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 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 Governing Biobanks written by Jane Kaye and published by Bloomsbury Publishing. This book was released on 2012-02-03 with total page 380 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 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.
Download or read book The Oxford Handbook of Public Health Ethics written by Anna C. Mastroianni and published by Oxford University Press. This book was released on 2019-07-23 with total page 939 pages. Available in PDF, EPUB and Kindle. Book excerpt: Natural disasters and cholera outbreaks. Ebola, SARS, and concerns over pandemic flu. HIV and AIDS. E. coli outbreaks from contaminated produce and fast foods. Threats of bioterrorism. Contamination of compounded drugs. Vaccination refusals and outbreaks of preventable diseases. These are just some of the headlines from the last 30-plus years highlighting the essential roles and responsibilities of public health, all of which come with ethical issues and the responsibilities they create. Public health has achieved extraordinary successes. And yet these successes also bring with them ethical tension. Not all public health successes are equally distributed in the population; extraordinary health disparities between rich and poor still exist. The most successful public health programs sometimes rely on policies that, while improving public health conditions, also limit individual rights. Public health practitioners and policymakers face these and other questions of ethics routinely in their work, and they must navigate their sometimes competing responsibilities to the health of the public with other important societal values such as privacy, autonomy, and prevailing cultural norms. This Oxford Handbook provides a sweeping and comprehensive review of the current state of public health ethics, addressing these and numerous other questions. Taking account of the wide range of topics under the umbrella of public health and the ethical issues raised by them, this volume is organized into fifteen sections. It begins with two sections that discuss the conceptual foundations, ethical tensions, and ethical frameworks of and for public health and how public health does its work. The thirteen sections that follow examine the application of public health ethics considerations and approaches across a broad range of public health topics. While chapters are organized into topical sections, each chapter is designed to serve as a standalone contribution. The book includes 73 chapters covering many topics from varying perspectives, a recognition of the diversity of the issues that define public health ethics in the U.S. and globally. This Handbook is an authoritative and indispensable guide to the state of public health ethics today.
Download or read book The Ethics of Research Biobanking written by Jan Helge Solbakk and published by Springer Science & Business Media. This book was released on 2009-07-31 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking, i.e. storage of biological samples or data emerging from such samples for diagnostic, therapeutic or research purposes, has been going on for decades. However, it is only since the mid 1990s that these activities have become the subject of considerable public attention, concern and debate. This shift in climate is due to several factors. The purpose of this book is to investigate some of the ethical, legal and social challenges raised by research biobanking in its different modern forms and formats. The issues raised by research biobanking in its modern form can be divided into four main clusters: how biological materials are entered into the bank; research biobanks as institutions; under what conditions researchers can access materials in the bank, and problems concerning ownership of biological materials and of intellectual property arising from such materials; and how the information is collected and stored, e.g. access-rights, disclosure, confidentiality, data security and data protection.
Download or read book Publications and patent written by United States. Agricultural Research Service. Eastern Regional Research Center and published by . This book was released on 1981 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Download or read book Principles and Practice in Biobank Governance written by Mark Stranger and published by Routledge. This book was released on 2016-04-15 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid technological advances, the establishment of large-scale biobanks, and the exchange of data across international boundaries raise a variety of questions for regulators struggling with the problem of how to govern such stores of information and the processes connected with them. Engaging with the pressing issues of privacy, consent, access to data, and benefit sharing, Principles and Practice in Biobank Governance draws together the latest empirical research from the UK, Europe, America, Australia and Asia to focus on these challenges. Current models of governance are critiqued, principles and policies are debated, and new models and theoretical frameworks are presented through this intellectually stimulating, informative volume. This truly international volume offers new insights from a range of disciplinary perspectives and will be essential reading for policy makers and scholars across a range of social sciences, including sociology, bioethics, law and social policy.
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
