Legal And Ethical Regulation Of Biomedical Research In Developing Countries
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Human Medical Research
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Author : Jan Schildmann
language : en
Publisher: Springer
Release Date : 2014-04-13
Human Medical Research written by Jan Schildmann and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-13 with Medical categories.
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.
Legal And Ethical Regulation Of Biomedical Research In Developing Countries
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Author : Dr Remigius N Nwabueze
language : en
Publisher: Ashgate Publishing, Ltd.
Release Date : 2013-05-28
Legal And Ethical Regulation Of Biomedical Research In Developing Countries written by Dr Remigius N Nwabueze and has been published by Ashgate Publishing, Ltd. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-28 with Law categories.
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.
Double Standards In Medical Research In Developing Countries
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Author : Ruth Macklin
language : en
Publisher: Cambridge University Press
Release Date : 2004-05-27
Double Standards In Medical Research In Developing Countries written by Ruth Macklin and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-05-27 with Law categories.
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.
Health Research Governance In Africa
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Author : Cheluchi Onyemelukwe-onuobia
language : en
Publisher: Routledge
Release Date : 2020-01-14
Health Research Governance In Africa written by Cheluchi Onyemelukwe-onuobia and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-14 with Human experimentation in medicine categories.
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.
Bioethics In Singapore
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Author : John Elliott
language : en
Publisher: World Scientific
Release Date : 2010
Bioethics In Singapore written by John Elliott and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
This book provides an analysis of the ways in which the BAC has established an ethical framework for biomedical research in Singapore, following the launch of the Biomedical Sciences Initiative by the Singapore Government. The editors and authors have an intimate knowledge of the working of the BAC, and the focus of the book includes the ways in which international forces have influenced the form and substance of bioethics in Singapore. Together, the authors offer a comparative account of the institutionalisation of biomedical research ethics in Singapore, considered in the wider context of international regulatory efforts. The book reviews the work of the BAC by placing it within the broader cultural, social and political discourses that have emerged in relation to the life sciences since the turn of the 21st century. This book is not primarily intended to be a retrospect or an appraisal of the contribution of the BAC, though this is one aspect of it. Rather, the main intention is to make a substantive contribution to the rapidly emerging field of bioethics. Ethical discussions in the book include consideration of stem cell research and cloning, genetics and research with human participants, and focus on likely future developments as well as the past.Many of the contributors of the book have been personally involved in this work, and hence they write with an authoritative first-hand knowledge that scholars in bioethics and public policy may appreciate. As indicated above, the book also explains the way in which ethics and science ? international and local ? have interacted in a policy setting. Scholars and policy makers may find the Singaporean experience to be a valuable resource, as the approach has been to make the ethical governance of research in Singapore consistent with international best practice while observing the requirements of a properly localised application of universally accepted principles. In addition, at least three chapters (the first three chapters in particular) are accessible to the lay reader interested in the development of bioethics and biomedical sciences, both inside and outside Singapore, from 2000 (the year in which the BAC was established). Both scholars and interested lay readers are therefore likely to find this publication a valuable reference.
Ethical And Policy Issues In International Research
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Author : United States. National Bioethics Advisory Commission
language : en
Publisher:
Release Date : 2001
Ethical And Policy Issues In International Research written by United States. National Bioethics Advisory Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Clinical trials categories.
Acceptable Risk In Biomedical Research
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Author : Sigmund Simonsen
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-01-04
Acceptable Risk In Biomedical Research written by Sigmund Simonsen and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-04 with Medical categories.
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.
The Ethical Aspects Of Biomedical Research In Developing Countries
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Author : Katerina Sukovski
language : en
Publisher:
Release Date : 2003
The Ethical Aspects Of Biomedical Research In Developing Countries written by Katerina Sukovski and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Biology categories.
The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe
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Author : Nils Hoppe
language : en
Publisher: Universitätsverlag Göttingen
Release Date : 2011
The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe written by Nils Hoppe and has been published by Universitätsverlag Göttingen this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.
"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
Ethics Law And Governance Of Biobanking
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Author : Deborah Mascalzoni
language : en
Publisher: Springer
Release Date : 2015-01-22
Ethics Law And Governance Of Biobanking written by Deborah Mascalzoni and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-01-22 with Medical categories.
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.