Legal and Ethical Regulation of Biomedical Research in Developing Countries

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.

Introduction; Chapter 1 Regulatory Contexts of Biomedical Research in Developing Countries; Chapter 2 Equipoise and the Normative Framework for Biomedical Research in Africa; Chapter 3 Case Studies of Research Governance in Africa; Chapter 4 The Machinery of Ethics Review: Nature, Functions and Scope; Chapter 5 Legal Liability of Research Ethics Committees in Actions by Research Subjects; Chapter 6 Liability of Research Ethics Committees in Actions by Investigators; Chapter 7 Legal Liability of Investigators in Actions by Research Subjects; Chapter 8 Conclusion — Themes, Suggestions and Ruminations;

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.