Download or read book Biobanking of Human Biospecimens written by Pierre Hainaut and published by Springer. This book was released on 2017-06-06 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is the first comprehensive text on human biobanking, authored by scientists and regulatory officers who have led the field over the past 10 years. It covers biobanking issues and its importance in advancing the field of research in cancer, cardiovascular, metabolic, and other diseases. Biobanks of human specimens have become the cornerstone for research on human health that harnesses the power of “omics” technologies to identify biomarkers for disease susceptibility. Biobanks are an essential component of the development of personalized medicine, which relies on the molecular analysis of biospecimens that are truly representative of individuals and of diseases. Over the past decade, biobanking has been the focus of major investments and developments aimed at developing appropriate infrastructure, methods, networking practice and evidence-based pre-analytical procedures. This volume explores topics including specimen storage, protocol design, specimen collection, pre-analytical processing and preservation, long-term storage, retrieval and separation, and distribution to analytical laboratory platforms. These activities are extremely complex and are essential for biomedical and biotechnological developments and this text provides critical information about biobanking for the development of future forms of medicine.​

Download or read book Biobanking of Human Biospecimens written by Pierre Hainaut and published by Springer Nature. This book was released on 2021-08-25 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past 25 years, biobanks of human specimens have become a cornerstone for research on human health and have empowered the “omics “revolution that characterizes biomedical science in the XXIst Century. Today, biobanking of human specimens is a critical component of the interface between clinical practice and translational research, supporting the discovery and validation of new biomarkers of disease etiology, risk, early detection, diagnosis, prognosis, prediction and relapse. With the development of personalized medicine, biobanking of cryopreserved specimens has become standard practice in order to investigate genetic, transcriptomic, proteomic, metabolomics and immunological biomarkers useful to inform caregivers for therapeutic decisions. Data generated from biobanked specimens represent a rapidly growing and highly valuable resource, participating in the emergence of Big Data Medicine. With the development of large computing capabilities and artificial intelligence, data associated with biobanked specimens constitute a unique resource for the discovery and validation of new biomarkers and therapeutically actionable targets. Interconnecting, interoperating and sharing this data have become major issues for national health systems, raising enormous stakes as well as major societal, legal and cybersecurity challenges in terms of compliance with the protection of personal sensitive information. This book project is the second part of an initiative launched in 2012 to produce a published corpus of knowledge encompassing all aspects of human biobanking as a central practice for research and medicine. The first volume, published in 2017, is entitled: Human Biobanking: Principles and Practice. This first volume compiled a series of high level contributions overseeing the main developments that carried the progression of human biobanking as a research and biotechnological field over the past two decades. This new book project will constitute de facto Volume 2 of the same initiative, under the title: Biobanking of Human Biospecimens: lessons from 25 years of biobanking experience. Hence, the two volumes will share the same generic title (Biobanking of Human Biospecimens), with different subtitles, making clear that the two volumes are interrelated while highlighting their specificities in terms of what they actually cover. As a result, the two books are “twins” but can also be used independently of each other. The overarching aim of the two volumes of Biobanking of Human Biospecimens is to provide a published “one-stop shop” for state-of-the-art information on what constitutes the field of human biobanking, from conception of a biobank, standard operating procedures, ethical and societal aspects, governance, networking, interoperability and economic sustainability. This inclusive publication concept meets the needs of a vast readership, including scientists, doctors and technical staffs who are directly involved in biobanking operations, scientists in other disciplines that heavily rely on biobanking (such as genomics or proteomics), stakeholders and policy makers, and of course students for whom biobanking is becoming an important part of the training curriculum. So far, there has been a lack of major textbooks on biobanking. Documentation for biobanking is widely available through numerous publications, regulatory documents published by International or Governmental Agencies, and sets of recommendations essentially accessible through the Internet. However, it is difficult to access a single, top-of-the shelf reference that provides at a glance a large coverage of all aspects of human biobanking. Fulfilling this need is the main origin of the concept for this back-to-back publication project. To our knowledge, there is currently no other publication project with the same breath and scope as this one in the field of biobanking.

Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. .

