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Vol 21 No 10 Oct/Nov 2016

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Legal and Ethical Regulation of Biomedical Research in Developing Countries

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ISBN13: 9781409466109
Published: April 2013
Publisher: Ashgate Publishing Ltd
Country of Publication: UK
Format: Hardback
Price: £95.00



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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.

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Subjects:
Medical Law
Contents:
Introduction
Regulatory contexts for biomedical research in developing countries
Equipoise and the normative framework for biomedical research in Africa
The machinery of ethics review: nature, functions and scope
Legal liability of research ethics committees in actions by research subjects
Liability of research ethics committees in actions by investigators
Legal liability of investigators in actions by research subjects
Conclusion: themes, suggestions and ruminations
Bibliography
Index.