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Ethical issues in international biomedical research: a casebook

Author: Lavery, James V. ; Grady, Christine ; Wahl, Elizabeth R. ; Emanuel, Ezekiel J.Publisher: Oxford University Press (OUP) 2007.Language: EnglishDescription: 371 p. ; 24 cm.ISBN: 0195179226Type of document: BookBibliography/Index: Includes bibliographical references and index
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Item type Current location Collection Call number Status Date due Barcode Item holds
Book Europe Campus
Main Collection
Print BJ57 .E84 2007
(Browse shelf)
Available 001214752
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Includes bibliographical references and index


Ethical Issues in International Biomedical Research A Case Book Contents Contributors, xix Introduction, 3 James V. Lavery, Christine Grady, Elizabeth R. Wahl, Ezekiel J. Emanuel PART I: Collaborative Partnership Case 1: Community Involvement in Biodiversity Prospecting in Mexico, 21 Commentary 1.1: Private and Public Knowledge in the Debate on Bioprospecting: Implications for Local Communities and Prior Informed Consent (Brent Berlin, Elois A. Berlin), 26 Commentary 1.2: Politics, Risk, and Community in the Maya ICBG Case (Fern Brunger, Charles Weijer), 35 Case 2: Selling Genes, 43 Commentary 2.1: What Might Tonga Learn from Iceland? (James Till, David L. Tritchler), 46 Commentary 2.2: Whose DNA? Tonga and Iceland, Biotech, Ownership, and Consent (Lopeti Senituli, Margaret Boyes), 53 Case 3: Sustainability of a Fluoride Varnish Feasibility Study in Nicaragua, 64 Commentary 3.1: Sustainability and Obligations to the Community in the Nicaragua Floride Varnish Pilot Study: The Investigator's Perspective (Martin Hobdell), 67 Commentary 3.2: Assessing the Sustainability of the Nicaragua Fluoride Varnish Study (Florencia Luna), 71 PART II: Social Value Case 4: Malarone Testing in Pregnant Women in Thailand, 79 Commentary 4.1: Proposed Phase 3 Trials of Malarone in Pregnancy Are Unethical (Juntra Karbwang), 82 Commentary 4.2: A Phase 3 Trial of Malarone in Pregnancy as a Pubic Good (Janis Lazdins), 84 Case 5: Neglected Diseases: Incentives to Conduct Research in Developing Countries, 87 Commentary 5.1: Drug Development for Visceral Leishmaniasis: A Failure of the Market and Public Policy (James Orbinski, Solomon Benatar), 90 Commentary 5.2: Bringing Innovations for Diseases of Poverty to Market: The Case of Paromomycin for Visceral Leishmaniasis (Hannah Kettler), 97 PART III: Scientific Validity Case 6: Evaluating Home-Based Treatment Strategies for Neonatal Sepsis in India, 105 Commentary 6.1: Did the SEARCH Neonatal Sepsis Trial Violate the Declaration of Helsinki? (Zulfiqar A. Bhutta), 109 Commentary 6.2: The SEARCH Neonatal Sepsis Study: Was It Ethical? (Marcia Angell), 114 Case 7: The Limitations of Knowledge, 116 Commentary 7.1: The Challenge of Clinical Equipoise in the Tigray Malaria Intervention Trial (James V. Lavery), 119 Commentary 7.2: Could the Investigators Foresee the Outcome of the Tigray Trial? (Jerome Singh), 126 Case 8: Controversy surrounding the Scientific Value of the VaxGen/Aventis (RV144) Phase 3 Vaccine Trial in Thailand, 131 Commentary 8.1: 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 Commentary 8.2: HIV Vaccine Trial Justified (John G. McNeil, Margaret I. Johnston, Deborah L. Birx, Edmund C. Tramont), 137 Commentary 8.3: Thailand's Prime-Boost HIV Vaccine Phase III (Charal Trinvuthipong), 139 Commentary 8.4: 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 Commentary 8.5: Support for the RV144 HIV Vaccine Trial (2) (The AIDS Vaccine Advocacy Coalition Board of Directors: Maureen Baehr, Dana Cappiello, Chris Collins, David Gold, Pontiano Kaleebu, Alexandre Menezes, Mike Powell, Robert Reinhard, Luis Santiago, Bill Snow, Jim Thomas, Steve Wakefield; and staff: Mitchell Warren, Ed Lee, Huntly Collins), 142 Commentary 8.6: 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 Commentary 8.7: Response from Gallo (Robert C. Gallo), 144 Commentary 8.8: Outstanding Questions on HIV Vaccine Trial (Richard Jefferys, Mark Harrington), 145 Commentary 8.9: Response to Jefferys and Harrington (John G. McNeil, Margaret I. Johnston, Edmund C. Tramont, Deborah L. Birx), 146 PART IV: Fair Subject and Community Selection Case 9: Pharmaceutical Research in Developing Countries, 151 Commentary 9.1: Benefit to Trial Participants or Benefit to the Community? How Far Should the Surfaxin Trial Investigators' and Sponsors' Obligations Extend? (Robert J. Temple), 155 Commentary 9.2: The Developing World as the "Answer" to