Littérature scientifique sur le sujet « Biobanca »

Atherosclerosis (also known as Arteriosclerotic Vascular Disease or ASVD) is the condition in which an artery wall thickens as the result of a build-up of fatty materials such as cholesterol. It is a syndrome affecting arterial blood vessels, a chronic inflammatory response in the walls of arteries, in large part due to the accumulation of macrophage white blood cells and promoted by Low-density lipoproteins (plasma proteins that carry cholesterol and triglycerides) without adequate removal of fats and cholesterol from the macrophages by functional high density lipoproteins (HDL). It is commonly referred to as a hardening or furring of the arteries. It is caused by the formation of multiple plaques within the arteries. Other arteriosclerotic disease is aortic aneurysm usually affecting the abdominal tract of the vessel. The prevalence of abdominal aortic aneurysm (AAA) varies ranging from 4.1% to 11.5% in European men. This disorder is characterized by localized structural deterioration of the aortic wall, leading to progressive dilatation and eventual aortic rupture. Rupture of AAA is responsible for 1.5% of the total mortality in males over 55 years of age. Both disease seem to share common causes in alteration in lipid metabolism and immune response against host and oxidised lipids, leading to a condition of chronic inflammation affecting all the vascular system, especially the big diameter arteries. There are several factors such as smoking, hypertension, hypercholesterolemia and male sex, which are well known risk factors for the development of AAA and carotid stenosis. However, better understanding of molecular mechanisms is an important step toward clarification of the pathophysiology, identification of genetic and molecular biomarkers and development of new therapeutic strategies for AAA and atherosclerosis in general. Gene expression profiling studies by microarray technologies are particularly appropriate to investigate and create working hypotheses to understand the pathophysiology of complex genetic tracts such as arteriosclerotic diseases. Previous microarray studies focused on AAA utilized RNA derived from aortic tissue samples. The use of tissue samples has several disadvantages, including the difficulty of obtaining control samples and bias introduced by use of normal specimens from non-age-matched cadavers, organ-transplant donors or patients with different diseases. Peripheral blood is a complex fluid with a high cellular turnover rate that provides physiological connectivity between tissues. Environmental or disease perturbations in the body may leave molecular signatures detectable by analyzing blood-derived RNA. Most importantly, since blood samples can be obtained readily and with little discomfort to patients, biomarkers derived from blood RNA provide an easier integration to clinical and imaging data for the diagnosis and prognosis of AAA and carotid stenosis. In this study we investigate the gene expression profile of venous whole peripheral blood obtained from AAA patients by using microarray technology to provide insight into systemic pathophysiological processes involved in this disease. Using the data obtained from the microarray analysis from which we detected 91 genes differentially expressed from patients and positive controls, we selected 10 gene belonging to pathways involved in lipid metabolism and immune response to deep our analysis and eventually confirm the microarray data in order to set up new reliable parameters for arteriosclerosis diseases diagnosis and prognosis. The genes we chosen are Lipid Metabolism: 8. Monoglyceride lipase - MGLL - U67963 - 11343 9. Free fatty acid receptor 2 - FFAR2 - AF024690 – 2867 10. Adiponectin receptor 1 - ADIPOR1 - AK001484 – 51094 11. Phospholipase A2, group IB (pancreas) - PLA2G1B - M21054 – 5319 12. Hydroxysteroid (17-beta) dehydrogenase 14 - HSD17B14 - NM_016246 3738 13. Acyl-Coenzyme A dehydrogenase, C-2 to C-3 short chain - ACADS Z80345 – 682 14. Low density lipoprotein receptor-related protein 5 - LRP5 - AF077820 - 4041 Immune system: 4. Toll-like receptor adaptor molecule 1 - TICAM1 - AF070530 - 7746 5. Interleukin 1 receptor accessory protein-like 1 - IL1RAPL1 - AJ243874 11141 6. Tumor necrosis factor type 1 receptor-associated protein - TRAP1 NM_016292 – 10131 We designed 10 couples of primers to analyze the expression levels of the genes onto 3 groups of subjects: 1. Control: N=40 2. AAA patients: N=40 3. Patients affected from carotid artery stenosis: N=40 We first analyze the expression levels of the control gene GAPDH of