Journal articles on the topic 'Biobanca'
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Meškys, Edvinas. "BIOBANKŲ SAMPRATA IR STATUS QUO LIETUVOJE." Teisė 92 (February 11, 2015): 80–95. http://dx.doi.org/10.15388/teise.2014..3908.
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Šiame straipsnyje siekiama atskleisti žmogaus biobanko sampratą ir parodyti šios sampratos įvairiapusiškumą užsienio šalių praktikoje, dėl kurio dažnai atsiranda teisinių kliūčių bendrai plėtoti tarpvalstybinius ar tarptautinius mokslinius projektus, kurti europinį biobankų tinklą. Kartu bandoma palyginti biobanką su kitomis biologinių mėginių kolekcijomis ir nustatyti, koks biobanko apibrėžimas galėtų būti priimtinas Lietuvoje. Galiausiai, daug dėmesio straipsnyje skiriama atskirų Lietuvos Respublikos įstatymų analizei, siekiant įvertinti, ar esama teisinė aplinka sukuria pakankamą pagrindą kurti ir plėtoti specifinius mokslinius biobankus Lietuvoje. Šis straipsnis – įvadas į daug detalesnę, su moksliniais biobankais susijusių probleminių klausimų analizę.
This article aims to reveal the definition of human biobank and show the diversity of this definition in foreign countries‘ practice, which often creactes legal barriers for development of intercountry or international scintific research projects, creation of European biobanks‘ network. Additionally, this article aims to compare the biobank with other collections of biological materials and identify the most appropriate definition for Lithuania. Finally, considerable attention is paid for the analysis of separate laws of the Republic of Lithuania in order to evaluate if exsiting legal framework creates a sufficient ground for establishment and development of specific research biobanks in Lithuania. This article is a introduction to a more detailed analysis of the problematic aspects of research biobanks.
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Meškys, Edvinas. "TRADICINIO INFORMUOTO ASMENS SUTIKIMO PRITAIKYMO MOKSLINIAMS BIOBANKAMS LIETUVOJE GALIMYBĖS." Teisė 92 (February 11, 2015): 96–108. http://dx.doi.org/10.15388/teise.2014..3907.
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Šiame straipsnyje siekiama įvertinti medicinos praktikoje išvystyto informuoto asmens sutikimo pritaikymo problematiką mokslinių biobankų veikloje, tai yra, paimant, tvarkant ir atliekant tyrimus su iš žmogaus gauta biologine medžiaga (organais ar jų dalimis, audiniais, ląstelėmis ar jų komponentais), su šia medžiaga susijusia medicinine ar kita asmenį identifikuojančia informacija. Straipsnyje analizuojama, ar nežinant mokslinio tyrimo tikslo, jo trukmės ir galimų padarinių, bei galimo kito, nei buvo išreikštas sutikimas, panaudojimo tikslo asmuo gali būti laikomas tinkamai sutikęs dalyvauti biobanko tyrimuose. Šis klausimas yra ypač problemiškas analizuojant aktyviąją teisės žinoti apie savo sveikatą pusę, t. y. kai asmuo renkasi aktyvų domėjimąsi savo sveikata, nori gauti informacijos. Kartu sprendžiama, ar asmuo turi teisę autonomiškai prisiimti riziką gaudamas ribotą informaciją iš biobankų (tyrėjų), ir jeigu taip, tai kokiais teisiniais būdais būtų galima šių teisinių rizikų išvengti arba jas sumažinti.
This article aims to assess the problematic of the applicablity of the informed consent, which was developed in the clinical practice, for the practice of the research biobanks, that is, taking, managing and conducting research with human biological material (organs or its parts, tissues, cells or their components), linked medical data or other informacion, which identifies the person. This article examines whether the lack of knowledge about the research objectives, duration of the research projects and possible consequences, as well as possible other, than expressed by the consent, purpose of use of such material, allows us to deem that the person has duly agreed to participate in biobank research. This question is specifically problematical, when analyzing the actine side of the rigzt to know about self health, i.e., when the person chooses the active interest in his health, wants to get the information. It is also being analyzed whether the person has the right to autonomously take the risk of receiving limited information from biobanks, and, if so, what legal safeguards would allow to avoid these legal risks or reduce them.
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Veloza Cabrera, Luis Alberto, Carolina Wiesner Ceballos, Martha Lucía Serrano López, Nelsy Ruth Peñaranda Correa, and Antonio Huertas Salgado. "Consideraciones éticas y legales de los biobancos para investigación." Revista Colombiana de Bioética 5, no. 1 (November 19, 2015): 121. http://dx.doi.org/10.18270/rcb.v5i1.1287.
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<p> Un biobanco es una colección de muestras biológicas y datos asociados con fines diagnósticos, terapéuticos o de investigación. Las actividades llevadas a cabo por los bancos de muestras biológicas conllevan muchos dilemas éticos y legales, por lo que en el ámbito internacional existen diversas normas y recomendaciones establecidas para salvaguardar los derechos de los donantes. En Colombia, el Instituto Nacional de Cancerología considera prioritario la creación de un biobanco con fines de investigación. El propósito de este artículo es realizar una revisión de la literatura, internacional como nacional, sobre los aspectos éticos y legales relacionados con los biobancos para investigación científica. La adaptación de los requerimientos internacionales sería el primer paso para la implementación de los estándares éticos y legales de los biobancos en Colombia. Se hace necesario el establecimiento de regulaciones nacionales que controlen las actividades de dichos biobancos y de esta manera se contribuya a la participación activa de la sociedad colombiana.</p>
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Salokannel, Marjut, Heta Tarkkala, and Karoliina Snell. "Legacy samples in Finnish biobanks: social and legal issues related to the transfer of old sample collections into biobanks." Human Genetics 138, no. 11-12 (October 16, 2019): 1287–99. http://dx.doi.org/10.1007/s00439-019-02070-0.
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Abstract Biobank operations started officially in Finland in 2013 when the Biobank Act defining and regulating biobank operations came into force. Since then, ten biobanks have been established and they have started to collect new prospective samples with broad consent. The main corpus of biobank samples, however, consists of approximately 10 million “legacy samples”. These are old diagnostic or research samples that were transferred to biobanks in accordance with the Biobank Act. The focus of this article is on ambiguities concerning these legacy samples and their transfer in terms of legality, human rights, autonomy, and social sustainability. We analyse the Finnish biobank operations in the context of international regulation, such as the European Convention of Human Rights, the Oviedo Convention, European Charter of Fundamental Rights, the GDPR, and EU Clinical Trials Regulation, and show that the practice of using legacy samples is at times problematic in relation to this regulatory framework. We argue that the prevailing interpretations of these regulations as translated into the Finnish biobank practices undermine the autonomy of individuals by not giving individuals a right to consent or an actionable right to opt-out of the transfer of these legacy samples to the biobank. This is due to the fact that individuals are not given effective notification of such transfers. Thus, issues regarding the legal status of the biobank samples and the social sustainability of biobank operations remain a challenge for biobanks in Finland despite governmental efforts to create pioneering, comprehensive, and enabling legislation.
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Artene, Stefan-Alexandru, Marius Eugen Ciurea, Stefana Oana Purcaru, Daniela Elise Tache, Ligia Gabriela Tataranu, Mihaela Lupu, and Anica Dricu. "Biobanking in a Constantly Developing Medical World." Scientific World Journal 2013 (2013): 1–5. http://dx.doi.org/10.1155/2013/343275.
