Biomedical Research in Developing Countries - UNICRI

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Varmus H., Satcher D., Ethical Complexities of Conducting Research in Developing Countries, New England Journal of Medicine, 1997, Vol. 337, No. 14, Pages 1003-1005 Volmink J., Dare L., Addressing inequalities in research capacity in Africa, All sides in partnerships must ensure that research aims to improve the health of all, British Medical Journal, 2005, Vol. 331, No. 7519, Pages 705–706 Von Elm E., Röllin A., Blümle A., Huwiler K., Witschi M., Egger M., Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee, Swiss Medical Weekly, 2008, Vol. 138, No. 13-14, Pages 197-203 Wager E., “Good Publication Practice for Pharmaceutical Companies”: Where Are We Now?, Current Medical Research and Opinion, Vol. 19, No. 3, Pages 149-154 Wagner C.S., Brahmakulam I., Jackson B., Wong A., Yoda T., Science and Technology Collaboration: Building Capacity in Developing Countries?, RAND Corporation, March 2001 Wasunna M., Challenges and institutional constraints on bioethics development in Africa, Kenya Medical Research Institute, 14th Session of the International Bioethics Committee, 2007 Weinfurt K.P., Friedman J.Y., Dinan M.A., Allsbrook J.S., Hall M.A., Dhillon J.K., Sugarman J., Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflicts of Interest Committees, and Investigators, The Journal of Law, Medicine and Ethics, 2006, Vol. 34, No. 3, Pages 581-591 WEMOS Foundation, A Bitter Pill, The Risks of Carrying out Clinical Drug Trials in Developing Countries, 2008 WEMOS Foundation and European Parliament, Final report of the expert meeting “Clinical trials and protection of trial subjects in low-income and developing countries”, 2007 WEMOS Foundation, Do European registration authorities ascertain whether clinical trials in developing countries have been conducted in an ethical manner?, 2007 Wendler D., Emanuel E.J., Lie R.K., The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsible to Those Countries Health Needs?, American Journal of Public Health, 2004, Vol. 94, No. 6, Pages 923-928 WHO/AFRO – World Health Organization Regional Office for Africa, Press Release 51 st Session of the WHO Regional Committee for Africa, Health Ministers to discuss Research Bioethics, 27 August-1 September 2001 WHO/EMRO – World Health Organization Regional Office for the Eastern Mediterranean, Colloque National de Bioéthique, Atelier de Formation à l'éthique de la recherche, Recommendations, Faculté de Médecine et de Pharmacie de Fès, Fès 8-11 Juin 2005 WHO/EMRO - World Health Organization Regional Office for the Eastern Mediterranean, UNESCO - United Nations Educational, Scientific and Cultural Organization, First Regional Meeting of National Bioethics Committees, Cairo 5/7 May 2007 242
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Page 1 and 2:
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
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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
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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
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
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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
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SAO TOME AND PRINCIPE National spec
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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 238 and 239: Struble K.A., Toigo T.A., Behrman R
Page 240 and 241: UNESCO - United Nations Educational
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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