Biomedical Research in Developing Countries - UNICRI

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Repère Médical, La bioéthique dans le pays en développement, 2008, No. 7 Lamine S.M., Réflexions sur la Bioéthique en Afrique, in Ndiaye A.L., Ba A.T., Becker C., Dia O. et al. (éds), Les biotechnologies, Potentiels, enjeux et perspectives: le cas du Sénégal, Dakar, Académie des Sciences et Techniques du Sénégal, 2004, Pages 73-81 Langlois A., The UNESCO Universal Declaration on Bioethics and Human Rights: Perspectives from Kenya and South Africa, Health Care Anal, 2008, Vol. 16, Pages 39-51 Lavery J.V., A Culture of Ethical Conduct in Research: The Proper Goal of Capacity Building in International Research Ethics CMH Working Paper Series Paper No. WG2:5, WHO/EMRO – World Health Organization Regional Office for the Eastern Mediterranean, Commission on Macroeconomics and Health, (date unknown) Lavery J.V., Grady C., Wahl E.R., Emanuel E.J. (Eds.), Ethical Issues in International Biomedical Research: A Casebook, Oxford University Press, 2007 Lavery J.V., The Challenge of Regulating International Research With Human Subjects, SciDevNet – Science And Development Network, 2004 Levine R.J., The Need to Revise the Declaration of Helsinki, New England Journal of Medicine, 1999, Vol. 341, No. 7, Pages 531-534 Levinson D.R., Review of Corrective Actions Concerning the Human Subject Research Program (A-06-06-00042), US Department of Health and Human Services, Office of Inspector General, 2006 Loff B., Africans discuss ethics of biomedical research, The Lancet, 2002, Vol. 359, No. 9310, Page 956 London L., Ethical Oversight of Public Health Research: Can Rules and IRBs Make a Difference in Developing Countries?, American Journal of Public Health, 2002, Vol. 92, No. 7, Pages 1079-1084 Lopez A.D., Mathers C.D., Ezzati M., Jamison D.T., Murray C.J. (Eds.), Global Burden of Disease and Risk Factors, World Bank Publications, 2006 Love C.B., Thomson E.J. (Eds.), D. Royal C.D., Current Bibliography in Medicine 99-3, Ethical Issues in Research involving Human Participants, US Department of Health and Human Services, Public Health Service, National Institutes of Health, 1999 Lucas A.O., Human Resources for Health in Africa (Ed.), British Medical Journal, 2005, Vol. 331, Pages 1037-1038 Lucas A.O., International Collaboration in Health Research CMH Working Paper Series, Paper No. WG2:2, WHO/EMRO - World Health Organization Regional Office for the Eastern Mediterranean, Commission on Macroeconomics and Health, CMH Working Paper Series, (date unknown) Lurie P., Wolfe S.M., The developing world as the “answer” to the dreams of pharmaceutical companies: the Surkaxin story, 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 159-170 228
Lurie P., Wolfe S.M., Unethical Trials of Interventions to reduce Perinatal Transmission of the Human Immunodeficiency in Developing Countries, New England Journal of Medicine, 1997, Vol. 337, No. 12, Pages 853-856 Maghrebmed, Santé et Médicine au Maghreb, Les Bonnes Pratiques Cliniques en Tunisie, (date unknown) Manafa O., Lindegger G., Ijsselmuiden C., Informed consent in an antiretroviral trial in Nigeria, Indian Journal of Medical Ethics, 2007, Vol. IV, No 1, Pages 26-30 Manafa O., Lindegger G, Ijsselmuiden C., Informed Consent in a Clinical Trials: Participants’ Satisfaction of the Consent Process and Voluntariness of Participation, SARETI - South African Research Ethics Training Initiative, (date unknown) Mangset M. et al., “I don’t like that, it’s tricking people too much…”: acute informed consent to participation in a trial of thrombolysis for stroke, Journal of Medical Ethics, 2008, Vol. 34, Pages 751-756 Mc Guire Dunn C., Chadwick G., Special Ethical concerns in Clinical Research, in Protecting Study Volunteers in Research, A Manual for Investigative Sites, 3 rd Edition, 2007 Mehdiratta R., Parida D.K., Saberwal G., Bio-business in brief: The challenges of clinical trials, Current Science, 2007, Vol. 93, No. 10, Pages 1367-1375 Marshall P.A., Ethical challenges in study design and informed consent for health research in resource-poor settings, Special Topics in Social, Economic and Behavioural (SEB) Research report series, No. 5, WHO - World Health Organization and TDR – UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, 2007 Mengistie G., Health research ethics and law in Ethiopia, (date unknown) Mgone C.S., Mocumbi P., Collaborative approach to Clinical Trials, Global Forum for Health Research, Health Partnerships Review, May 2008, Pages 61-63 Milano G., Farmaci con una doppia vita, Panorama 17/7/2008 Milford C., Wassenaar D. et al., Resources and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials, IRB, Ethics & Human Research, 2006, Vol. 28, No. 2, Pages 1-9 Mills E.J., Schabas W.J., Volmink J. et al., Should active recruitment of health workers from sub-Saharan Africa be viewed as a crime?, The Lancet, 2008, Vol. 371, Pages 685- 688 Ministerial Conference on Research for Health in the African Region, The Algiers Declaration, Algiers, 23–26 June 2008 Missinou M.A., Olola C.H.O., Issifou S., Matsiegui PB., Adegnika A.A., Borrmann S., Wypij D., Taylor T.E., Kremsner P.G., Short Report: piloting paperless data entry for clinical research in Africa, The American Journal of Tropical Medicine and Hygiene, 2005, Vol. 72, No. 3, Pages 301-303 229
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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://
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
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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 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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