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 law and policy in Nigeria is an evolving and complex field of law, spanning a broad legal landscape and drawn from various sources. In addressing and interacting with these sources the volume advances research on health care law and policy in Nigeria and spells the beginning of what may now be formally termed the ’Nigerian health law and policy’ legal field. The collection provides a comparative analysis of relevant health policies and laws, such as reproductive and sexual health policy, organ donation and transplantation, abortion and assisted conception, with those in the United Kingdom, United States, Canada and South Africa. It critically examines the duties and rights of physicians, patients, health institutions and organizations, and government parastatals against the backdrop of increased awareness of rights among patient populations. The subjects, which are discussed from a legal, ethical and policy-reform perspective, critique current legislation and policies and make suggestions for reform. The volume presents a cohesive, comparative, and comprehensive analysis of the state of health law and policy in Nigeria with those in the US, Canada, South Africa, and the UK. As such, it provides a valuable comparison between Western and Non-Western countries.

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the changes in form and content of international instruments for regulating the conduct of biomedical research.

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.

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.

Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the potential harm specific groups may suffer in genetic research, and the capacity for current frameworks of Western developed countries to provide adequate protections for these target populations. Using The People’s Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most discussion in this field focuses on the impact of genetic research on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. In evaluating current regulations concerning prevention of harm to vulnerable groups, the book also puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research.

This reader is a spin-off publication from Law, Science and Medicine, Third Edition. It offers an interdisciplinary perspective on ethical and moral questions raised by medicine and introduces undergraduates to the manner in which law and policy shape society's views on birth, death, human experimentation, reproduction, use of genetic information, and beyond.

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