Biomedical Research in Developing Countries - UNICRI

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Cameroon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157 Cape Verde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159 Chad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160 Congo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161 Côte d’Ivoire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162 Democratic Republic of Congo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163 Egypt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164 Equatorial Guinea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166 Ethiopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167 Gabon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169 Gambia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .170 Ghana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .172 Guinea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .173 Guinea Bissau . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174 Kenya . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175 Lybia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177 Malawi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178 Mali . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179 Mauritania . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180 Mauritius . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181 Morocco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182 Mozambique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184 Nigeria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185 Rwanda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187 Sao Tome and Principe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188 Senegal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189 Seychelles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .190 South Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191 Sudan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193 Swaziland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195 Tanzania . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196 Togo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .198 Tunisia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .199 Uganda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201 Zambia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203 Zimbabwe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .204 6
Annexes - International Round Table “Biomedical Research in Developing Countries: the Promotion of Ethics, Human Rights and Justice” Rome, 15-16 December 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .206 Conclusions and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .206 AIFA Proposals and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213 List of Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .247 7
Page 1 and 2: Agenzia Italiana del Farmaco GCP IN
Page 3 and 4: Table of Contents Authorship and Ac
Page 5: World Health Organization - WHO . .
Page 10 and 11: University of Oxford/Kemri and Well
Page 12 and 13: - this chapter also contains 42 cou
Page 14 and 15: UNICRI facilitates global partnersh
Page 17 and 18: PRESENTATION In welcoming the publi
Page 19: 3) the existence of centres or rese
Page 22 and 23: 3) the possibility to utilize a lar
Page 24 and 25: ethical and psychosocial problems i
Page 27 and 28: CHAPTER I THE INTERNATIONAL GUIDANC
Page 29 and 30: makers and the community in develop
Page 31 and 32: therapeutic methods identified by t
Page 33 and 34: to conduct large-scale trials for v
Page 35 and 36: preparatory work on a declaration o
Page 37 and 38: Consequently, these authorities rar
Page 39 and 40: new scientific developments made ac
Page 41 and 42: Additional Protocols are foreseen i
Page 43 and 44: applied in the protection of partic
Page 45 and 46: Guidelines for Good Clinical Practi
Page 47 and 48: Ethical and Policy Issues in Intern
Page 49 and 50: Drug Development Research in Resour
Page 51 and 52: Educating Bioethics Committees Guid
Page 53 and 54: processes and stifle competition, d
Page 55 and 56: European Medical Writers Associatio
Page 57 and 58:
prescribed to more than two million
Page 59:
Transparency is important both in t
Page 62 and 63:
investments in research”. Current
Page 64 and 65:
identify their needs and to plan fo
Page 66 and 67:
societies. The Foundation also host
Page 68 and 69:
annual, interdisciplinary and inter
Page 70 and 71:
project in the respect of internati
Page 72 and 73:
also to assess the training needs o
Page 74 and 75:
Fogarty International Center for Ad
Page 76 and 77:
Global Forum on Bioethics in Resear
Page 78 and 79:
the trainees home countries. Based
Page 80 and 81:
consolidate it in the fields of edu
Page 82 and 83:
KHRC is part of the INDEPTH Network
Page 84 and 85:
Research Center on Health, Cultures
Page 86 and 87:
Science with Africa The Science wit
Page 88 and 89:
exchange in health research ethics
Page 90 and 91:
objectives of SIDCER are to foster
Page 92 and 93:
national institutions, Tuskegee Uni
Page 94 and 95:
The Office for Human Research Prote
Page 96 and 97:
esearch, neuro-ethics, good clinica
Page 98 and 99:
are TDR (UNICEF/UNDP/World Bank/WHO
Page 100 and 101:
committees or scientific advisory c
Page 102 and 103:
The objective of the course was to
Page 104 and 105:
104
Page 106 and 107:
as passive recipients or, worse, as
Page 108 and 109:
THE HEALTH CARE SCENARIO IN THE DEV
Page 110 and 111:
Unfortunately, the “10/90 gap”
Page 112 and 113:
about 2,075 molecules were in devel
Page 114 and 115:
PATENTING ISSUES AND ACCESS TO ESSE
Page 116 and 117:
only on innovative products. A pate
Page 118 and 119:
In Africa, especially in the Sub-Sa
Page 120 and 121:
States agreed to increase funding f
Page 122 and 123:
very critical and difficult to ensu
Page 124 and 125:
The Botswana study was terminated a
Page 126 and 127:
THE CAPACITY FOR EDUCATION AND RESE
Page 128 and 129:
THE AFRICAN DIASPORA The need for A
Page 130 and 131:
with South Africa and Egypt account
Page 132 and 133:
Political and social instability, a
Page 134 and 135:
2) Promoting independence from poli
Page 136 and 137:
136
Page 138 and 139:
health care become critical issues.
