Biomedical Research in Developing Countries - UNICRI

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10) Republic of South Africa, Department of Health, South African Good Clinical Practice Guidelines, Second Edition, 2006 (Accessed on 10 July 2008 at http://www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/part1.pdf) 11) Republic of South Africa, Department of Health, South African National Clinical Trials Register, Research Ethics Committees, (Date unknown), (Accessed on 10 July 2008 at http://sancrt.gov.za/YourbrnbRights/ResearchEthicsCommittees/tabid/178/Default.aspx) 12) Republic of South Africa, Department of Health, The Patient’s Rights Charter, (Date unknown), (Accessed on 10 July 2008 at http://www.justice.gov.za/VC/docs/policy/Patient%20Rights%20Charter.pdf) 13) Republic of South Africa, Department of Health, What you should know when deciding to take part in a clinical trial as a research participant, 2002 (Accessed on 10 July 2008 at http://www.doh.gov.za/aids/docs/gcp2.html ) 14) Republic of South Africa, Department of Health, White Paper on the Transformation of the Health System in South Africa, 1997 (Accessed on 29 July 2008 at http://www.info.gov.za/whitepapers/1997/health.htm) 15) Republic of South Africa, Medical Research Council (MRC), Guidelines for Good Clinical Practice in Clinical Trials, MRC Clinical Trials Series, 1998 (Accessed on 17 July 2008 at www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=7525&dDocName= MRC002416&allowInterrupt=1) 16) Republic of South Africa, Medical Research Council (MRC), Guidelines on Ethics for Medical Research: General Principles including research on children, vulnerable groups, international collaboration and epidemiology, Book 1, 2003 (Accessed on 2 October 2008 at http://www.sahealthinfo.org/ethics/ethicsbook1.pdf) 17) Republic of South Africa, Medical Research Council (MRC), Guidelines on Ethics for Medical Research, HIV preventive vaccine research, Book 5, 2003 (Accessed on 17 July 2008 at http://www.sahealthinfo.org/ethics/ethicsbook5.pdf) 18) Republic of South Africa, Minister of Health, National Health Bill, 2003 (Accessed on 10 July 2008 at http://www.doh.gov.za/docs/bills/b32b.pdf) 19) Republic of South Africa, Minister of Health, South Africa Medicine & Related Substances Amendment Bill, 2002 (Accessed on 17 July 2008 at http://www.info.gov.za/view/DownloadFileAction?id=66947) 20) Republic of South Africa, National Health Act No. 61, Government Gazette, 23 July 2004,Vol. 469, No. 26595 (Accessed on 17 July 2008 at http://www.doh.gov.za/docs/legislation-f.html) 21) Singh J.A., Health Research and Human Rights in South Africa,The Lancet, 2004 Vol. 363, Issue 9418, Page 1393 (Accessed on 17 July 2008 at http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673604160546.pdf) 192
22) Slack C., Strode A., Fleischer T., Gray G., Ranchod C., Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa, BMC Medical Ethics, 2007,Vol. 8:5 (Accessed on 17 July 2008 at http://www.biomedcentral.com/content/pdf/1472-6939-8-5.pdf) 23) 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=) 24) 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/SouthAfrica.pdf) 193
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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
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 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 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
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Varmus H., Satcher D., Ethical Comp
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WHO - World Health Organization, Na
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246
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REC R&D RMTC RBM SARETI SEAICRN TDR
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