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Biobank is a very sophisticated system that consists of a programmed storage of biological material and corresponding data. Biobanks are created to be used in medical research, in clinical and translational medicine, and in healthcare. In the past 20 years, a large number of biobanks have been set up around the world, to support the modern research directions in medicine such as omix and personalized medicine. More recently, embryonic and adult stem cell banks have been developed. Stem cell banking was reported to be required for medical research as well as clinical transplant applications. The quality of the samples stored in a biobank is very important. The standardization is also important; the biological material stored in a biobank must be processed in a manner that allows compatibility with other biobanks that preserve samples in the same field. In this paper, we review some issues related to biobanks purposes, quality, harmonization, and their financial and ethical aspects.
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Verlinden, Michiel, Herman Nys, Nadine Ectors, and Isabelle Huys. "Access to Biobanks: Harmonization Across Biobank Initiatives." Biopreservation and Biobanking 12, no. 6 (December 2014): 415–22. http://dx.doi.org/10.1089/bio.2014.0034.
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Kryukova, E. S., and V. D. Ruzanova. "Legal regime of biobanks in domestic legislation." Juridical Journal of Samara University 7, no. 1 (July 7, 2021): 57–62. http://dx.doi.org/10.18287/2542-047x-2021-7-1-57-62.
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In the article on the basis of a critical analysis of the existing positions in the doctrine the concept of a biobank as an object of rights was formulated. At the same time, it is proposed to distinguish between the organizations in charge of biobanks and the collections themselves. It was concluded that biobank is a complex object, which is differentiated unity, since its elements, on the one hand, are autonomous, but on the other hand, are interconnected and interdependent. It is emphasized that the formation of a single legal regime of biobanks is complicated by the substantive heterogeneity of this object and the diversity of its elements. Taking into account the experience of European States in this field of legal regulation and scientific views, the idea of publishing as a basic special law on biobanks, which should establish their legal regime as an object of rights and rules for organizations under the jurisdiction of biobanks, was supported. The need for organizations working with biobanks to provide unprecedented protection is proven. The structure of the legal regime of biobank has been determined and as its most important component a group of rules on obtaining the consent of the holder for the further use of biobanks and data derived from them has been identified. The feasibility of introducing more diverse forms of consent to the circulation of the contents of biobanks is justified.
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Kaye, Jane, Jessica Bell, Linda Briceno, and Colin Mitchell. "Biobank Report: United Kingdom." Journal of Law, Medicine & Ethics 44, no. 1 (2016): 96–105. http://dx.doi.org/10.1177/1073110516644202.
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The United Kingdom is a leader in genomics research, and the presence of numerous types of biobanks and the linking of health data and research within the UK evidences the importance of biobank-based research in the UK. There is no biobank-specific law in the UK and research on biobank materials is governed by a confusing set of statutory law, common law, regulations, and guidance documents. Several layers of applicable law, from European to local, further complicate an understanding of privacy protections. Finally, biobanks frequently contain data in addition to the samples; the legal framework in the UK generally differentiates between data and samples and the form of the data affects the applicability of legal provisions. Biobanks must be licensed by the Human Tissue Authority; certain projects must be reviewed by Research Ethics Committees, and all projects are encouraged to be reviewed by them. Data Access Committees in biobanks are also common in the UK. While this confusing array of legal provisions leaves privacy protections in biobanking somewhat unclear, changes at the EU level may contribute to harmonization of approaches to privacy.
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Cervo, Silvia, Paolo De Paoli, Tiziana Perin, Vincenzo Canzonieri, and Agostino Steffan. "Cost-Effective Organization of an Institutional Human Cancer Biobank in a Clinical Setting: CRO-Biobank Experience Toward Harmonization." International Journal of Biological Markers 30, no. 2 (April 2015): 243–51. http://dx.doi.org/10.5301/jbm.5000138.
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This report describes the organization of the Biobank of the CRO Aviano National Cancer Institute, Aviano (CRO- Biobank), Italy, implemented as a structured facility dedicated to collecting human biological samples. It describes a particular disease-specific biobank and the integration of a research biobank in a clinical setting. The CRO-Biobank's mission is rooted in supporting and implementing cancer research, with its main focus on optimizing technical and quality processes, while also investigating ethical, legal and IT topics. The CRO-Biobank has implemented processes aimed at guaranteeing the safety of the providers, protecting patient privacy and ensuring both the traceability and quality of its samples. Our 8 years of experience allow us to offer insights and useful suggestions that may solve theoretical and practical issues that can arise when starting up new biobanks or developing existing biobanks further.
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Jiménez-Gómez, Giovanny, María L. Luna-González, Silvia Becerra-Bayona, Norma Serrano Díaz, Elizabeth Guio-Mahecha, and René Lobo-Quintero. "Aplicación de las TIC para monitoreo remoto de biobancos con fines de investigación." Revista Facultad de Ciencias de la Salud UDES 4, no. 2.S1 (June 30, 2017): 18. http://dx.doi.org/10.20320/rfcsudes.v4i2.s1.r05.
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Introducción. Los biobancos se encargan de gestionar colecciones de material biológico (MB) con fines diagnósticos o de investigación biomédica, por lo cual deben estar organizados como unidades técnicas con criterios de calidad, orden y destino. La Universidad Autónoma de Bucaramanga cuenta con un biobanco formado por ocho ultracongeladores que contienen MB colectado en proyectos de investigación y que requiere de supervisión para garantizar un entorno óptimo. Objetivo. Diseñar y validar un sistema de monitoreo para un biobanco utilizando hardware libre que vigile de manera constante las condiciones de almacenamiento del MB. Materiales y métodos. Se llevó a cabo la revisión bibliográfica (biobancos, sistemas de monitoreo e internet de las cosas-IoT) para posteriormente recopilar los requerimientos funcionales y no funcionales del biobanco y definir la tecnología de hardware libre a emplear para realizar el diseño y la validación del prototipo de monitoreo. Resultados. Se seleccionaron los sensores para capturar las variables ambientales y físicas de temperatura interna y tensión de entrada del ultracongelador, temperatura y humedad del ambiente, inundación del área y detección de sonido de alarmas emitidas por ultracongeladores. A continuación, se ensamblaron en el hardware libre (Arduino) y se crearon las variables de conexión y captura de los datos enviados por los sensores al software para IoT (ThingSpeak). Conclusiones. El monitoreo remoto de biobancos mediante el uso de tecnologías libres, permite garantizar la integridad del MB almacenado a un menor costo, y por tanto, mayor accesibilidad a este recurso.
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De Palma, Giuseppe, Giulia Bolondi, Antonio Tufaro, Giuseppe Pelagio, Giuseppe Brando, Daniela Vitale, and Angelo Virgilio Paradiso. "Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari." Cancers 14, no. 14 (July 16, 2022): 3460. http://dx.doi.org/10.3390/cancers14143460.
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Although research biobanks are among the most promising tools to fight disease and improve public health, there are a range of risks biobanks may face that mainly need to be assessed in an attempt to be relieved. We conducted a strategic insurance review of an institutional cancer biobank with the aim of both identifying the insurable risks of our own Biobank and gathering useful evidence of primary exposure to insurable risks. In this practical scenario, risks have been outlined and categorized into inherent and residual risks, along with their possible impact on biobank maintenance. Results at the Biobank of the Cancer Institute of Bari showed evidence of potentially significant and intrinsic risk due to highly relevant threats, along with already implemented improvements that significantly reduce risks to a range of relative acceptability.
