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| Contributors | p. xix |
| Introduction | p. 3 |
| Collaborative Partnership | |
| Community Involvement in Biodiversity Prospecting in Mexico | p. 21 |
| Private and Public Knowledge in the Debate on Bioprospecting: Implications for Local Communities and Prior Informed Consent | p. 26 |
| Politics, Risk, and Community in the Maya ICBG Case | p. 35 |
| Selling Genes | p. 43 |
| What Might Tonga Learn from Iceland? | p. 46 |
| Whose DNA? Tonga and Iceland, Biotech, Ownership, and Consent | p. 53 |
| Sustainability of a Fluoride Varnish Feasibility Study in Nicaragua | p. 64 |
| Sustainability and Obligations to the Community in the Nicaragua Floride Varnish Pilot Study: The Investigator's Perspective | p. 67 |
| Assessing the Sustainability of the Nicaragua Fluoride Varnish Study | p. 71 |
| Social Value | |
| Malarone Testing in Pregnant Women in Thailand | p. 79 |
| Proposed Phase 3 Trials of Malarone in Pregnancy Are Unethical | p. 82 |
| A Phase 3 Trial of Malarone in Pregnancy as a Pubic Good | p. 84 |
| Neglected Diseases: Incentives to Conduct Research in Developing Countries | p. 87 |
| Drug Development for Visceral Leishmaniasis: A Failure of the Market and Public Policy | p. 90 |
| Bringing Innovations for Diseases of Poverty to Market: The Case of Paromomycin for Visceral Leishmaniasis | p. 97 |
| Scientific Validity | |
| Evaluating Home-Based Treatment Strategies for Neonatal Sepsis in India | p. 105 |
| Did the SEARCH Neonatal Sepsis Trial Violate the Declaration of Helsinki? | p. 109 |
| The SEARCH Neonatal Sepsis Study: Was It Ethical? | p. 114 |
| The Limitations of Knowledge | p. 116 |
| The Challenge of Clinical Equipoise in the Tigray Malaria Intervention Trial | p. 119 |
| Could the Investigators Foresee the Outcome of the Tigray Trial? | p. 126 |
| Controversy surrounding the Scientific Value of the VaxGen/Aventis (RV144) Phase 3 Vaccine Trial in Thailand | p. 131 |
| A Sound Rationale Needed for Phase 3 HIV-1 Vaccine Trials | p. 135 |
| HIV Vaccine Trial Justified | p. 137 |
| Thailand's Prime-Boost HIV Vaccine Phase III | p. 139 |
| Support for the RV144 HIV Vaccine Trial | p. 141 |
| Support for the RV144 HIV Vaccine Trial (2) | p. 142 |
| Response from Burton et al. | p. 143 |
| Response from Gallo | p. 144 |
| Outstanding Questions on HIV Vaccine Trial | p. 145 |
| Response to Jefferys and Harrington | p. 146 |
| Fair Subject and Community Selection | |
| Pharmaceutical Research in Developing Countries | p. 151 |
| Benefit to Trial Participants or Benefit to the Community? How Far Should the Surfaxin Trial Investigators' and Sponsors' Obligations Extend? | p. 155 |
| The Developing World as the "Answer" to the Dreams of Pharmaceutical Companies: The Surfaxin Story | p. 159 |
| Trading Genes for Toothbrushes | p. 171 |
| Ethics and Research on Human Genetic Material | p. 174 |
| Should the Aka Pygmy People Be Targeted for Genetic Research? | p. 180 |
| Testing a Phase 1 Malaria Vaccine | p. 184 |
| The Paradox of Exploitation: The Poor Exploiting the Rich | p. 189 |
| Reverse Exploitation in the Baltimore Malaria Vaccine Study | p. 195 |
| Favorable Risk-Benefit Ratio | |
| Ethical Complications during an Investigation of Malaria Infection in Native Amazonian Populations in Western Brazil | p. 203 |
| Treating Asymptomatic Malaria Carriers in an Epidemiological Study in Rondonia, Brazil: The Investigator's Perspective | p. 207 |
| Treatment of Symptomatic and Asymptomatic Malaria Carriers in a Study of Native Amazonian Populations in Western Brazil: Is There a Favorable Risk-Benefit Ratio? | p. 212 |
| Access to Treatment for Trial Participants Who Become Infected with HIV during the Course of Phase 1 Trials of a Preventive HIV Vaccine in South Africa | p. 217 |
| The Limits of Obligations to Provide Treatment in the South African Phase I HIV Vaccine Trials | p. 219 |
| Shared Responsibilities for Treatment in the South African Phase 1 HIV Preventive Vaccine Trials | p. 225 |
| Independent Review | |
| How Independent Is Independent Review? | p. 233 |
| Context, Dual Obligations, and the Vulnerability of Independent Review | p. 237 |
| Research Ethics in South Africa: Putting the Mpumalanga Case into Context | p. 240 |
| Which Regulations Offer Subjects the Best Protection? | p. 246 |
| Ensuring Consent Forms Do Not Breach the Confidentiality of Trial Participants | p. 250 |
| Balancing Requirements of Confidentiality and Sponsorship Transparency in the Rakai Circumcision Trial | p. 255 |
| Informed Consent | |
| The Challenge of Informed Consent in a Genetic Epidemiology Study of Noma in Rural Nigeria | p. 263 |
| Local Culture and Informed Consent in the Noma Study | p. 267 |
| Refocusing the Ethics of Informed Consent: Could Ritual Improve the Ethics of the Noma Study? | p. 272 |
| Compensation for Families Who Consent to Research Autopsy for Their Children in a Study of Malaria Mortality in Malawi | p. 281 |
| What It Means to Offer an Autopsy in Malawi | p. 285 |
| Culturally Sensitive Compensation in Clinical Research | p. 287 |
| Respect for Enrolled Subjects and Study Communities | |
| A Randomized Trial of Low-Phytate Corn for Maternal-Infant Micronutrient Deficiency in Rural Guatemala | p. 297 |
| The Guatemala Low-Phytate Corn Trial: The Investigators' Assessment | p. 300 |
| A Community Welfare Perspective on the Ethics of the Guatemala Low-Phytate Corn Trial | p. 305 |
| Obligations to Participants Harmed in the Course of the N-9 Multicenter Vaginal Microbicide Trial in South Africa | p. 311 |
| Ethical Challenges in the N-9 Trial: The Investigator's Perspective | p. 314 |
| Was the N-9 Trial Ethical? Questions and Lessons | p. 319 |
| What Are the Investigators' Responsibilities to HIV-Positive Women Who Were Screened Out of the N-9 Trial? | p. 325 |
| Ethical Challenges and Controversy in a Retrospective Study of HIV-1 Transmission in Uganda | p. 330 |
| Obligations to Research Subjects in the Rakai HIV Transmission Study: The Investigator's Perspective | p. 333 |
| Researchers' Obligations to Uninfected Partners in Discordant Couples in an HIV-1 Transmission Trial in the Rakai District, Uganda | p. 340 |
| Protecting Subjects in a Study of Domestic Violence in South Africa | p. 347 |
| Generating Needed Evidence while Protecting Women Research Participants in a Study of Domestic Violence in South Africa: A Fine Balance | p. 350 |
| Minimizing the Risk to Women in a Study of Domestic Violence in South Africa: Easier Said Than Done | p. 355 |
| Economic, Social, Health, and Development Indicators for the Case Countries | p. 360 |
| Index | p. 363 |
| Table of Contents provided by Ingram. All Rights Reserved. |
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