each subject and than we check the expression levels of the all ten genes comparing the resulting CT values with the ones gotten from the housekeeping gene. The result is the so-called ∆CT and we got these values for all the 120 subjects for everyone of the 10 genes in duplicates for a total of 1200 ∆CT values. Than we compare the average ∆CT values of the 80 patients (40 AAA + 40 carotid stenosis) with the control values to get the ∆∆CT values from which calculate the fold number (2-∆∆CT =FOLD) that provides a numeric but qualitative value of the expression level of the target gene that allow to compare the values with others present in literature. Our analysis are only semiquantitative for the moment but we first needed to check the reliability of the experimental approach. For the future studies we are going to use Taqman® probes to rise the specificity and sensitivity of the analysis, introducing a quantitative method using titolation commercial kit that allow to quantify the exact numbers of copies of an m-RNA transcript calculating the exact amount of m-RNA by substituting the CT values in a linear equation. We confirmed the microarray data and extended the results to the carotid stenosis patients. We were able to confirm the genes upregulation and hypothesise that PBMCs could be a suitable base for the detection of novel risk and prognostic indicators for the arteriosclerotic diseases. In fact our aim is to identify new easy-to-detect markers to predict the risk of developing an artery stenosis or most important, an aneurismatic lesion that is symptomless until the very late phases and whose success in treating is proportional to well-timed diagnosis. In the end seems that the right direction to look into are the metabolism of lipids and phospholipids, that are involved in eicosanoids production and degradation (via fatty acid metabolism) and cell signalling in the immune system.

Submitted by Priscilla Araujo (priscilla@ibict.br) on 2016-10-10T17:10:18Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) RODRIGO PORTO BOZZETTI mestrado 2016.pdf: 883197 bytes, checksum: 050ebfc1523b4008448c5a32d7a953cc (MD5)<br>Made available in DSpace on 2016-10-10T17:10:18Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) RODRIGO PORTO BOZZETTI mestrado 2016.pdf: 883197 bytes, checksum: 050ebfc1523b4008448c5a32d7a953cc (MD5) Previous issue date: 2016-04-29<br>Investiga as dimensões informacionais e documentais dos dispositivos infocomunicacionais biobancos. Apresenta breve histórico sobre os processos de formação da genética como um campo de estudos. Realiza uma apresentação do conceito de biobanco demonstrando os propósitos e principais atividades realizadas. Discute sobre Eugenia e sobre potenciais usos sensíveis de informações genéticas. Discute o conceito de documento, tendo por base os trabalhos de Otlet, Briet, Meyriat, Frohmann entre outros autores da Ciência da Informação, no intuito de defender que amostras biológicas de seres humanos podem ser consideradas como documentos. Discute o conceito de dispositivo infocomunicacional na Ciência da Informação. Aponta o UK Biobank como unidade de análise para se estudar os biobancos a nível mundial e investiga o funcionamento, a estrutura, os documentos e os mecanismos de proteção de informações sigilosas desse biobanco tendo por principal fonte de informação o seu portal. Apresenta os biobancos como dispositivos que tem o potencial de classificar e criar taxonomias de seres humanos, potencializando a capacidade de gerar problemas de cunho ético aos envolvidos nas pesquisas.<br>Investigates the informational and documentary dimensions of infocommunicative devices biobanks. Presents brief history about the genetics as a field of study. Performs a presentation of the concept of biobank demonstrating the purpose and main activities. Discusses Eugenics and potential sesitive uses of genetic information. Discusses the concept of document, based on the work of Otlet, Briet, Meyriat, Frohmann among other authors of Information Science, in order to argue that biological samples from humans can be considered as documents. Discusses the concept of infocomunicacional device in Information Science. Pointing UK Biobank as units of analysis to study biobanks worldwide and investigates the operation, structure, documents and mechanisms of protection of sensitive information of this biobank usings it’s website as main source of information. It presents biobanks as devices that have the potential to classify and create taxonomies of humans, increasing the capacity to generate ethical problems to the people involved in the research.

