Biomedical Research in Developing Countries - UNICRI

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SUDAN 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 NO NO YES Sources: 1) Elsayed D.E.M., Kass N., Attitudes of Sudanese researchers on obtaining informed consent from study subjects involved in health research, Sudanese Journal of Public Health, 2007, Vol. 2, No. 2, Pages 95-102 (Accessed on 23 July at http://www.sjph.net.sd/files/vol2i2p95-102.pdf) 2) Elsayed D.E.M., National Framework for Ethics in Health Research involving Human Subjects, Sudanese Journal of Public Health, 2006,Vol. 1, No. 3, Pages 192-196 (Accessed on 23 July 2008 at http://www.sjph.net.sd/files/v1i3p192-196.pdf) 3) 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=) 4) 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) 194
SWAZILAND 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 NO Sources: 1) 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) 195
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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
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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
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ethical and psychosocial problems i
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CHAPTER I THE INTERNATIONAL GUIDANC
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makers and the community in develop
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therapeutic methods identified by t
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to conduct large-scale trials for v
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preparatory work on a declaration o
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Consequently, these authorities rar
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new scientific developments made ac
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Additional Protocols are foreseen i
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applied in the protection of partic
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Guidelines for Good Clinical Practi
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Ethical and Policy Issues in Intern
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Drug Development Research in Resour
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Educating Bioethics Committees Guid
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processes and stifle competition, d
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European Medical Writers Associatio
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prescribed to more than two million
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Transparency is important both in t
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investments in research”. Current
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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
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 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
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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
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WHO - World Health Organization, Na
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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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