1st Edition

Legal and Ethical Regulation of Biomedical Research in Developing Countries

ISBN 9781138279308
Published November 17, 2016 by Routledge
334 Pages

USD $59.95

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Book Description

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.



Remigius N. Nwabueze is a Senior Lecturer in Law at the University of Southampton. His research interests are in the areas of property law (equity and trust), intellectual property law, law and the human body, medical/health care law, bioethics and customary law. He has published widely on these and related areas.


’Research in developing countries, undertaken by researchers from the First World or even by for-profit contract research organisations, accounts for a growing percentage of all clinical trials. Remigius Nwabueze provides painstaking and comprehensive coverage of specific legal cases, concepts and tactics that can protect the rights of research subjects, particularly in Africa.’ Donna Dickenson, University of London, UK ’A highly scholarly work, accessible to the general reader, because of the importance and popularity of the issues considered as well as the clarity and simplicity with which they are discussed. Excepting South Africa, this book is a pioneer in sub-Saharan Africa; it examines the treatment of the ethics of research involving humans in the context of the law and argues strongly and cogently for legally enforceable ethics regulations; for ethics is the mother of the law, and the law ensures that ethics is taken seriously.’ Godfrey B. Tangwa, University of Yaounde 1, Cameroon ’The book’s thoughtful conclusions are based on a lucid interpretation of materials from across the common law world, a review of current ethical debates and field work in a number of African jurisdictions. Remigius Nwabueze offers a careful and wide ranging consideration of the law and ethics relating to medical research in Africa in this pioneering text.’ John Harrington, University of Liverpool, UK