Biomedical Research in Developing Countries - UNICRI

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Federal Democratic Republic of Ethiopia, Ethiopian Science and Technology Commission, National Health Science and Technology Council, Health Department, National Health Research Ethics, Review Guideline, Consultation Workshop Proceedings, 2005 Federal Democratic Republic of Ethiopia, Ethiopian Science and Technology Commission, National Health Science and Technology Council, Health Department, Ethiopia National Health Research Ethics Review Guideline, 2005 Federal Republic of Nigeria, Ministry of Health and Republic of Ghana, Ministry of Health with support of WHO and TDR, High Level Ministerial Meeting on Health Research in Africa 8-10 March 2006, Abuja, Nigeria, Communique High Level Ministerial Meeting, 2006 Federal Republic of Nigeria, Ministry of Health and Republic of Ghana, Ministry of Health with support of WHO and TDR, High Level Ministerial Meeting on Health Research in Africa 15-17 June 2006, Accra, Ghana, Health Research for Disease Control and Development, 2006 Federal Republic of Nigeria, Ministry of Health, National Health Research Ethics Committee of Nigeria (NHREC), National Code of Health Research Ethics, 2007 Federal Republic of Nigeria, NHREC - National Health Research Ethics Committee, About National Health Research Ethics Committee, (date unknown) Finlay K.A., Fernandez C.V., Failure to report and provide commentary on research ethics board approval and informed consent in medical journals, Journal of Medical Ethics, 2008, Vol. 34, Pages 761-764 Fischer B.A. IV, A Summary of Important Documents in the Field of Research Ethics, Schizophrenia Bulletin, 2005, Vol. 32, No. 1, Pages 69-80 Fuchs M., National Ethics Council, Their background, functions and modes of operations compared, Nationaler Ethikrat, 2005 Gardella F., Assi S., Simon F., Bogreau H., Eggelt T., Ba F., Foumane V., Henry MC., Kientega P.T., Basco L., Trape JF., Lalou R., Martelloni M., Desbordes M., Baragatti M., Briolant S., Almeras L., Pradines B., Fusai T., Rogier C., Antimalarial drug use in general populations of tropical Africa, Malaria Journal 2008, Vol. 7:124 Garrafa V., Lorenzo C., Moral imperialism and multi-centric clinical trials in peripheral countries, Cadernos de Saúde Pública, 2008, Vol. 24, No. 10, Pages 2219-2226 Gaudiano M.C., Di Maggio A., Cocchieri E., Antoniella E., Alimonti S., Valvo S., Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials, Malaria Journal, 2007, Vol. 6:22 Gedif T., Assessment of Ethics Review Application submitted in the period b/n June 1995/mid May 2004, Federal Democratic Republic of Ethiopia, Health Department Ethiopian Science and Technology Commission, (date unknown) Getz K., Borfitz D., Informed Consent: a Guide to the Risks and Benefits of Volunteering for Clinical Trials, Center Watch, 2006 222
Ghersi D., Clarke M., Berlin J., Gülmezoglu AM., Kush R., Lumbiganon P., Moher D., Rockhold F., Sim I., Wager E., Reporting the findings of clinical trials: a discussion paper, Bulletin of the World Health Organization, June 2008, Vol. 86, No. 6, Page 492-493 Gibbs Brown J., Institutional Review Boards: A Time for Reform, US Department of Health and Human Services, Office of Inspector General, 1998 Gibbs Brown J., Protecting Human Research Subjects Status of Recommendations, US Department of Health and Human Services, Office of Inspector General, 2000 Gibbs Brown J., Recruiting Human Subjects Pressures in Industry-Sponsored Clinical Research, US Department of Health and Human Services, Office of Inspector General, 2000 Gillon R., Medical Ethics: four principles plus attention to scope, British Medical Journal, 1994, Vol. 309:184 Giordani M.M., Per un’arte medica al servizio della persona, Bulletin Européen, Ed. Italiana, 2008, Anno 59, No. 698-699, Pages 1-2 Global Forum on Health Research, Case study – Choosing a research ethical committee system amongst the existing models? Critical decision of a middle-income country (Chile), 2007 Global Forum for Health Research, Cross-cutting Issues, Global Forum Update on Research for Health, 2005, Pages 129-146 Global Forum on Health Research, Health Research Institutions and Global Challenges, Global Forum Update on Research for Health, Vol. 2, Pages 127-140 Global Forum on Health Research, The 10/90 Report on Health Research 2001-2002, 2002 Global Forum on Health Research, The 10/90 Report on Health Research 2003-2004, 2004 Global Forum for Health Research, Universities, Schools of Public Health and Health Research Systems, Global Forum Update on Research for Health, Vol. 2, Pages 141-157 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 Greco D., Petrini C., Alcuni aspetti di etica in sanità pubblica, Annali dell’Istituto Superiore di Sanità, 2004, Vol. 40, No. 3, Pages 363-371 Gross A., Hirose M., Conducting Clinical Trials in Asia, Pacific Bridge Medical, Asia Medical Publications, March 2007 Halpern S., Karlawish J., for the University of Pennsylvania Research Ethics Working Group, Industry-sponsored research, The Lancet, 2000, Vol. 356, No. 9248, Pages 2193-2193 223
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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 . .
Page 7:
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
Page 24 and 25:
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
Page 39 and 40:
new scientific developments made ac
Page 41 and 42:
Additional Protocols are foreseen i
Page 43 and 44:
applied in the protection of partic
Page 45 and 46:
Guidelines for Good Clinical Practi
Page 47 and 48:
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
Page 68 and 69:
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
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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
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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
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 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 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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