Informed consent in biobanking and genetic research
DOI:
https://doi.org/10.3989/arbor.2008.i730.176Keywords:
Biobanks, informed consent, open-ended research, bioethics, systems biology, Law on Biomedical ResearchAbstract
Partially as a consequence of the results of the Human Genome Project, reductionist and determinist positions in genetics have been generally replaced by a more systemic view. In this paper we examine some consequences of this paradigm shift upon biobanks and the way research is to take place through them. Biobanks are shown to challenge to a certain degree the traditional rules in genetic research. Although there are pressing issues concerning privacy and confidentiality, the most visible area of disagreement has to do with informed consent. There is a gap between theory and practice, as most documents and declarations at the global level insist on the need of genuine informed consent, but this requirement faces serious problems of implementation. Thus the demands of research are bringing about new “open consent” models, which are making their way into legislation, as in the new Spanish Law on Biomedical Research.
Downloads
References
Annas, George J. (2001): “Reforming Informed Consent to Genetic Research”, Journal of the American Medical Association, 286, 2326-2328. doi:10.1001/jama.286.18.2326
Árnason, Vilhjálmur (2004): “Coding and Consent: Moral Challenges of the Database Project in Iceland”, Bioethics, 18 (1), 27-49. doi:10.1111/j.1467-8519.2004.00377.x
Beauchamp, Tom L. y Childress, James F. (2001): Principles of biomedical ethics, 5th edition, New York, Oxford University Press.
Cambon-Thomsen, Anne (2004): “The social and ethical issues of postgenomic human biobanks”, Nature RevGenetics, 5 (11), 866-73. doi:10.1038/nrg1473
Campbell, Eric G.; Clarridge, Brian R.; Gokhale, Manjusha; Birenbaum, Lauren; Hilgartner, Stephen; Holtzman, Neil A. y Blumenthal, David (2002): “Data Withholding in Academic Genetics: Evidence From a National Survey”, Journal of the American Medical Association, 287, 473-480. doi:10.1001/jama.287.4.473
Casado, Antonio (2004): “Ethical Aspects of Human Genetic Databases”, TRAMES. Journal of the Humanities and Social Sciences, 8 (1-2), 34-45.
Casado, Antonio y Etxeberria, Arantza (2004): “Problemas bioético-sociales con la información genética: el caso de la base de datos del sistema sanitario islandés”, Inguruak. Revista vasca de sociología y ciencia política, 40, 13-31.
Chadwick, Ruth (1999): “The Icelandic Database - Do Modern Times Need Modern Sagas?”, British Medical Journal, 319, 441-444.
Etxeberria, Arantza y Casado, Antonio (2001): “Islandiako lezioa: Genomita arlo publikoa eta pribatuaren artean”, Elhuyar. Zientzia eta teknika, 163, 20-25.
Etxeberria, Arantza y García-Azkonobieta, Tomás (2004): “Sobre la noción de información genética: semántica y excepcionalidad”, Theoria, 19 (50), 207-230.
Habermas, Jürgen (2002): El futuro de la naturaleza humana ¿Hacia una eugenesia liberal?, Barcelona, Paidós.
Hansson, Mats G. (2006): “Combining efficiency and concerns about integrity when using human biobanks”, Studies in the History and Philosophy of Biology and Biomedical Sciences, 37, 520-532. doi:10.1016/j.shpsc.2006.06.006
Kaye, Jane (2004): “Broad consent – the only option for population genetic databases?”, en G. Árnason, S. Nordal y V. Árnason (Eds.): Blood and Data - Ethical, Legal and Social Aspects of Human Genetic Databases, Reykjavik, University of Iceland Press, 103-109.
Keller, Evelyn Fox (2000): The century of the gene, Cambridge (Mass.), Harvard University Press.
Knoppers, Bartha M. y Fecteau, Claudine (2003): “Human genomic databases: a global public good?”, European Journal of Health Law, 10(1): 27-41. doi:10.1163/157180903100384659
López de la Vieja, M. Teresa (2006): “Posguerra y contracultura. Identidades en la ética aplicada”, ARBOR Ciencia, Pensamiento y Cultura CLXXXII(72), 787-796.
