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 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 Governing Biobanks written by Jane Kaye and published by Bloomsbury Publishing. This book was released on 2012-02-03 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.
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 The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe written by Nils Hoppe and published by Universitätsverlag Göttingen. This book was released on 2011 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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
Download or read book Genetics written by Lori B. Andrews and published by West Academic Publishing. This book was released on 2006 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the revised edition of the casebook, Genetics: Ethics, Law, and Policy, which has been used successfully in law schools in both the seminar and course context. It is authored by three of the nation's leading experts on genetic ethics, law and policy. Students enjoy the course because of the topicality of the subjects, many of which they hear about in the news (gene discoveries, embryo stem cell research). Faculty members enjoy teaching from the book because of the excellent teaching manual and because they can link it to other topics ? the casebook covers issues in health law, employment law, insurance law, criminal law, family law, and other fields. The casebook is supplemented regularly on the TWEN website, so that it is always current. A background in genetics is not required for either students or teachers. The casebook and teachers? manual are written so that the casebook can be used for undergraduate courses or courses for the health professions, for public health, or for public policy.
Download or read book The Immortal Life of Henrietta Lacks written by Rebecca Skloot and published by Crown. This book was released on 2010-02-02 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.
Download or read book The Oxford Handbook of Comparative Health Law written by David Orentlicher and published by Oxford University Press. This book was released on 2021-08-26 with total page 1135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Handbook of Comparative Health Law addresses some of the most critical issues facing scholars, legislators, and judges today: how to protect against threats to public health that can quickly cross national borders, how to ensure access to affordable health care, and how to regulate the pharmaceutical industry, among many others. When matters of life and death literally hang in the balance, it is especially important for policymakers to get things right, and the making of policy can be greatly enhanced by learning from the successes and failures of approaches taken in other countries. Where there are "common challenges" in law and health, there is much to be gained from experiences elsewhere. Thus, for example, countries that suffered early from the COVID-19 pandemic provided valuable lessons about public health interventions for countries that were hit later. Accordingly, the Handbook considers key health law questions from a comparative perspective. In health law, common challenges are frequent. In addition to ones already mentioned, there are questions about addressing the social determinants of health (e.g., poverty and pollution), organizing health systems to optimize use of available resources, ensuring that physicians provide care of the highest quality, protecting patient privacy in a data-driven world, and properly balancing patient autonomy with the interest in preserving life when reproductive and end-of-life decisions are made. This Handbook's wide scope and comparative take on health law are particularly timely. Economic globalization has made it increasingly important for different countries to harmonize their legal rules. Students, practitioners, scholars, and policymakers need to understand how health laws vary across national boundaries and how reforms can ensure a convergence toward an optimal set of legal rules, or ensure that specific legal arrangements are needed in particular contexts. Indeed, comparative analysis has become essential for legal scholars, and The Oxford Handbook of Comparative Health Law is the only resource that provides such an analysis in health law.
