Atnaujinkite slapukų nuostatas

El. knyga: Legal and Ethical Regulation of Biomedical Research in Developing Countries

  • Formatas: 334 pages
  • Išleidimo metai: 22-Apr-2016
  • Leidėjas: Routledge
  • Kalba: eng
  • ISBN-13: 9781317106418
  • Formatas: 334 pages
  • Išleidimo metai: 22-Apr-2016
  • Leidėjas: Routledge
  • Kalba: eng
  • ISBN-13: 9781317106418

DRM apribojimai

  • Kopijuoti:

    neleidžiama

  • Spausdinti:

    neleidžiama

  • El. knygos naudojimas:

    Skaitmeninių teisių valdymas (DRM)
    Leidykla pateikė šią knygą šifruota forma, o tai reiškia, kad norint ją atrakinti ir perskaityti reikia įdiegti nemokamą programinę įrangą. Norint skaityti šią el. knygą, turite susikurti Adobe ID . Daugiau informacijos  čia. El. knygą galima atsisiųsti į 6 įrenginius (vienas vartotojas su tuo pačiu Adobe ID).

    Reikalinga programinė įranga
    Norint skaityti šią el. knygą mobiliajame įrenginyje (telefone ar planšetiniame kompiuteryje), turite įdiegti šią nemokamą programėlę: PocketBook Reader (iOS / Android)

    Norint skaityti šią el. knygą asmeniniame arba „Mac“ kompiuteryje, Jums reikalinga  Adobe Digital Editions “ (tai nemokama programa, specialiai sukurta el. knygoms. Tai nėra tas pats, kas „Adobe Reader“, kurią tikriausiai jau turite savo kompiuteryje.)

    Negalite skaityti šios el. knygos naudodami „Amazon Kindle“.

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.

Recenzijos

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 books 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

Table of Cases
ix
Acknowledgements xv
Introduction 1(26)
The Growth of Externally-Sponsored Research in Developing Countries
1(4)
Externally-Sponsored Research as Foreign Direct Investment: The Indian Example
5(3)
Concerns About Exploitation: Ethical and Statutory Regulation
8(10)
Issues of Legal Liability and African Law
18(6)
Summary of
Chapters
24(3)
1 Regulatory Contexts of Biomedical Research in Developing Countries
27(32)
Introduction
27(1)
International Regulatory Contexts
28(6)
Frameworks of Response to International Research Scandals
34(3)
Impetus for the Regulation of Biomedical Research in Africa
37(12)
Regulatory Models in Africa
49(6)
Scope of Research Guidelines in Africa
55(1)
Enforceability of Guidelines in Africa
56(1)
Conclusion
57(2)
2 Equipoise and the Normative Framework for Biomedical Research in Africa
59(30)
Introduction
59(1)
Theoretical Equipoise
60(4)
Clinical Equipoise
64(6)
Which Way Africa? Clinical Equipoise or the Uncertainty Principle?
70(4)
Equipoise and the Duty to Provide the Best Treatment
74(5)
Equipoise and Placebo-Controlled Randomized Trials
79(4)
Equipoise and the Consent of Research Subjects
83(4)
Conclusion
87(2)
3 Case Studies of Research Governance in Africa
89(34)
Introduction
89(2)
Uganda
91(14)
Tanzania
105(6)
Nigeria
111(9)
Conclusion
120(3)
4 The Machinery of Ethics Review: Nature, Functions and Scope
123(42)
Introduction
123(1)
Functions of Research Ethics Committees
124(21)
Review of International Collaborative Research
145(8)
Bioethical Capacity Building and Training of Members of Ethics Committees in Africa
153(3)
Funding of Ethics Committees and the Charging of Fees for Ethics Review
156(2)
Commercial Ethics Review Committees
158(5)
Conclusion
163(2)
5 Legal Liability of Research Ethics Committees in Actions by Research Subjects
165(32)
Introduction
165(2)
Legal Personality of Research Ethics Committees
167(3)
Liability of Individual Members of Research Ethics Committees
170(4)
Negligent Acts and Omissions of Research Ethics Committees
174(3)
Recent Cases in Negligence against Research Ethics Committees
177(4)
Duty of Care
181(8)
Standard of Care and Breach of Duty
189(1)
Causation
190(2)
Liability to Professional Discipline
192(3)
Conclusion
195(2)
6 Liability of Research Ethics Committees in Actions by Investigators
197(36)
Introduction
197(1)
Judicial Control and Review of Decisions of Research Ethics Committees
198(7)
Grounds of Review
205(3)
Injunctions
208(3)
Procuring the Breach of a Research Contract
211(4)
Causing Loss by Unlawful Means or Unlawful Interference with Economic Interests
215(1)
Negligent Economic Loss
216(3)
Defamation
219(2)
Libel and Slander
221(2)
Defences to a Defamation Suit
223(2)
Right to Research
225(6)
Conclusion
231(2)
7 Legal Liability of Investigators in Actions by Research Subjects
233(54)
Introduction
233(1)
Actions in Negligence
233(6)
Investigator-Research Subject Duty of Care
239(4)
Battery
243(4)
Constitutional Claims
247(2)
Right to Life
249(4)
Right to Human Dignity: Against Torture, Inhuman and Degrading Treatment
253(3)
Unjust Enrichment
256(6)
Breach of Confidence
262(4)
Foreign Suits by African Research Subjects: Procedural and Substantive Problems
266(3)
USA
269(3)
England and Wales
272(2)
Conclusion
274(3)
Conclusion - Themes, Suggestions and Ruminations
277(1)
Research Involving Human Subjects in Africa: the Need for both Ethical and Legal Analyses
277(1)
African Charter on Human and Peoples' Rights - Protocol on Research Involving Human Subjects and Embedment of Equipoise
278(4)
Establishment of a Clinical Trials Registry in African Countries
282(3)
Legal Liability: the `Judicialization' of Research Involving Human Subjects
285(1)
Value of Extraterritorial Litigation
286(1)
Bibliography 287(24)
Index 311
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.