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Zalaf, Bianca Rapini, Mayara Bringel, Paula Karine Jorge, Bárbara de Oliveira, Kim Tanabe, Carlos Ferreira Santos, Rodrigo Cardoso Oliveira, et al. "A Biobank of Stem Cells of Human Exfoliated Deciduous Teeth: Overview of Applications and Developments in Brazil." Cells Tissues Organs 209, no. 1 (2020): 37–42. http://dx.doi.org/10.1159/000506677.
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A biobank is an organized collection of biological human material and its associated information stored for research according to regulations under institutional responsibility, without commercial purposes, being a mandatory and strategical activity for research, regenerative medicine, and innovation. Stem cells have largely been employed in research and frequently stored in biobanks, which have been used as an essential source of biological materials. Stem cells of human exfoliated deciduous teeth (SHED) are stem cells which have a high multipotency and can be easily obtained. Besides, this extremely accessible tissue has advantages with respect to storage, as the SHED obtained in childhood can be used in later life, which implies the necessity for the creation and regulation of biobanks. The proper planning for the creation of a biobank includes knowledge of the material types to be stored, requirements regarding handling and storage conditions, storage time, and room for the number of samples. Thus, this study aimed to establish an overview of the development of a SHED biobank. Ethical and legal standardization, current applications, specific orientations, and challenges for the implementation of a SHED biobank were discussed. Through this overview, we hope to encourage further studies to use SHED biobanks.
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Karaman, Paola Andrea Paz. "BIOBANCOS: CASOS DE ESTUDIO Y LECCIONES PARA COLOMBIA." Revista de Direito Sanitário 16, no. 3 (December 30, 2015): 102. http://dx.doi.org/10.11606/issn.2316-9044.v16i3p102-121.
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En este artículo se describen a partir de dos casos, el biobanco de Islandia y el de Estonia, los elementos característicos de cada biobanco y las condiciones necesarias para su creación. Igualmente se analizan el interés político, médico y económico vinculado a los biobancos en el marco de los derechos individuales y el Estado. Posteriormente se analiza la iniciativa de Proyecto de Ley que pretendía crear el primer banco de ADN financiado por el Estado colombiano, sus carencias y repercusiones en la sociedad colombiana.
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McInnes, Gregory, Yosuke Tanigawa, Chris DeBoever, Adam Lavertu, Julia Eve Olivieri, Matthew Aguirre, and Manuel A. Rivas. "Global Biobank Engine: enabling genotype-phenotype browsing for biobank summary statistics." Bioinformatics 35, no. 14 (December 5, 2018): 2495–97. http://dx.doi.org/10.1093/bioinformatics/bty999.
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Abstract Summary Large biobanks linking phenotype to genotype have led to an explosion of genetic association studies across a wide range of phenotypes. Sharing the knowledge generated by these resources with the scientific community remains a challenge due to patient privacy and the vast amount of data. Here, we present Global Biobank Engine (GBE), a web-based tool that enables exploration of the relationship between genotype and phenotype in biobank cohorts, such as the UK Biobank. GBE supports browsing for results from genome-wide association studies, phenome-wide association studies, gene-based tests and genetic correlation between phenotypes. We envision GBE as a platform that facilitates the dissemination of summary statistics from biobanks to the scientific and clinical communities. Availability and implementation GBE currently hosts data from the UK Biobank and can be found freely available at biobankengine.stanford.edu.
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Hartung, Mara Lena, Ronny Baber, Esther Herpel, Cornelia Specht, Daniel Peer Brucker, Anne Schoneberg, Theresa Winter, and Sara Yasemin Nussbeck. "Harmonization of Biobank Education for Biobank Technicians: Identification of Learning Objectives." BioTech 10, no. 2 (April 14, 2021): 7. http://dx.doi.org/10.3390/biotech10020007.
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The quality of biospecimens stored in a biobank depends tremendously on the technical personnel responsible for processing, storage, and release of biospecimens. Adequate training of these biobank employees would allow harmonization of correct sample handling and thus ensure a high and comparable quality of samples across biobank locations. However, in Germany there are no specific training opportunities for technical biobank staff. To understand the educational needs of the technical personnel a web-based survey was sent to all national biobanks via established e-mail registers. In total, 79 biobank employees completed the survey, including 43 technicians. The majority of the participating technical personnel stated that they had worked in a biobank for less than three years and had never participated in an advanced training. Three-quarters of the technicians indicated that they were not able to understand English content instantly. Based on these results and the results of a workshop with 16 biobank technicians, 41 learning objectives were formulated. These learning objectives can be used as a basis for advanced training programs for technical personnel in biobanks. Setting up courses based on the identified learning objectives for this group of biobank staff could contribute to harmonization and sustainability of biospecimen quality.
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Aquilante, Christina L., David P. Kao, Katy E. Trinkley, Chen-Tan Lin, Kristy R. Crooks, Emily C. Hearst, Steven J. Hess, et al. "Clinical implementation of pharmacogenomics via a health system-wide research biobank: the University of Colorado experience." Pharmacogenomics 21, no. 6 (April 2020): 375–86. http://dx.doi.org/10.2217/pgs-2020-0007.
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In recent years, the genomics community has witnessed the growth of large research biobanks, which collect DNA samples for research purposes. Depending on how and where the samples are genotyped, biobanks also offer the potential opportunity to return actionable genomic results to the clinical setting. We developed a preemptive clinical pharmacogenomic implementation initiative via a health system-wide research biobank at the University of Colorado. Here, we describe how preemptive return of clinical pharmacogenomic results via a research biobank is feasible, particularly when coupled with strong institutional support to maximize the impact and efficiency of biobank resources, a multidisciplinary implementation team, automated clinical decision support tools, and proactive strategies to engage stakeholders early in the clinical decision support tool development process.
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Shekhovtsov, Volodymyr A., and Johann Eder. "Metadata Quality for Biobanks." Applied Sciences 12, no. 19 (September 23, 2022): 9578. http://dx.doi.org/10.3390/app12199578.
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The mission of biobanks is to provide biological material and data for medical research. Reproducible medical studies of high quality require material and data with established quality. Metadata, defined as data that provides information about other data, represents the content of biobank collections, particularly which data accompanies the stored samples and which quality the available data features. The quality of biobank metadata themselves, however, is currently neither properly defined nor investigated in depth. We list the properties of biobanks that are most important for metadata quality management and emphasize both the role of biobanks as data brokers, which are responsible not for the quality of the data itself but for the quality of its representation, and the importance of supporting the search for biobank collections when the sample data is not accessible. Based on an intensive review of metadata definitions and definitions of quality characteristics, we establish clear definitions of metadata quality attributes and their metrics in a design science approach. In particular, we discuss the quality measures accuracy, completeness, coverage, consistency, timeliness, provenance, reliability, accessibility, and conformance to expectations together with their respective metrics. These definitions are intended as a foundation for establishing metadata quality management systems for biobanks.
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Shickle, Darren, Marcus Griffin, and Karen El-Arifi. "Inter- and Intra-Biobank Networks: Classification of Biobanks." Pathobiology 77, no. 4 (2010): 181–90. http://dx.doi.org/10.1159/000292651.
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Aleni, Chiara, Carmela Rinaldi, Valentina Bettio, Eleonora Mazzucco, Annamaria Antona, Cristina Meini, Emiliano Loria, et al. "Public Attitude towards Biobanking: An Italian University Survey." International Journal of Environmental Research and Public Health 19, no. 20 (October 11, 2022): 13041. http://dx.doi.org/10.3390/ijerph192013041.
