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The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe


The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe
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The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe


The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe
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Author : Nils Hoppe
language : en
Publisher: Universitätsverlag Göttingen
Release Date : 2011

The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe written by Nils Hoppe and has been published by Universitätsverlag Göttingen this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.


"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



Biobanks And Tissue 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.



Human Tissue Research


Human Tissue Research
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Author : Christian Lenk
language : en
Publisher: Oxford University Press, USA
Release Date : 2011-01-27

Human Tissue Research written by Christian Lenk and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-27 with Medical categories.


The use of human tissue for medical research and scientific progress raises many ethical and legal challenges. This multi-authored interdisciplinary text provides a fascinating insight into interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe.



The Ethics Of Research Biobanking


The Ethics Of Research Biobanking
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Author : Jan Helge Solbakk
language : en
Publisher: Springer Science & Business Media
Release Date : 2009-07-31

The Ethics Of Research Biobanking written by Jan Helge Solbakk 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 2009-07-31 with Medical categories.


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.



Gdpr And Biobanking


Gdpr And Biobanking
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Author : Jane Reichel
language : en
Publisher: Springer Nature
Release Date : 2021

Gdpr And Biobanking written by Jane Reichel and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Biobanks categories.


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. .



Biobanks And Tissue Research


Biobanks And Tissue Research
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Author : Christian Lenk
language : en
Publisher: Springer
Release Date : 2011-07-30

Biobanks And Tissue Research written by Christian Lenk and has been published by Springer 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.



Healthcare Research Ethics And Law


Healthcare Research Ethics And Law
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Author : Hazel Biggs
language : en
Publisher: Routledge
Release Date : 2009-10-16

Healthcare Research Ethics And Law written by Hazel Biggs and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-16 with Law categories.


The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.



Human Medical Research


Human Medical Research
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Author : Jan Schildmann
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-03-14

Human Medical Research written by Jan Schildmann 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 2012-03-14 with Medical categories.


Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.



Altruism Reconsidered


Altruism Reconsidered
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Author : Peter Sýkora
language : en
Publisher: Routledge
Release Date : 2016-04-01

Altruism Reconsidered written by Peter Sýkora and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-01 with Law categories.


As the use of human body parts has become increasingly commercialized, a need has arisen for new approaches to regulation that moves beyond the paradigm of altruism. During the course of this discussion, the notion of property has become a key concept. Focusing on practical and conceptual perspectives, the multidisciplinary group of authors, which includes specialists in philosophy, law, sociology, biology and medicine, have come together with practicing lawyers to consider both legal provisions and patterns of regulation in countries across Europe. Identifying divergences between different legal traditions, the authors explore various conceptual models which could be used to improve and to guide policy making. With this twin focus on practical and conceptual perspectives, this volume sets the standard for a detailed and innovative discussion of issues surrounding the regulation of research on human tissue.



Amniotic Membrane


Amniotic Membrane
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Author : Ana Catarina Mamede
language : en
Publisher: Springer
Release Date : 2015-07-14

Amniotic Membrane written by Ana Catarina Mamede and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-14 with Medical categories.


This book describes the human amniotic membrane from its origin, characterization and medical applications, summarizing all the latest developments and findings related to this tissue with contributions from some of the leading researchers in the field. The book addresses issues for its preservation, separation and identification of amniotic membrane-derived cells, as well as the potential ethical issues involved in their use. The topic of this book is particularly pertinent for clinicians and researchers involved in the research and use of this tissue.