Principles and Practice in Biobank Governance

Author: Mark Stranger
Publisher: Routledge
ISBN: 1317075889
Format: PDF, ePub
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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.

Governing Biobanks

Author: Jane Kaye
Publisher: Bloomsbury Publishing
ISBN: 1847318843
Format: PDF, Kindle
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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.

Ethics Law and Governance of Biobanking

Author: Deborah Mascalzoni
Publisher: Springer
ISBN: 9401795738
Format: PDF, Mobi
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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.

Comparative Issues in the Governance of Research Biobanks

Author: Giovanni Pascuzzi
Publisher: Springer Science & Business Media
ISBN: 3642331165
Format: PDF
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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.

Governing Knowledge Commons

Author: Brett M. Frischmann
Publisher: Oxford University Press
ISBN: 0190225823
Format: PDF
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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.

The Limits to Governance

Author: Theo Papaioannou
Publisher: Routledge
ISBN: 1317025296
Format: PDF, Docs
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Does the state still frame debates about new technology? Can policy-makers ensure the benefits of health developments through genomics while still satisfying the expectations of society and the economic imperatives? In this critique of the new governance agenda for research and innovation in life sciences, the authors discuss the world-wide policy decisions needed, with particular reference to genomics. They suggest the many facets of policy and could be treated as a government-governance continuum, where different aspects of genomics may sit at different points, and co-exist. Their findings offer valuable insights for the future and will help promote a global solution to this problem.

The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe

Author: Katharina Beier
Publisher: Universitätsverlag Göttingen
ISBN: 3863950313
Format: PDF, ePub, Mobi
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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.

Biobanking of Human Biospecimens

Author: Pierre Hainaut
Publisher: Springer
ISBN: 3319551205
Format: PDF, Docs
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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.​

Routledge Handbook of Medical Law and Ethics

Author: Yann Joly
Publisher: Routledge
ISBN: 1134448724
Format: PDF, Kindle
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This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.

Genetics and Society

Author: Anne Kerr
Publisher: Routledge
ISBN: 1134494440
Format: PDF, Docs
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Genetic science has advanced rapidly in recent years; things happen now that might have seemed like science fiction only ten years ago. Genetics and Society looks at the history of this science and the wide-ranging impact it has had on contemporary society. Using fascinating and cutting-edge examples throughout, Anne Kerr examines topics as diverse as: the institutional structures that have grown up around the diagnosis and treatment of genetic disorders the media representation of genetic debates from designer babies to the genetic sources of alcoholism the politics of genetic decision-making and the state regulation of both genetic research and the biomedicine industry. Each chapter begins with a summary and a definition of key terms and ends with annotated notes on further reading, meaning that it is as accessible for the layman as it is for the scientist. The resulting student-friendly text will be essential reading for anybody with an interest in genetic science and the impact it is having on society.