Comparative Issues In The Governance Of Research Biobanks
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Comparative Issues In The Governance Of Research Biobanks
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Author : Giovanni Pascuzzi
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-01-30
Comparative Issues In The Governance Of Research Biobanks written by Giovanni Pascuzzi and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-30 with Law categories.
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
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Author : Herbert Gottweis
language : en
Publisher: Routledge
Release Date : 2008-04-28
Biobanks written by Herbert Gottweis and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-28 with Business & Economics categories.
This groundbreaking book makes it clear that biobanks are a phenomenon that cannot be disconnected from considerations of power, politics and the reshaping of current practices in governance.
Principles And Practice In Biobank Governance
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Author : Mark Stranger
language : en
Publisher: Routledge
Release Date : 2016-04-15
Principles And Practice In Biobank Governance written by Mark Stranger and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-15 with Social Science categories.
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.
Ethics And Governance Of Biomedical Research
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Author : Daniel Strech
language : en
Publisher: Springer
Release Date : 2016-05-09
Ethics And Governance Of Biomedical Research written by Daniel Strech and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-09 with Philosophy categories.
In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.
Biobanks And Tissue Research
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Author : Christian Lenk
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-07-30
Biobanks And Tissue Research written by Christian Lenk and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-30 with Medical categories.
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.
Global Genes Local Concerns
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Author : Timo Minssen
language : en
Publisher: Edward Elgar Publishing
Release Date : 2019
Global Genes Local Concerns written by Timo Minssen and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with LAW categories.
With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
Governing Intellectual Property Rights Within Publicly Funded Biobanks
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Author : Rajam Neethu
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2019-06-21
Governing Intellectual Property Rights Within Publicly Funded Biobanks written by Rajam Neethu and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-21 with Law categories.
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.
Governing Biobanks
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Author : Jane Kaye
language : en
Publisher: Bloomsbury Publishing
Release Date : 2012-02-03
Governing Biobanks written by Jane Kaye and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-03 with Law categories.
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.
Law Development And Innovation
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Author : Giuseppe Bellantuono
language : en
Publisher: Springer
Release Date : 2015-07-24
Law Development And Innovation written by Giuseppe Bellantuono and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-24 with Law categories.
This book deals with one strand of the intense debate concerning the links between law and development, namely the coordination of innovation processes and legal change. It analyzes how innovation, and ultimately development, can be fostered or hindered by existing or new legal infrastructures. The book includes eleven original contributions from senior and junior scholars and is divided into two parts, the first focusing on theoretical frameworks and the second presenting several case studies on various institutional aspects. A particular strength of this part is its broad geographical coverage, which encompasses the legal frameworks in Europe, the Americas, Africa, and Asia. The contributions collected in this book will be of value to a broad readership. Academic scholars will find useful information on lessons learned from reforms implemented in different areas and come to better understand the methodological hurdles involved in reform assessment. Policymakers in national and international organizations can draw on these studies when designing new programs. Lastly, practitioners in developed and developing countries can use these contributions to promote the success of current or new initiatives.
Gdpr Requirements For Biobanking Activities Across Europe
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Author : Valentina Colcelli
language : en
Publisher: Springer Nature
Release Date : 2024-01-27
Gdpr Requirements For Biobanking Activities Across Europe written by Valentina Colcelli and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-01-27 with Law categories.
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.