Esta tesis se enfrentó al reto de resolver la cuestión sobre si los derechos de propiedad intelectual creados por los biobancos pueden gestionarse más abiertamente para garantizar la distribución equitativa del conocimiento y las mejoras de la investigación genética. Se propone fomentar que los biobancos usen licencias más abiertas en sus obras protegidas por derechos de autor, bases de datos e inventos patentados. Para facilitar la transferencia de conocimiento entre biobancos y garantizar que la investigación genética mejore, se realiza una reflexión sobre la aplicación de licencias abiertas. La tesis describe el modelo de intercambio colectivo y apoya la posibilidad de usar derechos de propiedad intelectual de forma no restrictiva. La tesis también propone el uso del consentimiento informado amplio en las actividades de los biobancos. Un consentimiento informado amplio garantizaría el equilibrio adecuado entre los derechos individuales y el derecho de los biobancos de compartir la información recogida, especialmente, porque existen incentivos para tratar la genética humana como patrimonio común. El consentimiento abierto puede usarse en las actividades del biobanco para garantizar que los tejidos no permanecen sin uso. Este tipo de consentimiento puede asegurar el máximo valor de los tejidos biológicos recogidos. Si las muestras recogidas no están restringidas a un solo uso o a una sola investigación, podemos esperar que otros estudios lleven a cabo investigaciones sobre las mismas muestras y se presente información científica más amplia y relevante.<br>This thesis faced the challenge of answering the question if intellectual property rights that are created by the biobanks can be managed more openly to ensure the equitable distribution of knowledge and improvements of the genetic research. The proposal is made to encourage the biobanks to use more broadly open licenses in their copyrighted works, databases and patented inventions. To ease the transfer of knowledge between biobanks and ensure that the genetic research is improving, the reflection to apply open licenses is made. The thesis describes the open sharing model and supports the possibilities to use IP rights in a non-restricting way. The thesis also proposes to use broad informed consent in the biobanks’ activities. Broad informed consent would ensure the right balance between individual rights and biobanks’ need to share collected information, especially, because there are incentives to treat human genetics as a common good. Open consent can be used in the biobank’s activities to ensure that the tissues are not left unutilised. Such form of consent can assure the maximum value of the collected biological tissues. If collected samples are not restricted to the one-time or one-research use, we can expect that other studies perform research on the same samples and the broader scientific information is presented.

Durant la segona meitat del segle passat es van estabilitzar algunes tecnologies i maneres de pensar i generar coneixement entorn del que s’ha vingut a denominar biomedicina, la medicina biologicista posterior a la Segona Guerra Mundial. La criopreservació en glicerol, el desenvolupament de maquinària per a la producció de baixes temperatures, l’estandardització de les anàlisis biològiques, la tècnica PCR o la seqüenciació del genoma humà han estat alguns dels esdeveniments que han propiciat l’auge de les ciències “ómicas” i la molecularització de la vida. Els biobancs, un tipus de biorepositori amb mostres i dades associades d’origen humà, que són l’objecte principal d’aquesta tesi, van començar a establir-se formalment a diferents països al final del segle passat i inici del present mil·lenni. S’estableixen així en un moment en el qual la genòmica havia posat sota escrutini la recerca biomolecular i la ciència en general, donant pas a la problematització i formalització del camp de la bioètica. És en aquest context quan a la fi dels anys 90 els biobancs, són presentats com les condicions de possibilitat per a la medicina i recerca biomèdica esdevenidora, per a la producció de coneixement, tractaments i fàrmacs. A diferència d’altres bancs de mostres biològiques d’origen humà que tenen fins terapèutics o reproductius, el que caracteritza als biobancs són els “fins de recerca biomèdica”. Els biobancs són així un tipus de biorepositori que recull, processa, conserva (majoritàriament a baixa temperatura) i distribueixen mostres biològiques d’origen humà i dades associades amb finalitats de recerca biomèdica. L’objectiu general d’aquesta tesi doctoral és analitzar els biobancs en el context de la biomedicina contemporània, un objectiu que em permet explorar de què està feta (parcialment) la biomedicina. Per a estudiar els biobancs m’he servit dels abordatges analítics, conceptuals i