Double Standards In Medical Research In Developing Countries
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Double Standards in Medical Research in Developing Countries by Ruth Macklin Pdf
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.
Post-Trial Access to Drugs in Developing Nations by Evaristus Chiedu Obi Pdf
This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in developing countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries – patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular.
Legal and Ethical Regulation of Biomedical Research in Developing Countries by Remigius N. Nwabueze Pdf
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.
Health Research Governance in Africa by Cheluchi Onyemelukwe-Onuobia Pdf
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.
Human Medical Research by Jan Schildmann,Verena Sandow,Oliver Rauprich,Jochen Vollmann Pdf
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.
The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel Pdf
The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings.
Practical Decision Making in Health Care Ethics by Raymond J. Devettere Pdf
For more than twenty years Practical Decision Making in Health Care Ethics has offered scholars and students a highly accessible and teachable alternative to the dominant principle-based theories in the field. Raymond J. Devettere's approach is not based on an ethics of abstract obligations and duties but, following Aristotle, on how to live a fulfilled and happy life—in short, an ethics of personal well-being grounded in prudence, the virtue of ethical decision making. New sections added in this revised fourth edition include sequencing whole genomes, even those of newborns; the new developments in genetic testing now provided by online commercial companies such as 23andMe; the genetic testing of fetuses by capturing their DNA circulating in the pregnant woman's blood; the Stanford Prison experiment and its relevance to the abuses at the Abu Graib prison; recent breakthroughs in the diagnosis of consciousness disorders such as PVS; the ongoing controversy generated by the NIH study of premature babies at many NICUs throughout the county, a study known as SUPPORT that the OHRP (Office of Human Research Protections, an office within the department of HHS) deemed unethical. Devettere updates most chapters. New cases include Marlise Munoz (dead pregnant woman's body kept on life support by a Texas hospital), Jahi McMath (teenager pronounced dead in California but treated as alive in New Jersey), Margot Bentley (nursing home feeding a woman dying of end stage Alzheimer’s despite her advance directive that said no nourishment or liquids if she was dying with dementia), Brittany Maynard (dying 29-year-old California woman who moved to Oregon to commit suicide with a physician's help), and Samantha Burton (woman with two children who suffered rupture of membranes at 25 weeks and whose physician obtained a court order to keep her at the hospital to make sure she stayed on bed rest). Thoughtfully updated and renewed for a new generation of readers, this classic textbook will be required reading for students and scholars of philosophy and medical ethics.
Rethinking the Ethics of Clinical Research by Alan Wertheimer Pdf
Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
Equitable Access to Human Biological Resources in Developing Countries by Roger Scarlin Chennells Pdf
The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: • Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. • With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). • Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement.
Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings by Patricia A. Marshall,Patricia Loomis Marshall Pdf
This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.
Ethical and Legal Issues in Neurology by James L. Bernat,Richard Beresford Pdf
Advances in our understanding of the brain and rapid advances in the medical practice of neurology are creating questions and concerns from an ethical and legal perspective. Ethical and Legal Issues in Neurology provides a detailed review of various general aspects of neuroethics, and contains chapters dealing with a vast array of specific issues such as the role of religion, the ethics of invasive neuroscience research, and the impact of potential misconduct in neurologic practice. The book focuses particular attention on problems related to palliative care, euthanasia, dementia, and neurogenetic disorders, and concludes with examinations of consciousness, personal identity, and the definition of death. This volume focuses on practices not only in North America but also in Europe and the developing world. It is a useful resource for all neuroscience and neurology professionals, researchers, students, scholars, practicing clinical neurologists, mental health professionals, and psychiatrists. A comprehensive introduction and reference on neuroethics Includes coverage of how best to understand the ethics and legal aspects of dementia, palliative care, euthanasia and neurogenetic disorders Brings clarity to issues regarding ethics and legal responsibilities in the age of rapidly evolving brain science and related clinical practice
Global Bioethics by Ronald M. Green,Aine Donovan,Steven A. Jauss Pdf
Medical care and biomedical research are rapidly becoming global. Ethical questions that once arose only in the narrow context of the physician-patient relationship in relatively prosperous societies are now being raised across societies, cultures, and continents. For example, what should be the "standard of care" for clinical trials of medical innovations in poorer countries? Are researchers obligated to compare new therapies or drugs with the best known ones available, or can they use as a benchmark the actual treatments (or lack of treatments) available to poor people? Should pharmaceutical companies seeking to lower the costs of new drug trials be allowed to enrol citizens of less developed countries in them even when those individuals cannot afford and will not be eligible for the resulting drugs? More generally, should the norms of medicine and research be the same across cultures or can they adapt to local social, economic, or religious conditions? Global Bioethics gathers some of the world's leading bioethicists to explore many of the new questions raised by the globalization of medical care and biomedical research. Among the topics covered are the impact of globalization on the norms of medical ethics, the conduct of international research, the ethics of international collaborations, challenges to medical professionalism in the international setting, and the relation of religion to global bioethics.
Research Ethics in the Arab Region by Henry Silverman Pdf
This book addresses the pressing issues involved with the ethical conduct of research in one developing world region – the Arab Region. Clinical research has soared in the developing world -as pharmaceutical companies continue their search for regions with large, treatment naive populations - including the Arab region, and has profound implications for the health and the economies for the area. The ethical issues involved with the conduct of such research, however, have so far not been adequately addressed. This volume presents the issues regarding research ethics and research governance that have relevance for health authorities, regulators, industry, and academia. As a multi-authored volume it includes both international and local experts on ethical issues in research, representing all stakeholders, thus presenting a balanced view on this timely topic.
International Development by Seth Appiah-Opoku Pdf
This book brings together leading researchers in the field of international development to examine issues relating to food security, health, rural development, human development, and institutional strengthening in developing countries. Based on empirical research, the book discusses a variety of topics including nutrition-sensitive agricultural development in South Africa, household food security in Tanzania, medical research in Egypt, child mortality in Christian and Islamic countries, spot improvement of rural roads in Asia and Africa, resilience in natural disaster, the relationship between foreign aid and human development in Africa, and finally developing competencies for rural development project management through the creation of local action groups in Argentina. The book is insightful and serves as an important reference material on international development.
Ethical Research by Ulf Schmidt,Andreas Frewer,Dominique Sprumont Pdf
At the heart of research with human beings is the moral notion that the experimental subject is altruistic, and is primarily concerned for the welfare of others. Beneath the surface, however, lies a very different ethical picture. Individuals participating in potentially life-saving research sometimes take on considerable risks to their own well-being. Efforts to safeguard human participants in clinical trials have intensified ever since the first version of the World Medical Association's Declaration of Helsinki (1964) and are now codified in many national and international laws and regulations. However, a comprehensive understanding of how this cornerstone document originated, changed, and functions today does not yet exist in the sphere of human research. Ethical Research brings together the work of leading experts from the fields of bioethics, health and medical law, the medical humanities, biomedicine, the medical sciences, philosophy, and history. Together, they focus on the centrality of the Declaration of Helsinki to the protection of human subjects involved in experimentation in an increasingly complex industry and in the government-funded global research environment. The volume's historical and contemporary perspectives on human research address a series of fundamental questions: Is our current human protection regime adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science? How important has the Declaration been in non-Western regions, for example in Eastern Europe, Africa, China, and South America? Why has the bureaucratization of regulation led to calls to pay greater attention to professional responsibility? Ethical Research offers insight into the way in which philosophy, politics, economics, law, science, culture, and society have shaped, and continue to shape, the ideas and practices of human research.
