Ethical Issues in International Biomedical Research: A Casebook Book

Contributors     xix
Introduction   James V. Lavery   Christine Grady   Elizabeth R. Wahl   Ezekiel J. Emanuel     3
Collaborative Partnership
Community Involvement in Biodiversity Prospecting in Mexico     21
Private and Public Knowledge in the Debate on Bioprospecting: Implications for Local Communities and Prior Informed Consent   Brent Berlin   Elois A. Berlin     26
Politics, Risk, and Community in the Maya ICBG Case   Fern Brunger   Charles Weijer     35
Selling Genes     43
What Might Tonga Learn from Iceland?   James Till   David L. Tritchler     46
Whose DNA? Tonga and Iceland, Biotech, Ownership, and Consent   Lopeti Senituli   Margaret Boyes     53
Sustainability of a Fluoride Varnish Feasibility Study in Nicaragua     64
Sustainability and Obligations to the Community in the Nicaragua Floride Varnish Pilot Study: The Investigator's Perspective   Martin Hobdell     67
Assessing the Sustainability of the Nicaragua Fluoride Varnish Study   Florencia Luna     71
Social Value
Malarone Testing in Pregnant Women in Thailand     79
Proposed Phase 3 Trials of Malarone in Pregnancy Are Unethical   Juntra Karbwang     82
A Phase 3 Trial of Malarone in Pregnancy as a Pubic Good   Janis Lazdins     84
Neglected Diseases: Incentives to Conduct Research in Developing Countries     87
Drug Development for Visceral Leishmaniasis: A Failure of the Market and Public Policy   James Orbinski   Solomon Benatar     90
Bringing Innovations for Diseases of Poverty to Market: The Case of Paromomycin for Visceral Leishmaniasis   Hannah Kettler     97
Scientific Validity
Evaluating Home-Based Treatment Strategies for Neonatal Sepsis in India     105
Did the SEARCH Neonatal Sepsis Trial Violate the Declaration of Helsinki?   Zulfiqar A. Bhutta     109
The SEARCH Neonatal Sepsis Study: Was It Ethical?   Marcia Angell     114
The Limitations of Knowledge     116
The Challenge of Clinical Equipoise in the Tigray Malaria Intervention Trial   James V. Lavery     119
Could the Investigators Foresee the Outcome of the Tigray Trial?   Jerome Singh     126
Controversy surrounding the Scientific Value of the VaxGen/Aventis (RV144) Phase 3 Vaccine Trial in Thailand     131
A Sound Rationale Needed for Phase 3 HIV-1 Vaccine Trials   Dennis R. Burton   Ronald C. Desrosiers   Robert W. Doms   Mark B. Feinberg   Robert C. Gallo    Beatrice Hahn   James A. Hoxie   Eric Hunter   Bette Korber   Alan Landay   Michael M. Lederman   Judy Lieberman   Joseph M. McCune   John P. Moore   Neal Nathanson   Louis Picker   Douglas Richman   Charles Rinaldo   Mario Stevenson   David I. Watkins   Steven M. Wolinsky   Jerome A. Zack     135
HIV Vaccine Trial Justified   John G. McNeil   Margaret I. Johnston   Deborah L. Birx   Edmund C. Tramont     137
Thailand's Prime-Boost HIV Vaccine Phase III   Charal Trinvuthipong     139
Support for the RV144 HIV Vaccine Trial   Robert Belshe   Genoveffa Franchini   Marc P. Girard   Frances Gotch   Pontiano Kaleebu   Marta L. Marthas   Michael B. McChesney   Rose McCullough   Fred Mhalu   Dominique Salmon-Ceron   Rafick-Pierre Sekaly   Koen van Rompay   Bernard Verrier   Britta Wahren   Mercedes Weissenbacher     141
Support for the RV144 HIV Vaccine Trial (2)   Maureen Baehr   Dana Cappiello   Chris Collins   David Gold   Pontiano Kaleebu   Alexandre Menezes   Mike Powell   Robert Reinhard   Luis Santiago   Bill Snow   Jim Thomas   Steve Wakefield$dstaff: Mitchell Warren$dEd Lee$dHuntly Collins     142
Response from Burton et al.   Dennis R. Burton   Ronald C. Desrosiers   Robert W. Doms   Mark B. Feinberg   Beatrice H. Hahn   James A. Hoxie   Eric Hunter   Bette T. M. Korber   Alan L. Landay   Michael M. Lederman   Judy Lieberman   Joseph M. McCune   John P. Moore   Neal Nathanson   Louis Picker   Douglas D. Richman   Charles R. Rinaldo   Mario Stevenson   David I. Watkins   Steven M. Wolinsky   Jerome A. Zack     143
Response from Gallo   Robert C. Gallo     144
Outstanding Questions on HIV Vaccine Trial   Richard Jefferys   Mark Harrington     145
Response to Jefferys and Harrington   John G. McNeil   Margaret I. Johnston   Edmund C. Tramont   Deborah L. Birx     146
Fair Subject and Community Selection
Pharmaceutical Research in Developing Countries     151
Benefit to Trial Participants or Benefit to the Community? How Far Should the Surfaxin Trial Investigators' and Sponsors' Obligations Extend?   Robert J. Temple     155