metodològics dels estudis en ciència i tecnologia (STS) i l’antropologia. Es tracta d’una recerca qualitativa (anàlisi documental, treball de camp multisituat i un estudi de cas etnogràfic) on l’abordatge empíric se centra en les perspectives i la quotidianitat del personal que treballa en els biobancs. Al llarg de la tesi he analitzat quina és la posada en escena dels biobancs, tant pel que fa a les polítiques científiques europees en matèria d’infraestructures per a la recerca i la normativa de l’estat espanyol, com per part del personal que treballa en ells. Amb l’estudi dels biobancs indago “problemes antropològics”, els quals tenen a veure amb l’existència humana com a productora de coneixement, intervenció tecnològica i problematitzacions eticopolítiques (Collier and Ong, 2008). Els biobancs són presentats a les polítiques científiques com a infraestructures imprescindibles per a la recerca biomèdica i les seves projeccions futuristes a les polítiques científiques. Aquesta tesi problematitza aquesta lectura a través del seu estudi qualitatiu i adoptant un abordatge criopolític. Mitjançant l’anàlisi qualitatiu aporto una redefinició densa de què és/fa un biobanc, la qual cosa ens condueix a preguntar-nos què estan deixant de ser i fer, cap a on transiten i amb ells la coproducció d’un coneixement biomèdic particular. En aquesta recerca analitzo com la condició de mediadors converteix als biobancs en infraestructures oscil·lants, articulant maneres de biodisponibilitat complexes entre l’altruisme i l’emprenedoria neoliberal. Per a això, en aquesta tesi proposo un abordatge empíric que s’aproximi a les friccions que sorgeixen de la praxi bioclínica i que indagui com ampliar el principalisme ètic per tal d’alterar la inèrcia del pensament i l’acció eticopolítica. Finalment, la tesi conclou assenyalant que les recerques qualitatives empíriques són imprescindibles per a configurar un abordatge eticopolític que tingui en compte el caràcter relacional i distribuït de la recerca biomèdica.<br>Durante la segunda mitad del siglo pasado se estabilizaron algunas tecnologías y formas de pensar y generar conocimiento en torno a lo que se ha venido a denominar biomedicina, la medicina biologicista posterior a la Segunda Guerra Mundial. La criopreservación en glicerol, el desarrollo de maquinaria para la producción de bajas temperaturas, la estandarización de los análisis biológicos, la técnica PCR o la secuenciación del genoma humano han sido algunos de los acontecimientos que han propiciado el auge de las ciencias ómicas y la molecularización de la vida. Los biobancos, un tipo de biorepositorio con muestras y datos asociados de origen humano, que son el objeto principal de esta tesis, comenzaron a establecerse formalmente a lo largo del globo a finales del siglo pasado comienzo del presente milenio. Se establecen así en un momento en el que la genómica había puesto bajo escrutinio la investigación biomolecular y la ciencia en general, dando paso a la problematización y formalización del campo de la bioética. Es en este contexto, cuando a finales de los años 90, los biobancos son presentados como las condiciones de posibilidad para la medicina e investigación biomédica venidera, para la producción de conocimiento, tratamientos y fármacos. A diferencia de otros bancos de muestras biológicas de origen humano que tienen fines terapéuticos o reproductivos, lo que caracteriza a los biobancos son sus “fines de investigación biomédica”. Los biobancos son así un tipo de biorepositorio que recoge, procesa, conserva (mayoritariamente a baja temperatura) y distribuye muestras biológicas de origen humano y datos asociados con fines de investigación biomédica. El objetivo general de la presente tesis doctoral es analizar los biobancos en el contexto de la biomedicina contemporánea, un objetivo que me permite explorar de qué está hecha (parcialmente) la biomedicina. Para estudiar los biobancos me he servido de los abordajes analíticos, conceptuales y metodológicos de los estudios en ciencia y tecnología (STS) y de la antropología social. Se trata de una investigación cualitativa (análisis documental, trabajo de campo multisituado y un estudio de caso etnográfico) donde el abordaje empírico se centra en las perspectivas y cotidianidad del personal que trabaja en los biobancos. A lo largo de la tesis he analizado cuál es la puesta en escena de los biobancos tanto en las políticas científicas europeas en materia de infraestructuras para la investigación y la normativa del estado español, como por parte del personal que trabaja en ellos. Con el estudio de los biobancos indago “problemas antropológicos”, los cuales tienen que ver con la existencia humana como productora de conocimiento, intervención tecnológica y problematizaciones ético-políticas (Collier and Ong, 2008). Los