Comparative Issues In The Governance Of Research Biobanks

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Comparative Issues in the Governance of Research Biobanks

Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti
Comparative Issues in the Governance of Research Biobanks Book PDF

Author : Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti
Publisher : Springer Science & Business Media
Page : 334 pages
File Size : 46,5 Mb
Release : 2013-01-30
Category : Law
ISBN : 9783642331169

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Comparative Issues in the Governance of Research Biobanks by Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti Pdf

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

Herbert Gottweis,Alan Petersen
Biobanks Book PDF

Author : Herbert Gottweis,Alan Petersen
Publisher : Routledge
Page : 248 pages
File Size : 45,7 Mb
Release : 2008-04-28
Category : Science
ISBN : 9781134090273

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Biobanks by Herbert Gottweis,Alan Petersen Pdf

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.

Ethics and Governance of Biomedical Research

Daniel Strech,Marcel Mertz
Ethics and Governance of Biomedical Research Book PDF

Author : Daniel Strech,Marcel Mertz
Publisher : Springer
Page : 225 pages
File Size : 43,8 Mb
Release : 2016-05-09
Category : Philosophy
ISBN : 9783319287317

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Ethics and Governance of Biomedical Research by Daniel Strech,Marcel Mertz Pdf

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.

Global Genes, Local Concerns

Timo Minssen,Janne Rothmar Herrmann,Jens Schovsbo
Global Genes Local Concerns Book PDF

Author : Timo Minssen,Janne Rothmar Herrmann,Jens Schovsbo
Publisher : Edward Elgar Publishing
Page : 304 pages
File Size : 44,5 Mb
Release : 2019
Category : LAW
ISBN : 9781788116190

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Global Genes, Local Concerns by Timo Minssen,Janne Rothmar Herrmann,Jens Schovsbo Pdf

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

Rajam Neethu
Governing Intellectual Property Rights Within Publicly Funded Biobanks Book PDF

Author : Rajam Neethu
Publisher : Kluwer Law International B.V.
Page : 342 pages
File Size : 50,5 Mb
Release : 2019-06-21
Category : Law
ISBN : 9789403506227

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Governing Intellectual Property Rights Within Publicly Funded Biobanks by Rajam Neethu Pdf

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.

GDPR and Biobanking

Jane Reichel,Santa Slokenberga,Olga Tzortzatou,Springer Nature
GDPR and Biobanking Book PDF

Author : Jane Reichel,Santa Slokenberga,Olga Tzortzatou,Springer Nature
Publisher : Springer Nature
Page : 432 pages
File Size : 41,8 Mb
Release : 2021
Category : Biobanks
ISBN : 9783030493882

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GDPR and Biobanking by Jane Reichel,Santa Slokenberga,Olga Tzortzatou,Springer Nature Pdf

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. .

Law, Development and Innovation

Giuseppe Bellantuono,Fabiano Teodoro Lara
Law Development and Innovation Book PDF

Author : Giuseppe Bellantuono,Fabiano Teodoro Lara
Publisher : Springer
Page : 215 pages
File Size : 46,5 Mb
Release : 2015-07-24
Category : Law
ISBN : 9783319133119

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Law, Development and Innovation by Giuseppe Bellantuono,Fabiano Teodoro Lara Pdf

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

Valentina Colcelli,Roberto Cippitani,Christoph Brochhausen-Delius,Rainer Arnold
GDPR Requirements for Biobanking Activities Across Europe Book PDF

Author : Valentina Colcelli,Roberto Cippitani,Christoph Brochhausen-Delius,Rainer Arnold
Publisher : Springer Nature
Page : 627 pages
File Size : 44,8 Mb
Release : 2024-01-27
Category : Law
ISBN : 9783031429446

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GDPR Requirements for Biobanking Activities Across Europe by Valentina Colcelli,Roberto Cippitani,Christoph Brochhausen-Delius,Rainer Arnold Pdf

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.

Global Governance of Intellectual Property in the 21st Century

Mark Perry
Global Governance of Intellectual Property in the 21st Century Book PDF

Author : Mark Perry
Publisher : Springer
Page : 254 pages
File Size : 43,8 Mb
Release : 2016-05-24
Category : Law
ISBN : 9783319311777

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Global Governance of Intellectual Property in the 21st Century by Mark Perry Pdf

This book analyses the governance foundations of innovation, brands, inventions, secrets and expression, which are the keys to a century based on knowledge. They are reflected in legal rights that have been fermenting over centuries of national policy deliberations on intellectual property rights, constantly in flux in the face of new advances in science, but overall a trend towards greater protectionism. As countries are challenged by the strictures of international agreements, often extorted through imbalanced power relationships, they seek their own national means for beneficial differentiation from the new global norms, whilst complying with international obligations. This book deals with the outcomes of regional governance of intellectual property, which often creates ripples in the search for harmony in the laws that form the basis for the future of intellectual property. The work has contributions that come from developing and developed nations, showing a common theme of the struggle to find the balance in an area of law that often does not provide clearcut solutions to real world environments. There are many intellectual property struggles illustrated in this work: patent at the boundaries of nature and invention, the need for drug development, which is driven by profit based on the patent monopoly; copyright, the expression of original thought, seeking to maximise exposure facilitated by the internet, but a system that facilitates rampant copying; trade marks, supporting company branding, seeks to exploit global branding through naming domains names; and other areas concomitant to the globalisation of intellectual property governance, such as foreign direct investment. This book holds up a mirror to the issues of world governance of intellectual property rights in this century, asking whether the direction we are currently following is in the best interest of global citizens, and showing the divergence that constraints are stimulating on a national level.

