Ethics Law And Governance Of Biobanking

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Ethics, Law and Governance of Biobanking

Deborah Mascalzoni
Ethics Law and Governance of Biobanking Book PDF

Author : Deborah Mascalzoni
Publisher : Springer
Page : 275 pages
File Size : 40,8 Mb
Release : 2015-01-22
Category : Medical
ISBN : 9789401795739

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Ethics, Law and Governance of Biobanking by Deborah Mascalzoni Pdf

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.

New Challenges for Biobanks

Kris Dierickx
New Challenges for Biobanks Book PDF

Author : Kris Dierickx
Publisher : Unknown
Page : 308 pages
File Size : 46,6 Mb
Release : 2009
Category : Law
ISBN : STANFORD:36105134516223

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New Challenges for Biobanks by Kris Dierickx Pdf

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.

Trust in Biobanking

Peter Dabrock,Jochen Taupitz,Jens Ried
Trust in Biobanking Book PDF

Author : Peter Dabrock,Jochen Taupitz,Jens Ried
Publisher : Springer Science & Business Media
Page : 267 pages
File Size : 49,5 Mb
Release : 2012-02-22
Category : Law
ISBN : 9783540788454

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Trust in Biobanking by Peter Dabrock,Jochen Taupitz,Jens Ried Pdf

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.

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 : 41,9 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. .

Principles and Practice in Biobank Governance

Mark Stranger
Principles and Practice in Biobank Governance Book PDF

Author : Mark Stranger
Publisher : Routledge
Page : 316 pages
File Size : 43,7 Mb
Release : 2016-04-15
Category : Social Science
ISBN : 9781317075875

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Principles and Practice in Biobank Governance by Mark Stranger Pdf

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.

Principles and Practice in Biobank Governance

Jane Kaye,Mark Stranger
Principles and Practice in Biobank Governance Book PDF

Author : Jane Kaye,Mark Stranger
Publisher : Ashgate Publishing Company
Page : 292 pages
File Size : 44,6 Mb
Release : 2009
Category : Law
ISBN : 0754678253

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Principles and Practice in Biobank Governance by Jane Kaye,Mark Stranger Pdf

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.

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

Nils Hoppe,Silvia Schnorrer,Christian Lenk
The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe Book PDF

Author : Nils Hoppe,Silvia Schnorrer,Christian Lenk
Publisher : Universitätsverlag Göttingen
Page : 183 pages
File Size : 44,6 Mb
Release : 2011
Category : Medical
ISBN : 9783863950316

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The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe by Nils Hoppe,Silvia Schnorrer,Christian Lenk Pdf

"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"--Publisher's description

Governing Biobanks

Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart
Governing Biobanks Book PDF

Author : Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart
Publisher : Bloomsbury Publishing
Page : 380 pages
File Size : 48,9 Mb
Release : 2012-02-03
Category : Law
ISBN : 9781847318848

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Governing Biobanks by Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart Pdf

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 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 : 44,9 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.

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 : 51,7 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.

Ethical Issues in Governing Biobanks

Nikola Biller-Andorno,Alexander M. Capron
Ethical Issues in Governing Biobanks Book PDF

Author : Nikola Biller-Andorno,Alexander M. Capron
Publisher : Routledge
Page : 296 pages
File Size : 50,5 Mb
Release : 2016-05-13
Category : Science
ISBN : 9781317141488

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Ethical Issues in Governing Biobanks by Nikola Biller-Andorno,Alexander M. Capron Pdf

Population genomics research drawing on genetic databases has expanded rapidly, with some of this information being combined in 'biobanks'. Managing this information in an appropriate way is a highly complex ethical issue in the health policy arena. This book combines theoretical and empirical research to analyze the areas of conflict and consensus in the regulatory and ethical frameworks that have been developed to govern biobanks. Ethicists from the Department of Ethics, Trade, Human Rights and Health Law (ETH) of the World Health Organization, the Institute of Biomedical Ethics of Geneva University and the Institute of Biomedical Ethics of the University of Zurich, with the support of the Geneva International Academic Network (GIAN), examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with experts around the world concerning the most unresolved and controversial issues. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.

Governing Biobanks

Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart
Governing Biobanks Book PDF

Author : Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart
Publisher : Bloomsbury Publishing
Page : 380 pages
File Size : 42,8 Mb
Release : 2012-02-03
Category : Law
ISBN : 9781847318831

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Governing Biobanks by Jane Kaye,Susan Gibbons,Catherine Heeney,Andrew Smart Pdf

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.

Biobanks and Tissue Research

Christian Lenk,Judit Sándor,Bert Gordijn
Biobanks and Tissue Research Book PDF

Author : Christian Lenk,Judit Sándor,Bert Gordijn
Publisher : Springer Science & Business Media
Page : 240 pages
File Size : 55,6 Mb
Release : 2011-07-30
Category : Medical
ISBN : 9789400716735

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Biobanks and Tissue Research by Christian Lenk,Judit Sándor,Bert Gordijn Pdf

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

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 : 46,5 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 : 43,6 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.