The Developing World as the "Answer" to the Dreams of Pharmaceutical Companies: The Surfaxin Story   Peter Lurie   Sidney M. Wolfe     159
Trading Genes for Toothbrushes     171
Ethics and Research on Human Genetic Material   Simona Giordano   John Harris     174
Should the Aka Pygmy People Be Targeted for Genetic Research?   Mohammed G. Kiddugavu     180
Testing a Phase 1 Malaria Vaccine     184
The Paradox of Exploitation: The Poor Exploiting the Rich   Ezekiel J. Emanuel     189
Reverse Exploitation in the Baltimore Malaria Vaccine Study   Bernard Dickens     195
Favorable Risk-Benefit Ratio
Ethical Complications during an Investigation of Malaria Infection in Native Amazonian Populations in Western Brazil     203
Treating Asymptomatic Malaria Carriers in an Epidemiological Study in Rondonia, Brazil: The Investigator's Perspective   Fabiana Alves     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?   Ambrose Otau Talisuna     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     217
The Limits of Obligations to Provide Treatment in the South African Phase I HIV Vaccine Trials   Catherine Slack   Melissa Stobie   Nicola Barsdorf     219
Shared Responsibilities for Treatment in the South African Phase 1 HIV Preventive Vaccine Trials   Christine Grady   Robert J. Levine     225
Independent Review
How Independent Is Independent Review?     233
Context, Dual Obligations, and the Vulnerability of Independent Review   Donna Knapp van Bogaert   Godfrey Tangwa     237
Research Ethics in South Africa: Putting the Mpumalanga Case into Context   Peter Cleaton-Jones     240
Which Regulations Offer Subjects the Best Protection?     246
Ensuring Consent Forms Do Not Breach the Confidentiality of Trial Participants   Ron Gray     250
Balancing Requirements of Confidentiality and Sponsorship Transparency in the Rakai Circumcision Trial   Mary Ann Luzar   Linda Ehler     255
Informed Consent
The Challenge of Informed Consent in a Genetic Epidemiology Study of Noma in Rural Nigeria     263
Local Culture and Informed Consent in the Noma Study   Patricia Marshall     267
Refocusing the Ethics of Informed Consent: Could Ritual Improve the Ethics of the Noma Study?   James V. Lavery     272
Compensation for Families Who Consent to Research Autopsy for Their Children in a Study of Malaria Mortality in Malawi     281
What It Means to Offer an Autopsy in Malawi   Kondwani Kayira   Lloyd Bwanaisa   Alfred Njobvu   Grace Malenga   Terrie Taylor     285
Culturally Sensitive Compensation in Clinical Research   Trudo Lemmens   Remigius Nwabueze     287
Respect for Enrolled Subjects and Study Communities
A Randomized Trial of Low-Phytate Corn for Maternal-Infant Micronutrient Deficiency in Rural Guatemala     297
The Guatemala Low-Phytate Corn Trial: The Investigators' Assessment   Michael Hambidge   Manolo Mazariegos   Noel W. Solomons     300
A Community Welfare Perspective on the Ethics of the Guatemala Low-Phytate Corn Trial   Eric M. Meslin   Godwin Ndossi     305
Obligations to Participants Harmed in the Course of the N-9 Multicenter Vaginal Microbicide Trial in South Africa     311
Ethical Challenges in the N-9 Trial: The Investigator's Perspective   Gita Ramjee     314
Was the N-9 Trial Ethical? Questions and Lessons   Douglas Wassenaar   Carel IJsselmuiden     319
What Are the Investigators' Responsibilities to HIV-Positive Women Who Were Screened Out of the N-9 Trial?   Leah Belsky   Christine Pace     325
Ethical Challenges and Controversy in a Retrospective Study of HIV-1 Transmission in Uganda     330
Obligations to Research Subjects in the Rakai HIV Transmission Study: The Investigator's Perspective   Thomas C. Quinn     333
Researchers' Obligations to Uninfected Partners in Discordant Couples in an HIV-1 Transmission Trial in the Rakai District, Uganda   Dirceu Greco     340
Protecting Subjects in a Study of Domestic Violence in South Africa     347
Generating Needed Evidence while Protecting Women Research Participants in a Study of Domestic Violence in South Africa: A Fine Balance   Rachel Jewkes   Jennifer Wagman     350
Minimizing the Risk to Women in a Study of Domestic Violence in South Africa: Easier Said Than Done   Angela Wasunna     355
Economic, Social, Health, and Development Indicators for the Case Countries     360
Index     363