Biomedical Research in Developing Countries - UNICRI

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8) Republic of Uganda, National Health Research Organization (UNHRO), An analysis of institutions doing health research in Uganda, 2000 (Accessed on 28 July 2008 at http://www.health.go.ug/docs/unhro_analysis.pdf) 9) Republic of Uganda, National Health Research Organization (UNHRO),The Council on Health Research for Development (COHRED), Essential National Health Research in Uganda, A case study of progress and challenges in implementing the ENHR strategy, 2000 (Accessed on 28 July 2008 at http://www.cohred.org/main/CommonCategories/content/546.pdf) 10) Uganda AIDS Commission, European Union and the Uganda HIV/AIDS Partnership, Uganda Guidelines for AIDS Vaccine Research, A Guide for Vaccine Research, Development and Evaluation, 2006 (Accessed on 26 August 2008 at http://www.iavi.or.ug/pdf/guidelines.pdf) 11) WHO – UNAIDS HIV Vaccine Initiative, HIV/AIDS Vaccine Country Profile, 2005 (Accessed on 25 August 2008 at http://www.who.int/vaccine_research/diseases/hiv/aavp/uganda_profile.pdf) 202
ZAMBIA National specific legislation on ethics in biomedical research Guidelines and/or SOPs concerning ethics in research National/Institutional Bioethics Committees that review ethics of biomedical research with human participants N/A N/A YES Sources: 1) Dawad S.,Veenstra N., Comparative health systems research in a context of HIV/AIDS: lessons from a multi-country study in South Africa,Tanzania and Zambia, BMC BioMed Central, 2007,Vol. 5:13 (Accessed on 22 July 2008 at http://www.health-policysystems.com/content/pdf/1478-4505-5-13.pdf) 2) Kirigia J. M,Wambebe C., Baba-Moussa A., Status of national research bioethics committees in the WHO African region, BMC Medical Ethics, 2005,Vol. 6:10 (Accessed on 21 August 2008 at http://www.biomedcentral.com/1472-6939/6/10) 203
Page 1 and 2:
Agenzia Italiana del Farmaco GCP IN
Page 3 and 4:
Table of Contents Authorship and Ac
Page 5 and 6:
World Health Organization - WHO . .
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Annexes - International Round Table
Page 10 and 11:
University of Oxford/Kemri and Well
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- this chapter also contains 42 cou
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UNICRI facilitates global partnersh
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PRESENTATION In welcoming the publi
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3) the existence of centres or rese
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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
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makers and the community in develop
Page 31 and 32:
therapeutic methods identified by t
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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
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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
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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
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societies. The Foundation also host
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annual, interdisciplinary and inter
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project in the respect of internati
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also to assess the training needs o
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Fogarty International Center for Ad
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Global Forum on Bioethics in Resear
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the trainees home countries. Based
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consolidate it in the fields of edu
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KHRC is part of the INDEPTH Network
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Research Center on Health, Cultures
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Science with Africa The Science wit
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exchange in health research ethics
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objectives of SIDCER are to foster
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national institutions, Tuskegee Uni
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The Office for Human Research Prote
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esearch, neuro-ethics, good clinica
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are TDR (UNICEF/UNDP/World Bank/WHO
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committees or scientific advisory c
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The objective of the course was to
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104
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as passive recipients or, worse, as
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THE HEALTH CARE SCENARIO IN THE DEV
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Unfortunately, the “10/90 gap”
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about 2,075 molecules were in devel
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PATENTING ISSUES AND ACCESS TO ESSE
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only on innovative products. A pate
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In Africa, especially in the Sub-Sa
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States agreed to increase funding f
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very critical and difficult to ensu
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The Botswana study was terminated a
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THE CAPACITY FOR EDUCATION AND RESE
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THE AFRICAN DIASPORA The need for A
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with South Africa and Egypt account
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Political and social instability, a
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2) Promoting independence from poli
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136
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health care become critical issues.
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not yet developed a uniform model f
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In order to calculate the percentag
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Finally, the analysis was performed
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there can be considerable differenc
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The diffusion of GCP Inspectorates
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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 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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