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Biobanks have established a critical role in biomedical research by collecting, preserving, organizing, and disseminating biospecimens and related health data, contributing to precision medicine development. Participation in biobanks is influenced by several factors, such as trust in institutions and scientists, knowledge about biobanking, and the consideration of benefit sharing. Understanding public attitudes, fears, and concerns toward biobanking is fundamental to designing targeted interventions to increase trust towards biobanks. The aim of our study was to investigate the level of knowledge and perception of biobanks in students and personnel of the University of Piemonte Orientale. An online questionnaire was designed and administered via e-mail. A total of 17,758 UPO personnel and students were invited to participate in the survey, and 1521 (9.3%) subjects completed the survey. The results showed that 65.0% of the participants were aware of the term “biobank” and knew what the activity of a biobank was, and 76.3% of subjects were willing to provide biospecimens to a research biobank, whereas 67.3% of the respondents were willing to contribute, in addition to biospecimens, their health and lifestyle data. Concerns were raised about the confidentiality of the information (25.6%) and the commercial use of the samples (25.0%). In conclusion, participants were aware of the role that biobanks play in research and were eager to participate for the sake of furthering scientific research. Still, several concerns need to be addressed regarding the confidentiality of the data along with the commercial use of the samples and associated data.
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Antonova, N. A., K. Y. Eritsyan, and L. A. Tsvetkova. "Attitudes towards Biobank Donation Among University Community." Social Psychology and Society 10, no. 1 (2019): 169–81. http://dx.doi.org/10.17759/sps.2019100110.
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Worldwide significant efforts are invested in building biobanks—specialized facilities for storing biological materials for research and medical purposes. The successful functioning of biobanks depends directly on people’s willingness to donate their biological materials. Fragmentary empirical studies of people’s attitudes toward donations to biobanks have been undertaken in Russia. The goal of this study was to measure at titudes toward biobank donation among Russians population and to evaluate potential sociopsychological factors that play a role in a person’s readiness to become a donor. Data from 542 students and 254 scientific staff at St. Petersburg State University were collected from group-administered paper-and-pencil and online surveys respectively. Both students (74%) and scientific staff (52%) indicated a relatively high level of readiness to become biobank donors. Regression analysis showed that refusal to be a biobahk donor was correlated significantly with being university scientific staff vs. students, no previous awareness about biobank, need for relative’s or friend’s opinion before decision making, presence of payment for donation and type of requested biological material.
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Soini, Sirpa. "Biobanks as a Central Part of the Finnish Growth and Genomic Strategies: How to Balance Privacy in an Innovation Ecosystem?" Journal of Law, Medicine & Ethics 44, no. 1 (2016): 24–34. http://dx.doi.org/10.1177/1073110516644187.
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Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research.
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Dallari, Sueli Gandolfi, Felipe Angel Bocchi Castellaro, and Iara Coelho Zito Guerriero. "Biobanking and Privacy Law in Brazil." Journal of Law, Medicine & Ethics 43, no. 4 (2015): 714–25. http://dx.doi.org/10.1111/jlme.12314.
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Recent scientific and technological developments have promoted the emergence of biobanks on a population scale. Although the storage of human biological material has taken place for a long time, it is only recently that biobanks have acquired a broader scientific significance, especially for genomic research. The increase in biobanks creates many ethical dilemmas, such as the protection of privacy, and creates the need for a new regulatory framework, which must enable the sustainable development of biobanks while also protecting the rights of research subjects and biobank participants.
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Quinn, Carmel M., Mamta Porwal, Nicola S. Meagher, Anusha Hettiaratchi, Carl Power, Jitendra Jonnaggadala, Sue McCullough, et al. "Moving with the Times: The Health Science Alliance (HSA) Biobank, Pathway to Sustainability." Biomarker Insights 16 (January 2021): 117727192110057. http://dx.doi.org/10.1177/11772719211005745.
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Human biobanks are recognised as vital components of translational research infrastructure. With the growth in personalised and precision medicine, and the associated expansion of biomarkers and novel therapeutics under development, it is critical that researchers can access a strong collection of patient biospecimens, annotated with clinical data. Biobanks globally are undertaking transformation of their operating models in response to changing research needs; transition from a ‘classic’ model representing a largely retrospective collection of pre-defined specimens to a more targeted, prospective collection model, although there remains a research need for both models to co-exist. Here we introduce the Health Science Alliance (HSA) Biobank, established in 2012 as a classic biobank, now transitioning to a hybrid operational model. Some of the past and current challenges encountered are discussed including clinical annotation, specimen utilisation and biobank sustainability, along with the measures the HSA Biobank is taking to address these challenges. We describe new directions being explored, going beyond traditional specimen collection into areas involving bioimages, microbiota and live cell culture. The HSA Biobank is working in collaboration with clinicians, pathologists and researchers, piloting a sustainable, robust platform with the potential to integrate future needs.
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Kinkorová, Judita, Ondřej Topolčan, and Radek Kučera. "Informed Consent in the Newly Established Biobank." International Journal of Environmental Research and Public Health 16, no. 20 (October 16, 2019): 3943. http://dx.doi.org/10.3390/ijerph16203943.
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Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank informed consent forms differs between biobank-related institutions, national biobanks, between EU states, and to find the optimal informed consent requires one to fulfil national and international laws and regulations. The Biobank in Pilsen, Czech Republic was officially opened on April the 20th 2017 as a hospital-integrated biobank, and the informed consent was one of the essential documents that had to be ready prior the opening. The process of formulating informed consent corresponding with institutional, national, and international rules and laws to share the experience, to present the challenges, and to demonstrate the national dissimilarity are tasks of the article.
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Lazareva, Tatyana E., Yury A. Barbitoff, Anton I. Changalidis, Alexander A. Tkachenko, Evgeniia M. Maksiutenko, Yulia A. Nasykhova, and Andrey S. Glotov. "Biobanking as a Tool for Genomic Research: From Allele Frequencies to Cross-Ancestry Association Studies." Journal of Personalized Medicine 12, no. 12 (December 9, 2022): 2040. http://dx.doi.org/10.3390/jpm12122040.
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In recent years, great advances have been made in the field of collection, storage, and analysis of biological samples. Large collections of samples, biobanks, have been established in many countries. Biobanks typically collect large amounts of biological samples and associated clinical information; the largest collections include over a million samples. In this review, we summarize the main directions in which biobanks aid medical genetics and genomic research, from providing reference allele frequency information to allowing large-scale cross-ancestry meta-analyses. The largest biobanks greatly vary in the size of the collection, and the amount of available phenotype and genotype data. Nevertheless, all of them are extensively used in genomics, providing a rich resource for genome-wide association analysis, genetic epidemiology, and statistical research into the structure, function, and evolution of the human genome. Recently, multiple research efforts were based on trans-biobank data integration, which increases sample size and allows for the identification of robust genetic associations. We provide prominent examples of such data integration and discuss important caveats which have to be taken into account in trans-biobank research.
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Barcan, Edmond, Stefan-Alexandru Artene, and Anica Dricu. "BIOBANKS. ASSOCIATED RISKS AND BENEFITS." Medico Oncology 1, no. 1 (May 18, 2021): 61–69. http://dx.doi.org/10.52701/monc.2020.v1i1.11.
