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.
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 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Post Trial Access to Drugs in Developing Nations written by Evaristus Chiedu Obi and published by Springer. This book was released on 2017-07-26 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 334 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.
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 268 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.
Download or read book Human Medical Research written by Jan Schildmann and published by Springer Science & Business Media. This book was released on 2012-03-12 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.
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.
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to 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. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Practical Decision Making in Health Care Ethics written by Raymond J. Devettere and published by Georgetown University Press. This book was released on 2016-05-20 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Rethinking the Ethics of Clinical Research written by Alan Wertheimer and published by Oxford University Press. This book was released on 2011 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ethics Dumping written by Doris Schroeder and published by Springer. This book was released on 2017-12-04 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Download or read book Equitable Access to Human Biological Resources in Developing Countries written by Roger Scarlin Chennells and published by Springer. This book was released on 2015-07-17 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ethical Challenges in Study Design and Informed Consent for Health Research in Resource poor Settings written by Patricia A. Marshall and published by World Health Organization. This book was released on 2007 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Disease Control Priorities in Developing Countries written by Dean T. Jamison and published by World Bank Publications. This book was released on 2006-04-02 with total page 1449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.
Download or read book Ethical and Legal Issues in Neurology written by James L. Bernat and published by Newnes. This book was released on 2014-01-09 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Global Bioethics written by Ronald M. Green and published by OUP Oxford. This book was released on 2008-11-06 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