biobancos son presentados como infraestructuras imprescindibles para la investigación biomédica y sus proyecciones futuristas. Esta tesis complejiza dicha lectura a través de su estudio cualitativo y adoptando un abordaje criopolítico. Mediante el análisis cualitativo aporto una redefinición densa de qué es/hace un biobanco, lo que nos lleva a preguntarnos qué están dejando de ser y hacía dónde transitan y con ellos la coproducción de un conocimiento biomédico particular. Argumento en esta investigación que la condición de mediadores convierte a los biobancos en infraestructuras oscilantes, articulando modos de biodisponibilidad complejos entre altruismo y emprendimiento neoliberal. Para ello, en esta tesis propongo un abordaje empírico que se aproxime a las fricciones que surgen de la praxis bioclínica y que indague cómo ampliar el principialismo ético y disrumpir la inercia del pensamiento y la acción ético-política. Concluyo señalando que las investigaciones cualitativas empíricas son imprescindibles para configurar un abordaje ético-político que tenga en cuenta el carácter relacional y distribuido de la investigación biomédica.<br>During the second half of the last century, some technologies, ways of thinking, and forms of knowledge production were stabilized around what has come to be called biomedicine, a biologicist medicine of the post-World War II era. Cryopreservation in glycerol, machinery for low-temperature manufacturing, the standardization of biological analyses, the PCR technique, and the sequencing of the human genome are some of the events that have led to the rise of the omics sciences and the molecularization of life. Biobanks, a type of biorepository with samples and associated data of human origin, which are the subject of inquiry of this thesis, began to be formally established around the world at the end of the last century and the beginning of the present millennium, along with the aforementioned events. They were born in a context in which genomics had brought biomolecular research and scientific projects under scrutiny, giving rise to the problematization and formalization of the field of bioethics. In this context, during the late 1990s biobanks started to be presented as the condition of possibility for future biomedical research and medicines, including the production of knowledge, treatments, and drugs. Unlike other banks of biological samples of human origin that have therapeutic or reproductive purposes, what characterizes biobanks are their “biomedical research purposes.” Biobanks are thus a type of biorepository that collects, processes, preserves (mainly at low temperatures), and distributes biological samples of human origin and associated data for biomedical research purposes. Overall, the main objective of this dissertation is to analyze biobanks in the context of contemporary biomedicine, which allows me to explore what biomedicine (partially) consists of. I use the analytical, conceptual, and methodological approaches of science and technology studies and anthropology to study biobanks. This research draws upon qualitative methods (documentary analysis, multi-sited fieldwork, and an ethnographic case study) and an empirical approach that revolves around biobankers’ concerns and daily work. Throughout the thesis, I have analyzed the staging of biobanks in European scientific policies on research infrastructures, Spanish state regulations, and by the staff working in them. This doctoral dissertation is a study about biobanks and the staff working in them. In this approach to biobanks, I investigate “anthropological problems”, which have to do with human existence as a producer of knowledge, technological intervention, and ethico-political problematizations (Collier and Ong, 2008). Biobanks are generally presented as essential infrastructures for biomedical research and its futuristic projections. This thesis complexifies such a reading through its qualitative study and cryopolitical approach. Through qualitative analysis, I provide a grounded redefinition of what a biobank is/does, leading us to consider what they are ceasing to be, what they are transiting into, and the accompanying co-production of particular biomedical knowledge. I argue that as mediators, biobanks are oscillating infrastructures, articulating complex modes of bioavailability between altruism and neoliberal entrepreneurship. To this end, in this thesis, I propose an empirical approach that responds to the frictions arising from bioclinical praxis and asks how to broaden ethical principlism and disrupt the inertia of ethico-political thought and action. I conclude by noting that empirical qualitative inquiries are essential to configure an ethico-political approach that accounts for the relational and distributed character of biomedical research.

