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.

Medical research and its attendant technical development are considerable economically imperative as well as vital to the future well-being of humankind. Research involving human subjects increasingly took place in developing countries in the past two decades. A recent publication has disclosed unethical trials concerned with reducing the perinatal transmission of the human immunodeficiency virus (HIV) in developing countries, and this has revealed to the global society how complicated ethical issues in international research may be. It has further brought about substantial debate as to the ethics of research in developing countries. Amongst the many ethical controversies, the debate on the standards used to control trials in developing countries is most complex. In this paper, the author will make a comparison between the relative legitimacy of those who argue for the "best proven therapy" and those who argue for the "highest attainable therapy" Issues includes the reasons that frosted the emerging trend of international researches, the ethical and legal controversies in terms of the double standards approach, as well as a partnership approach will addressed.

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.

A critical and detailed analysis of inequalities of world trade systems.

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.

"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.