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.
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.
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.
In pursuing a holistic bioethics while dialoguing with different sciences’ appreciation of moral affinities between human and nonhuman entities, Dr. Buyondo argues for a minimum moral status for nonhuman entities. The minimum normative basics of approaches to biomedical ethics are at the very least not distinctive to either human animals or nonhuman animals only. The investigation builds further on the African understanding of life—where no creation is lifeless. In establishing a more inclusive, functional bioethics, the African approach goes further than biocentrism, ecocentrism, and holism to ground an inclusive African “holistic moral egalitarianism,” suggesting that “all forces” and “all created things have life.” We are not emphasizing how every system and creature command equal respect; rather, everything has life, commands respect, and moral concern as a minimum imperative within a Black African holistic approach to bioethics. However, holistic bioethics can neither be Western nor an African invention that people of other cultures only admire from a distance. Moreover, holistic bioethics doesn’t offer the last word on the ethics of nonhuman animals, holistic anamnetic solidarity, the relational Other, and intercultural theological bioethics.
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.
Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues raised by that question.Much writing on the ethics of research with human subjects assumes that participation in research is a distinctive activity that requires distinctive moral principles. In most contexts, we allow people to choose the activities in which they engage. By contrast, people are permitted to participate in research only after Institutional Review Boards determine that it is appropriate for them to do so. Although we assume that consent to participate in research must be preceded by an elaborate disclosure of information, we make no such assumption in many other areas of life. Although it is thought to be morally problematic to provide financial inducements to prospective subjects, we make no such assumptions when we hire people as loggers, fishermen, and fire fighters. Although we readily accept the "off-shoring" of manufacturing, many regard the off-shoring of medical research with great skepticism. This book seeks to widen the lens through which we consider such issues. When we do so, we will find that many standard principles of research ethics are difficult to defend.The book first argues that because respect for "autonomy" has been a central tenet of research ethics, many have failed to recognize that the structure of the regulation of research is deeply paternalistic and have therefore failed to justify such paternalism. The book then rejects "the autonomous authorization" model that characterizes most writing in bioethics and argues for a "fair transaction" model. Although many worry that the use of financial payment to recruit research subjects is coercive or constitutes an undue inducement, the book argues that most of those worries are misplaced. Shifting its attention to research in developing societies, the book considers the claim that international researchers exploit research abroad often exploits its subjects. Finally, the book considers the claim that because researchers benefit from their use of research subjects, they acquire special obligations to them or their communities.