Submitted by Oliveira Santos Dilzaná (dilznana@yahoo.com.br) on 2016-04-04T14:54:45Z No. of bitstreams: 1 Tese de Rosanita Ferreira e Baptista.pdf: 2893108 bytes, checksum: 82b1fb069c85249aab41ed18da8212cb (MD5)<br>Approved for entry into archive by Ana Portela (anapoli@ufba.br) on 2016-04-06T14:26:35Z (GMT) No. of bitstreams: 1 Tese de Rosanita Ferreira e Baptista.pdf: 2893108 bytes, checksum: 82b1fb069c85249aab41ed18da8212cb (MD5)<br>Made available in DSpace on 2016-04-06T14:26:35Z (GMT). No. of bitstreams: 1 Tese de Rosanita Ferreira e Baptista.pdf: 2893108 bytes, checksum: 82b1fb069c85249aab41ed18da8212cb (MD5)<br>As biociências, ao tomarem o corpo humano como objeto de escrutínio e experimentação, mobilizam questões e atores que não são apenas científicos e técnicos, mas também políticos, legais e éticos. A imbricação dessas esferas parece tornar problemáticas as perspectivas que se fundamentam em dualidades, como natureza x cultura, fato x valor. Esse é o caso dos biorrepositórios e biobancos com finalidades de pesquisa, cujas práticas de manusear e colecionar material biológico humano e informações associadas para uso em pesquisas, ao tempo em que gera expectativas para o desenvolvimento da saúde e da medicina, também trazem incertezas e controvérsias sobre a natureza e destino das coleções, bem como sobre as consequências dos experimentos. É um contexto em que as práticas científicas engendram entidades que não se enquadram confortavelmente nas ontologias modernas e, mais especificamente, tornam ambíguas as fronteiras do “humano”, demandando novas regulamentações e ordenações. Assim, sob o referencial da Teoria Ator-Rede, esta tese propõe explorar as controvérsias que tomaram forma nos eventos de construção da regulamentação dos biobancos e biorrepositórios no Brasil, no período de 2009 a 2011, sob condução do Ministério da Saúde (MS) e do Conselho Nacional de Saúde (CNS) e que resultaram na publicação das Diretrizes para Análise Ética de Projetos de Pesquisas que Envolvam Armazenamento de Material Biológico Humano ou Uso de Material Armazenado em Pesquisas (Resolução CNS Nº 441/11) e nas Diretrizes Nacionais para Biorrepositórios e Biobancos com Finalidade de Pesquisa (Portaria do MS nº 2.201/ 11). Dois objetivos principais norteiam a investigação: mapear as controvérsias que envolvem a temática do armazenamento e uso de informações e material biológico humano em pesquisa e apreender a tessitura híbrida que conformaram normas e padrões para estas práticas tecnocientíficas. By adopting the human body as an object of scrutiny and experimentation, the biosciences has mobilized issues and actors who are not only scientific and technical, but also political, legal and ethical. The overlapping of these spheres seems to interfere with prospects that are based on dualities, such as nature vs. culture, fact vs. value. This is the case with regards to biobanks and biorepositories that are intended for research, where the practices of collecting and handling human biological material and associated information for use in research. This also creates expectations for the development of health and medicine, they too bring uncertainties and controversies about the nature and destination of the collections, as well as on the consequences of the experiments. It is a context in which scientific practices create entities that do not fit comfortably in modern ontologies, and more specifically, they make unclear the boundaries of the "human", demanding new regulations and ordinances. Therefore, under the Actor- Network Theory framework, this thesis intends to explore the controversies that took shape in the conception event of the regulation of biobanks and biorrepositórios in Brazil, in the 2009-2011 period, under the guidance of the Ministry of Health (MOH) and the National Health Council (CNS), which resulted in the publication of the Guidelines for ethical analyzing of research projects that involve material storage or utilization of stored materials in prior researches (Ordinance No. 2201) and the Brazilian Resolution on the storage and use of human biological material in research projects (Resolution 441/11). There are two main objectives guiding the research: to map the controversies surrounding the issue of storage and use of information and human biological material in research and to learn the hybrid composition that followed norms and patterns for these techno-scientific practices.

