Double Standards In Medical Research In Developing Countries

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.

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.

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.

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.

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 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.

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.

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.