Page 140 and 141:
not yet developed a uniform model f
Page 142 and 143:
In order to calculate the percentag
Page 144 and 145:
Finally, the analysis was performed
Page 146 and 147:
there can be considerable differenc
Page 148 and 149:
The diffusion of GCP Inspectorates
Page 150 and 151:
Table 5 - List of not analyzed coun
Page 152 and 153:
ANGOLA National specific legislatio
Page 154 and 155:
BOTSWANA National specific legislat
Page 156 and 157:
BURUNDI National specific legislati
Page 158 and 159:
10) République du Cameroun, Minist
Page 160 and 161:
CHAD National specific legislation
Page 162 and 163:
COTE D’IVOIRE National specific l
Page 164 and 165:
EGYPT National specific legislation
Page 166 and 167:
EQUATORIAL GUINEA National specific
Page 168 and 169:
8) Mengistie G., Health research et
Page 170 and 171:
GAMBIA National specific legislatio
Page 172 and 173:
http://www.fdbghana.gov.gh/pdf/drug
Page 174 and 175:
GUINEA BISSAU National specific leg
Page 176 and 177:
(Accessed on 9 July 2008 at http://
Page 178 and 179:
MALAWI National specific legislatio
Page 180 and 181:
MAURITANIA National specific legisl
Page 182 and 183:
MOROCCO National specific legislati
Page 184 and 185:
MOZAMBIQUE National specific legisl
Page 186 and 187:
9) neBRA - Networking for Ethics on
Page 188 and 189:
SAO TOME AND PRINCIPE National spec
Page 190 and 191:
SEYCHELLES National specific legisl
Page 192 and 193:
10) Republic of South Africa, Depar
Page 194 and 195:
SUDAN National specific legislation
Page 196 and 197:
TANZANIA National specific legislat
Page 198 and 199:
TOGO National specific legislation
Page 200 and 201:
Conférence Annuelle, 2005 (Accesse
Page 202 and 203:
8) Republic of Uganda, National Hea
Page 204 and 205:
ZIMBABWE National specific legislat
Page 206 and 207:
ANNEXES INTERNATIONAL ROUND TABLE
Page 208 and 209:
c) We recommend the appropriate ide
Page 210 and 211:
AIFA INVITES 1) International and r
Page 212 and 213:
212
Page 214 and 215:
Arab Republic of Egypt, Minister of
Page 216 and 217:
Chong W., China sets up rules to co
Page 218 and 219:
Collier J., Confusion over use of p
Page 220 and 221:
Dramé B., Becker C., Samba Cor Sar
Page 222 and 223:
Federal Democratic Republic of Ethi
Page 224 and 225:
Hamza B., Spécificités et Rôle d
Page 226 and 227:
Japan Pharmaceutical Manufacturers
Page 228 and 229:
Repère Médical, La bioéthique da
Page 230 and 231:
Molyneux C.S., Peshu N., Marsh K.,
Page 232 and 233:
Petrini C. (Ed.), Informed consent
Page 234 and 235:
Republic of South Africa, Medical R
Page 236 and 237:
République Tunisienne, Ministère
Page 238 and 239:
Struble K.A., Toigo T.A., Behrman R
Page 240 and 241:
UNESCO - United Nations Educational
Page 242 and 243:
Varmus H., Satcher D., Ethical Comp
Page 244 and 245:
WHO - World Health Organization, Na
Page 246 and 247:
246
Page 248:
REC R&D RMTC RBM SARETI SEAICRN TDR
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Biomedical Research in Developing Countries - UNICRI

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