Double Standards in Medical Research in Developing Countries

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Cambridge University Press, May 27, 2004 - Law - 280 pages
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This book examines the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out in developing countries. Is it acceptable to lower the ethical standards adopted in the industrialized world when carrying out research in developing or resource-poor countries? This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable.
 

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Contents

International research contested controversies and debates
1
Why do clinical research in developing countries?
6
Which countries are developing?
9
Health needs in developing countries
12
The controversy that launched debates
13
The proposed Surfaxin study
17
Revision of the Declaration of Helsinki
18
Procedural solutions
21
Allegations of violations
133
Inadequacies of safeguards
136
standards and practices
139
universal standards or ethical imperialism?
145
do they provide adequate protection?
150
What the guidelines say
152
The CIOMS debates
154
the NBAC survey
157

Agreement on underlying propositions
24
pragmatic or aspirational?
30
Maintaining ethical standards in research
36
Ethical standards and standard of care
38
Treat like cases alike
44
What do the guidelines say?
47
Conclusions
64
Striving for justice in research
68
Distributive justice in global research
69
Global disparities and health equity
72
Justice health care and research
75
obligation or charity?
77
What the guidelines say
82
Responses to the CIOMS guideline
88
The FDA and PhRMA
90
National regulations and guidelines
92
Conclusions
94
Avoiding exploitation
99
Definitional debates
101
What is exploitation in multinational research?
105
What guidelines and commentators say
107
Candidates for circumstances of exploitation in international research
118
Inducing vulnerable subjects as exploitation
122
Best current treatment and posttrial benefits as undue inducements
124
Conclusion
127
Providing safeguards informed consent and review of research
131
Conclusions
158
Making drugs affordable
163
Differential pricing
166
Prior agreements
171
International collaborative efforts and publicprivate partnerships
174
Manufacture of generic copies of patented drugs and compulsory licensing
182
Respecting protecting and fulfilling human rights
193
Human rights and the concept of dignity
196
The United States and human rights
198
Human rights in the conduct of research
200
Right to health care right to health
202
HIVAIDS and the right to health
208
Human rights access and affordability of drugs
210
Human rights international guidelines and ethical principles
214
Striving for a single standard
226
A single standard for control groups
230
Providing successful products after a trial is concluded
238
Irreconcilable differences
241
Building capacity and assessing ethics in ongoing research
245
Dilemmas in future HIVAIDS preventive vaccine trials
248
What the guidelines say
254
Harmonizing international guidelines
257
The future
260
Index
263
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About the author (2004)

Professor of Bioethics, Albert Einstein College of Medicine, New York.

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