"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

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 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.

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.

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.

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

Founded during the Civil War as the Army Medical Museum, the Armed Forces Institute of Pathology (AFIP) amassed the world's largest collection of human pathologic specimens and was considered a premier consultation, education, and research facility by the end of the 20th century. Samples from the AFIP were instrumental in helping to solve public health mysteries, such as the sequence of the genome of the 1918 influenza virus that killed more than 40 million people worldwide. In 2005, the federal Base Realignment and Closure Commission recommended that the AFIP be closed, and its biorepository was transferred to the newly created Joint Pathology Center. During the transition, the Department of Defense asked the IOM to provide advice on operating the biorepository, managing its collection, and determining appropriate future use of specimens for consultation, education, and research. Future Uses of the Department of Defense Joint Pathology Center Biorepository, the IOM proposes a series of protocols, standards, safeguards, and guidelines that could help to ensure that this national treasure continues to be available to researchers in the years to come, while protecting the privacy of the people who provided the materials and maintaining the security of their personal information.

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.

This textbook is an ambitious and engaging introduction to the more advanced writings on medical law and ethics, primarily designed to allow students to 'get under the skin' of the topic and begin to build their critical thinking and analysis skills. Each chapter is structured around key questions and debates that provoke deeper thought and, ultimately, a clearer understanding. The aim of the book is not to present a complete overview of theoretical issues in medical law and ethics, but rather to illustrate the current debates which are currently going on among those working in and shaping the area. The text features summaries of the views of notable experts on key topics and each chapter ends with a list of guided further reading. A perfect book for students taking a module in medical law, or for those wanting to deepen their knowledge. New to this Edition: - The Supreme Court decision in Montgomery receives extensive discussion and analysis - Recent developments on the best interests test under the Mental Capacity Act are explored - The latest case law on end of life decision making is set out - Debates over whether abortion should be decriminalised are examined - The Charlie Gard case is considered

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. .