Gdpr And Biobanking
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Gdpr And Biobanking
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Author : Santa Slokenberga
language : en
Publisher: Springer Nature
Release Date : 2021-01-05
Gdpr And Biobanking written by Santa Slokenberga and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-05 with Law categories.
This open access book focuses on the discrepancies in biobank research regulations that are among the most significant hurdles to effective research collaboration. The General Data Protection Regulation (GDPR) has established stringent requirements for the processing of health and genetic data, while simultaneously allowing considerable multi-level exceptions for the purposes of scientific research. In addition to directly applicable exceptions, the GDPR places the regulatory responsibility for further defining how the Member States strike a balance between the individuals' rights and the public interest in research within their national legal orders. Since Member States' approaches to the trade-off between data subjects' rights on the one hand, and appropriate safeguards on the other, differ according to their ethical and legal traditions, their data protection requirements for research also differ considerably. This study takes a comprehensive approach to determine how the GDPR affects regulatory regimes on the use of personal data in biobanking research, with a particular focus on the balance between individuals' rights, public interest and scientific research. In this regard, it has two main goals: first, to scrutinize the GDPR research regime, its objective and constitutive elements, the impact it has on biobanking, and its role in a changing EU landscape post-Brexit; and second, to examine how various exceptions have been operationalized nationally, and what challenges and opportunities this diversification entails. The book not only captures the complexity GDPR creates for biobanking, but also sheds light on various approaches to tackling the corresponding challenges. It offers the first comprehensive analysis of GDPR for biobanking, and the most up-to-date overview of the national biobank regulatory frameworks in Europe.
Protecting Genetic Privacy In Biobanking Through Data Protection Law
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Author : Dara Hallinan
language : en
Publisher:
Release Date : 2021
Protecting Genetic Privacy In Biobanking Through Data Protection Law written by Dara Hallinan and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Law categories.
Hallinan argues that the substantive framework presented by the GDPR offers an admirable base-line level of protection for the range of genetic privacy rights engaged by biobanking.
Gdpr Requirements For Biobanking Activities Across Europe
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Author : Valentina Colcelli
language : en
Publisher: Springer Nature
Release Date : 2023-12-26
Gdpr Requirements For Biobanking Activities Across Europe written by Valentina Colcelli and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-26 with Law categories.
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.
Handbook On European Data Protection Law
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Author : Council of Europe
language : en
Publisher: Council of Europe
Release Date : 2018-04-15
Handbook On European Data Protection Law written by Council of Europe and has been published by Council of Europe this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-15 with Political Science categories.
The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.
Chesley S Hypertensive Disorders In Pregnancy
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Author : Robert N. Taylor
language : en
Publisher: Elsevier
Release Date : 2014-08-28
Chesley S Hypertensive Disorders In Pregnancy written by Robert N. Taylor and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-28 with Medical categories.
Chesley's Hypertensive Disorders in Pregnancy continues its tradition as one of the beacons to guide the field of preeclampsia research, recognized for its uniqueness and utility. Hypertensive disorders remain one the major causes of maternal and fetal morbidity and death. It is also a leading cause of preterm birth now known to be a risk factor in remote cardiovascular disease. Despite this the hypertensive disorders remain marginally studied and management is often controversial. The fourth edition of Chesley's Hypertensive Disorders in Pregnancy focuses on prediction, prevention, and management for clinicians, and is an essential reference text for clinical and basic investigators alike. Differing from other texts devoted to preeclampsia, it covers the whole gamut of high blood pressure, and not just preeclampsia. - Features new chapters focusing on recent discoveries in areas such as fetal programming, genomics/proteomics, and angiogenesis - Includes extensive updates to chapters on epidemiology, etiological considerations, pathophysiology, prediction, prevention, and management - Discusses the emerging roles of metabolic syndrome and obesity and the increasing incidence of preeclampsia - Each section overseen by one of the editors; each chapter co-authored by one of the editors, ensuring coherence throughout book
Reciprocity In Population Biobanks
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Author : Ma'n H. Zawati
language : en
Publisher: Academic Press
Release Date : 2021-09-22
Reciprocity In Population Biobanks written by Ma'n H. Zawati and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-22 with Medical categories.
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
Protecting Genetic Privacy In Biobanking Through Data Protection Law
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Author : Dara Hallinan
language : en
Publisher:
Release Date : 2021
Protecting Genetic Privacy In Biobanking Through Data Protection Law written by Dara Hallinan and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Biobanks categories.
Biobanks are critical infrastructure for medical research but they are also the subject of considerable ethical and legal uncertainty. Given that biobanks process large quantities of genomic data, questions have emerged as to how genetic privacy should be protected. What types of genetic privacy rights and rights holders should be protected and to what extent? Since 25th May 2018 the General Data Protection Regulation (GDPR) has applied and now occupies a key position in the European legal framework for the regulation of biobanking. This book takes an in-depth look at the function, problems, and opportunities presented by European data protection law under the GDPR as a framework for the protection of genetic privacy in biobanking in Europe.
Integrity Of Scientific Research
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Author : Joel Faintuch
language : en
Publisher: Springer Nature
Release Date : 2022-10-13
Integrity Of Scientific Research written by Joel Faintuch and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-13 with Medical categories.
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.
Biobanking Of Human Biospecimens
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Author : Pierre Hainaut
language : en
Publisher: Springer Nature
Release Date : 2021-08-25
Biobanking Of Human Biospecimens written by Pierre Hainaut and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-25 with Medical categories.
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.
Medical Genetics And Law
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Author : Mair Crouch
language : en
Publisher: Springer Nature
Release Date : 2025-04-28
Medical Genetics And Law written by Mair Crouch and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-04-28 with Law categories.
This book is an essential resource to understanding the intersection of medical genetics and law. In a unique approach, it provides an overview on the biological principles of DNA basics and genetic inheritance linking the knowledge with the ethical and legal challenges presented by modern developments in genetics. The first chapters educate the reader in key concepts such as cell division, genetic inheritance, genome study methods, genetic screening and testing across various countries. It further expands into complex issues where regulation is required, in particular: controversial aspects of genetic modifications, ethical concerns around patient confidentiality and biobanks' role in linking genetic variation to complex diseases. It includes legal cases regarding negligence claims from conception to adulthood and reflects on the impact of present and future developments in genomics on the law. Readers will gain a deeper understanding of how developments in genetics impact individuals and society, helping them navigate this rapidly evolving field. Given the interdisciplinary approach, the book is suitable for both medical and law students, practicing lawyers, medical practitioners, and genetic counselors. It is particularly beneficial for those who deal with medical negligence and need to understand the genetic aspects of such cases.