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Biobanks are repositories of human organic material, that have an important role in the clinic. The World Health Organization (WHO) and the Global Health Ethics Unit have a great contribution considering the ideology of a well-functioning biobank. At the European Union, the functioning of biobanks is strictly regulated and research is being sustained by programs financed at a community level. The administration of biobanks brings both advantages and risks socially. To prevent these, international standards have been implemented for biobanks. In the research domain but also in the public health domain, an analysis in accordance with the legal framework must be considered in order to preserve the well-functioning of biobanks.
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Dwianingsih, Ery Kus, Junaedy Yunus, Lutfan Lazuardi, Amirah Ellyza Wahdi, Aulia Fitri Rhamadianti, Florentina Linda, Sunandar Hariyanto, and Jajah Fachiroh. "Building a Biobank Network for Health Research in Indonesia." Open Access Macedonian Journal of Medical Sciences 10, A (March 21, 2022): 1067–73. http://dx.doi.org/10.3889/oamjms.2022.8875.
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BACKGROUND: Biobanks play an essential role in the development of personalized medicine since they collect large numbers of high-quality biomaterials corresponding to clinical data. Despite its extensive population diversity, research institutions in Indonesia have indicated less awareness regarding biobanking for research practices. AIM: The journey to harmonize the knowledge and understanding of biobanks for health research and the development of the network in Indonesia has been summarized in this article. METHODS: To build a national biobank network, in 2015 the Faculty of Medicine, Public Health and Nursing, UGM held the first national biobank network meeting in Indonesia. Follow-up meetings were then held to identify challenges and constraints faced by the network. Five annual national workshops (2015–2019) have been held. RESULTS: Four working groups (WG) were formed to effectively coordinate the network, addressing the infrastructure and Laboratory Information Management System (WG 1), SOP and Best Practices (WG 2), Training and Education and Legal (WG 3), and Ethical and Social Issues (WG 4). CONCLUSION: The formation of a national biobank network in Indonesia is based on the hope for multi-institutional collaboration to mainly foster the development of biobanks for health research with best available practices and provide a central hub of coordination.
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Borisova, A. L., M. S. Pokrovskaya, A. N. Meshkov, V. A. Metelskaya, A. M. Shatalova, and O. M. Drapkina. "ISO 20387 biobanking standard. Analysis of requirements and experience of implementation." Russian Clinical Laboratory Diagnostics 65, no. 9 (September 16, 2020): 587–92. http://dx.doi.org/10.18821/0869-2084-2020-65-9-587-592.
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Currently one of the most important problems facing biobanking specialists is the standardization of biobanks operation. Close attention is paid to this issue by international biobanking organizations, such as ISBER and BBMRI-ERIC, which develop regulatory documentation in this area. The article provides examples of standardization tools - implementation of the ISO 9001 quality standard and ISBER Best Practices. General information about the development, scope, and structure of the ISO 20387 standard is provided. The standard does not provide ready-made solutions and does not contain specific requirements for storage temperature or biosamples processing in biobanks, allowing each biobank to adapt its own management system to existing conditions and needs. The standard contains requirements for both the organization of the biobanking and the supporting processes - personnel competence; requirements for biological safety; infrastructure management, including equipment used by the biobank, environmental parameters that affect the storage of biomaterial. The standard contains requirements for the quality management system of biobank, as a necessary element of the organization of any biorepository. At the initiative of the Russian National Association of biobanks and biobanking specialists (NASBIO), development of the Russian standard GOST R ISO 20387 «Biotechnology. Collection and storage of biological samples in biobanks. General requirements» is included in the plan of the National Standardization Program for 2020 by order of Rosstandart No. 2612 of 11/01/2019. Implementing quality standards is a long and painstaking process that requires the involvement of all employees and certain resources. However, the effectiveness of strict compliance exceeds the cost of developing, implementing and maintaining management systems, as it significantly increases the confidence of researchers in the work of biobanks, guarantees high quality of biospecimens and associated data, and creates opportunities for cooperation, both at the national and international level, based on the application of common quality standards in the work.
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Pereira, Alexandre C., Isabela M. Bensenor, Ligia M. Fedeli, Cristina Castilhos, Pedro G. Vidigal, Viviane Maniero, Claudia M. Leite, et al. "Delineamento e implementacao do biobanco do ELSA-Brasil: estudo prospectivo na populacao brasileira." Revista de Saúde Pública 47, suppl 2 (June 2013): 72–78. http://dx.doi.org/10.1590/s0034-8910.2013047003822.
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O Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) é uma coorte prospectiva multicêntrica de funcionários públicos delineada para avaliar os determinantes das doenças crônicas, principalmente a doença cardiovascular e o diabetes tipo 2. Neste artigo são descritos os principais pontos do delineamento e implementação do projeto do biobanco do ELSA-Brasil. São detalhados aspectos econômicos, políticos, logísticos e tecnológicos do estudo. O artigo também discute o protocolo final de estocagem de material biológico e as instalações implementadas para atingir esse objetivo. O processo de delineamento e implementação do biobanco do ELSA-Brasil durou três anos. Tanto os biobancos centrais quanto os locais foram constituídos de acordo com as melhores práticas de estocagem de material biológico, usando soluções tecnológicas diferentes para as diferentes necessidades previstas no estudo.
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Riso, Brígida. "“Not Storing the Samples It’s Certainly Not a Good Service for Patients”: Constructing the Biobank as a Health Place." Societies 12, no. 4 (August 6, 2022): 113. http://dx.doi.org/10.3390/soc12040113.
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Biobanks have been established from the beginning of the millennium as relevant infrastructures to support biomedical research. These repositories have also transformed the paradigm of collecting and storing samples and associated clinical data, moving these practices from the healthcare services and research laboratories to dedicated services. In Portugal, the establishment of biobanks is happening in the absence of a specific legal framework, turning it difficult to fully understand the scope of their action. This ethnographic research explored how establishing a biobank challenges the dynamics between healthcare and biomedical research. The ethnography intended to follow the path of biological samples from the hospital, where they were collected, to the biobank in a research institute, where they were stored. Findings suggest that although the nature of the biobank’s technical work seemed to inscribe it as a research-oriented setting, the biobank’s daily work was performed through symbolic action in the logic of care. Biobank staff constantly recalled the human nature of the samples, and they built complex illness narratives of each sample, promoting a connection with the absent donor. These practices were crucial to constructing the biobank as a health place, one that was designed to be life-saving in the near future.
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Vergès, Claude, María Angélica Sotomayor Saavedra, Patricia Sorokin, and Luis Manuel López Dávila. "Propuestas para “democratizar” los beneficios de los biobancos en América Latina." Revista Grafía- Cuaderno de trabajo de los profesores de la Facultad de Ciencias Humanas. Universidad Autónoma de Colombia 12, no. 2 (July 18, 2015): 50. http://dx.doi.org/10.26564/16926250.547.
