Double standards medical research developing countries

Cover......Page 1
Half-title......Page 3
Series-title......Page 4
Title......Page 5
Copyright......Page 6
Contents......Page 7
Acknowledgments......Page 9
1 International research contested: controversies and debates......Page 11
Why do clinical research in developing countries?......Page 16
Which countries are “developing”?......Page 19
Health needs in developing countries......Page 22
The controversy that launched debates......Page 23
The proposed Surfaxin study......Page 27
Revision of the Declaration of Helsinki......Page 28
Procedural solutions......Page 31
Agreement on underlying propositions......Page 34
Responsiveness to the health needs of the population......Page 35
Needed research in developing countries......Page 37
Ethical guidelines: pragmatic or aspirational?......Page 40
NOTES......Page 41
2 Maintaining ethical standards in research......Page 46
Ethical standards and “standard of care”......Page 48
Treat like cases alike......Page 54
Declaration of Helsinki......Page 57
The CIOMS International Guidelines......Page 59
The UNAIDS Guidance Document......Page 66
The NBAC Report......Page 67
The Nuffield Council Report......Page 68
US Regulations and the FDA......Page 71
ICH Guidelines for Good Clinical Practice......Page 73
Conclusions......Page 74
NOTES......Page 75
3 Striving for justice in research......Page 78
Distributive justice in global research......Page 79
Global disparities and health equity......Page 82
Justice, health care, and research......Page 85
Post-trial benefits of research: obligation or charity?......Page 87
What the guidelines say......Page 92
Responses to the CIOMS guideline......Page 98
The FDA and PhRMA......Page 100
National regulations and guidelines......Page 102
Conclusions......Page 104
NOTES......Page 105
4 Avoiding exploitation......Page 109
Definitional debates......Page 111
What is exploitation in multinational research?......Page 115
What guidelines and commentators say......Page 117
CIOMS Guideline 10......Page 118
UNAIDS Guidance Document......Page 122
NBAC report......Page 124
Nuffield report......Page 125
Candidates for circumstances of exploitation in international research......Page 128
Inducing vulnerable subjects as exploitation......Page 132
Best current treatment and post-trial benefits as undue inducements......Page 134
Conclusion......Page 137
NOTES......Page 138
5 Providing safeguards: informed consent and review of research......Page 141
Allegations of violations......Page 143
Inadequacies of safeguards......Page 146
Fraud and corruption......Page 148
The challenge of cultural differences......Page 149
Spousal authorization for research......Page 153
Adherence to US rules: universal standards or ethical imperialism?......Page 155
Signing consent forms......Page 157
Unfamiliarity with modern science......Page 158
Research ethics committees: do they provide adequate protection?......Page 160
What the guidelines say......Page 162
The CIOMS debates......Page 164
More disagreements: the NBAC survey......Page 167
Conclusions......Page 168
NOTES......Page 170
6 Making drugs affordable......Page 173
Differential pricing......Page 176
Prior agreements......Page 181
International collaborative efforts and public–private partnerships......Page 184
The Concept Foundation......Page 185
The vaccine gap......Page 186
Combating malaria......Page 187
The Global Fund......Page 189
Manufacture of generic copies of patented drugs and compulsory licensing......Page 192
NOTES......Page 199
7 Respecting, protecting, and fulfilling human rights......Page 203
Human rights and the concept of dignity......Page 206
The United States and human rights......Page 208
Human rights in the conduct of research......Page 210
Right to health care, right to health......Page 212
The role of WHO......Page 214
HIV/AIDS and the right to health......Page 218
Human rights, access, and affordability of drugs......Page 220
Human rights, international guidelines, and ethical principles......Page 224
Respect for autonomy......Page 225
Protection of vulnerable persons......Page 227
Beneficence......Page 229
Justice......Page 231
NOTES......Page 233
8 Striving for a single standard......Page 236
A single standard for control groups......Page 240
“Early Versus Delayed Initiation of Antiretroviral Therapy”......Page 241
Providing successful products after a trial is concluded......Page 248
Irreconcilable differences......Page 251
Building capacity and assessing ethics in ongoing research......Page 255
Dilemmas in future HIV/AIDS preventive vaccine trials......Page 258
The control group in vaccine trials......Page 259
Treatment for subjects who become infected......Page 262
What the guidelines say......Page 264
Harmonizing international guidelines......Page 267
The future......Page 270
NOTES......Page 271
Index......Page 273