Manson, Neil C. y O’Neill, Onora (2007): Rethinking Informed Consent in Bioethics, Cambridge, Cambridge University Press.
Murray, Thomas H. (1997): “Genetic exceptionalism and ¦Future diaries’: Is genetic information different from other medical information?” En M. Rothstein (Ed.): Genetic Secrets, New Haven (Co.), Yale University Press, 60-73.
NBAC (2001): Ethical and Policy Issues in Research Involving Human Participants (Summary), Bethesda (Maryland), National Bioethics Advisory Commission.
Nomper, Ants (2005): Open consent: a new form of informed consent for population genetic databases, Dissertation for obtaining the degree of doctor iuris, University of Tartu. Acceso en http://www.utlib.ee/ekollekt/diss/dok/2005/b17285835/nomper.pdf el 21 de mayo de 2007.
O’Malley, Maureen A.; Calvert, Jane y Dupré, John (2007): “The Study of Socioethical Issues in Systems Biology”, The American Journal of Bioethics, 7 (4), 67-78. doi:10.1080/15265160701221285
O’Malley, Maureen A. y Dupré, John (2005): “Fundamental issues in systems biology”, BioEssays, 27, 1270-1276. doi:10.1002/bies.20323
O’Neill, Onora (2002): Autonomy and Trust in Bioethics: the Gifford lectures 2001, Cambridge, Cambridge University Press.
Robert, Jason S.; Maienschein, Jane y Laubichler, Manfred (2006): “Systems Bioethics and Stem Cell Biology”, Journal of Bioethical Inquiry 3 (1-2), 19-31. doi:10.1007/s11673-006-9001-x
Seoane, José Antonio (2002): “De la intimidad genética al derecho a la protección de datos genéticos. La protección iusfundamental de los datos genéticos en el Derecho español (A propósito de las SSTC 290/2000 y 292/2000, de 30 de noviembre)”, Revista de Derecho y Genoma Humano 16, 17, 71-105, 135-175.
Seoane, José Antonio (2003): “Ética, Derecho y datos personales”, Cuadernos de Derecho Público 19-20, 91-130.
Shickle, Darren (2006): “The consent problem within DNA biobanks”, Studies in the History and Philosophy of Biology and Biomedical Sciences, 37, 503-519. doi:10.1016/j.shpsc.2006.06.007
Simón, Pablo (2000): El consentimiento informado. Historia, teoría y práctica, Madrid, Triacastela.
Taylor, Sandra D. (2004): “Predictive genetic test decisions for Huntington’s disease: context, appraisal and new moral imperatives”, Social Science & Medicine, 58, 137-149. doi:10.1016/S0277-9536(03)00155-2
Thomas, Sandy M. (2004): “Society and ethics - the genetics of disease”, Current Opinion in Genetics & Development, 14, 287-291. doi:10.1016/j.gde.2004.04.014
Umerez, Jon (2006): “Habermas y la biotecnología. ¿Indisponibilidad frente a irrevocabilidad?”, en F. Martínez Man rique y L. M. Peris-Viñé (Eds.), Actas del V Congreso de la Sociedad de Lógica. Metodología y Filosofía de la Ciencia en España, Granada, SLMFCE, 457-461.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2008 Consejo Superior de Investigaciones Científicas (CSIC)
This work is licensed under a Creative Commons Attribution 4.0 International License.
© CSIC. Manuscripts published in both the printed and online versions of this Journal are the property of Consejo Superior de Investigaciones Científicas, and quoting this source is a requirement for any partial or full reproduction.All contents of this electronic edition, except where otherwise noted, are distributed under a “Creative Commons Attribution 4.0 International” (CC BY 4.0) License. You may read here the basic information and the legal text of the license. The indication of the CC BY 4.0 License must be expressly stated in this way when necessary.
Self-archiving in repositories, personal webpages or similar, of any version other than the published by the Editor, is not allowed.