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ResumenEl desarrollo de biobancos conlleva diversas interrogantes. Nuestro objetivo se circunscribe a cuestiones de confidencialidad y confianza pública en la ciencia y las instituciones. Un problema actual y acuciante en investigaciones biomédicas transnacionales, es la recolección de muestras para almacenamiento y exportación con consentimientos abiertos, con riesgo de violación de la privacidad personal. La necesidad de contar con biobancos para investigación, de proteger el reparto de beneficios de la investigación y la participación de las minorías étnicas presentes en América Latina, nos lleva a proponer una democratización de los biobancos sobre la base de la estructura de Derechos Humanos de la Región, representada por el Pacto de San José de Costa Rica.Palabras clave: Democratizar, biobanco, privacidad, confidencialidad, datos sensibles, muestras biológicas, investigaciones biomédicas transnacionales, dignidad.***************************************************Proposal to “democratize” the benefits of bio-banks in Latin AmericaAbstractThe development of bio-banks carries several questions. Our objective is delimited to confidentiality and public trust issues regarding science and institutions. A current and acute problem in bio-medical international research is the collection of samples for storage and exportation with open consent, with risk of violation of personal privacy. The need to count on research bio-banks, to protect the distribution of research benefits and assuring the participation of Latin American ethnic minorities take us to propose the “democratization” of bio-banks based on the Human rights structure of the region, represented by the Pact of San Jose, Costa Rica. Key words: democratize, bio-bank, privacy, confidentiality, sensitive data, biological samples, transnational biomedical research, dignity.***************************************************Propostas para democratizar os benefícios dos biobancos em América LatinaResumoO desenvolvimento dos biobancos implica diversos interrogantes. Nosso objetivo se circunscreve a questões de confidencialidade e confiança pública na ciência e nas instituições. Um problema atual e urgente nas investigações biomédicas transnacionais é a coleta de mostras para armazenamento e exportação com consentimentos abertos, com riscos de violação de privacidade pessoal. A necessidade de contar com biobancos para investigação, de proteger o reparto de benefícios da pesquisa e a participação das minorias étnicas presentes na América Latina nos leva a propor uma democratização dos biobancos sobre a base da estrutura dos direitos humanos da região, representada pelo Pacto de San José de Costa Rica. Palavras chave: Democratizar, biobanco, privacidade, confidencialidade, dados sensíveis, amostras biológicas, investigações biomédicas transnacionais, dignidade.
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Capocasa, Marco, Paolo Anagnostou, Flavio D’Abramo, Giulia Matteucci, Valentina Dominici, Giovanni Destro Bisol, and Fabrizio Rufo. "Samples and data accessibility in research biobanks: an explorative survey." PeerJ 4 (February 25, 2016): e1613. http://dx.doi.org/10.7717/peerj.1613.
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Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact, making bio-resources promptly accessible to everybody may increase the benefits for society. Furthermore, optimizing their use and ensuring their quality will promote scientific creativity and, in general, contribute to the progress of bio-medical research. Although this has become a rather common belief, several laboratories are still secretive and continue to withhold samples and data. In this study, we conducted a questionnaire-based survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii) the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate.
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Pokrovskaya, M. S., A. L. Borisova, O. V. Sivakova, V. A. Metelskaya, A. N. Meshkov, A. M. Shatalova, and O. M. Drapkina. "QUALITY MANAGEMENT IN BIOBANK. WORLD TENDENCIES AND EXPERIENCE OF BIOBANK OF FSI «NMRC FOR PREVENTIVE MEDICINE» OF THE MINISTRY OF HEALTHCARE OF RUSSIA." Russian Clinical Laboratory Diagnostics 64, no. 6 (October 7, 2019): 380–84. http://dx.doi.org/10.18821/0869-2084-2019-64-6-380-384.
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This paper provides several definitions of the term “biobank”; a list of standards developed by the International Organization for Standardization (ISO) applicable to the activities of biobanks; analyzes the legal and ethical requirements; the Russian legal framework in the field of biobanking, the best international practices and recommendations; describes the experience of the development and implementation of quality management systems according to ISO 9001 in Biobanks established in different countries, and the experience of the Bank of Biological Material of the National Medical Research Center for Preventive Medicine of the Ministry of Healthcare of Russia. The ISO 20387 Biobanking Standard, released in August 2018, combined the knowledge and experience of specialists from around the world and defined the general requirements that must be fulfilled by biobanks and repositories wishing to guarantee their customers the high quality of the preanalytical stage of scientific research, biological samples and associated data. In 2019, the Russian version of this standard is expected. Documents of the quality management system provide the reproducibility of activities on the main storage processes and facilitates the process of incorporating a new employee; conducting internal and external audits; Biobank knowledge management - continuous staff education. The introduction of an effective quality management system into biobank activity warrants the high quality of biological samples, the standardized pre-analytical stage, reliable, regulated long-term storage of biomaterial and related information for use in research purposes today and in future.
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Jahns, Roland, Jörg Geiger, Irene Schlünder, Daniel Strech, Matthias Brumhard, and Sebastian Graf von Kielmansegg. "Broad donor consent for human biobanks in Germany and Europe: a strategy to facilitate cross-border sharing and exchange of human biological materials and related data." Journal of Laboratory Medicine 43, no. 6 (December 18, 2019): 291–99. http://dx.doi.org/10.1515/labmed-2017-0064.
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Abstract Background Human biobanks are generally recognized as essential resources for effective biomedical research. All over the world biosamples and data from human subjects are collected in large biobanks. The biological material is stored long term for current and future (undetermined) research issues, which often require cross-border exchange of biosamples and related data. Content Commonly, the informed consent for research on human biospecimen is intended to cover only defined, specific research objectives. In June 2016, the biobank Task-Force of the Working Party of the German Medical Ethics Committees (WP-GMEC) updated its template for the broad use of human biological samples and related data. It complies with the current Organisation for Economic Co-operation and Development (OECD) and World Medical Association (WMA) recommendations and furnishes a framework that permits long-term storage and multi-purpose research use of human biological material and related data, including cross-border research. However, both (i) human biobanks storing and (ii) research projects requesting “broad consent” biological samples generally require an ethical approval; in addition, “broad consent” conditions should be reciprocated by making biobank processes transparent and by fostering both donor and public involvement. Outlook The broad consent template of the WP-GMEC clearly states that biological samples and data donated for medical research serve to address current and future research questions. It appears perfectly suited as a template for a Europe-wide harmonized broad consent facilitating biobank-based cross-border research.
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Caenazzo, Luciana, and Pamela Tozzo. "The Future of Biobanking: What Is Next?" BioTech 9, no. 4 (November 23, 2020): 23. http://dx.doi.org/10.3390/biotech9040023.
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Biobanks are an extraordinary tool for research and scientific progress. Since their origin, the debate on the main technical, regulatory and ethical aspects has not stopped. The future of biobanks should take into account many factors: the need to improve the technical standards of collection, conservation and use of the sample, the usefulness of achieving forms of harmonization and common governance, the improvement of biobank networks, including through public–private partnerships and improving the sustainability of these infrastructures.
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Jain, Jugnu, Sreevatsa Natarajan, and Soma Chatterjee. "Using human medical waste to build biobanks." International Journal of Molecular and Immuno Oncology 1, no. 1 (November 25, 2016): 24. http://dx.doi.org/10.18203/issn.2456-3994.intjmolimmunooncol20164385.
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India has a high disease burden and a large number of patients. There is a tremendous need for Indian biobanks to preserve Indian samples, to capture the great diversity of diseases to spur research into earlier, more precise diagnosis and better treatments for diseases plaguing India. This review article summarizes the key components of building a systematic comprehensive biobank, type and formats of sample and data, and the ethical and regulatory guidelines in India. An example of a growing Indian biobank, Sapien Biosciences, is shared along with its business model to reach sustainability. This is done by developing clinical diagnostics internally using the annotated samples but also sharing samples and outcomes data with external investigators. Our goal is to highlight the immense untapped value of Indian biospecimens and data, to catalyze the formation of collaborative networks of biobanks both within and outside India.