the Dreams of Pharmaceutical Companies: The Surfaxin Story (Peter Lurie, Sidney M. Wolfe), 159 Case 10: Trading Genes for Toothbrushes, 171 Commentary 10.1: Ethics and Research on Human Genetic Material (Simona Giordano, John Harris), 174 Commentary 10.2: Should the Aka Pygmy People Be Targeted for Genetic Research? (Mohammed G. Kiddugavu), 180 Case 11: Testing a Phase 1 Malaria Vaccine, 184 Commentary 11.1: The Paradox of Exploitation: The Poor Exploiting the Rich (Ezekiel J. Emanuel), 189 Commentary 11.2: Reverse Exploitation in the Baltimore Malaria Vaccine Study (Bernard Dickens), 195 PART V: Favorable Risk-Benefit Ratio Case 12: Ethical Complications during an Investigation of Malaria Infection in Native Amazonian Populations in Western Brazil, 203 Commentary 12.1: Treating Asymptomatic Malaria Carriers in an Epidmiological Study in Rondônia, Brazil: The Investigator's Perspective (Fabiana Alves), 207 Commentary 12.2: 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 Case 13: 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 Commentary 13.1: The Limits of Obligations to Provide Treatment in the South African Phase I HIV Vaccine Trials (Catherine Slack, Melissa Stobie, Nicola Barsdorf ), 219 Commentary 13.2: Shared Responsibilities for Treatment in the South African Phase 1 HIV Preventive Vaccine Trials (Christine Grady, Robert J. Levine), 225 PART VI: Independent Review Case 14: How Independent Is Independent Review? 233 Commentary 14.1: Context, Dual Obligations, and the Vulnerability of Independent Review (Donna Knapp van Bogaert, Godfrey Tangwa), 237 Commentary 14.2: Research Ethics in South Africa: Putting the Mpumalanga Case into Context (Peter Cleaton-Jones), 240 Case 15: Which Regulations Offer Subjects the Best Protection? 246 Commentary 15.1: Ensuring Consent Forms Do Not Breach the Confidentiality of Trial Participants (Ron Gray), 250 Commentary 15.2: Balancing Requirements of Confidentiality and Sponsorship Transparency in the Rakai Circumcision Trial (Mary Ann Luzar, Linda Ehler), 255 PART VII: Informed Consent Case 16: The Challenge of Informed Consent in a Genetic Epidemiology Study of Noma in Rural Nigeria, 263 Commentary 16.1: Local Culture and Informed Consent in the Noma Study (Patricia Marshall), 267 Commentary 16.2: Refocusing the Ethics of Informed Consent: Could Ritual Improve the Ethics of the Noma Study? ( James V. Lavery), 272 Case 17: Compensation for Families Who Consent to Research Autopsy for Their Children in a Study of Malaria Mortality in Malawi, 281 Commentary 17.1: What It Means to Offer an Autopsy in Malawi (Kondwani Kayira, Lloyd Bwanaisa, Alfred Njobvu, Grace Malenga, Terrie Taylor), 285 Commentary 17.2: Culturally Sensitive Compensation in Clinical Research (Trudo Lemmens, Remigius Nwabueze), 287 PART VIII: Respect for Enrolled Subjects and Study Communities Case 18: A Randomized Trial of Low-Phytate Corn for Maternal-Infant Micronutrient Deficiency in Rural Guatemala, 297 Commentary 18.1: The Guatemala Low-Phytate Corn Trial: The Investigators' Assessment (Michael Hambidge, Manolo Mazariegos, Noel W. Solomons), 300 Commentary 18.2: A Community Welfare Perspective on the Ethics of the Guatemala Low-Phytate Corn Trial (Eric M. Meslin, Godwin Ndossi), 305 Case 19: Obligations to Participants Harmed in the Course of the N-9 Multicenter Vaginal Microbicide Trial in South Africa, 311 Commentary 19.1: Ethical Challenges in the N-9 Trial: The Investigator's Perspective (Gita Ramjee), 314 Commentary 19.2: Was the N-9 Trial Ethical? Questions and Lessons (Douglas Wassenaar, Carel IJsselmuiden), 319 Commentary 19.3: What Are the Investigators' Responsibilities to HIV-Positive Women Who Were Screened Out of the N-9 Trial? (Leah Belsky, Christine Pace), 325 Case 20: Ethical Challenges and Controversy in a Retrospective Study of HIV-1 Transmission in Uganda, 330 Commentary 20.1: Obligations to Research Subjects in the Rakai HIV Transmission Study: The Investigator's Perspective (Thomas C. Quinn), 333 Commentary 20.2: Researchers' Obligations to Uninfected Partners in Discordant Couples in an HIV-1 Transmission Trial in the Rakai District, Uganda (Dirceu Greco), 340 Case 21: Protecting Subjects in a Study of Domestic Violence in South Africa, 347 Commentary 21.1: 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 Commentary 21.2: Minimizing the Risk to Women in a Study of Domestic Violence in South Africa: Easier Said Than Done (Angela Wasunna), 355 Appendix: Economic, Social, Health, and Development Indicators for the Case Countries, 360 Index, 363

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