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Legal And Ethical Regulation Of Biomedical Research In Developing Countries
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Book Synopsis Legal and Ethical Regulation of Biomedical Research in Developing Countries by : Remigius N. Nwabueze
Download or read book Legal and Ethical Regulation of Biomedical Research in Developing Countries written by Remigius N. Nwabueze and published by Routledge. This book was released on 2016-04-22 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has been a rapid increase in the pace and scope of international collaborative research in developing countries in recent years. This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as the role of ethics committees. Providing a detailed analysis of the law of negligence and its application to research ethics committees and their members, common law and constitutional forms of action and potential negligence claims, the book concludes by suggesting new protocols and frameworks, improved regulation and litigation. This book will be a valuable guide for students, researchers, and policy-makers with an interest in medical law and ethics, bioethics, customary law in Africa and regulation in developing countries.
Book Synopsis Double Standards in Medical Research in Developing Countries by : Ruth Macklin
Download or read book Double Standards in Medical Research in Developing Countries written by Ruth Macklin and published by Cambridge University Press. This book was released on 2004-05-27 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.
Book Synopsis Health Research Governance in Africa by : Cheluchi Onyemelukwe-Onuobia
Download or read book Health Research Governance in Africa written by Cheluchi Onyemelukwe-Onuobia and published by Routledge. This book was released on 2018-09-06 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: The globalisation of research has resulted in the increased location of research involving humans in developing countries. Countries in Africa, along with China and India, have seen research grow significantly. With emerging infectious diseases, such as Ebola and Zika, emphasising the risk of public health crises throughout the world, a further increase in health research, including clinical research in developing countries, which are often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and the governance of health research. This book presents a comprehensive and systemic view of the regulation of research involving humans in African countries. It employs case studies from four countries in which research activities continue to rise, and which have taken steps to regulate health research activity: South Africa, Nigeria, Kenya, and Egypt. The book examines the historical and political contexts of these governance efforts. It describes the research context, some of the research taking place, and the current challenges. It also looks at the governance mechanisms, ranging from domestic ethical guidelines to legal frameworks, the strengthening of existing regulatory agencies to the role of professional regulatory bodies. The book analyses the adequacy of current governance arrangements within African countries, and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries. It book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the areas of health research, biomedical ethics, health law and regulation in developing countries.
Book Synopsis Human Medical Research by : Jan Schildmann
Download or read book Human Medical Research written by Jan Schildmann and published by Springer Science & Business Media. This book was released on 2012-03-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :World Health Organization ISBN 13 :9789290360889 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)
Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Book Synopsis Law and Ethics in Biomedical Research by : Duff William Ramus Waring
Download or read book Law and Ethics in Biomedical Research written by Duff William Ramus Waring and published by University of Toronto Press. This book was released on 2006-01-01 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
Book Synopsis Globalization and Health by : Belinda Bennett
Download or read book Globalization and Health written by Belinda Bennett and published by Springer Science & Business Media. This book was released on 2006-06-21 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within contemporary society, globalization has emerged as a key concern at the centre of ethical, legal and policy debates relating to health care. Conflicts between public interests and individual rights, the challenge of regulating health professionals and access to health services, and the effects of a global market all feature prominently in these discussions. As a result of globalization, these issues can no longer be understood solely within the political boundaries that define traditional notions of individuals and communities. Rather, solutions demand a global conception of rights and obligations, which in turn requires new approaches to health policy formulation and a reevaluation of existing ethical and legal frameworks. In essence, the impact of globalization on human health is testing the robustness of modern regulatory systems, legal doctrines and ethical paradigms. PUBLIC HEALTH: DEVELOPING GLOBAL CONCERNS The interconnectedness of the global economy presents new challenges in public health. While globalization has facilitated improvements in health care, it has also created new hazards and avenues for the exploitation of vulnerable persons. It is becoming increasingly apparent that both national and international responses are required. Indeed, as the chapters in this section convey, public health is rightly a global concern. Globalization has led to a sharing of both risks and responsibilities in public health. Belinda Bennett reminds us of the ease with which infectious diseases can spread within the global community, given the speed of modern travel and trade.
Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission
Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : ISBN 13 : Total Pages :614 pages Book Rating :4.:/5 (327 download)
Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Ethical Aspects of Biomedical Research in Developing Countries by : Katerina Sukovski
Download or read book The Ethical Aspects of Biomedical Research in Developing Countries written by Katerina Sukovski and published by . This book was released on 2003 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Routledge Handbook of Medical Law and Ethics by : Yann Joly
Download or read book Routledge Handbook of Medical Law and Ethics written by Yann Joly and published by Routledge. This book was released on 2014-09-19 with total page 607 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.
Book Synopsis The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe by : Nils Hoppe
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
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309379512 Total Pages :283 pages Book Rating :4.3/5 (93 download)
Book Synopsis Optimizing the Nation's Investment in Academic Research by : National Academies of Sciences, Engineering, and Medicine
Download or read book Optimizing the Nation's Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.
Book Synopsis Ethics, Law and Governance of Biobanking by : Deborah Mascalzoni
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 Beyond Consent written by Jeffrey P. Kahn and published by Oxford University Press. This book was released on 2018 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Since the publication of the first edition of Beyond Consent, issues of justice remain critical in discussions, debates, and policy making in biomedical research in involving human subjects. The second edition adds new content in two different ways, first by asking authors to examine the issues identified in the first edition by asking what has changed and what new issues arise in the contemporary environment, and second by adding chapters to take on issues that are salient today and looking forward. The result is a new treatment of the issues of justice in research through fresh perspectives and by examining the latest issues. The editors have assembled a group of leading scholars and researchers as contributors, and author the final chapter themselves. This collection is a vital resource for students and scholars of bioethics, medicine, and public health policy; as well as for members of institutional review boards (IRBs), research administrators, and policy makers."--
Book Synopsis Human Population Genetic Research in Developing Countries by : Yue Wang
Download or read book Human Population Genetic Research in Developing Countries written by Yue Wang and published by Routledge. This book was released on 2013-11-12 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the potential harm specific groups may suffer in genetic research, and the capacity for current frameworks of Western developed countries to provide adequate protections for these target populations. Using The People’s Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most discussion in this field focuses on the impact of genetic research on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. In evaluating current regulations concerning prevention of harm to vulnerable groups, the book also puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research.
Book Synopsis Acceptable Risk in Biomedical Research by : Sigmund Simonsen
Download or read book Acceptable Risk in Biomedical Research written by Sigmund Simonsen and published by Springer Science & Business Media. This book was released on 2012-01-04 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.