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Soini, Sirpa. "Finland on a Road towards a Modern Legal Biobanking Infrastructure." European Journal of Health Law 20, no. 3 (2013): 289–94. http://dx.doi.org/10.1163/15718093-12341278.
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Abstract Finland has enacted a Biobank Act that will come into force on 1 September 2013. Finland is regarded as a highly successful environment for medical research using population samples and data for many reasons. One of the rationales behind the new legislation was to solve the problems due to the overly strict informed consent doctrine hindering access to old samples and data and asking for multi-purpose consents. Yet although consent is the primary justification to use biobank samples and data, the Biobank Act allows asking for a consent for several unspecified future research purposes. The guiding principles of the Biobank Act are promotion of trust, equal access to data and samples, protection of privacy, acceleration of innovation activities, and bringing biobank activities under public scrutiny. To the author’s knowledge, this is the first “all purpose” Biobank Act in Europe applied to all biobanks in one country.
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Lhousni, Saida, Karam Yahya Belmokhtar, Ihab Belmokhtar, Mounia Elidrissi Errahhali, Manal Elidrissi Errahhali, Redouane Boulouiz, Mariam Tajir, et al. "Morocco’s First Biobank: Establishment, Ethical Issues, Biomedical Research Opportunities, and Challenges." BioMed Research International 2020 (December 8, 2020): 1–11. http://dx.doi.org/10.1155/2020/8812609.
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Background. Biobanks are highly organized infrastructures that allow the storage of human biological specimens associated with donors’ personal and clinical data. These infrastructures play a key role in the development of translational medical research. In this context, we launched, in November 2015, the first biobank in Morocco (BRO Biobank) in order to promote biomedical research and provide opportunities to include Moroccan and North African ethnic groups in international biomedical studies. Here, we present the setup and the sample characteristics of BRO Biobank. Methods. Patients were recruited at several departments of two major health-care centers in the city of Oujda. Healthy donors were enrolled during blood donation campaigns all over Eastern Morocco. From each participant, personal, clinical, and biomedical data were collected, and several biospecimens were stored. Standard operating procedures have been established in accordance with international guidelines on human biobanks. Results. Between November 2015 and July 2020, 2446 participants were recruited into the BRO Biobank, of whom 2013 were healthy donors, and 433 were patients. For healthy donors, the median age was 35 years with a range between 18 and 65 years and the consanguinity rate was 28.96%. For patients, the median age was 11 years with a range between 1 day and 83 years. Among these patients, 55% had rare diseases (hemoglobinopathies, intellectual disabilities, disorders of sex differentiation, myopathies, etc.), 13% had lung cancer, 4% suffered from hematological neoplasms, 3% were from the kidney transplantation project, and 25% had unknown diagnoses. The BRO Biobank has collected 5092 biospecimens, including blood, white blood cells, plasma, serum, urine, frozen tissue, FFPE tissue, and nucleic acids. A sample quality control has been implemented and suggested that samples of the BRO Biobank are of high quality and therefore suitable for high-throughput nucleic acid analysis. Conclusions. The BRO Biobank is the largest sample collection in Morocco, and it is ready to provide samples to national and international research projects. Therefore, the BRO Biobank is a valuable resource for advancing translational medical research.
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Andry, Chris, Elizabeth Duffy, Christopher A. Moskaluk, Shannon McCall, Michael H. A. Roehrl, and Daniel Remick. "Biobanking—Budgets and the Role of Pathology Biobanks in Precision Medicine." Academic Pathology 4 (January 1, 2017): 237428951770292. http://dx.doi.org/10.1177/2374289517702924.
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Biobanks have become an important component of the routine practice of pathology. At the 2016 meeting of the Association of Pathology Chairs, a series of presentations covered several important aspects of biobanking. An often overlooked aspect of biobanking is the fiscal considerations. A biobank budget must address the costs of consenting, procuring, processing, and preserving high-quality biospecimens. Multiple revenue streams will frequently be necessary to create a sustainable biobank; partnering with other key stakeholders has been shown to be successful at academic institutions which may serve as a model. Biobanking needs to be a deeply science-driven and innovating process so that specimens help transform patient-centered clinical and basic research (ie, fulfill the promise of precision medicine). Pathology’s role must be at the center of the biobanking process. This ensures that optimal research samples are collected while guaranteeing that clinical diagnostics are never impaired. Biobanks will continue to grow as important components in the mission of pathology, especially in the era of precision medicine.
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Cruz, Rafael Evangelista da, Hanna Gabriela da Silva Oliveira, and Felipe Masiero Salvarani. "Biobancos de animais selvagens: revisão de literatura." Research, Society and Development 11, no. 8 (June 26, 2022): e48411831268. http://dx.doi.org/10.33448/rsd-v11i8.31268.
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Um banco de amostras biológicas ou biobanco é, por definição, uma coleção biológica de qualquer amostra humana, animal, vegetal ou microbiana, associadas com os dados da amostra, gerenciados de acordo com padrões técnico-científicos. O objetivo deste artigo foi realizar um estudo retrospectivo acerca dos biobancos de animais selvagens, enfatizando sua importância na conservação de espécies, assim como os procedimentos necessários para sua formação, gerenciamento de dados e desafios. Os biobancos devem ser encarados como uma enorme oportunidade de conservação da vida selvagem, por meio da manutenção de amostras biológicas de DNA, células somáticas, tecidos, sangue, germoplasma e embriões, constituindo uma base de dados científicos fundamental para traçar estratégias de proteção de espécies sob ameaça. Todavia, há a necessidade no aprimoramento dos protocolos para uma gama de amostras, com intuito de minimizar as injúrias provocadas pelos crioprotetores e temperaturas de resfriamento ou congelamento. Os biobancos são ferramentas fundamentais no propósito de salvaguardar e gerenciar um conjunto de dados da fauna selvagem, criando uma rede de informações para o desenvolvimento de estratégias de conservação de espécies, frente aos impasses impostos pelos processos de extinção.
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O’Doherty, K. C., and M. M. Burgess. "Engaging the Public on Biobanks: Outcomes of the BC Biobank Deliberation." Public Health Genomics 12, no. 4 (2009): 203–15. http://dx.doi.org/10.1159/000167801.
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Busby, Helen, and Paul Martin. "Biobanks, national identity and imagined communities: The case of UK biobank." Science as Culture 15, no. 3 (September 2006): 237–51. http://dx.doi.org/10.1080/09505430600890693.
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Panovski-Nikoljski, Elena, Aleksandar Petanovski, and Ivo Spiroski. "Analysis of the methods for projection of spaces for good manufacturing practice." South East European Journal of Architecture and Design 2019 (December 29, 2019): 1–6. http://dx.doi.org/10.3889/seejad.2019.10042.
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BACKGROUND: In this Paper we will present the evolution of the best practice for biobanks, the technical and medical standards for collecting, processing and storing, as well as the socio-economic standards for biobank management.
AIM: The aim of this Thesis is to analyse and to present the methods for projection of spaces for good manufacturing practice.
METHODS: The European Union has adopted guidelines for good manufacturing practice which define the requirements for manufacturing of sterile products. In the following text we will describe the details for determining microbiological cleanliness and cleanliness of the particles in the air, on the surfaces, etc.
