Biomedical Research in Developing Countries - UNICRI

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Conférence Annuelle, 2005 (Accessed on 23 September 2008 at http://www.comiteethique.rns.tn/ethique/CONFERENCES/CONFERENCE9.pdf) 9) République Tunisienne, Ministère de la Santé Publique, Comité National d’Ethique Médicale, Présentation et Mission (Date unknown), (Accessed on 23 September 2008 at http://www.comiteethique.rns.tn/ethique/ethique.html) 10) République Tunisienne, Ministère de la Santé Publique, Décret n. 94-1939 du 19 Septembre 1994, fixant les attributions, la composition et les modalités de fonctionnement du comité national d’éthique médicale,1994 (Accessed on 23 September 2008 at http://www.atds.org.tn/CNEM2.pdf) 11) République Tunisienne, Ministère de la Santé Publique, Décret n. 2001-2133 du 10 Septembre 2001, modifiant et completant le décret n. 94-1939 du 19 Septembre 1994, fixant les attributions, la composition et les modalités de fonctionnement du comité national d’éthique medicale, 2001 (Accessed on 23 September 2008 at http://www.comiteethique.rns.tn/ethique/textes%20juridiques/DECRET-2001-2133- fr.pdf) 12) République Tunisienne, Ministère de la Santé Publique, Dispositions et Principes directeurs relatifs aux Bonnes Pratiques dans les Essais Cliniques, (Date unknown), (Accessed on 23 September 2008 on http://www.dpm.tn/PDF/Annexeexperim.PDF) 13) République Tunisienne, Ministère de la Santé Publique, L’Industrie Pharmaceutique, (Date unknown), (Accessed on 23 July 2008 at http://www.santetunisie.rns.tn/msp/sante_tunisie/industrie_phar.html) 14) République Tunisienne, Président de la République, Code de déontologie médicale tunisine, Décret n° 93-1155 du 17 mai 1993, portant code de déontologie médicale, 1993 (Accessed on 21 August 2008 at http://www.ordre medecins.org.tn/images/code_deontologie.pdf) 15) République Tunisienne, Président de la République, Décret n° 90-1401 du 3 Septembre 1990, fixant les modalités de l’expérimentation médicale ou scientifique des médicaments destinés à la médecine humaine, 1990 (Accessed on 23 July 2008 at http://www.amilcar.com.tn/doc/decret90-1401.doc) 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) 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) 200
UGANDA 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 YES YES Sources: 1) AITRP - Fogarty AIDS International Training Program, University of California, Berkeley and University of California, A Survival Guide for Conducting International Collaborative Research in Uganda, 2004 (Accessed on 28 July 2008 at http://epi.berkeley.edu/AITRP_Survival_Guide_Uganda_Final_10May2004.pdf) 2) COHRED - Council on Health Research for Development, Data for health research planning and development in Uganda, Learning Brief, 2002, No. 2 (Accessed on 28 July 2008 at http://www.cohred.org/main/CommonCategories/content/719.pdf) 3) COHRED - The Council on Health Research for Development, Identifying Capacities, Country Analysis Ghana and Uganda, 1999 (Accessed on 28 July 2008 at http://www.cohred.org/main/CommonCategories/content/542.pdf) 4) Grady C.,Wagman J., Ssekubugu R.,Wawer M.J., Serwadda D., Kiddugavu M., Nalugoda F., Gray R.H.,Wendler D., Dong Q., Dixon D.O.,Townsend B.,Wahl E., Emanuel E.J., Research Benefits for Hypothetical HIV Vaccine Trials: the View of Ugandans in the Rakai District, IRB Ethics and Human Research, 2008,Vol. 30, No. 2, Pages 1-7 (Accessed on 12 November 2008 at http://www.thehastingscenter.org/uploadedFiles/Publications/IRB/Articles/2008_March -April/irb_2008_mar_apr_sample1.pdf) 5) Neema S., Community participation in essential national health research process: Uganda’s Experience, COHRED - The Council on Health Research for Development, 1999 (Accessed on 28 July 2008 at http://www.cohred.org/main/CommonCategories/content/545.pdf) 6) Republic of Uganda, National Council for Science and Technology (UNCST), National Guidelines for Research involving Humans as Research Participants, 2007 (Accessed on 28 July 2008 at http://www.cohred.org/HealthResearchWeb/insidepages/africa/pdf/Human_Subjects_ Guidelines_March_27.pdf) 7) Republic of Uganda, National Council for Science and Technology (UNCST), Research Registration and Clearance Policy and Guidelines, 2007 (Accessed on 28 July 2008 at http://www.cohred.org/HealthResearchWeb/insidepages/africa/pdf/Research_registrati on_UNCST_2007.pdf) 201
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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
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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
Page 45 and 46:
Guidelines for Good Clinical Practi
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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
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annual, interdisciplinary and inter
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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
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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
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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
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 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
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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