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

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 : 55,6 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

Human Tissue Research

Christian Lenk
Human Tissue Research Book PDF

Author : Christian Lenk
Publisher : Oxford University Press, USA
Page : 217 pages
File Size : 45,7 Mb
Release : 2011-01-27
Category : Medical
ISBN : 9780199587551

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Human Tissue Research by Christian Lenk Pdf

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.

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 : 48,6 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.

The Ethics of Research Biobanking

Jan Helge Solbakk,Soren Holm,B. Hofmann
The Ethics of Research Biobanking Book PDF

Author : Jan Helge Solbakk,Soren Holm,B. Hofmann
Publisher : Springer Science & Business Media
Page : 361 pages
File Size : 47,6 Mb
Release : 2009-07-31
Category : Medical
ISBN : 9780387938721

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The Ethics of Research Biobanking by Jan Helge Solbakk,Soren Holm,B. Hofmann Pdf

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

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 : 46,7 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. .

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
Page : 238 pages
File Size : 55,7 Mb
Release : 2013-11-27
Category : Medical
ISBN : 9400737319

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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.

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 : 51,7 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.

Healthcare Research Ethics and Law

Hazel Biggs
Healthcare Research Ethics and Law Book PDF

Author : Hazel Biggs
Publisher : Routledge
Page : 207 pages
File Size : 40,5 Mb
Release : 2009-10-16
Category : Law
ISBN : 9781135309282

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Healthcare Research Ethics and Law by Hazel Biggs Pdf

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

Jan Schildmann,Verena Sandow,Oliver Rauprich,Jochen Vollmann
Human Medical Research Book PDF

Author : Jan Schildmann,Verena Sandow,Oliver Rauprich,Jochen Vollmann
Publisher : Springer Science & Business Media
Page : 192 pages
File Size : 55,6 Mb
Release : 2012-03-14
Category : Medical
ISBN : 9783034803892

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Human Medical Research by Jan Schildmann,Verena Sandow,Oliver Rauprich,Jochen Vollmann Pdf

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.

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 : 40,7 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.

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.

Amniotic Membrane

Ana Catarina Mamede,Maria Filomena Botelho
Amniotic Membrane Book PDF

Author : Ana Catarina Mamede,Maria Filomena Botelho
Publisher : Springer
Page : 254 pages
File Size : 53,8 Mb
Release : 2015-07-14
Category : Medical
ISBN : 9789401799751

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Amniotic Membrane by Ana Catarina Mamede,Maria Filomena Botelho Pdf

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.

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 : 45,5 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.

Essentials of Tissue and Cells Banking

George Galea,Marc Turner,Sharon Zahra
Essentials of Tissue and Cells Banking Book PDF

Author : George Galea,Marc Turner,Sharon Zahra
Publisher : Springer Nature
Page : 288 pages
File Size : 54,5 Mb
Release : 2021-07-02
Category : Medical
ISBN : 9783030716219

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Essentials of Tissue and Cells Banking by George Galea,Marc Turner,Sharon Zahra Pdf

It has been 10 years since the first edition of ‘Essentials of Tissue Banking’ has been published. There is still relatively little published on the technical and scientific principles on routine tissue and cell banking based on scientific principles. The 1st edition was very successful and, after a 10 year gap, there is a need of an update and an expansion of the book’s remit. The format of the book follows that of the previous edition- split into 5 sections. Management of donors and the banking of common tissues and cells; Principles of storage and processing of tissues and cells; Ensuring the safety of the products by testing the donor, the tissues and the environment, supported by a quality system and an IT infrastructure- all working within the constraints of current regulatory and ethical environments. This edition however provides a significant update. Many the chapters have been completely rewritten by different experts. Like the 1st edition, they were given a free hand in the way they wrote their chapter, with a guideline that they had to be concise, clear and up to date. The authors were also asked to provide the scientific and technical basis that provides the rationale of the processes they describe. Also, the scope of the book has been somewhat extended. In view of the fact that many cellular therapies are now routinely practiced, 2 new chapters have been added: one on the banking of haematopoietic stem cells and one on human embryonic stem cells. They have been deliberately chosen to illustrate the extreme spectrum of cellular therapies from one of the simplest to one of the most complex. The intention of the book has remained the same: to cover and update banking of current practices in essential tissue and cell banking. It is therefore hoped that by keeping the book as concise and up to date as possible, it will find a place on the shelves of many tissue establishments.

Explorations in Baltic Medical History, 1850-2015

Nils Hansson,Jonatan Wistrand
Explorations in Baltic Medical History 1850 2015 Book PDF

Author : Nils Hansson,Jonatan Wistrand
Publisher : Rochester Studies in Medical H
Page : 272 pages
File Size : 54,8 Mb
Release : 2019
Category : History
ISBN : 9781580469401

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Explorations in Baltic Medical History, 1850-2015 by Nils Hansson,Jonatan Wistrand Pdf

Examines medical history in northern Europe from 1850 to 2015 and sheds new light on the circulation of medical knowledge in that region