Biobanks

Antonella De Robbio
Biobanks Book PDF

Author : Antonella De Robbio
Publisher : Elsevier
Page : 70 pages
File Size : 53,9 Mb
Release : 2012-11-26
Category : Science
ISBN : 9781908818614

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Biobanks by Antonella De Robbio Pdf

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

Routledge Handbook of Medical Law and Ethics

Yann Joly,Bartha Maria Knoppers
Routledge Handbook of Medical Law and Ethics Book PDF

Author : Yann Joly,Bartha Maria Knoppers
Publisher : Routledge
Page : 607 pages
File Size : 43,8 Mb
Release : 2014-09-19
Category : Law
ISBN : 9781134448722

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Routledge Handbook of Medical Law and Ethics by Yann Joly,Bartha Maria Knoppers Pdf

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.

Property in the Body

Donna Dickenson
Property in the Body Book PDF

Author : Donna Dickenson
Publisher : Cambridge University Press
Page : 225 pages
File Size : 50,9 Mb
Release : 2017-06-22
Category : Law
ISBN : 9781107160774

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Property in the Body by Donna Dickenson Pdf

Commodification of the human body is gaining ground, strengthened by powerful interests. This book helps us understand and regulate it.

Contract and Regulation

Roger Brownsword,Rob A.J. van Gestel,Hans-W. Micklitz
Contract and Regulation Book PDF

Author : Roger Brownsword,Rob A.J. van Gestel,Hans-W. Micklitz
Publisher : Edward Elgar Publishing
Page : 400 pages
File Size : 44,7 Mb
Release : 2017-09-29
Category : Business ethics
ISBN : 9781784710668

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Contract and Regulation by Roger Brownsword,Rob A.J. van Gestel,Hans-W. Micklitz Pdf

Contract and Regulation: A Handbook on New Methods of Law Making in Private Law sheds light on the darker side of contracts. It begins by exploring the ‘regulatory space’ in which projects are planned, deals are done, and goods and services are consumed, then shows how a ‘bottom-up’ approach can be adopted in order to view this transactional space through the eyes of contractors. The expert contributors explore modes of governance that do not fit nicely into traditional contract theory, paying special attention to three key examples: governance and codes of conduction, networks and relations, compliance and use.

Specimen Science

Holly Fernandez Lynch,Barbara E. Bierer,I. Glenn Cohen,Suzanne M. Rivera
Specimen Science Book PDF

Author : Holly Fernandez Lynch,Barbara E. Bierer,I. Glenn Cohen,Suzanne M. Rivera
Publisher : MIT Press
Page : 440 pages
File Size : 50,7 Mb
Release : 2017-10-13
Category : Medical
ISBN : 9780262339728

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Specimen Science by Holly Fernandez Lynch,Barbara E. Bierer,I. Glenn Cohen,Suzanne M. Rivera Pdf

Legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in research using human biospecimens. Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research. After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators. Contributors Rebecca A. Anderson, Heide Aungs, Avery Avrakotos, Mark Barnes, Jill Barnholtz-Sloan, Benjamin Berkman, Barbara E. Bierer, Mark A. Borreliz, Jeffrey R. Botkin, Dan Brock, Ellen Wright Clayton, I. Glenn Cohen, Lisa Eckstein, Barbara J. Evans, Emily Chi Fogler, Nanibaa' A. Garrison, Pamela Gavin, Aaron J. Goldenberg, Christine Grady, Kate Gallin Heffernan, Marylana Saadeh Helou, Sara Chandros Hull, Elisa A. Hurley, Steven Joffe, Erin P. Johnson, Julie Kaneshiro, Aaron S. Kesselheim, Isaac Kohane, David Korn, Russell Korobkin, Bernard Lo, Geoffrey Lomax, Kimberly Hensle Lowrance, Holly Fernandez Lynch, Bradley A. Malin, Karen J. Maschke, Eric M. Meslin, P. Pearl O'Rourke, Quinn T. Ostrom, David Peloquin, Rebecca Pentz, Jane Perlmutter, Ivor Pritchard, Suzanne M. Rivera, Erin Rothwell, Andrew P. Rusczek, Rachel E. Sachs, Carol Weil, David Wendler, Benjamin Wilfond, Susan M. Wolf

Law, Technology and Society

Roger Brownsword
Law Technology and Society Book PDF

Author : Roger Brownsword
Publisher : Routledge
Page : 327 pages
File Size : 43,5 Mb
Release : 2019-02-18
Category : Law
ISBN : 9781351128162

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Law, Technology and Society by Roger Brownsword Pdf

This book considers the implications of the regulatory burden being borne increasingly by technological management rather than by rules of law. If crime is controlled, if human health and safety are secured, if the environment is protected, not by rules but by measures of technological management—designed into products, processes, places and so on—what should we make of this transformation? In an era of smart regulatory technologies, how should we understand the ‘regulatory environment’, and the ‘complexion’ of its regulatory signals? How does technological management sit with the Rule of Law and with the traditional ideals of legality, legal coherence, and respect for liberty, human rights and human dignity? What is the future for the rules of criminal law, torts and contract law—are they likely to be rendered redundant? How are human informational interests to be specified and protected? Can traditional rules of law survive not only the emergent use of technological management but also a risk management mentality that pervades the collective engagement with new technologies? Even if technological management is effective, is it acceptable? Are we ready for rule by technology? Undertaking a radical examination of the disruptive effects of technology on the law and the legal mind-set, Roger Brownsword calls for a triple act of re-imagination: first, re-imagining legal rules as one element of a larger regulatory environment of which technological management is also a part; secondly, re-imagining the Rule of Law as a constraint on the arbitrary exercise of power (whether exercised through rules or through technological measures); and, thirdly, re-imagining the future of traditional rules of criminal law, tort law, and contract law.