COMPARATIVE ISSUES IN THE GOVERNANCE OF RESEARCH BIOBANKS PROPERTY PRIVACY INTELLECTUAL PROPERTY AND THE ROLE OF TECHNOLOGY

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Comparative Issues In The Governance Of Research Biobanks

Author : Giovanni Pascuzzi
ISBN : 9783642331169
Genre : Law
File Size : 52.45 MB
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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.
Category: Law

Property In The Body

Author : Donna Dickenson
ISBN : 9781108211239
Genre : Law
File Size : 77.89 MB
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We live in an era when all bodies are potentially 'feminised' by being rendered 'open-access' for biomedical research and clinical practice. Adopting a theoretically sophisticated and practical approach, Property in the Body: Feminist Perspectives rejects the notion that the sale of bodily tissue enhances the freedom of the individual through an increase in moral agency. Combining feminist theory and bioethics, it also addresses the omissions which are inherent in policy analysis and academic debate. For example, whilst women's tissue is particularly central to new biotechnologies, the requirement for female labour is largely ignored in subsequent evaluation. In its fully revised second edition, this book also considers how policies and developments vary between countries and within specific areas of biomedicine itself. Most importantly, it analyses the new and emerging technologies of this field whilst returning to the core questions and fears which are inextricably linked to the commercialisation of the body.
Category: Law

The Sage Handbook Of Neoliberalism

Author : Damien Cahill
ISBN : 9781526415974
Genre : Political Science
File Size : 52.60 MB
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Over the last two decades, ‘neoliberalism’ has emerged as a key concept within a range of social science disciplines including sociology, political science, human geography, anthropology, political economy, and cultural studies. The SAGE Handbook of Neoliberalism showcases the cutting edge of contemporary scholarship in this field by bringing together a team of global experts. Across seven key sections, the handbook explores the different ways in which neoliberalism has been understood and the key questions about the nature of neoliberalism: Part 1: Perspectives Part 2: Sources Part 3: Variations and Diffusions Part 4: The State Part 5: Social and Economic Restructuring Part 6: Cultural Dimensions Part 7: Neoliberalism and Beyond This handbook is the key reference text for scholars and graduate students engaged in the growing field of neoliberalism.
Category: Political Science

Comparative Issues In The Governance Of Research Biobanks

Author : Giovanni Pascuzzi
ISBN : 3642439330
Genre : Law
File Size : 90.64 MB
Format : PDF, Docs
Download : 142
Read : 441

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.
Category: Law

Governing Biobanks

Author : Jane Kaye
ISBN : 9781847318848
Genre : Law
File Size : 41.36 MB
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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.
Category: Law

Law And Bioethics

Author : Michael D. A. Freeman
ISBN : STANFORD:36105134406730
Genre : Law
File Size : 67.62 MB
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Current Legal Issues, like its sister volume Current Legal Problems, is based upon an annual colloquium held at University College London. Each year, leading scholars from around the world gather to discuss the relationship between law and another discipline of thought. Each colloquium examines how the external discipline is conceived in legal thought and argument, how the law is pictured in that discipline, and analyses points of controversy in the use, and abuse, of extra-legal arguments within legal theory and practice. Law and Bioethics, the latest volume in the Current Legal Issues series, contains a broad range of essays by scholars interested in the interactions between law and bioethics. It includes studies examining the regulation of stem cell research, human rights and bioethics, the regulation of reproductive technologies, and distributive justice in healthcare and pandemic planning.
Category: Law

Genomic And Precision Medicine

Author : Geoffrey S. Ginsburg
ISBN : 9780128006566
Genre : Science
File Size : 27.21 MB
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Genomic and Precision Medicine: Translation and Implementation highlights the various points along the continuum from health to disease where genomic information is impacting clinical decision-making and leading to more personalization of health care. The book pinpoints the challenges, barriers, and solutions that have been, or are being, brought forward to enable translation of genome based technologies into health care. A variety of infrastructure (data systems and EMRs), policy (regulatory, reimbursement, privacy), and research (comparative effectiveness research, learning health system approaches) strategies are also discussed. Readers will find this volume to be an invaluable resource for the translational genomics and implementation science that is required to fully realize personalized health care. Provides a comprehensive volume on the translation and implementation of biology into health care provision Presents succinct commentary and key learning points that will assist readers with their local needs for translation and implementation Includes an up-to-date overview on major ‘translational events’ in genomic and personalized medicine, along with lessons learned
Category: Science

The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe

Author : Katharina Beier
ISBN : 9783863950316
Genre : Biobanks
File Size : 75.53 MB
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Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss. EU project ("Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis") to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results.
Category: Biobanks

Governing Knowledge Commons

Author : Brett M. Frischmann
ISBN : 9780190225827
Genre : Law
File Size : 45.12 MB
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"Knowledge commons" describes the institutionalized community governance of the sharing and, in some cases, creation, of information, science, knowledge, data, and other types of intellectual and cultural resources. It is the subject of enormous recent interest and enthusiasm with respect to policymaking about innovation, creative production, and intellectual property. Taking that enthusiasm as its starting point, Governing Knowledge Commons argues that policymaking should be based on evidence and a deeper understanding of what makes commons institutions work. It offers a systematic way to study knowledge commons, borrowing and building on Elinor Ostrom's Nobel Prize-winning research on natural resource commons. It proposes a framework for studying knowledge commons that is adapted to the unique attributes of knowledge and information, describing the framework in detail and explaining how to put it into context both with respect to commons research and with respect to innovation and information policy. Eleven detailed case studies apply and discuss the framework exploring knowledge commons across a wide variety of scientific and cultural domains.
Category: Law