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Author: Remigius N. Nwabueze
Publisher: Routledge
ISBN: 1317106415
Category : Law
Languages : en
Pages : 377
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Book Description
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.
Author: Remigius N. Nwabueze
Publisher: Routledge
ISBN: 1317106415
Category : Law
Languages : en
Pages : 377
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Book Description
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.
Author: Ruth Macklin
Publisher: Cambridge University Press
ISBN: 9780521541701
Category : Law
Languages : en
Pages : 292
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Book Description
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.
Author: Cheluchi Onyemelukwe-Onuobia
Publisher: Routledge
ISBN: 1351713051
Category : Business & Economics
Languages : en
Pages : 341
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Book Description
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.
Author: Jan Schildmann
Publisher: Springer Science & Business Media
ISBN: 3034803893
Category : Medical
Languages : en
Pages : 192
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Book Description
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: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
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Book Description
"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.
Author: Duff William Ramus Waring
Publisher: University of Toronto Press
ISBN: 0802086438
Category : Medical
Languages : en
Pages : 281
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Book Description
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.
Author: Belinda Bennett
Publisher: Springer Science & Business Media
ISBN: 1402041969
Category : Social Science
Languages : en
Pages : 225
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Book Description
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.
Author: United States. National Bioethics Advisory Commission
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 24
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Book Description
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: Katerina Sukovski
Publisher:
ISBN:
Category : Biology
Languages : en
Pages : 108
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Book Description