Download or read book Ethics Law and Governance of Biobanking written by Deborah Mascalzoni and published by Springer. This book was released on 2015-01-22 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biobanking in the 21st Century written by Feridoun Karimi-Busheri and published by Springer. This book was released on 2015-09-29 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking, an emerging field supported by academia, industry and health administrators alike, is distinctly different today from the practice that once defined it. The science of Biobanking, which initially involved simply storing blood or tissue samples in a freezer, is now a highly sophisticated field of research, and expected to grow exponentially over the next decade or two. This book aims to serve the purpose of further enriching the available literature on Biobanking, by offering unique and more useful collection of ideas for the future. The book outlines the experiences of developing modern Biobanking repositories in different countries, whilst covering specific topics regarding the many aspects of Biobanking. This book will be of interest to a wide range of readers including: academics, students, volunteers and advocates of patients’ rights.

Download or read book Biobanks in Low and Middle Income Countries Relevance Setup and Management written by Karine Sargsyan and published by Springer Nature. This book was released on 2022-03-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces the fundamentals of biobanking and guides through the practical planning thereof, with a special focus on the situation in low- and middle-income countries. On the example of the setup of a Ukrainian biobank the book discusses the main steps and aspects of successful biorepository implementation and management. Topics covered include collection, storage and shipping of samples, establishment of an IT system, development of a sustainability plan, and project and risk management. Furthermore, the importance of the formation of international biobanking societies such as the Ukraine Association of Biobanks is highlighted, and their main objectives and tasks are discussed. The book addresses life science and business professionals as well as national authorities who are interested in biobanking in general and in setting up a biobank in particular.

Download or read book Population Biobank Studies A Practical Guide written by Zhengming Chen and published by Springer Nature. This book was released on 2020-12-09 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management. Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity. The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.

Download or read book Global Genes Local Concerns written by Timo Minssen and published by Edward Elgar Publishing. This book was released on 2019 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Research Ethics in the Arab Region written by Henry Silverman and published by Springer. This book was released on 2018-01-09 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the pressing issues involved with the ethical conduct of research in one developing world region – the Arab Region. Clinical research has soared in the developing world -as pharmaceutical companies continue their search for regions with large, treatment naive populations - including the Arab region, and has profound implications for the health and the economies for the area. The ethical issues involved with the conduct of such research, however, have so far not been adequately addressed. This volume presents the issues regarding research ethics and research governance that have relevance for health authorities, regulators, industry, and academia. As a multi-authored volume it includes both international and local experts on ethical issues in research, representing all stakeholders, thus presenting a balanced view on this timely topic.

Download or read book Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research written by International Agency for Research on Cancer and published by IARC Technical Reports. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking has developed at a rapid pace in recent years, initiated by the drive for personalized medicine and the need for high-quality biological resources, associated data for scientific research, and technological advancement of analytical platforms for molecular and genetic research. This book includes guidelines and recommendations for biobanks not only in high-income countries but also in low- and middle-income countries (LMICs). The recommendations are based on validated and/or evidence-based guidelines. The book also includes sections on sample sharing, ethical, legal, and social issues (ELSI) and harmonization guidelines that are important in supporting the collaborative research efforts that make use of biological materials. In particular, the section on open access deals with the principles of sharing and provides recommendations for biobanks in relation to sample and data sharing, which is key to establishing research collaboration. The section on governance provides guidelines on governance structures and standard templates for biobanks for transparent and effective running of the facilities. This book also benefits from the experience and knowledge gained by IARC from coordinating the LMICs Biobank and Cohort Building Network (BCNet) and managing an international biobank, which contains diverse collections of specimens and data drawn from studies across the world, including the EPIC (European Prospective Investigation into Cancer and Nutrition) collection.

Download or read book Manual of Biobank Quality Management written by Agnieszka Matera-Witkiewicz and published by Springer Nature. This book was released on 2023-02-14 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: This pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way. The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices. Aimed at both biobank employees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network. On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC „Quality Standards for Polish Biobanks” Handbook (QSPB).

