Ethical Issues in International Biomedical Research A Casebook

, by Lavery, James V.; Grady, Christine; Wahl, Elizabeth R.; Emanuel, Ezekiel J.

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ISBN: 9780195179224 | 0195179226
Cover: Hardcover
Copyright: 2/15/2007

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Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

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
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Ethical Issues in International Biomedical Research A Casebook

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