Ethics, Law and Governance of Biobanking PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Ethics, Law and Governance of Biobanking PDF full book. Access full book title Ethics, Law and Governance of Biobanking by Deborah Mascalzoni. Download full books in PDF and EPUB format.
Author: Deborah Mascalzoni Publisher: Springer ISBN: 9401795738 Category : Medical Languages : en Pages : 275
Book Description
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.
Author: Deborah Mascalzoni Publisher: Springer ISBN: 9401795738 Category : Medical Languages : en Pages : 275
Book Description
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.
Author: Jane Reichel Publisher: Springer Nature ISBN: 3030493881 Category : Biobanks Languages : en Pages : 432
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. .
Author: Jane Kaye Publisher: Bloomsbury Publishing ISBN: 1847318843 Category : Law Languages : en Pages : 407
Book Description
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.
Author: Timo Minssen Publisher: Edward Elgar Publishing ISBN: 1788116194 Category : Biobanks Languages : en Pages : 299
Book Description
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.
Author: Mark Stranger Publisher: Routledge ISBN: 1317075870 Category : Social Science Languages : en Pages : 442
Book Description
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.
Author: Lori B. Andrews Publisher: West Academic Publishing ISBN: Category : Law Languages : en Pages : 1000
Book Description
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.
Author: Rebecca Skloot Publisher: Crown ISBN: 0307589382 Category : Science Languages : en Pages : 386
Book Description
#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.
Author: Mark Stranger Publisher: Routledge ISBN: 1317075889 Category : Social Science Languages : en Pages : 317
Book Description
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.
Author: Nils Hoppe Publisher: Universitätsverlag Göttingen ISBN: 3863950313 Category : Medical Languages : en Pages : 183
Book Description
"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
Author: David Orentlicher Publisher: Oxford University Press ISBN: 0190846771 Category : Law Languages : en Pages : 1135
Book Description
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.
Author: Deborah Mascalzoni
Author: Deborah Mascalzoni
Author: Jane Reichel
Author: Jane Kaye
Author: Timo Minssen
Author: Mark Stranger
Author: Lori B. Andrews
Author: Rebecca Skloot
Author: Mark Stranger
Author: Nils Hoppe
Author: David Orentlicher