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Comparative Issues in the Governance of Research Biobanks

Comparative Issues in the Governance of Research Biobanks
Author: Giovanni Pascuzzi
Publisher: Springer Science & Business Media
Total Pages: 334
Release: 2013-01-30
Genre: Law
ISBN: 3642331165

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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.


Biobanking of Human Biospecimens

Biobanking of Human Biospecimens
Author: Pierre Hainaut
Publisher: Springer Nature
Total Pages: 210
Release: 2021-08-25
Genre: Medical
ISBN: 3030559017

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Over the past 25 years, biobanks of human specimens have become a cornerstone for research on human health and have empowered the “omics “revolution that characterizes biomedical science in the XXIst Century. Today, biobanking of human specimens is a critical component of the interface between clinical practice and translational research, supporting the discovery and validation of new biomarkers of disease etiology, risk, early detection, diagnosis, prognosis, prediction and relapse. With the development of personalized medicine, biobanking of cryopreserved specimens has become standard practice in order to investigate genetic, transcriptomic, proteomic, metabolomics and immunological biomarkers useful to inform caregivers for therapeutic decisions. Data generated from biobanked specimens represent a rapidly growing and highly valuable resource, participating in the emergence of Big Data Medicine. With the development of large computing capabilities and artificial intelligence, data associated with biobanked specimens constitute a unique resource for the discovery and validation of new biomarkers and therapeutically actionable targets. Interconnecting, interoperating and sharing this data have become major issues for national health systems, raising enormous stakes as well as major societal, legal and cybersecurity challenges in terms of compliance with the protection of personal sensitive information. This book project is the second part of an initiative launched in 2012 to produce a published corpus of knowledge encompassing all aspects of human biobanking as a central practice for research and medicine. The first volume, published in 2017, is entitled: Human Biobanking: Principles and Practice. This first volume compiled a series of high level contributions overseeing the main developments that carried the progression of human biobanking as a research and biotechnological field over the past two decades. This new book project will constitute de facto Volume 2 of the same initiative, under the title: Biobanking of Human Biospecimens: lessons from 25 years of biobanking experience. Hence, the two volumes will share the same generic title (Biobanking of Human Biospecimens), with different subtitles, making clear that the two volumes are interrelated while highlighting their specificities in terms of what they actually cover. As a result, the two books are “twins” but can also be used independently of each other. The overarching aim of the two volumes of Biobanking of Human Biospecimens is to provide a published “one-stop shop” for state-of-the-art information on what constitutes the field of human biobanking, from conception of a biobank, standard operating procedures, ethical and societal aspects, governance, networking, interoperability and economic sustainability. This inclusive publication concept meets the needs of a vast readership, including scientists, doctors and technical staffs who are directly involved in biobanking operations, scientists in other disciplines that heavily rely on biobanking (such as genomics or proteomics), stakeholders and policy makers, and of course students for whom biobanking is becoming an important part of the training curriculum. So far, there has been a lack of major textbooks on biobanking. Documentation for biobanking is widely available through numerous publications, regulatory documents published by International or Governmental Agencies, and sets of recommendations essentially accessible through the Internet. However, it is difficult to access a single, top-of-the shelf reference that provides at a glance a large coverage of all aspects of human biobanking. Fulfilling this need is the main origin of the concept for this back-to-back publication project. To our knowledge, there is currently no other publication project with the same breath and scope as this one in the field of biobanking.


New Challenges for Biobanks

New Challenges for Biobanks
Author: Kris Dierickx
Publisher:
Total Pages: 308
Release: 2009
Genre: Law
ISBN:

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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.


Global Genes, Local Concerns

Global Genes, Local Concerns
Author: Timo Minssen
Publisher: Edward Elgar Publishing
Total Pages: 304
Release: 2019
Genre: LAW
ISBN: 1788116194

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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.


Trust in Biobanking

Trust in Biobanking
Author: Peter Dabrock
Publisher: Springer Science & Business Media
Total Pages: 267
Release: 2012-02-22
Genre: Law
ISBN: 354078845X

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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.


Governing Intellectual Property Rights Within Publicly Funded Biobanks

Governing Intellectual Property Rights Within Publicly Funded Biobanks
Author: Rajam Neethu
Publisher: Kluwer Law International B.V.
Total Pages: 342
Release: 2019-06-21
Genre: Law
ISBN: 9403506229

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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.


The Ethics of Research Biobanking

The Ethics of Research Biobanking
Author: Jan Helge Solbakk
Publisher: Springer Science & Business Media
Total Pages: 361
Release: 2009-07-31
Genre: Medical
ISBN: 0387938729

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Biobanking, i.e. storage of biological samples or data emerging from such samples for diagnostic, therapeutic or research purposes, has been going on for decades. However, it is only since the mid 1990s that these activities have become the subject of considerable public attention, concern and debate. This shift in climate is due to several factors. The purpose of this book is to investigate some of the ethical, legal and social challenges raised by research biobanking in its different modern forms and formats. The issues raised by research biobanking in its modern form can be divided into four main clusters: how biological materials are entered into the bank; research biobanks as institutions; under what conditions researchers can access materials in the bank, and problems concerning ownership of biological materials and of intellectual property arising from such materials; and how the information is collected and stored, e.g. access-rights, disclosure, confidentiality, data security and data protection.


Biobanks and Tissue Research

Biobanks and Tissue Research
Author: Christian Lenk
Publisher: Springer Science & Business Media
Total Pages: 240
Release: 2011-07-30
Genre: Medical
ISBN: 9400716737

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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.


Principles and Practice in Biobank Governance

Principles and Practice in Biobank Governance
Author: Mark Stranger
Publisher: Routledge
Total Pages: 317
Release: 2016-04-15
Genre: Social Science
ISBN: 1317075889

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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.


GDPR and Biobanking

GDPR and Biobanking
Author: Jane Reichel
Publisher: Springer Nature
Total Pages: 432
Release: 2021
Genre: Biobanks
ISBN: 3030493881

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Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .