Biomedical Research in Developing Countries - UNICRI

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(Accessed on 9 July 2008 at http://www.springerlink.com/content/p655787h217h0236/fulltext.pdf) 10) Molyneux C.S., Peshu N., Marsh K., Trust and informed consent: insights from a community members on the Kenyan coast, Social Science and Medicine, 2005,Vol. 61, Pages 1463-1473 11) Pandit J.M., Kenya… on the move for Drug Quality, Safety and Efficacy, Republic of Kenya, Ministry of Health, Pharmacy and Poison Board, 2007 (Accessed on 26 August 2008 at http://www.who-umc.org/graphics/14031.pdf) 12) Patel V., Clinical Trials in Kenya, Stichting Onderzoek Multinationale Ondermingen (SOMO), 2006 (Accessed on 26 August 2008 at http://somo.nl/html/paginas/pdf/Kenya_clinical_trials_2006_EN.pdf) 13) Republic of Kenya, Ministry of Health, Kenya National Guidelines for Research & Development of HIV/AIDS Vaccine, 2005 (Accessed on 9 July 2008 at http://www.iavi.org/file.cfm?fid=31372) 14) Republic of Kenya, Ministry of Health, Pharmacy and Poison Board, Guideline for the National Pharmacovigilance System in Kenya, 2007 (Accessed on 9 July 2008 at http://www.pharmacyboardkenya.org/assets/files/Pharmacovigilance%20Guideline.pdf 15) Research-Africa, Kenyan Science and Technology System, A brief profile, (Date unknown), (Accessed on 9 July 2008 at http://www.research-africa.net/media/pdf/Kenya-ST.pdf) 16) UNESCO – United Nations Educational, Scientific and Cultural Organization, Global Ethics Observatory, (Accessed on 30 September 2008 at http://www.unesco.org/shs/ethics/geo/user/?action=select&lng=en&db=) 17) Wasunna M., Challenges and institutional constraints on bioethics development in Africa, Kenya Medical Research Institute, 14th Session of the International Bioethics Committee, 2007 (Accesssed on 15 November 2008 at http://portal.unesco.org/shs/en/files/10961/11818103761African_perspectives_- _Wassuna.pdf/African%2Bperspectives%2B-%2BWassuna.pdf) 18) WHO – UNAIDS HIV Vaccine Initiative, HIV/AIDS Vaccine Country Profile Kenya, 2005 (Accessed on 25 August 2008 at http://www.who.int/vaccine_research/diseases/hiv/aavp/Kenya_profile.pdf) 176
LYBIA 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) UNESCO – United Nations Educational, Scientific and Cultural Organization, Global Ethics Observatory, (Accessed on 30 September 2008 at http://www.unesco.org/shs/ethics/geo/user/?action=map&lng=en&db=) 2) WHO/EMRO - World Health Organization Regional Office for the Eastern Mediterranean, UNESCO - United Nations Educational, Scientific and Cultural Organization, First Regional Meeting of National Bioethics Committees, Cairo 5/7 May 2007 (Accessed on 30 September 2008 at http://unesdoc.unesco.org/images/0015/00152805e.pdf) 177
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Agenzia Italiana del Farmaco GCP IN
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Table of Contents Authorship and Ac
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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
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
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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
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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
Page 102 and 103:
The objective of the course was to
Page 104 and 105:
104
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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”
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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
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In Africa, especially in the Sub-Sa
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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 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
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REC R&D RMTC RBM SARETI SEAICRN TDR
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Biomedical Research in Developing Countries - UNICRI

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