Biomedical Research in Developing Countries - UNICRI

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Struble K.A., Toigo T.A., Behrman R.E., Birnkrant D.B., Enrollment of Women in HIV Clinical Trials, United States of America, Food and Drug Administration, Presented at the IX International AIDS Conference, Vancouver, British Columbia, Canada, July 1996 Sugarman J., Ethics in the Design and Conduct of Clinical Trials, Epidemiologic Reviews, 2002, Vol. 24, No.1, Pages 54-58 Swiss Commission for Research Partnership with Developing Countries KFPE, Guidelines for Research in Partnership with Developing Countries, 11 Principles, Third Edition 2003 Tazi A., Les Comités d’Éthique au Maroc et dans la région: États des lieux et enjeux, 2005 TDR – UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards, 2005 TDR – UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, TDR News, December 2007, No. 79 TDR – UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, TDR News, September 2007, No. 78 Tebeje A., Brain drain and capacity building in Africa, The International Development Research Centre (IDRC), 2005 Teka T., Ethiopian Health Research Ethics Application and Review Process, Federal Democratic Republic of Ethiopia, Ethiopian Science and Technology Commission, (date unknown) Temple R.J. Benefit to trials participants or benefit to the community? How far should the Surfaxin trial investigators’ and sponsors’ obligations extend?, in Lavery J.V., Grady C., Wahl E.R., Emanuel E.J. (Eds.), Ethical Issues in International Biomedical Research: A Casebook, Oxford University Press, 2007, Pages 155-159 The Top 500 World Universities, Academic ranking of Top World Universities 2007, Institute of the Higher Education, Shanghai Jiao Tong Universities, 2007 Tillet T., Global collaboration gives greater voice to African journals, Environmental Health Perspectives, 2005, Vol. 113, No. 7, Pages A452-A454 Tonks A., A clinical trials register for Europe, British Medical Journal, 2002, Vol. 325, Pages 314-1315 Transparency International, Corruption Perception Index, 2008 Transparency International, Global Corruption Report, 2008 Transparency International, Persistent corruption in low-income countries requires global action, concerted efforts needed in rich and poor countries to stem flow of corrupt monies and make justice work for the poorest, 2007 238
Trouiller P., Olliaro P., Torreele E., Orbinski J., Laing R., Ford N., Drug development for neglected diseases: a deficient market and a public-health policy failure, The Lancet, Volume, 2002, Vol. 359, No. 9324, Pages 2188 - 2194 Tung T., Organ C.H. Jr., Ethics in Surgery, Historical perspective, Archives of Surgery, 2000, Vol. 135, No. 1, Pages 10-13 Uganda AIDS Commission, European Union and the Uganda HIV/AIDS Partnership, Uganda Guidelines for AIDS Vaccine Research, A Guide for Vaccine Research, Development and Evaluation, 2006 Uganda edges closer to AIDS treatment for all, Bulletin of the World Health Organization, June 2008, Vol. 86, No. 6, Pages 423-425 Uhl K., Miller M.A., Kennedy D.L., Complex Clinical, Legal and Ethical Issues of Pregnant and Postpartum Women as Subjects in Clinical Trials, Journal of Women’s Health, 2004, Vol. 13, No. 6, Pages 743-744 UNAIDS - Joint United Nations Programme on HIV/AIDS, Ethical considerations in HIV preventive vaccine research, UNAIDS guidance document, 2000 UNAIDS - Joint United Nations Programme on HIV/AIDS, Experts meet on women and HIV clinic trials, 2007 UNAIDS - Joint United Nations Programme on HIV/AIDS, Making HIV trials “work for women?”, 2007 UNAIDS - Joint United Nations Programme on HIV/AIDS, The role of women in HIV trials, 2007 UNECA - United Nations Economic Commission for Africa and African Union, Science with Africa, Conference Report, 2008 UNESCO - United Nations Educational, Scientific and Cultural Organization, ABC Project “Assisting Bioethics Committees”, 2006 UNESCO - United Nations Educational, Scientific and Cultural Organization, ABC Project, Meeting to discuss the establishment of the National Bioethics Committee in Malawi, 2007 UNESCO - United Nations Educational, Scientific and Cultural Organization, ABC Project, 1st Preparatory Meeting on the Establishment of a National Ethics Committee in Gabon, 2007 UNESCO - United Nations Educational, Scientific and Cultural Organization, ABC Project, 1st Preparatory mission on the establishment of a National Bioethics Committee in Mauritius, Mauritius, 2007 UNESCO - United Nations Educational, Scientific and Cultural Organization, Cloning, Ethical Issues, 2004 Updated 2005 UNESCO - United Nations Educational, Scientific and Cultural Organization, Division of Ethics of Science and Technology, Avicenna and the ethics of science and technology today, 2004 239
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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
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processes and stifle competition, d
Page 55 and 56:
European Medical Writers Associatio
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prescribed to more than two million
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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
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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
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MOZAMBIQUE National specific legisl
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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 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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