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. .

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.

Reciprocity in Population Biobanks: Relational Autonomy and the Duty to Inform in the Genomic Era begins by discussing how current judicial interpretation keeps standard of disclosure at the core of genomic research. The book then outlines multiple limitations individualistic autonomy faces in the context of gene and population biobanks, including an analysis of the complexities of benefit considerations in the research setting. Second, the book explores how individualistic autonomy fails to acknowledge the multilateral relationships implicated in genomic research, including those that affect the broader research community, research participants' families, and the general public. In carrying out this analysis, this book pays special attention to alternative approaches and ways researchers, public health officials, and judicial bodies might interact in years to come. In other words, implementing an understanding of relational autonomy that acknowledges and sustains the multilateral relationships found in genomic research without compromising the rights of participants. In short, this book proposes a reconceived duty to inform for researchers and a new standard of disclosure that is more meaningful and impactful for research participants and researchers. - Examines the limitations individualistic autonomy faces in the context of gene and population biobanks - Proposes a reconceived duty to inform for researchers and a new standard of disclosure more meaningful to genomic research participants - Suggests ways researchers, public health officials, and judicial bodies might interact to drive genomic research while still protecting research participants

This book provides a scientific and ethical approach to all forms of fraud and misconduct focusing on a scholarly however practice-oriented description of the problems, roots and potential solutions. Organized in dedicated parts, an international team of experts systematically analyzes the most prevalent forms of misconduct, ghost writing, pseudo-science, dubious trials, predatory journals, fake news, mistreatment and harassment, in research, publications, at academic institutions, and in the professional and healthcare environment. A special focus is given to corrective interventions and the role of prevention, education and training. Comprehensive in its scope, the book offers an easy-to-read overview along with a number of real cases for experienced and novice personnel alike. The significance of scientific integrity and research ethics increased during the last couple of years and ethic committees and offices have become an integral part at universities, hospitals, research institutions, government agencies and major private organizations all over the world. Thus, this book provides an indispensable, comprehensive overview across disciplines and for everybody working in research and affiliated institutions. Chapter 37 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. - Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine - Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology - Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

This new edition of the classic textbook on health informatics provides readers in healthcare practice and educational settings with an unparalleled depth of information on using informatics methods and tools. However, this new text speaks to nurses and — in a departure from earlier editions of this title — to all health professionals in direct patient care, regardless of their specialty, extending its usefulness as a textbook. This includes physicians, therapists, pharmacists, dieticians and many others. In recognition of the evolving digital environments in all healthcare settings and of interprofessional teams, the book is designed for a wide spectrum of healthcare professions including quality officers, health information managers, administrators and executives, as well as health information technology professionals such as engineers and computer scientists in health care. The book is of special interest to those who bridge the technical and caring domain, particularly nurse and medical informaticians and other informaticians working in the health sciences. Nursing Informatics: An Interprofessional and Global Perspective contains real-life case studies and other didactic features to illustrate the theories and principles discussed, making it an ideal resource for use within health and nursing informatics curricula at both undergraduate and graduate level, as well as for workforce development. It honors the format established by the previous editions by including a content array and questions to guide the reader. Readers are invited to look out of the box through a dedicated global perspective covering health informatics applications in different regions, countries and continents.

Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law at EU level affecting the physician-patient relationship and the interaction of physicians with other healthcare providers and the healthcare system. Although the legal aspects of healthcare in Europe most often fall under national law, the past two decades have witnessed the emergence of a distinctive field of EU health law with its own underlying principles and structural coherence, founded in a series of directives and CJEU decisions. This book examines the areas in which EU law now must be taken into account in healthcare, including aspects of patients’ rights, recognition of professional qualifications and minimum training conditions, professional rules of conduct, clinical trials and investigations of medicinal products and medical devices, health and genetic data, and beginning and end of life issues. Succinct and practical, this book will prove to be of great value to professional organizations of physicians, nurses, hospitals, and relevant government agencies. Lawyers representing parties with interests in the European Union will welcome this very useful guide, and academics and researchers will appreciate its comparative value as a contribution to the study of health law and medical law in the international context.

The Handbook of Bioethical Decisions is aimed at addressing and analyzing the most important ethical concerns and moral quandaries arisen in biomedical and scientific research. As such, it identifies and problematizes on a comprehensive range of ethical issues researchers must deal with in different critical contexts. Thus, the Handbook, Vol. I, may be helpful for them to make decisions and deliberate in complex practical scenarios. In this fashion, the volume reunites different points of view to give readers room enough to get a better knowledge and take their own position on pressing bioethical issues of the day. Consequently, this work seeks to engender dense ethical epistemology scientists can count on when conducting latest generation biomedical research. By bringing together an impressive array of contributions on the most important elements and categories for “at the bench” bioethical decisions as well as offering chapters by some of the most world renowned and prominent experts in bioethics, the Handbook, Vol. I, is a paradigmatic text in its area and a valuable resource for courses on bioethics, and biomedical research, as well as courses that discuss ethics and the biosciences at different professional levels, biomedical industry, pharmacological companies and the public sphere in general.

This book provides an introduction into the field of digital medicine, its wide spectrum of current clinical applications, and the future practice of medicine. With "digital health" and "digital medicine" at its core, it focuses on the combination of therapeutics with modern hard- and software solutions, including artificial intelligence and advanced diagnostic technologies such as augmented imaging and ingestible or wearable (nano)sensors, to provide best patient care. In the four parts of this book, experts in the field have authored use cases and guiding principles on the visualization of patient data analytics and clinical decision support tools, including robotic-guided interventions, as well as nursing research along with palliative and inpatient care. The book also provides examples of "digital medicine" from almost all clinical disciplines together with technical and e-learning solutions.