Article

The uneasy ethical and legal underpinnings of large-scale genomic biobanks.

Stanford University, Stanford, California 94305, USA.
Annual Review of Genomics and Human Genetics (Impact Factor: 9.13). 02/2007; 8:343-64. DOI: 10.1146/annurev.genom.7.080505.115721
Source: PubMed

ABSTRACT Abstract Large-scale genomic databases are becoming increasingly common. These databases, and the underlying biobanks, pose several substantial legal and ethical problems. Neither the usual methods for protecting subject confidentiality, nor even anonymity, are likely to protect subjects' identities in richly detailed databases. Indeed, in these settings, anonymity is itself ethically suspect. New methods of consent will need to be created to replace the blanket consent common to such endeavors, with a consent procedure that gives subjects some real control over what they might consider inappropriate use of their information and biological material. Through their use, these biobanks are also likely to yield information that will be of some clinical significance to the subjects, information that they should have access to. Failure to adjust to these new challenges is not only legally and ethically inappropriate, but puts at risk the political support on which biomedical research depends.

0 Followers
 · 
148 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: This article describes the software architecture designed to cope with the computing demand of research usage of complex data from the Imaging Biobank of the Regional Ministry of Health in the Valencia Region (CS). It proposes the use of self-configured virtual clusters on top of on-premise and public cloud infrastructures. It uses a model based on recipes and autoconfiguration to deploy virtual elastic clusters that adjust themselves to the actual workload of the study, therefore reducing operating costs and preventing the need of up-front investments both at the level of the Imaging Biobank or the final user. All the software used is released under open-source licenses.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondition for biobank research. Valid consent protects donors' rights and helps maintain public trust in biobank research. Harmonization of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks including data and sample sharing. So far, no study has assessed and compared the content of current consent forms especially for biobank research. The objective of this study was to perform a content analysis of consent forms in German biobanks. Methods: Based on ten guidelines for biomedical research, we developed an assessment matrix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012. Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items "Right to withdraw consent (without disadvantage)," "Policy for genetic information/consent to genetic analyzes" and "International cooperation/transborder use" were addressed in 97, 40, and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22-88% out of 41 items). Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent issues that must be addressed in biobank research. The findings show that the majority of consent forms for German biobanks, if not all, should be improved and harmonized to better support an informed and balanced choice of potential donors and to facilitate networking of biobanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.
    Frontiers in Genetics 11/2013; 4:240. DOI:10.3389/fgene.2013.00240
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Los estudios de mapeo genético han influido directamente en áreas biológicas, clínicas e incluso sociales y filosóficas. Dentro de los principales alcances se encuentran: la secuenciación del genoma humano completo; comparación y relación molecular con otras especies; rastreo de poblaciones y cambios adaptativos entre especies; replanteamiento de conceptos en biología, psicología e incluso filosofía; desarrollo de métodos de control del comportamiento a partir de la interacción genómica de especies; y desarrollo para acceso, entendimiento y manipulación de datos de forma inmediata. Concomitante a estos alcances han surgido profundas limitaciones como lo son: poca asociación clínica entre genes y enfermedades o condiciones; la inversión de grandes cantidades de dinero público y privado para enfermedades poco representativas; generación de falsos positivos; algunas limitaciones en las explicaciones, sugiriendo un abandono del determinismo genético; la custodia y protección del anonimato de los participantes en los estudios y finalmente, y quizá la oposición más importante que se escapa al objetivo académico de la ciencia, los intereses económicos particulares que se encuentran detrás del desarrollo de estos estudios genéticos. A modo de reflexión final, no es posible pensar en abandonar este tipo de estudios pero sí reconocer las implicaciones que a futuro se generan.