Con la presente trattazione ci si e' posto l' obbiettivo di affrontare la questione relativa alla conservazione degli embrioni prodotti tramite le tecniche di fecondazione artificiale e non immediatamente impiantati. In assenza di specifiche disposizioni normative in grado di regolamentare tale materia, si e' cercato di individuare quali possano essere gli obblighi giuridici ed etici che incombono su un centro che si occupa della conservazione degli embrioni residuali, anche alla luce degli interventi comunitari in materia di biobanche, della legge 40/2004 e delle linee guida adottate dal Ministero della Salute in materia di accesso alle tecniche di procreazione medicalmente assistita. La questione non poteva essere trattata in maniera totalmente avulsa dal contesto piu' ampio che riguarda in generale la conservazione del materiale biologico, di cui si occupano le diverse biobanche, ormai diffuse ampiamente tanto a livello internazionale quanto in quello nazionale, le quali hanno iniziato ad operare in assenza di un preciso quadro normativo di riferimento, ricorrendo a forme di autoorganizzazione, mediante le quali ogni centro ha stabilito una propria governance, dettando i propri canoni, i propri metodi, i propri obiettivi. I successivi interventi comunitari in materia non sono stati in grado di dar luogo ad una disciplina precisa, chiara e coerente per quel che riguarda la conservazione del materiale biologico, lasciando dei grossi spazi di indeterminatezza legislativa, vuoi per l'eccessivo tecnicismo da un lato, vuoi per l'ambiguita' lessicale dall' altro. Una volta analizzate le principali questioni che riguardano le biobanche in generale, ci si e' proposti di guardare alla tematica della conservazione degli embrioni in particolare. In questo campo infatti si aggravano in maniera esponenziale, tanto le questioni etiche, quanto la confusione normativa, data dall'assenza di una precisa regolamentazione in materia. Il problema della conservazione degli embrioni nasce successivamente allo sviluppo delle tecniche di congelamento che hanno permesso di conservare gli embrioni prodotti in eccedenza ed e' rimasto aperto anche dopo l'entrata in vigore della legge 40/04 che, nonostante l'apparente rigore, non si occupa della condizione degli embrioni sovranumerai crioconservati. Una volta individuate le disposizioni normative, comunitarie ed interne, da applicare anche alle biobanche di embrioni, ed analizzate le varie questioni etiche sollevate dalla pratica della crioconservazione di embrioni, si e' tentato di ricostruire una possibile disciplina giuridica in grado di regolamentare in maniera piu' precisa l'attivita' di tali tecno-strutture Si e' tentato, infatti, di ricostruire, a partire dai dati normativi esistenti e ricorrendo poi a tradizionali schemi giuridici, una disciplina piu' precisa che possa regolamentare il rapporto che si svolge tra un centro di PMA che si occupa della produzione e conservazione di embrioni e coppia che accede alle tecniche di fecondazione assistita e a cui fanno capo gli embrioni conservati, individuando gli obblighi che assume la biobanca e le susseguenti responsabilita' che possono derivare da un inadempimento. L'obiettivo fondamentale e', quindi, quello della responsabilizzazione dei centri di conservazione degli embrioni attraverso il ricorso agli strumenti giuridici a nostra disposizione. L'esigenza di fondare spazi di responsabilita' giuridica si avverte fortemente in questo campo in quanto si scorge la sacralita' del soggetto coinvolto, l'embrione, che necessita di una tutela estremamente forte in quanto entita' che racchiude in se tutti i caratteri dell'essenza umana ed e' persona dal momento iniziale del suo ciclo vitale.

