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