RESULTS: The length of time between the collecting of blood or tissues could affect the final result. The preparation of sterile products requires special conditions, in order the risk of microbiological contamination and certain pyrogenic contaminations to be minimized. We make difference between four levels of guidelines for good manufacturing practice, which in this Paper are taken from the practice of the European Union. Level A is local zone with high-risk procedures, e.g. filling, closing of bottles, opening of ampoules and bottles and making septic connections. Level B is aseptic preparation and filling of the samples. Level C and D are the clean spaces for less critical procedures for preparation of sterile products.
CONCLUSION: Technical standards, medical standards, socio-economic standards for biobank management, informatics practices for biobanks, economic recommendations for biobanks have been established, as well as a quality of biobanks has been provided.
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Hoeyer, Klaus. "The Emergence of an Entitlement Framework for Stored Tissue - Elements and Implications of an Escalating Conflict in Sweden." Science & Technology Studies 17, no. 2 (January 1, 2004): 63–82. http://dx.doi.org/10.23987/sts.55166.
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In 1999, a biotech company was established in Västerbotten County, in Sweden, and given what was termed ‘all commercial rights’ to a major research biobank containing blood samples of the majority of the adult population. It was predicted that the company would place the otherwise rather marginalised community at the centre of international life-science research. International investments failed to appear, however. During the spring of 2002, internal disagreements concerning dispositional rights in the biobank resulted in court appeals, critical newspaper articles and, more informally, mutual threats among parties with different interests in the biobank material. In this article, it is argued that scrutiny of this conflict provides a chance to understand the emergence of delineated entitlements in material contained in Swedish biobanks.
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Tarling, Tamsin E., Jennifer A. Byrne, and Peter H. Watson. "The Availability of Human Biospecimens to Support Biomarker Research." Biomarker Insights 17 (January 2022): 117727192210917. http://dx.doi.org/10.1177/11772719221091750.
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Preserved biospecimens held in biobank inventories and clinical archives are important resources for biomarker research. Recent advances in technologies have led to an increase in use of clinical archives in particular, in order to study retrospective cohorts and to generate data relevant to tissue biomarkers. This raises the question of whether the current sizes of biobank inventories are appropriate to meet the demands of biomarker research. This commentary discusses this question by considering data concerning overall biobank and biospecimen numbers to estimate current biospecimen supply and use. The data suggests that biospecimen supply exceeds current demand. Therefore, it may be important for individual biobanks to reassess the targets for their inventories, consider culling unused portions of these inventories, and shift resources towards providing prospective custom biobanking services.
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Meinung, Bettina, Dunja Martin, and Uwe Zimmermann. "Standardization in biobanking – between cooperation and competition." Journal of Laboratory Medicine 43, no. 6 (December 18, 2019): 317–28. http://dx.doi.org/10.1515/labmed-2019-0105.
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Abstract This article presents the current situation of German biobanks and shows future fields of action in the European and international context on the basis of upcoming legal and normative challenges. It gives an overview of the development of the international biobank standard ISO 20387 and the commitment of German biobank experts in the ISO committee TC276. Less attention than the biobank standard per se has so far been paid to the basic mechanisms by which standards are developed and the potential of their application and accreditation. In this sense, this article deals with the motivation for active participation in standardization projects. We discuss the status of ISO 20387 as a conformity assessment standard and the consequence of accreditation as a performance monitor.
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Mitchell, Phoebe B., Sonja I. Ziniel, Sarah K. Savage, Kurt D. Christensen, Elissa R. Weitzman, Robert C. Green, Noelle L. Huntington, Debra J. Mathews, and Ingrid A. Holm. "Enhancing Autonomy in Biobank Decisions: Too Much of a Good Thing?" Journal of Empirical Research on Human Research Ethics 13, no. 2 (February 23, 2018): 125–38. http://dx.doi.org/10.1177/1556264617753483.
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The opportunity to receive individual research results (IRRs) in accordance with personal preferences may incentivize biobank participation and maximize perceived benefit. This trial investigated the relationship between parents’ preferences and intent to participate (ITP) in biobank research utilizing their child’s genetic information. We randomized parents of pediatric patients to four hypothetical biobanks, one of which employed a preference-setting model for return of results regarding their child. ITP was highest among those desiring all types of IRRs (93.3%) and decreased as participants became increasingly selective with their preferences ( p < .0001). We demonstrated that most parents would participate in a biobank that allows for preference setting; however, those who set preferences to receive a narrower set of IRRs are less likely to participate.
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De Vries, Raymond G., Kerry A. Ryan, Linda Gordon, Chris D. Krenz, Tom Tomlinson, Scott Jewell, and Scott Y. H. Kim. "Biobanks and the Moral Concerns of Donors: A Democratic Deliberation." Qualitative Health Research 29, no. 13 (August 10, 2018): 1942–53. http://dx.doi.org/10.1177/1049732318791826.
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Do members of the public believe that biobanks should accommodate the moral concerns of donors about the types of research done with their biospecimens? The answer to this question is critical to the future of genomic and precision medicine, endeavors that rely on a public willing to share their biospecimens and medical data. To explore public attitudes regarding the requirements of consent for biobank donations, we organized three democratic deliberations involving 180 participants. The deliberative sessions involved small group discussions informed by presentations given by experts in both biobank research and ethics. We found that participants had a sophisticated understanding of the ethical problems of biobank consent and the complexity of balancing donor concerns while promoting research important to the future of health care. Our research shows how deliberative methods can offer policy makers creative ideas for accommodating the moral concerns of donors in the biobank consent process.
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Mate, Sebastian, Marvin Kampf, Wolfgang Rödle, Stefan Kraus, Rumyana Proynova, Kaisa Silander, Lars Ebert, et al. "Pan-European Data Harmonization for Biobanks in ADOPT BBMRI-ERIC." Applied Clinical Informatics 10, no. 04 (August 2019): 679–92. http://dx.doi.org/10.1055/s-0039-1695793.
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Abstract Background High-quality clinical data and biological specimens are key for medical research and personalized medicine. The Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) aims to facilitate access to such biological resources. The accompanying ADOPT BBMRI-ERIC project kick-started BBMRI-ERIC by collecting colorectal cancer data from European biobanks. Objectives To transform these data into a common representation, a uniform approach for data integration and harmonization had to be developed. This article describes the design and the implementation of a toolset for this task. Methods Based on the semantics of a metadata repository, we developed a lexical bag-of-words matcher, capable of semiautomatically mapping local biobank terms to the central ADOPT BBMRI-ERIC terminology. Its algorithm supports fuzzy matching, utilization of synonyms, and sentiment tagging. To process the anonymized instance data based on these mappings, we also developed a data transformation application. Results The implementation was used to process the data from 10 European biobanks. The lexical matcher automatically and correctly mapped 78.48% of the 1,492 local biobank terms, and human experts were able to complete the remaining mappings. We used the expert-curated mappings to successfully process 147,608 data records from 3,415 patients. Conclusion A generic harmonization approach was created and successfully used for cross-institutional data harmonization across 10 European biobanks. The software tools were made available as open source.
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O'Sullivan, Lydia, Tomás Carroll, Niamh Clarke, Sarah Cooper, Ann Cullen, Laura Gorman, Billy McCann, et al. "Harmonising the human biobanking consent process: an Irish experience." HRB Open Research 4 (September 15, 2021): 96. http://dx.doi.org/10.12688/hrbopenres.13384.2.
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Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by documentation in the form of Participant Information Leaflets and Informed Consent Forms (PILs/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation (GDPR) and the related Irish Health Research Regulation (HRR) presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, GDPR/HRR-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.