Download or read book Personalized Medicine in the Making written by Chiara Beneduce and published by Springer Nature. This book was released on 2022-03-07 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a multidisciplinary look at the much-debated concept of “personalized medicine”. By combining a humanistic and a scientific approach, the book builds up a multidimensional way to understand the limits and potentialities of a personalized approach in medicine and healthcare. The book reflects on personalized medicine and complex diseases, the relationship between personalized medicine and the new bio-technologies, personalized medicine and personalized nutrition, and on some ethical, political, economic, and social implications of personalized medicine. This volume is of interest to researchers from several disciplines including philosophy, bio-medicine, and the social sciences. Chapter 16, “The Impact of Fantasy” is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
Download or read book Governing Intellectual Property Rights Within Publicly Funded Biobanks written by Rajam Neethu and published by Kluwer Law International B.V.. This book was released on 2019-06-21 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Governing Intellectual Property Rights Within Publicly Funded Biobanks R. Neethu The boom in biobanks and health databases as research infrastructures have evoked various legal and ethical debates. Since then numerous new developments have emerged such as digitalization, big-data research and artificial intelligence which has important implications for biobank-based research and collaborations. This new paradigm offers new legal challenges for commercial involvement particularly within a publicly funded setting. In this innovative book, the author shows that securing maximum social benefit out of the knowledge emanating from the use of biobank resources lies in managing intellectual property inputs and outputs effectively in keeping with the values core to such research. Focusing on the challenges of involving intellectual property rights (IPRs) particularly in the precompetitive phase of biobank-based research, the book offers an extensive understanding of the role of different IPRs and identifies the gaps in the law and its implications for biobanks. The analysis covers important aspects in relation to biobanks such as: Digital integration and biomedical data storage; Ownership of biological samples; Commercialization and benefit sharing; Partnership models; Public sector research; Disposition of samples; Consent; Cross-border exchange; Trade secrecy; Privacy; Regulatory stewardship; Business strategies; Ethical considerations over biological resources; Patenting of inventions relating to personalized medicine; Ethical parameters within patent law; and Rights regarding genetic data and databases. The book includes observations, case studies and interviews conducted by the author. In conclusion, the author offers cogent recommendations for legal interoperability of IP rules and research practices designed to enhance the ability of biobanks to share, access and reuse data. This book is the first of its kind to explore the organizational and legislative choices for biobanks particularly while engaging in the protection of research results and technology transfer within a publicly funded setting. It will be of substantial interest to all stakeholders in biobanking, especially policymakers, biobankers and researchers working in the field of health law as well as for legal practitioners, academics and patient interest groups.
Download or read book Integrity of Scientific Research written by Joel Faintuch and published by Springer Nature. This book was released on 2022-10-13 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biobanks and Tissue Research written by Christian Lenk and published by Springer Science & Business Media. This book was released on 2011-07-30 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.
Download or read book Protecting Genetic Privacy in Biobanking through Data Protection Law written by Dara Hallinan and published by Oxford University Press. This book was released on 2021-03-11 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Hallinan argues that the substantive framework presented by the GDPR already offers an admirable base-line level of protection for the range of genetic privacy rights engaged by biobanking. The book further argues that, whilst numerous problems with this standard of protection are indeed identifiable, the GDPR offers the flexibility to accommodate solutions to these problems, as well as the procedural mechanisms to realise these solutions.
Download or read book Reciprocity in Population Biobanks written by Ma'n H. Zawati and published by Academic Press. This book was released on 2021-09-22 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book GDPR Requirements for Biobanking Activities Across Europe written by Valentina Colcelli and published by Springer Nature. This book was released on 2024-01-27 with total page 627 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Ethics of Cybersecurity written by Markus Christen and published by Springer Nature. This book was released on 2020-02-10 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides the first comprehensive collection of papers that provide an integrative view on cybersecurity. It discusses theories, problems and solutions on the relevant ethical issues involved. This work is sorely needed in a world where cybersecurity has become indispensable to protect trust and confidence in the digital infrastructure whilst respecting fundamental values like equality, fairness, freedom, or privacy. The book has a strong practical focus as it includes case studies outlining ethical issues in cybersecurity and presenting guidelines and other measures to tackle those issues. It is thus not only relevant for academics but also for practitioners in cybersecurity such as providers of security software, governmental CERTs or Chief Security Officers in companies.
Download or read book Ethics and Law of Intellectual Property written by Christian Lenk and published by Routledge. This book was released on 2016-05-13 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: Divided into three parts, this edited volume gives an overview of current topics in law and ethics in relation to intellectual property. It addresses practical issues encountered in everyday situations in politics, research and innovation, as well as some of the underlying theoretical concepts. In addition, it provides an insight into the process of international policy-making, showing the current problems in the area of intellectual property in science and research. It also highlights changes in the fundamental understanding of common and private property and the possible implications and challenges for society and politics.
