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Biobanks and Tissue Research

Biobanks and Tissue Research
  • Author : Christian Lenk,Judit Sándor,Bert Gordijn
  • Publisher :Unknown
  • Release Date :2011-07-30
  • Total pages :238
  • ISBN : 9400716737
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Summary : The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.

Biobanks

Biobanks
  • Author : Herbert Gottweis,Alan Petersen
  • Publisher :Unknown
  • Release Date :2008-04-28
  • Total pages :248
  • ISBN : 9781134090273
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Summary : In recent years, a number of large population-based biobanks – genetic databases that combine genetic information derived from blood samples with personal data about environment, medical history, lifestyle or genealogy – have been set up in order to study the interface between disease, and genetic and environmental factors. Unsurprisingly, these studies have sparked a good deal of controversy and the ethical and social implications have been widely debated. Biobanks: Governance in Comparative Perspective is the first book to explore the political and governance implications of biobanks in Europe, the United States, Asia, and Australia. This book explores: the interrelated conditions needed for a biobank to be created and to exist the rise of the new bio-economy the redefinition of citizenship accompanying national biobank developments This groundbreaking book makes clear that biobanks are a phenomenon that cannot be disconnected from considerations of power, politics, and the reshaping of current practices in governance. It will be a valuable read for scholars and students of genetics, bioethics, risk, public health and the sociology of health and illness.

Governing Biobanks

Governing Biobanks
  • Author : Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart
  • Publisher :Unknown
  • Release Date :2012-02-03
  • Total pages :380
  • ISBN : 9781847318848
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Summary : Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.

Biobanks

Biobanks
  • Author : Antonella De Robbio
  • Publisher :Unknown
  • Release Date :2012-11-26
  • Total pages :70
  • ISBN : 9781908818614
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Summary : Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages and disadvantages of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term ‘biobank’ came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault. Considers biobanks as both repositories and as collections of tangible assets Argues that the data in biobanks represents a high value intangible asset Explores regulatory gaps exploited by the private sector

Comparative Issues in the Governance of Research Biobanks

Comparative Issues in the Governance of Research Biobanks
  • Author : Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti
  • Publisher :Unknown
  • Release Date :2013-01-30
  • Total pages :339
  • ISBN : 9783642331169
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Summary : In the last few years, the boom in biobanking has prompted a lively debate on a host of interrelated legal issues, such as the Gordian knot of the ownership of biological materials, as well as privacy concerns. The latter are due to the difficulty of accepting that biological samples must be completely anonymous without making it practically impossible to exploit their information potential. The issues also include the delicate role and the changing content of the donor’s “informed consent” as the main legal tool that may serve to link the privacy and property interests of donors with the research interests and the set of principles that should be at the core of the biobanking practice. Lastly, the IP issues and the patentability of biological samples as well as the protection of databases storing genetic information obtained from the samples are covered. Collecting eighteen essays written by eminent scholars from Italy, the US, the UK and Canada, this book provides new solutions to these problems. From a comparative viewpoint, it explores the extent to which digital technology may assist in tackling the numerous regulatory issues raised by the practice of biobanking for research purposes. These issues may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property.

Biobanks as Essential Tools for Translational Research: The Belgian Landscape

Biobanks as Essential Tools for Translational Research: The Belgian Landscape
  • Author : Sofie J. S. Bekaert,Annelies Debucquoy,Veronique T’Joen,Laurent Georges Dollé,Loes Linsen
  • Publisher :Unknown
  • Release Date :2020-09-17
  • Total pages :229
  • ISBN : 9782889660162
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Summary :

Human Genetic Biobanks in Asia

Human Genetic Biobanks in Asia
  • Author : Margaret Sleeboom-Faulkner
  • Publisher :Unknown
  • Release Date :2008-11-19
  • Total pages :224
  • ISBN : 9781135784515
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Summary : This volume investigates human genetic biobanking and its regulation in various Asian countries and areas, including Japan, Mainland China, Taiwan, Hong Kong, India and Indonesia.. It sheds light on how cultural, socio-political and economic factors influence the set-up of bioethical regulation for human genetic biobanks and how bioethical sensitivities surrounding biobanks are handled. Apart from placing discourses of trust in an international perspective, the comparative materials presented in this volume also put into perspective the concepts of genetic theft and exploitation, and genetic wealth and trust. This collection contains case studies of biobanking practices in societies with different needs and welfare levels, and provides insights into government strategies towards genetic resources by examining bioethics as practised at home.

Governing Intellectual Property Rights Within Publicly Funded Biobanks

Governing Intellectual Property Rights Within Publicly Funded Biobanks
  • Author : Rajam Neethu
  • Publisher :Unknown
  • Release Date :2019-06-21
  • Total pages :352
  • ISBN : 9789403506227
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Summary : Governing Intellectual Property Rights Within Publicly Funded Biobanks R. Neethu The boom in biobanks and health databases as research infrastructures have evoked various legal and ethical debates. Since then numerous new developments have emerged such as digitalization, big-data research and artificial intelligence which has important implications for biobank-based research and collaborations. This new paradigm offers new legal challenges for commercial involvement particularly within a publicly funded setting. In this innovative book, the author shows that securing maximum social benefit out of the knowledge emanating from the use of biobank resources lies in managing intellectual property inputs and outputs effectively in keeping with the values core to such research. Focusing on the challenges of involving intellectual property rights (IPRs) particularly in the precompetitive phase of biobank-based research, the book offers an extensive understanding of the role of different IPRs and identifies the gaps in the law and its implications for biobanks. The analysis covers important aspects in relation to biobanks such as: Digital integration and biomedical data storage; Ownership of biological samples; Commercialization and benefit sharing; Partnership models; Public sector research; Disposition of samples; Consent; Cross-border exchange; Trade secrecy; Privacy; Regulatory stewardship; Business strategies; Ethical considerations over biological resources; Patenting of inventions relating to personalized medicine; Ethical parameters within patent law; and Rights regarding genetic data and databases. The book includes observations, case studies and interviews conducted by the author. In conclusion, the author offers cogent recommendations for legal interoperability of IP rules and research practices designed to enhance the ability of biobanks to share, access and reuse data. This book is the first of its kind to explore the organizational and legislative choices for biobanks particularly while engaging in the protection of research results and technology transfer within a publicly funded setting. It will be of substantial interest to all stakeholders in biobanking, especially policymakers, biobankers and researchers working in the field of health law as well as for legal practitioners, academics and patient interest groups.

Ethical Issues in Governing Biobanks

Ethical Issues in Governing Biobanks
  • Author : Nikola Biller-Andorno,Alexander M. Capron
  • Publisher :Unknown
  • Release Date :2016-05-13
  • Total pages :268
  • ISBN : 9781317141495
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Summary : Population genomics research drawing on genetic databases has expanded rapidly, with some of this information being combined in 'biobanks'. Managing this information in an appropriate way is a highly complex ethical issue in the health policy arena. This book combines theoretical and empirical research to analyze the areas of conflict and consensus in the regulatory and ethical frameworks that have been developed to govern biobanks. Ethicists from the Department of Ethics, Trade, Human Rights and Health Law (ETH) of the World Health Organization, the Institute of Biomedical Ethics of Geneva University and the Institute of Biomedical Ethics of the University of Zurich, with the support of the Geneva International Academic Network (GIAN), examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with experts around the world concerning the most unresolved and controversial issues. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.

Ethics, Law and Governance of Biobanking

Ethics, Law and Governance of Biobanking
  • Author : Deborah Mascalzoni
  • Publisher :Unknown
  • Release Date :2015-01-22
  • Total pages :277
  • ISBN : 9789401795739
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Summary : Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn’t only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.

