Biomedical Research in Developing Countries - UNICRI

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Dramé B., Becker C., Samba Cor Sarr, Le Conseil national de recherche en santé: naissance d’une instance éthique au Sénégal, Animation régionale de Dakar, Réseau des chercheurs “Droit de la Santé”, Agence Universitaire de la Francophonie, (date unknown) Drug company to make its trial results public, British Medical Journal, 2004, Vol. 329:366 Dubois W., New drug research, the extraterritorial application of FDA regulations and the need for international cooperation, Vanderbilt Journal of Transnational Law, 2003, Vol. 36 Eckstein S., Efforts to build capacity in research ethics: an overview, SciDevNet - Science and Development Network, 2004 EDCTP - European and Developing Countries Clinical Trials Partnership, EDCTP Newsletter, 2006, Vol. 4, No. 1 EDCTP - European and Developing Countries Clinical Trials Partnership, EDCTP Newsletter, 2007, Vol. 2, No. 4 Edejer T.T.T., North-South research partnerships: the ethics of carrying out research in developing countries, British Medical Journal, 1999, Vol. 319, Pages 438-441 EFGCP – European Forum for Good Clinical Practice, Guidelines and Recommendation for European Ethics Committees, 1997 EGE – European Group on Ethics in Science and New Technologies to the European Commission, Ethical Aspects Of Clinical Research In Developing Countries - Opinion No. 17, 2003 EGE - European Group on Ethics in Science and New Technologies to the European Commission, Recommendations on the Ethical Review of hESC FP7 Research Projects, Opinion No. 22, 2007 EGE - European Group on Ethics in Science and New Technologies to the European Commission, The ethical aspects of biomedical research in developing countries, Proceedings of the Round Table Debate, Brussels on 1st October 2002 Elkebir F.Z., L’état de la bioéthique en Algérie, CEBACORES – Centro de Estudo de Bioética Polo Açores, 2005, Pages 347-350 Elliott C., Abadie R., Exploiting a Research Underclass in Phase 1 Clinical Trials, New England Journal of Medicine, 2008, Vol. 358, No. 22, Pages 2136-2137 Elsayed D.E.M., Assessment of the ethical review process in Sudan, Developing World Bioethics, 2004, Vol. 4, No. 2, Pages 154-159 Elsayed D.E.M., Kass N.E., Attitudes of Sudanese researchers on obtaining informed consent from study subjects involved in health research, Sudanese Journal of Public Health, 2007, Vol. 2, No. 2, Pages 95-102 Elsayed D.E.M., National Framework for Ethics in Health Research involving Human Subjects, Sudanese Journal of Public Health, 2006, Vol.1, No. 3, Pages 192-196 220
Emanuel E.J., Ending Concerns About Undue Inducement, Journal of Law, Medicine & Ethics, 2004, Vol. 32, Pages 100-105 Emanuel E.J., Wendler D., Grady C., What Makes Clinical Research Ethical, Journal of the American Medical Association, 2000, Vol. 283, No. 20, Pages 2701-2711 Emanuel E.J., Wendler D., Killen J., Grady C., What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research, Journal of Infectious Diseases, 2004, Vol. 189, No. 5, Pages 930-937 EMEA – European Medicines Agency, EMEA/EFGCP Workshop on Ethics in Clinical Trials Development, From Legislation to Implementation, 2003 EMWA – European Medical Writers Association, Clinical Trials, The Write Stuff, The Journal of the European Medical Writers Association, 2006, Vol.15, No.1 Epstein R., Overdose, Come una regolamentazione eccessiva mette a rischio le medicine del futuro, Rubbettino/Leonardo Facco, 2007 EURETH.NET – European Information Ethics in Medicine and Biotechnology, Ethical and legal aspects on clinical trials with children, A bibliography, 2004 European Commission, EGE - European Group on Ethics in Science and New Technologies, Ethically Speaking, 2007, No. 8 European Commission, EGE - European Group on Ethics in Science and New Technologies, Ethically Speaking, 2008, No. 9 European Commission, Ethics, Research And Globalization, Europe and its partners building capacity in research ethics, Conference proceedings, Brussels, 14-15 May 2007 European Commission, Medicines for Children, 2007 European Commission, Who is privy to medical research data?, 2005 European Parliament and the Council of the European Union, Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal of the European Communities, 1 May 2001, L 121/34 European Parliament and the Council of the European Union, Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medical products for human and veterinary use and establishing a European Medicines Agency, Official Journal of the European Union, 31 March 2004, L 136/1 European Union, Consolidated Versions of the Threaty establishing the European Community, Title XVIII Research and Technological Development, Official Journal of the European Union C 321 E/1, 2006, C 321 E/1 Falguni S., Muthuswamy Y., Capacity Building for Clinical Trials in India, Editorial, Indian Journal of Medical Research, 2006, Vol. 124, Pages 605-607 221
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Agenzia Italiana del Farmaco GCP IN
Page 3 and 4:
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
Page 12 and 13:
- 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
Page 27 and 28:
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
Page 35 and 36:
preparatory work on a declaration o
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Consequently, these authorities rar
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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
Page 70 and 71:
project in the respect of internati
Page 72 and 73:
also to assess the training needs o
Page 74 and 75:
Fogarty International Center for Ad
Page 76 and 77:
Global Forum on Bioethics in Resear
Page 78 and 79:
the trainees home countries. Based
Page 80 and 81:
consolidate it in the fields of edu
Page 82 and 83:
KHRC is part of the INDEPTH Network
Page 84 and 85:
Research Center on Health, Cultures
Page 86 and 87:
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
Page 98 and 99:
are TDR (UNICEF/UNDP/World Bank/WHO
Page 100 and 101:
committees or scientific advisory c
Page 102 and 103:
The objective of the course was to
Page 104 and 105:
104
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as passive recipients or, worse, as
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THE HEALTH CARE SCENARIO IN THE DEV
Page 110 and 111:
Unfortunately, the “10/90 gap”
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about 2,075 molecules were in devel
Page 114 and 115:
PATENTING ISSUES AND ACCESS TO ESSE
Page 116 and 117:
only on innovative products. A pate
Page 118 and 119:
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
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 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 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
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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