"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 National Human Monitoring Program (NHMP) identifies concentrations of specific chemicals in human tissues, including toxicologic testing and risk assessment determinations. This volume evaluates the current activities of the NHMP; identifies important scientific, technical, and programmatic issues; and makes recommendations regarding the design of the program and use of its products.

Brain Banking, Volume 150, serves as the only book on the market offering comprehensive coverage of the functional realities of brain banking. It focuses on brain donor recruitment strategies, brain bank networks, ethical issues, brain dissection/tissue processing/tissue dissemination, neuropathological diagnosis, brain donor data, and techniques in brain tissue analysis. In accordance with massive initiatives, such as BRAIN and the EU Human Brain Project, abnormalities and potential therapeutic targets of neurological and psychiatric disorders need to be validated in human brain tissue, thus requiring substantial numbers of well characterized human brains of high tissue quality with neurological and psychiatric diseases. - Offers comprehensive coverage of the functional realities of brain banking, with a focus on brain donor recruitment strategies, brain bank networks, ethical issues, and more - Serves as a valuable resource for staff in existing brain banks by highlighting best practices - Enhances the sharing of expertise between existing banks and highlights a range of techniques applicable to banked tissue for neuroscience researchers - Authored by leaders from brain banks around the globe – the broadest, most expert coverage available

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. .

DIVA cultural studies account of how the "bio-value" of blood, stem cells, organs, and cell lines moves back and forth between 'gift' and 'commodity'./div

This important book discusses the need for gamma irradiation in the processing of tissue allografts. With particular emphasis on tissue banking in the Asia-Pacific region, it covers a wide range of issues in tissue banking, including the basic science of radiation, quality control of the irradiation process, and clinical applications of irradiated bone grafts and amnions.A compulsory textbook for the well-regarded Singapore-based IAEA/NUS Diploma Course in Tissue Banking, it is also a useful guide for tissue bankers in establishing quality systems in their banks. Whether they be tissue banking students, tissue graft producers, radiation scientists, or transplantation surgeons, readers of this book will discover the latest developments in this exciting interdisciplinary field.

Transfusion Medicine, Apheresis, and Hemostasis: Review Questions and Case Studies is the collaborative effort that spanned a time period of 2 years and included 50 experts, many whom are national leaders in their respected fields. It also represents the passion and privilege we feel to teach the next generation of physicians in Transfusion Medicine and Apheresis. The main goal for this book is to help the readers build a solid foundation of both basic and advanced conceptual knowledge to prepare for the American Board of Pathology (ABP) certification exam in Transfusion Medicine. This book is not intended to be a substitute for textbooks, original research or review articles, and/or clinical training. Further, since the field of medicine, both from a scientific and regulatory perspective, rapidly changes, the readers are advised to continuously update their knowledge by attending national meetings and reading clinical journals. To equip the readers with the basic knowledge in critical reading and data analysis, which is an essential skill in daily medical practice, a novel chapter titled "Data Interpretation in Laboratory Medicine was included in this book. In this chapter, the readers are asked to make logical conclusions based on the given data and/or statistical results. Moreover, there is also a chapter on "Practical Calculations in Transfusion Medicine, Apheresis, and Hemostasis to help consolidate all the necessary formulas commonly used in daily practice for easy reference. These chapters are unique to our book and will not be found in any other currently on the market. All of the questions in this book were originally created by the authors of each chapter. Each question can either be standalone or part of a case scenario representing challenge cases in Transfusion Medicine, Apheresis, and Hemostasis. These questions often represent both rare and common clinical scenarios that the authors have seen during their clinical practice. Each question is then followed by 5 possible answers, with only one being correct (or the best answer). After the question, there is a conceptual explanation followed by a more factual explanation of the right and wrong answers. We gave the individual authors the freedom to choose how they explained the wrong answer choices. Some authors chose to be more direct (e.g. Answer A is incorrect because...), while other authors chose a more conversational style (e.g. Human resources (answer A) includes staffing, selection, orientation, training, and competency assessment of employees). This format is designed to help the student linking the conceptual and factual knowledge together to form a solid foundation for use in clinical practice. At the end of each chapter, there is a list of articles and textbooks that will prove useful to the motivated student who wishes to become an expert in the field. Another special feature to our textbook is the presence of a pre-test and post-test, which are provided to help the readers with self-assessment. As stated above, the main focus of this book is to help the readers preparing for the ABP certification exam in Transfusion Medicine. However, due to the interdisciplinary nature of the field of Transfusion Medicine, Apheresis, and Hemostasis, we believe that this book is also beneficial to and can be used by all clinicians involved in the management of complex transfusion, apheresis, and hemostasis issues, such as hematologists, anesthesiologists, surgeons, and critical care physicians. We further believe that it is a helpful guide for these specialists to prepare for their own specialty certification exam, when the topics are related to Transfusion Medicine, Apheresis, and Hemostasis.

Xenotransplantation involves the transplantation of cells, tissues, and whole organs from one species to another. Interest in animal-to-human xenotransplants has been spurred by the continuing shortage of donated human organs and by advances in knowledge concerning the biology of organ and tissue rejection. The scientific advances and promise, however, raise complex questions that must be addressed. This book considers the scientific and medical feasibility of xenotransplantation and explores the ethical and public policy issues surrounding the possibility of renewed clinical trials. The volume focuses on the science base of xenotransplantation, public health risks of infectious disease transmission, and ethical and public policy issues, including the views of patients and their families.