Size matters: the ethical, legal, and social issues surrounding large-scale genetic biobank initiatives

Hoeyer, Klaus

doi:10.5324/nje.v21i2.1496

Cited by 28 publications

(28 citation statements)

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“…Although they have existed in some form for over 60 years, their recent surge in numbers, size, and prominence [1] has focused attention on the changing nature of biomedical research and relationships among investigators, research participants, and the organizations that fund and manage these entities [2-9]. This surge in numbers coincides with success in sequencing the human genome in 2003, the subsequent explosion of new bioinformatics technologies and developments in next-generation sequencing [10,11], and the vision of improved health through genomic medicine [12].…”

Section: Introductionmentioning

confidence: 99%

Characterizing biobank organizations in the U.S.: results from a national survey

et al. 2013

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BackgroundEffective translational biomedical research hinges on the operation of 'biobanks,' repositories that assemble, store, and manage collections of human specimens and related data. Some are established intentionally to address particular research needs; many, however, have arisen opportunistically, in a variety of settings and with a variety of expectations regarding their functions and longevity. Despite their rising prominence, little is known about how biobanks are organized and function beyond simple classification systems (government, academia, industry).MethodsIn 2012, we conducted the first national survey of biobanks in the U.S., collecting information on their origins, specimen collections, organizational structures, and market contexts and sustainability. From a list of 636 biobanks assembled through a multi-faceted search strategy, representatives from 456 U.S. biobanks were successfully recruited for a 30-minute online survey (72% response rate). Both closed and open-ended responses were analyzed using descriptive statistics.ResultsWhile nearly two-thirds of biobanks were established within the last decade, 17% have been in existence for over 20 years. Fifty-three percent listed research on a particular disease as the most important reason for establishment; 29% listed research generally. Other reasons included response to a grant or gift, and intent to centralize, integrate, or harmonize existing research structures. Biobank collections are extraordinarily diverse in number and types of specimens and in sources (often multiple) from which they are obtained, including from individuals, clinics or hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include postmortem specimens. Most biobanks are affiliated in one or multiple ways with other entities: 88% are part of at least one or more larger organizations (67% of these are academic, 23% hospitals, 13% research institutes). The majority of biobanks seem to fill a particular 'niche' within a larger organization or research area; a minority are concerned about competition for services, although many are worried about underutilization of specimens and long-term funding.ConclusionsEffective utilization of biobank collections and effective policies to govern their use will require understanding of the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.

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Section: Introductionmentioning

confidence: 99%

Characterizing biobank organizations in the U.S.: results from a national survey

et al. 2013

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“…Los biobancos han existido en alguna forma desde hace más de 60 años, pero su reciente aumento en el número, tamaño e importancia 24 , se ha dado especialmente por la naturaleza cambiante de la investigación biomédica, las relaciones entre los investigadores, los actores participantes en la investigación y las organizaciones que financian la investigación [25][26][27] . El incremento en número de los biobancos coincide con el éxito en la secuenciación del genoma humano en el año 2003, la posterior explosión de las nuevas tecnologías en bioinformática y la evolución de secuenciación de nueva generación 28 y la visión de mejorar la salud por medio de la medicina genómica 29 , por lo tanto, los descubrimientos pertinentes derivados de la investigación biomédica traslacional dependen en gran medida del funcionamiento de los biobancos.…”

Section: Relevancia De Los Biobancosunclassified

Biobanco: Herramienta fundamental para la investigación biomédica actual

Díaz¹,

Páez-Leal²,

Luna-Gonzalez³

et al. 2016

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RESUMENLa investigación biomédica enfocada a la preservación de la salud y manejo de la enfermedad requiere hoy del trabajo articulado bidireccional entre básicos y clínicos, lo cual ha generado una nueva tendencia, denominada investigación traslacional. Este tipo de investigación se fundamenta en poder brindar una atención en salud oportuna, pertinente, eficaz y personalizada, para lo cual se requieren muestras biológicas e información clínica asociada, garantizando a su vez seguridad, calidad y confidencialidad para los donantes. Promover la investigación traslacional y la aplicación de los avances del conocimiento y de la tecnología derivados de la investigación y la innovación, requiere del apoyo de infraestructuras de fácil acceso que faciliten la rápida demostración experimental de una hipótesis o la comprobación de un modelo simulado previamente. Dentro de las diversas plataformas biomédicas y de salud existentes, los Biobancos, en sus diferentes modalidades, se constituyen en una de las más atractivas plataformas a la hora de contribuir a establecer puentes entre la investigación básica y clínica, con la práctica asistencial. La necesidad de contar con muestras biológicas humanas de alta calidad y, al mismo tiempo, la obligación de preservar los derechos de los donantes, ha elevado la gestión de los Biobancos a la categoría de disciplina científico-técnica, con una complejidad particular que involucra múltiples aspectos entre los cuales se incluyen aspectos científicos, técnicos, éticos, jurídicos y sociales. Esta serie de artículos, que serán publicados en los diferentes números de la revista durante el 2016, tienen como objetivo hacer una revisión crítica de los aspectos más relevantes en torno a la gestión de los Biobancos con fines de investigación y proponer una serie de guías de manejo del material biológico humano a conservar las cuales se han desarrollado en el marco del Programa Cardiecol.

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“…Allen and Mcnamara 2011;Hoeyer 2002Hoeyer , 2004Hoeyer and Lynöe 2006) and in terms of governance and regulation of biobanks and biologicals stored there (e.g. Busby 2006;Gottweiss and Zatloukal 2007;Hoeyer 2012;Papaioannou 2012;Patra and Sleeboom-Faulkner 2009). In this article, I extend the focus of this body of literature from issues regarding the acquisition and maintenance of biological material to its restoration.…”

Section: Introductionmentioning

confidence: 99%

Suitable substances: how biobanks (re)store biologicals

Bärnreuther

2018

New Genetics and Society

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Biobanks connected to In Vitro Fertilization hospitals do not merely function as repositories for biologicals. They also contribute to the restoration of reproductive substances to distinct social environments. Cases of commercial gamete donation in India often entail the infringement of social boundaries, as the socioeconomic backgrounds of gamete donors and recipients diverge. In a highly stratified society, biobanks perform "relational work" in order to nevertheless enable the transaction of substances. The selection of donors, the secluded laboratory, medical protocols, bureaucratic procedures, policies of anonymity, and rhetorical devices all reconfigure intimate material provided by specific donors into standardized products and relatable entities, thereby augmenting their economic value. The fact that relational work is not only performed on substances but also on suppliers and biodata sheets invites more general reflections about notions of "the living" or "the biological" in biobanks around the world.

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Size matters: the ethical, legal, and social issues surrounding large-scale genetic biobank initiatives

Cited by 28 publications

References 84 publications

Characterizing biobank organizations in the U.S.: results from a national survey

Characterizing biobank organizations in the U.S.: results from a national survey

Biobanco: Herramienta fundamental para la investigación biomédica actual

Suitable substances: how biobanks (re)store biologicals

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