Research biobanking ethical and social issues between the protection of individual’s rights and communitarian perspective

Main Article Content

Mária Suleková, Dra.

Abstract




In the last decade, the establishment of organized biobanks (co- llections of biological samples and associated data) has grown at both the national and international level. The metaphor of the bank was questioned, as it recalls a lucrative scope and reduces 





a new field of biomedicine that could develop innovative me- thods for promotion of human health to the perspective of indivi- dual profit. Other analogies such as art collections, voluntary or- ganizations, libraries or repositories ("teca") were proposed as the primary function of these collections is an advance of resear- ch for public interest.


New strategies of diagnosis, prevention and therapy for vario- us illnesses are expected to be derived from studies that focus on the understanding of the contributions of genes, lifestyle and environment, to the development of complex diseases. However, at the same time, activities related to research biobanking carry significant ethical risks and arise for social concern. This paper after such a general examination focuses on the specific ethical and socio-ethical issues in this field. This involved topics such as public trust, informed consent, privacy, return of results, risk of genetic discrimination and social stigmatization, commercializa- tion, property and benefit sharing.


Furthermore, while analyzing these topics, two fundamental theoretical approaches in the ethics of biobanking were addres- sed: the protection of individual's rights perspective and the com- munitarian perspective. The central concern in pointing out this debate is to solve the problem of how biobanks should be organi- zed and managed between guarantees of individual interests and rights (like informed consent and privacy) on one hand and the realization of the common good (in terms of research progress and benefits for public health) on other. While one perspective risks being excessively paternalistic and procedural, the other can tend to be rhetoric, purely utilitarian or contractual. Finally, the article ends with an open-ended discussion by considering critical points of both frameworks, by referring to some particular "bridging concepts" aimed at balancing the excessive views, and by emphasizing the relevance of some socio-political challenges of current biobank research policy.







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How to Cite
Suleková, M. (2014). Research biobanking: ethical and social issues between the protection of individual’s rights and communitarian perspective. Medicina Y Ética, 25(3), 403–441. Retrieved from https://publicaciones.anahuac.mx/index.php/bioetica/article/view/716
Section
Articles
Author Biography

Mária Suleková, Dra., Catholic University of the Sacro Cuore of Rome

PhD in Research in Bioethics from the Institute of Bioethics, Faculty of Medicine and Surgery “A. Gemelli ”from the Catholic University of the Sacred Heart of Rome

References

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56 "Dictionary attacks" son un conjunto de técnicas de deciframiento en el campo del criptoanálisis y de computer security para “romper” un algoritmo o mecanis- mo de autentificación, buscando identificar la clave o password posibles.
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59 Interesante e innovadora resulta la iniciativa DataSHIELD, técnica que logra analizar los datos sin que estos dejen el lugar donde son conservados. Para más informaciones: http://www.p3gobservatory.org:8080/datashield/intro.htm
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70 “Un elemento aislado del cuerpo humano diversamente producido, mediante un procedimiento técnico, incluida la secuencia o la secuencia parcial de un gen, puede constituir una invención registrable, aún si la estructura de dicho elemento es idéntica a la de un elemento natural”. Direttiva 98/44/CE del Parlamento Euro- peo e del Consiglio del 6 luglio 1998 sulla protezione giuridica delle invenzioni bio- tecnologiche.
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73 Ibid.
74 PESSINA A. Il corpo non è proprietà. Avvenire 14.09.2012, p. 17.
75 Para profundizar: TALLACCHINI MC. Il corpo e le sue parti. L'allocazione giuridica dei materiali biologici umani. Medicina e Morale, 1998, 3: 499-544.
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79 FERIOLI, PICOZZI. La conservazione del materiale..., p. 563.
80 MACILOTTI M. Proprietà, informazione ed interessi nella disciplina delle bioban- che a fini di ricerca. Nuova giurisprudenza civile commentata 2008; II: 222-235.
81 HUMAN GENOM PROJECT (HUGO) ETHICS COMMITTEE. Statement on benefit-sha- ring (April 9, 2000), (acceso del 25.06.2013, en: http://mbrdb.nibio.go.jp/kibanOl/ downloadEN/HUGOStatement_on_Benefit_Sharing .htm).
82 PALAZZANI L. Biobanche: problemi e sfide per la bioetica ed il biodiritto. Relazio- ne tenuta al Convegno Biobanche: aspetti scientifici ed etico-giuridici a confronto. Milano (Istituto Auxiologico Italiano); 18.05.2012 (actas en curso de impresión).
83 Recientemente la Corte Suprema de los Estados Unidos ha emanado la sen- tencia según la cual es posible registrar el material genético producido sintética- mente, mientras no es posible hacerlo con los genes extraídos del cuerpo huma- no aislando el ADN. New York Times, 13.06.2013 (acceso del 25.06.2013, en: http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may- not-be-patented.html?ref=global-home&_r=0).
84 Como propuesta de JA Bovenberg en: BOVENBERG. One sample, One share..., pp. 81-94.

