Population Biobank Studies: A Practical Guide


Book Description

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.




GDPR and Biobanking


Book Description

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. .




Conducting Biosocial Surveys


Book Description

Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.




Epidemiological Studies: A Practical Guide


Book Description

To successfully conduct an epidemiological study, academic subject knowledge must be combined with careful consideration of the practical elements involved. From an academic perspective, insights into the basis of epidemiology, the concepts behind how we study diseases, and the challenges and limitations of the results that emerge are prioritised. However, the success of the academic analysis depends on how, when, and where the data used is collected. Epidemiological Studies: A Practical Guide focuses on the practical challenges of epidemiological data collection. Essential topics, such as how to choose the population to study, how to maximise participation and retention, and how to frame questions so that subjects provide the information required, are the core of the material presented. The book explains the skills needed to conduct a study where data is collected and presented accurately, and in appropriate formats. In addition to presenting a step-by-step guide to epidemiological investigations, the chapters in the book are accompanied by examples of how to phrase the letters and forms needed for each stage of conducting a study. Focusing on measurement, study designs, statistics, methodological issues, and key skills, the book provides a valuable background to epidemiological study. With detailed tables and figures, a clear chapter outline, and a straightforward index, the information presented is easily accessible and can quickly be applied to the reader's own work. Extensively revised, this new edition includes updates on case-crossover, Mendelian randomisation, and case-cohort. New chapters have been added to reflect the areas a student is now likely to encounter in an introductory epidemiological course, such as evidence synthesis, use of routine data, association or causation, feasibility, and pilot studies. Epidemiological Studies: A Practical Guide is ideal for students in epidemiology, public health, health research, and health services research. It is also highly relevant to post-graduate research students, and early stage clinical and non-clinical researchers.




Ethical Issues in Clinical Research


Book Description

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.




Health Informatics: Practical Guide Seventh Edition


Book Description

Health informatics is the discipline concerned with the management of healthcare data and information through the application of computers and other information technologies. The field focuses more on identifying and applying information in the healthcare field and less on the technology involved. Our goal is to stimulate and educate healthcare and IT professionals and students about the key topics in this rapidly changing field. This seventh edition reflects the current knowledge in the topics listed below and provides learning objectives, key points, case studies and extensive references. Available as a paperback and eBook. Visit the textbook companion website at http://informaticseducation.org for more information.--Page 4 de la couverture.




Biobanking of Human Biospecimens


Book Description

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.​




A Practical Guide to Drug Development in Academia


Book Description

"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review of first edition from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to start transforming their basic research discoveries into novel drugs. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. This comprehensive book lays out simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from discovery, optimization and preclinical studies through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. The SPARK model has been adopted in over 60 institutions on six continents, and the program has been honored with multiple awards including the 2020 Xconomy Award for Ecosystem Development, the 2020 Cures Within Reach Award for Patient Impact Research, and the 2022 California Life Sciences Pantheon Award for Academia, Non-Profits, & Research. The new edition updates every chapter with the latest developments since the 2014 publication of the first edition.




Biobanks in Low- and Middle-Income Countries: Relevance, Setup and Management


Book Description

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.