do desenvolvimento e da aplicação das ferramentas éticas, jurídicas e administrativas baseadas na transparência, abertura e igualdade no acesso ao material biológico, com a finalidade de construir redes de investigação sólidas. Por serem as amostras biológicas um bem escasso e valioso, concluimos que o controle do acesso a este recurso, por meio da lei, sem um sistema de biobancos bem implementado e sem uma política científica clara, pode levar a uma relação assimétrica entre os grupos de investigação de um mesmo país em desenvolvimento. Gostaríamos advertir aos países que pretendem proteger suas amostras biológicas e dados associados que, antes de elaborar leis contra possíveis intromissões, é necessário projetar estratégias para promover o acesso justo e equitativo aos recursos primordiais para a investigação biomédica.

El Genoma en los Cordados: Introducción a la Genómica Comparada / The Genome in the Chordates: Introduction to Comparative Genomics

El objetivo del presente trabajo es describir brevemente conceptos de la genómica de los cordados así como de la genómica comparada y sus aspectos éticos. El genoma de los cordados cambió ligeramente dando lugar al genoma de los vertebrados, entre ellos el de los mamíferos, entre los que se incluye el ser humano. La genómica comparada estudia las semejanzas y diferencias entre genomas de diferentes organismos; trata de explicar la información proporcionada por la selección natural para entender la función y los procesos evolutivos que actúan sobre los genomas. La complejidad de los procesos evolutivos constituye todo un desafío a la hora de analizar e interpretar la información biológica generada; en este sentido, la Bioinformática y la Biología Computacional proporcionan un amplio abanico de técnicas estadísticas, matemáticas y algorítmicas para el análisis de datos biológicos. Un reto clave es analizar el caudal de datos de secuencias de ADN con el fin de comprender la información almacenada en términos de estructura, función y evolución proteicas. En Biología computacional BLAST y ClustalW2 son las herramientas más empleadas para el análisis de alineamientos múltiples de secuencias. La Genómica está resultando clave también en el campo de la medicina; conocer la cartografía del genoma humano proporciona una valiosa información a tener en cuenta a la hora de detectar genes implicados en ciertas enfermedades. Esto conlleva que en la actualidad nos centremos más en la predicción de patologías que en la prevención, por lo que la tendencia es que en el futuro la Medicina Genómica acabe desbancando a la Medicina Preventiva. El Proyecto Genoma Humano presenta diversas aplicaciones que, al no tener una clara cobertura legal, traen consigo un nuevo paradigma con problemas éticos, sociales y legales que la comunidad científica trata de resolver para compaginar los aspectos morales con el progreso en la investigación.

The aim of this paper is to briefly describe concepts of genomics of chordates and comparative genomics and its ethical aspects. The genome of chordates changed slightly resulting in the genome of vertebrates, including mammals. The human being belongs to the phylum chordates. Comparative genomics studies the similarities and differences between genomes of different organisms, trying to explain the information provided by natural selection to understand the function and evolutionary processes that act on genomes. Evolutive processes' complexity is considered a major challenge in terms of analyzing and interpreting all the biological information generated; in this sense, Bioinformatics and Computational Biology provide an enormous range of statistical, mathematical and algorythmical techniques for biological data analyses. A key challenge for bioinformatics is to analyze the flow of DNA sequence data to understand the information stored in terms of structure, function and protein evolution. BLAST and ClustalW2 tools are used for the analysis of multiple sequence alignments in Computational Biology. Genomics is also playing a key role in Medicine; human genome's cartography provides valuable information to detect genes involved in certain diseases. It entails that nowadays it is better to focus on prediction much more than on prevention. The current tendency is that in the future Genomic Medicine will displace Preventive Medicine. The Human Genome Project implies diverse applications that do not have clear legal coverage. This brings a new paradigm with ethical, social and legal problems that the scientific community is trying to resolve in order to combine morality and research progress.

Ethical Considerations in Genomic Cohort Study / 예방의학회지

During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised important ethical concerns including genetic privacy, confidentiality, discrimination, and informed consent. Informed consent for biobank poses an important question: whether true informed consent is possible in populationbased genomic cohort research where the nature of future studies is unforeseeable when consent is obtained. Due to the sensitive character of genetic information, protecting privacy and keeping confidentiality become important topics. To minimize ethical problems and achieve scientific goals to its maximum degree, each country strives to build population-based genomic cohort research project, by organizing public consultation, trying public and expert consensus in research, and providing safeguards to protect privacy and confidentiality.

Attitudes towards genomic: research in four Latin American countries

The present reflection refers to data obtained about the social representations of genomic research and its applications through interviews with legislators and lawyers, biomedical researchers and civilians and the review of scientific and legal literature in four Latin American countries: Argentine, Chile, Mexico and Peru. Several issues are addressed: little access to prevention and therapeutic methods, lack of equity in health benefits, commercialization of gene sequences through patents which leads to commercial exploitation of underdeveloped countries, the possibility of physical or psychological damage or genetic discrimination, the possibility of genetic modifications or abortion for eugenic reasons, the necessity of safeguarding confidentiality, risks and benefits of the use of transgenics and cloning, the necessity of legal regulation to prevent the pathway towards genetic enhancement or reproductive human cloning and of regulating access to genetic information. Using the method of content analysis of verbal behaviour to evaluate the degree of anxiety and hostility of subjects in relation to the Human Genome Project (HGP) developed by Gottschalk and Gleser, an inverse relation between levels of anxiety and level of knowledge was observed which highlights the importance of educating the population. Differences in the level of hostility towards the HGP were also found among the groups.

Genomics, public health and identity

This paper questions the utility of the ethical principles that are usually invoked to deal with genomic issues, particularly genetic databases. Concepts such as solidarity, benefit sharing, equity, public participation, and collective identity are discussed. The author argues that genetic banks are precipitating new concern over group interest, as opposed to concern over issues arising from individualistic medical ethics. Genomics era needs new paradigms in ethics. An individualistic approach based on choice and autonomy is not useful, because we make choices not only as individuals but also as members of different groups. The doctrine of informed consent evolved in different historical conditions from the ones we face in the era of genomics. This is complicated by the global context of genetic research, in addition to powerful commercial interests. This suggests that it is not sufficient to move from an individual-centred ethic approach to a morecommunity-centred one; an approach of renegotiating the relationship between individual and community. We need also to be clear about what the interests at stake are, which may mean reconceiving the terms ÔindividualÕ and "community" in this context and the ways in which their interests are affected, identifying the sources of collective identity that are at stake.

La comunicación genética desde la perspectiva de los sistemas sociales / A report of genetics from a social system perspective

En este artículo se aplica la teoría de los sistemas sociales para analizar las repercusiones de las aplicaciones biocientíficas en la sociedad contemporánea y explicar el posicionamiento del riesgo como un medio habitual de comunicación. Desde esta perspectiva, trata la investigación genética como un problema emergente y autoproducido, que apunta a situaciones que las sociedades latinoamericanas recién empiezan a enfrentar. Los objetivos fueron relacionar, desde una observación de segundo orden, comunicaciones que van desde los alimentos transgénicos hasta las expectativas generadas por la investigación genómica. Finalmente, se indican los medios que incrementan en complejidad las operaciones sociales involucradas en la comunicación genética y que guían su evolución, como es el caso de la comunicación bioética.