Ethical issues in international biomedical research a casebook
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| Sprache: | English |
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Oxford
Oxford University Press
2007
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| 245 | 1 | 0 | |a Ethical issues in international biomedical research |b a casebook |c edited by James V. Lavery ... |
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| 300 | |a XXVII, 371 S. |c 24 cm | ||
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| 650 | 4 | |a Ethik | |
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Medicine |x Research |x Moral and ethical aspects |v Case studies | |
| 650 | 4 | |a Medicine |x Research |x Moral and ethical aspects |v Cross-cultural studies | |
| 650 | 4 | |a Human experimentation in medicine |x Moral and ethical aspects |v Case studies | |
| 650 | 4 | |a Human experimentation in medicine |x Moral and ethical aspects |v Cross-cultural studies | |
| 650 | 4 | |a Human Experimentation |x ethics | |
| 650 | 4 | |a Biomedical Research |x ethics | |
| 650 | 4 | |a Internationality | |
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| 700 | 1 | |a Lavery, James V. |e Sonstige |4 oth | |
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Datensatz im Suchindex
| _version_ | 1819699407974563840 |
|---|---|
| adam_text | 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 Ma a
1CBG 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: Sustainahility 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
xii CONTENTS
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
CONTENTS xiii
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
xiv CONTENTS
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 Rondonia, 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
CONTENTS XV
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
xvi CONTENTS
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 Usselmuiden), 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
CONTENTS xvii
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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| indexdate | 2024-12-23T20:59:07Z |
| institution | BVB |
| isbn | 0195179226 |
| language | English |
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| spellingShingle | Ethical issues in international biomedical research a casebook Ethik Medizin Medicine Research Moral and ethical aspects Case studies Medicine Research Moral and ethical aspects Cross-cultural studies Human experimentation in medicine Moral and ethical aspects Case studies Human experimentation in medicine Moral and ethical aspects Cross-cultural studies Human Experimentation ethics Biomedical Research ethics Internationality Medizinische Ethik (DE-588)4074672-0 gnd Biomedizin (DE-588)4647152-2 gnd |
| subject_GND | (DE-588)4074672-0 (DE-588)4647152-2 (DE-588)4522595-3 |
| title | Ethical issues in international biomedical research a casebook |
| title_auth | Ethical issues in international biomedical research a casebook |
| title_exact_search | Ethical issues in international biomedical research a casebook |
| title_full | Ethical issues in international biomedical research a casebook edited by James V. Lavery ... |
| title_fullStr | Ethical issues in international biomedical research a casebook edited by James V. Lavery ... |
| title_full_unstemmed | Ethical issues in international biomedical research a casebook edited by James V. Lavery ... |
| title_short | Ethical issues in international biomedical research |
| title_sort | ethical issues in international biomedical research a casebook |
| title_sub | a casebook |
| topic | Ethik Medizin Medicine Research Moral and ethical aspects Case studies Medicine Research Moral and ethical aspects Cross-cultural studies Human experimentation in medicine Moral and ethical aspects Case studies Human experimentation in medicine Moral and ethical aspects Cross-cultural studies Human Experimentation ethics Biomedical Research ethics Internationality Medizinische Ethik (DE-588)4074672-0 gnd Biomedizin (DE-588)4647152-2 gnd |
| topic_facet | Ethik Medizin Medicine Research Moral and ethical aspects Case studies Medicine Research Moral and ethical aspects Cross-cultural studies Human experimentation in medicine Moral and ethical aspects Case studies Human experimentation in medicine Moral and ethical aspects Cross-cultural studies Human Experimentation ethics Biomedical Research ethics Internationality Medizinische Ethik Biomedizin Fallstudiensammlung |
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