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Abstract(s)
A presente tese é fruto do estudo desenvolvido no âmbito do Doutoramento em Bioética do Instituto de Bioética da Universidade Católica Portuguesa. A importância do estabelecimento de coleções organizadas de material biológico humano, a que são associados dados de saúde ou outra informação relevante, tem vindo a crescer nas últimas décadas. Os biobancos para fins de investigação científica e, mais concretamente, biomédica, são hoje globalmente reconhecidos como infraestruturas fundamentais para o progresso do conhecimento científico e para a melhoria da saúde e da qualidade de vida das pessoas. Podem ser locais, nacionais ou transfronteiriços, trabalhar isolados ou em rede. Podem ser detidos por Estados, hospitais, universidades, entidades privadas, ser orientados para uma determinada patologia ou representar toda uma população. Podem ter em vista o bem comum ou o lucro dos seus acionistas. Estas caraterísticas são determinantes para o escopo e os modos de funcionamento dos biobancos e para as modalidades de consentimento que adota. É fundamental saber qual a amplitude e os elementos constitutivos do consentimento informado como forma de legitimação ética para o uso de amostras biológicas humanas para fins de investigação biomédica. Importa refletir sobre os desafios colocados ao consentimento como a única forma, ou a mais adequada, de assegurar a validade ética deste tipo de investigação. Através de uma reflexão sobre os aspetos éticos da relação da pessoa com a sua amostra biológica e as implicações do consentimento no contexto da governança dos biobancos, pretendemos apontar pistas para o desenvolvimento de modelos éticos de tomada de decisão para e com os biobancos, aplicáveis à realidade portuguesa
This dissertation is the outcome of a study developed within the scope of the PhD in Bioethics at the Bioethics Institute of the Portuguese Catholic University, Porto. The importance of organized collections of human biological material, to which health data or other relevant information is associated, has increased in recent decades. At present, biobanks are widely recognised as fundamental infrastructures for the advancement of scientific knowledge, with a view to improving people's health and quality of life with benefits for society as a whole. Biobanks for biomedical research come in a variety of sizes and shapes. They can be local, national or cross-border, standalone projects or part of a wider network. They can be owned by states, hospitals, universities, private entities. They can be populational or pathologyspecific. They can aim for profit or for the common good. These features are decisive in determining biobanks’ scope and modes of operation, starting with their models of consent. The extent, the constitutive elements and the validity of informed consent are key elements to legitimise the use of preserved human biological samples for scientific and biomedical research purposes. It is necessary to reflect on the challenges faced by informed consent and question whether this is the only or the most appropriate means to ensure the ethical validity of this type of research. By reflecting on the ethical aspects of the relationship between the person and his/her biological sample and the implications of consent within a framework for governance, we propose to point out avenues for the development of ethical decision-making models for and with biobanks which are applicable to the Portuguese context.
This dissertation is the outcome of a study developed within the scope of the PhD in Bioethics at the Bioethics Institute of the Portuguese Catholic University, Porto. The importance of organized collections of human biological material, to which health data or other relevant information is associated, has increased in recent decades. At present, biobanks are widely recognised as fundamental infrastructures for the advancement of scientific knowledge, with a view to improving people's health and quality of life with benefits for society as a whole. Biobanks for biomedical research come in a variety of sizes and shapes. They can be local, national or cross-border, standalone projects or part of a wider network. They can be owned by states, hospitals, universities, private entities. They can be populational or pathologyspecific. They can aim for profit or for the common good. These features are decisive in determining biobanks’ scope and modes of operation, starting with their models of consent. The extent, the constitutive elements and the validity of informed consent are key elements to legitimise the use of preserved human biological samples for scientific and biomedical research purposes. It is necessary to reflect on the challenges faced by informed consent and question whether this is the only or the most appropriate means to ensure the ethical validity of this type of research. By reflecting on the ethical aspects of the relationship between the person and his/her biological sample and the implications of consent within a framework for governance, we propose to point out avenues for the development of ethical decision-making models for and with biobanks which are applicable to the Portuguese context.
Description
Keywords
Biobancos Autonomia Consentimento Bioética Investigação biomédica Governança Biobanks Autonomy Consent Bioethics Biomedical research Governance