Thesis (M. Arch.)--Massachusetts Institute of Technology, Dept. of Architecture, 2011.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 116-120).<br>More than 300 million biospecimens - blood samples, saliva swabs, excised tumors - are housed in different collections all over the country right now. Meanwhile, biometric data is constantly being compiled by sophisticated security systems, by lifestyle products, and even by ordinary ATMs. Because private companies, hospitals, for-profit testing facilities, and security companies 'own' the information they collect, it can't work for you. Billions of dollars in grants are spent each year on focused medical studies seeking information that is most likely already available, but unobtainable. The availability of biometric information to researchers able to draw real statistical conclusions from it is impeded both by a shaky notion of individuals' privacy and the proprietary funding structure by which much of the information has been gathered. The data is out there - it's not a question of wanting to share personal data or not. Measures like the Genetic Information Nondiscrimination Act treat a symptom of the end of privacy, but by no means secure it. The only productive embrace of this national mine of information is to make it fully transparent, to make it available to the public and researchers alike, to nationally acknowledge the end of an antiquated notion of privacy, and to stave off the flow of research dollars into patented pharmaceuticals. The Biobank for America does just that by making transparent the collection and storage of biometric information on a national scale and finally collating it into a comprehensive, searchable archive.<br>by Sarah Hirschman.<br>M.Arch.

The forward march of biobanking creates the need for an alternative approach to biobank governance. Biobanking encourages medical advancement by making the conduct of health-related research more efficient, by minimising physical harms to participants, and by facilitating personalised medicine and greater understandings of disease. Nonetheless, its characteristics that distinguish it from general health-related research often give rise to many ethical and social issues. For example, multiple and unexpected uses of biobank resources can render conventional informed consent inadequate for safeguarding participants and maintaining public trust and confidence. Also, because the size of a biobank cohort is normally large, biobanking usually requires considerable management resources and this can mean that biobanks can likely be financially dependent upon for-profit entities. This dependency can cause concern among participants and publics about commercial exploitation. These issues suggest that a new approach to biobank governance is required to address them. Indeed, their complexity and the sheer longevity of biobanking itself also suggest that it is relatively feasible and coherent to address them by focusing on a relationship between participants and biobankers. This involves many aspects of interaction and reflects an element of continuity, which is crucial to biobanking success, as opposed to one-off measures. Consequently, with the aim of addressing issues that arise from biobanking, this thesis offers an analysis of the participant-biobanker relationship that can deal with these issues. Such a relationship constitutes an authentic research relationship in biobanking (“ARR”). Based on this premise, the main research question of my thesis is to ask: What form of research relationship is appropriate for effective and ethical biobanking practices? Three sub-questions are raised to solve this top-level research question. They start with a normative question of why the ARR proposed in this thesis is desirable for biobanking. The next sub-question asks what this ARR should look like from a conceptual perspective. For a practical respect on my proposals, the last sub-question concerns the ways in which the ARR can be fostered in practice. To address these research questions, my thesis first establishes the main characteristics of the proposed ARR as the fundamental notion thereof. These main characteristics are used to answer the first sub-question. For the second sub-question, the thesis suggests that the ARR should be based on the concept of partnership, as opposed to solidarity, mainly because partnership can exhibit the main characteristics of the ARR – as argued – and can also be prescribed in a governance manner. The thesis then uses partnership as a basis for proposing the key features of the ARR, which are deemed to be a conceptual framework for the ARR. To answer the last sub-question, the thesis uses this conceptual framework to propose a partnership model for biobank governance that can be used to develop the ARR in practice. My original contribution is to propose a novel approach to an ARR, and this ARR is based on the concept of partnership. In other words, my thesis argues that the pursuit of the ARR, which looks like a partnership relationship, is an important element of biobanking success. In this respect, my thesis is about a sociologically informed role for partnership in biobank governance. It also provides a nuanced epistemological grounding for a participant-biobanker relationship in both conceptual and practical ways. From a philosophical perspective, my thesis proposes an ethical framework for biobank governance that perceives partnership as a virtuous trait for biobankers and provides rules for acquiring this trait through biobanking practices. Notably, it is argued that this partnership is not – nor need it be – the legal paradigm of partnership, which fundamentally refers to for-profit business association. While law might have a role to play in facilitating the development of the ARR, it cannot prescribe the ARR nor should it attempt to do so.