Biomedical Research in Developing Countries - UNICRI

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Republic of South Africa, Medical Research Council (MRC), Book 5 Guidelines on Ethics for Medical Research, HIV preventive vaccine research, 2003 Republic of South Africa, Medical Research Council (MRC), Guidelines for Good Clinical Practice in Clinical Trials, MRC Clinical Trials Series, 1998 Republic of South Africa, Minister of Health, South Africa Medicine & Related Substances Amendment Bill, 2002 Republic of South Africa, Minister of Health, National Health Bill, 2003 Republic of the Gambia, Constitution of the Second Republic of the Gambia, Adopted on 8 August 1996, entered into force in January 1997, last amended in 2001 Republic of Uganda, National Council for Science and Technology (UNCST), National Guidelines for Research involving Humans as Research Participants, 2007 Republic of Uganda, National Council for Science and Technology (UNCST), Research Registration and Clearance Policy and Guidelines, 2007 Republic of Uganda, National Health Research Organization (UNHRO), An analysis of institutions doing health research in Uganda, 2000 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 Republic of Zimbabwe, Medicine and Allied Substances Control Act, 1969 Republic of Zimbabwe, Medicine and Allied Substances Control General Regulation, 1991 Republic of Zimbabwe, Medicines Control Authority (MCAZ), Guideline on submission of documentation for registration of multi-source (generic) finished pharmaceutical products (FPPS), 2008 Republic of Zimbabwe, Medicines Control Authority (MCAZ), Guidelines for Good Clinical Practice, 2002 Republic of Zimbabwe, Medicines Control Authority (MCAZ), Guidelines for Good Clinical Trial Practice in Zimbabwe, 2002 Republic of Zimbabwe, Medicines Control Authority (MCAZ), Guidelines for submitting application for registration of a medicine in Zimbabwe, (Date unknown) Republic of Zimbabwe, Medical Research Council (MRC), Conducting Health Research In Zimbabwe: What researchers need to know, 2004 République Algérienne Démocratique et Populaire, Ministère de la Santé de la Population et de la Reforme Hospitalière, Arrêté n. 387 du 31 Juillet 2006 relatif aux essais cliniques, 2006 République de Guinée, Assemblée Nationale de la République de Guinée, Loi L/97/021/An portant Code de Santé Publique, 1997 234
République de Guinée, Loi Fondamentale, 1990 République du Burkina Faso, Assemblé des Députés du Peuple, Loi n° 23/94/ADP portant Code de la Santé publique, 1994 République du Burkina Faso, Ministère de la Santé, Décret N°97-050/PRES/PM/MS portant Code de Déontologie des Médecins du Burkina Faso, 1997 République du Burkina Faso, Plan général et Extraits du Code la Santé publique du Burkina Faso relatifs à l’éthique, 1994 République du Burkina Faso, President du Faso et President du Conseil des Ministres, Décret n° 2005-100/PRES/PM/MPDH du 23 février 2005 portant création, attributions, composition et fonctionnement du comité interministériel des droits humains et du droit international humanitaire, 2005 République du Cameroun, La Constitution du Cameroun, 1996 République du Cameroun, Le Premier Ministre, Chef du Gouvernement, Décret n° 98/405/PM du 22 Octobre 1998 fixant les modalités d'homologation et de mise sur le marché des produits pharmaceutiques, 1998 République du Cameroun, Le Président de la République, Décret n° 2005/091 du 29 mars 2005 _portant organisation du Ministère de la Recherche Scientifique et de l'Innovation, 2005 République du Cameroun, Ministère de la Santé and COHRED - Council on Health Research for Development, Cameroon Strong National Health Research Systems Enable Success Of Health Sector Reform Cameroon and COHRED work supports better evidence for the health sector and better donor alignment with national priorities, 2007 République du Congo, Constitution, Texte du 20 Janvier 2002 République du Sénégal, Conseil National de Recherche en Santé, Règlement intérieur du Conseil National de la Recherche en Santé, 2006 République du Sénégal, Ministère de la Santé, Analyse: Arrêté portant création et organisation du Conseil National de la Recherche en Santé, 2001 République du Sénégal, Ministère de la Santé, Arrêté ministériel n° 3224 MSP-DERF-DER en date du 17 mars 2004 abrogeant et remplaçant l’arrêté n° 1422 MS-DERF-DER du 2 mars 2001 portant création et organisation du Conseil National de Recherche en Santé/CNRS, 2004 République Gabonaise, La Constitution, 2000 République Togolaise, Comité Consultatif National de Bioéthique and Commission Nationale pour l’UNESCO, CCNB – TOGO, Réunion Constitutive, Rapport Final, 2007 République Tunisienne, Comité National d’Ethique Médicale, Les Essais Cliniques des nouveaux médicaments chez l’homme: impératifs éthiques et cadre juridiques, IXème Conférence Annuelle, 2005 235
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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
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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
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ANGOLA National specific legislatio
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BOTSWANA National specific legislat
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BURUNDI National specific legislati
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10) République du Cameroun, Minist
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CHAD National specific legislation
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COTE D’IVOIRE National specific l
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EGYPT National specific legislation
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EQUATORIAL GUINEA National specific
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8) Mengistie G., Health research et
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GAMBIA National specific legislatio
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http://www.fdbghana.gov.gh/pdf/drug
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GUINEA BISSAU National specific leg
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(Accessed on 9 July 2008 at http://
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MALAWI National specific legislatio
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MAURITANIA National specific legisl
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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
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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 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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