Biobanking of Human Biospecimens

Biobanking of Human Biospecimens
  • Author : Pierre Hainaut,Jim Vaught,Kurt Zatloukal,Markus Pasterk
  • Publisher :Unknown
  • Release Date :2017-07-06
  • Total pages :240
  • ISBN : 9783319551203
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Summary : This volume is the first comprehensive text on human biobanking, authored by scientists and regulatory officers who have led the field over the past 10 years. It covers biobanking issues and its importance in advancing the field of research in cancer, cardiovascular, metabolic, and other diseases. Biobanks of human specimens have become the cornerstone for research on human health that harnesses the power of “omics” technologies to identify biomarkers for disease susceptibility. Biobanks are an essential component of the development of personalized medicine, which relies on the molecular analysis of biospecimens that are truly representative of individuals and of diseases. Over the past decade, biobanking has been the focus of major investments and developments aimed at developing appropriate infrastructure, methods, networking practice and evidence-based pre-analytical procedures. This volume explores topics including specimen storage, protocol design, specimen collection, pre-analytical processing and preservation, long-term storage, retrieval and separation, and distribution to analytical laboratory platforms. These activities are extremely complex and are essential for biomedical and biotechnological developments and this text provides critical information about biobanking for the development of future forms of medicine.​

GDPR and Biobanking

GDPR and Biobanking
  • Author : Santa Slokenberga
  • Publisher :Unknown
  • Release Date :2021
  • Total pages :229
  • ISBN : 9783030493882
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Summary :

Trust in Biobanking

Trust in Biobanking
  • Author : Peter Dabrock,Jochen Taupitz,Jens Ried
  • Publisher :Unknown
  • Release Date :2012-02-22
  • Total pages :266
  • ISBN : 9783540788454
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Summary : Biobanks are promising instruments of biomedical research and of transnational medicine in particular. Ethical, legal and social issues associated with biobanking, however, have recently led to a more critical view on this concept. All efforts addressing these concerns have been grounded on well-established standards of biomedical ethics such as informed consent procedures, protection of individual autonomy, benefit sharing etc. By additionally highlighting the widely neglected aspect of trust, this book aims at broadening the horizon of the ELSI-debate and thus filling a gap in current research on biobanking. The contributions of leading experts and junior researchers cover a wide field of disciplines relevant for biobanking including law, ethics, medicine, public health, social sciences, philosophy and theology.

New Challenges for Biobanks

New Challenges for Biobanks
  • Author : Kris Dierickx
  • Publisher :Unknown
  • Release Date :2009
  • Total pages :277
  • ISBN : STANFORD:36105134516223
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Summary : The book is a collection of papers presented during an international conference, held in Leuven May 18-20, 2009, organized by the Centre for Biomedical Ethics and Law of the Catholic University of Leuven and the GeneBanC project.

Advances in Biobanking Practice Through Public and Private Collaborations

Advances in Biobanking Practice Through Public and Private Collaborations
  • Author : Elena Salvaterra ,Julie Corfield
  • Publisher :Unknown
  • Release Date :2017-07-10
  • Total pages :135
  • ISBN : 9781681085104
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Summary : Advances in Biobanking Practice Through Public and Private Collaborations presents an analysis of methods and current models of partnership between public and private organizations designed to improve biobanking practices in European countries. Chapters describe the state-of-the-art of public-private collaborations in biobanking on a global scale, innovative approaches to public-private partnership the role of a quality management system in biobanking collaborations, quality standard criteria specifically shaped for tumor biobanks, theoretical and practical access conditions to biobanks, the general legal framework governing biobanks at national, European and international levels and a concrete public-private partnership model for managing sample requests. The contributions in this book include examples of established biobanking institutions (such as Spanish National Cancer Research Centre, National Institute of Health, Italy, and 3C-R, France among others) which serve to give readers a concrete perspective on current biobanking practices and relevant legal and ethical issues that shape the field. This book is an ideal handbook for all medical researchers, healthcare professionals and biobanking stakeholders seeking information about international biobanking practices and business models.

Ethical Issues in Governing Biobanks

Ethical Issues in Governing Biobanks
  • Author : Nikola Biller-Andorno,Alexander M. Capron
  • Publisher :Unknown
  • Release Date :2016-05-13
  • Total pages :268
  • ISBN : 9781317141488
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Summary : Population genomics research drawing on genetic databases has expanded rapidly, with some of this information being combined in 'biobanks'. Managing this information in an appropriate way is a highly complex ethical issue in the health policy arena. This book combines theoretical and empirical research to analyze the areas of conflict and consensus in the regulatory and ethical frameworks that have been developed to govern biobanks. Ethicists from the Department of Ethics, Trade, Human Rights and Health Law (ETH) of the World Health Organization, the Institute of Biomedical Ethics of Geneva University and the Institute of Biomedical Ethics of the University of Zurich, with the support of the Geneva International Academic Network (GIAN), examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with experts around the world concerning the most unresolved and controversial issues. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.

Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research

Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research
  • Author : International Agency for Research on Cancer
  • Publisher :Unknown
  • Release Date :2017-05-08
  • Total pages :104
  • ISBN : 9283224639
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Summary : Biobanking has developed at a rapid pace in recent years, initiated by the drive for personalized medicine and the need for high-quality biological resources, associated data for scientific research, and technological advancement of analytical platforms for molecular and genetic research. This book includes guidelines and recommendations for biobanks not only in high-income countries but also in low- and middle-income countries (LMICs). The recommendations are based on validated and/or evidence-based guidelines. The book also includes sections on sample sharing, ethical, legal, and social issues (ELSI) and harmonization guidelines that are important in supporting the collaborative research efforts that make use of biological materials. In particular, the section on open access deals with the principles of sharing and provides recommendations for biobanks in relation to sample and data sharing, which is key to establishing research collaboration. The section on governance provides guidelines on governance structures and standard templates for biobanks for transparent and effective running of the facilities. This book also benefits from the experience and knowledge gained by IARC from coordinating the LMICs Biobank and Cohort Building Network (BCNet) and managing an international biobank, which contains diverse collections of specimens and data drawn from studies across the world, including the EPIC (European Prospective Investigation into Cancer and Nutrition) collection.

Biobanking and Regenerative Medicine

Biobanking and Regenerative Medicine
  • Author : David T. Harris
  • Publisher :Unknown
  • Release Date :2020-11-19
  • Total pages :100
  • ISBN : 9783039435395
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Summary : Regenerative medicine and tissue engineering play significant roles in the treatment of currently intractable conditions, such as chronic heart failure, stroke, chronic osteoarthritis, and other maladies. Regenerative medicine and tissue engineering generally depend on the utilization of stem cells to treat patients but may also utilize mature cells that would not normally be considered as stem cells (e.g., skin). Stem cells (like mature cells) may be obtained from many sources in the body including bone marrow, cord blood, cord tissue, adipose tissue, etc. Although stem cells are often used in therapy immediately upon isolation, in many circumstances, the stem and progenitor cells will be harvested, processed and banked frozen until a later time. Biobanking is a convenient alternative to same-day therapeutic use, in that it allows for patient recovery (e.g., from liposuction), provides time to identify the best treatment options, and may allow for multiple interventions with additional patient inconvenience or risk.

Biobanking: How the Lack of a Coherent Policy Allowed the Veterans Administration to Destroy an Irreplaceable Collection ..., Serial No. 110-120, September 9, 2008, 110-2 Hearing, *

Biobanking: How the Lack of a Coherent Policy Allowed the Veterans Administration to Destroy an Irreplaceable Collection ..., Serial No. 110-120, September 9, 2008, 110-2 Hearing, *
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2009
  • Total pages :229
  • ISBN : STANFORD:36105050506737
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Summary :

Open Biobanks

Open Biobanks
  • Author : Jurate Breimelyte
  • Publisher :Unknown
  • Release Date :2018
  • Total pages :312
  • ISBN : 8449081750
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Summary : 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.

Principles and Practice in Biobank Governance

Principles and Practice in Biobank Governance
  • Author : Mark Stranger
  • Publisher :Unknown
  • Release Date :2016-04-15
  • Total pages :316
  • ISBN : 9781317075882
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Summary : Rapid technological advances, the establishment of large-scale biobanks, and the exchange of data across international boundaries raise a variety of questions for regulators struggling with the problem of how to govern such stores of information and the processes connected with them. Engaging with the pressing issues of privacy, consent, access to data, and benefit sharing, Principles and Practice in Biobank Governance draws together the latest empirical research from the UK, Europe, America, Australia and Asia to focus on these challenges. Current models of governance are critiqued, principles and policies are debated, and new models and theoretical frameworks are presented through this intellectually stimulating, informative volume. This truly international volume offers new insights from a range of disciplinary perspectives and will be essential reading for policy makers and scholars across a range of social sciences, including sociology, bioethics, law and social policy.