85 Para profundizar la cuestión de la propiedad intelectual, de los registros de marca y del acercamientos de open data sharing: DE ROBBIO A. Biobanche e pro- prietà intelettuale: commons o caveau? Bibliotime, 2010, 13 (3) (acceso del 25.06.2013, en: http://eprints.rclis.org/l5197/1/oda_biobanche_20101026.pdf).
86 Press release, 2002, UK Biobank website (en: http://www.wellcome.ac.uk/ doc_WTD002895.html) referido en LEVITT M. UK Biobank: model for public enga- gement. Genomics, Society and Policy 2005; 1: 378-391; CAULFIELD, KAYE. Broad consent..., pp. 85-100.
87 CHADWICK R, BERG K. Solidarity and equity: new ethical frameworks for genetic databases. Nature Rev Genet, 2001, 2: 318-321.
88 CAULFIELD, KAYE. Broad consent..., pp. 85-100.
89 HOFFMAN. Broadening..., p. 126.
90 BARBOUR V. UK Biobank: a project in search of protocol? The Lancet, 2003, 361 (9370): 1734-1738.
91 El pensamiento de M. Sutrop es referido en Beier K, Schnorrer S. The future of biobanking in Europe: searching for answers to the ethical and legal challenges of human tissue research, en BEIER K, SCHNORRER, HOPPE N ET AL. (curador). The ethical and legal regulation of human tissue and biobank research in europe. Pro- ceedings of the Tiss. EU Project. Universitätsverlag Göttingen, 2011, 131-138 (acce- so del 25.06.2013, en: http://webdoc.sub.gwdg.de/univerlag/20 llftiss_eu_book.pdf).
92 WMA. Dichiarazione di Helsinky..., art. 5.
93 Ha de notarse en este contexto que las recomendaciones de la Declaración de Helsinki (por ejemplo relativas al consentimiento) se refieren antes que nada al campo de la experimentación clínica, que incluye a los sujetos que están clara- mente orientados hacia estudios farmacológicos e intervencionistas. CAENAZZO L, TOZZO P, PEGORARO R. Biobanking research on oncological residual material: a framework between the rights of the individual and the interest of society. BMC Medical Ethics, 2013, 14:17.
94 BLACKSTONE W. Commentaries on the Laws of England. Oxford: Clarendon Press, 1765, 138 referido en CAULFIELD, KAYE. Broad consent..., pp. 85-100.
95 BEIER, SCHNORRER, HOPPE ET AL. (curador). The Ethical and Legal..., p. 148.
96 Para una ulterior profundización teórica de las dos perspectivas ver: CHRISTEN- SEN E. The re-emergence of the liberal-communitarian debate in bioethics: exerci- sing self-determination and participation in biomedical research. J Med Philos. 2012; 37(3): 255-276, doi: 10.1093/jmp/jhs012.
97 BEIER, SCHNORRER, HOPPE Y AL (curador). The Ethical and Legal..., p. 148.
98 BEIER K. Beyond the dichotomy of individualism and solidarity: participation in biobank research in Sweden and Norway en LENK CH. HOPPE N, BEIER K, WIESE- MANN C. Human tissue research. A European perspective on the ethical and legal challenges. Oxford-New York: Oxford University Press, 2011: 65-75.
99 WILLIAMS G. Bioethics and large-scale biobanking: individualistic ethics and co- llective projects. Genomics, Society and Policy, 2005, l (2): 50-66.
100 Ibid. "Here we can no longer maintain artificial divides between the ethical and the political, between individual rights and public goods".
101 DOUKAS DJ. BERG JW. The family covenant and genetic testing. American Jour- nal of Bioethics, 2001, l (3): 3-10 referido en WIDDOWS H. Constructing communal models of governance en WIDDOWS H, MULLEN C (curador). The governance of genetic injormation. Who decides? Cambridge: Cambridge University Press, 2009: 75-98.