Download or read book Biobanking written by William H. Yong and published by Humana Press. This book was released on 2018-12-14 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume not only discusses various common biobanking topics, it also delves into less-discussed subjects such as what is needed to start a biobank, training of new biobanking personnel, and ethnic representation in biospecimen research. Other chapters in this book span practical topics including: disaster prevention and recovery; information technology; flora and fauna preservation including zoological fluid specimen photography; surgical and autopsy biobanking; biobanking of bodily fluids; biosafety; cutting frozen sections; immunohistochemistry; nucleic acid extraction; and biospecimen shipping. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Unique and comprehensive, Biobanking: Methods and Protocols is a valuable resource for novice and practicing biobankers, and for end-user researchers. This book aims to bring new insight into the field and expand on current biomedical biobanking studies.

Download or read book Development and Implementation of an Enterprise wide Data Quality Improvement EDQI System for Biobanking Software written by James S. Morgan and published by . This book was released on 2015 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biobanking in the Era of the Stem Cell written by Jennifer C. Moore and published by Morgan & Claypool Publishers. This book was released on 2012 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: The study of mental health disorders and the genetics behind these disorders can be greatly enhanced by the use of induced pluripotent stem cells (iPSC). Since many mental health disorders develop after puberty, the only way in which to study the genetic mechanism of these diseases previously was through cellular surrogates, such as blood or cultured fibroblasts. Having the ability to reprogram adult cells to the pluripotent stage provides the capacity to study the onset of these disorders during a culture model of neural development and to include the impact of genetic risk factors and potential environmental triggers. Working with the National Institute of Mental Health (NIMH), the Rutgers Cell and DNA Repository (RUCDR) has begun banking iPSC source cells and converting those source cells into iPSC for distribution to the scientific community. Although initial protocols were developed to reprogram fibroblasts, the ability to reprogram blood cells has several advantages including less invasive collection, less post collection manipulation, and the large number of samples in existing collections. Here, we provide detailed protocols for reprogramming either fibroblasts with retroviral vectors or cryopreserved lymphocytes with Sendai viral vectors. Our goal is to support the discovery of effective treatments for mental health disorders. Table of Contents: Acknowledgments / Introduction / Appendix / General Protocols / References / Author Biographies

Download or read book Pre Analytics of Pathological Specimens in Oncology written by Manfred Dietel and published by Springer. This book was released on 2015-01-30 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents an overview of the most important current developments in the pre-analytical handling of tissue. It addresses in particular potential ways to improve the situation whereby methods employed in the pre-analytical phase – the period from surgical removal of tissue to the start of pathological processing – have remained essentially unchanged for decades with only modest standardization. It is examined how the pre-analytical period can be optimized, resulting not only in an increase in diagnostic quality but also in a reduction in processing time and costs. Among the key topics examined are the so-called cold ischemia time between tissue removal and fixation, the potential superiority of vacuum-based preservation over immediate formalin fixation, two-temperature fixation, molecular analysis methods, and the pre-analytics of specimens from particular tissues. Readers will find this book to be an important update that reveals the full importance of the pre-analytical phase for quality of pathological work-up.

Download or read book Biological Resource Centres Underpinning the Future of Life Sciences and Biotechnology written by OECD and published by OECD Publishing. This book was released on 2001-05-22 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and the genomics revolution are changing our world’s scientific-technological and socio-economic framework. A new type of raw material – one invisible to the naked eye – will become the essential ingredient of the life sciences and ...

Download or read book Biomedical Research and Integrated Biobanking An Innovative Paradigm for Heterogeneous Data Management written by Massimiliano Izzo and published by Springer. This book was released on 2016-03-17 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: This doctoral thesis reports on an innovative data repository offering adaptive metadata management to maximise information sharing and comprehension in multidisciplinary and geographically distributed collaborations. It approaches metadata as a fluid, loosely structured and dynamical process rather than a fixed product, and describes the development of a novel data management platform based on a schemaless JSON data model, which represents the first fully JSON-based metadata repository designed for the biomedical sciences. Results obtained in various application scenarios (e.g. integrated biobanking, functional genomics and computational neuroscience) and corresponding performance tests are reported on in detail. Last but not least, the book offers a systematic overview of data platforms commonly used in the biomedical sciences, together with a fresh perspective on the role of and tools for data sharing and heterogeneous data integration in contemporary biomedical research.