Biomedical Research in Developing Countries - UNICRI

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Chong W., China sets up rules to combat scientific misconduct, SciDevNet - Science and Development Network, 2006 CIOMS - Council for International Organizations of Medical Sciences, International ethical guidelines for biomedical research involving human subjects, 2002 CIOMS - Council for International Organizations for Medical Sciences in cooperation with WHO - World Health Organization and IOMS - Islamic Organizations for Medical Sciences, International Ethical Guidelines for Biomedical Research involving Human Subjects (An Islamic perspective), 2004 CIOMS – Council for International Organizations for Medical Sciences and WHO- World Health Organization, Drug Development Research In Resource-Limited Countries, How to succeed in Implementation of Good Clinical Practice Guidelines, Draft Report of the joint CIOMS/WHO Working Group, 2005 Clarke M., Collinson A., Faal H., Gaye A., Jallow M., Joof-Cole A., McAdam K., Schim van der Loeff M., Thomas V., Whittle H., Gambia Government/Medical Research Council Joint Ethical Committee, Ethical issues facing medical research in developing countries, The Lancet, 1998, Vol. 351, No. 9098, Pages 286-287 Cleaton-Jones P., Research injury in clinical trials in South Africa, The Lancet, 2006, Vol. 367, No. 9509, Pages 458-459 COHRED-The Council on Health Research for Development, AIDS and HIV in Kenya: an issue of economic development, Research into Action, 2000, No. 20, Pages 2-3 COHRED - The Council on Health Research for Development, AHA Study: donor alignment and harmonisation in health research, (date unknown) COHRED - The Council on Health Research for Development, Can communities influence national health research agendas? A learning process leading to a framework for community engagement in shaping health research policy, Country experiences: Bolivia, Cambodia, India, Kenya, Pakistan, Tajikistan, Zimbabwe, 2006 COHRED - Council on Health Research for Development, Data for health research planning and development in Uganda, Learning Brief, 2002, No. 2 COHRED - The Council on Health Research for Development, Essential National Health Research in Kenya, 1998 COHRED - The Council on Health Research for Development, Francophone African countries meet to discuss networking opportunities, Research into Action, 2001, No. 23, Pages 6-8 COHRED -The Council on Health Research for Development, From a little known entity to a functional health research network: The Tanzania National Health Research Forum, Research into Action, 2000, No. 20, Pages 5-6 COHRED - The Council on Health Research for Development, Getting Research into Policy and Practice in Malawi: The experience of the National TB Control Programme, Research into Action, 2000, No. 19, Page 5 216
COHRED - The Council on Health Research for Development, Health Research for Development in Benin – a summary, 2000 COHRED - The Council on Health Research for Development, Health Research for Development in Burundi – a summary, 2000 COHRED - The Council on Health Research for Development, Health Research in Ethiopia - A country overview, 2000 COHRED - The Council on Health Research for Development, Identifying capacities: country analysis Ghana and Uganda, 1999 COHRED -The Council on Health Research for Development, International Conference on Health Research for Development – Bangkok 2000: Consultative Processes for Africa and Latin America, Research into Action, 2000, No. 20, Pages 11-12 COHRED - The Council on Health Research for Development, Kenyan Consultative Process on Health Research – A summary, 2000 COHRED - The Council on Health Research for Development, Malawi – Prioritised health research in support of the National Health Plan, Research into Action, 2001, No. 25, Pages 4-5 COHRED - The Council on Health Research for Development, National Health Research Priorities Cameroon, (date unknown) COHRED - The Council on Health Research for Development, National survey of health research for development in Tanzania - a summary, 2000 COHRED - The Council on Health Research for Development, NIMR celebrates 20th anniversary, Tanzania’s Minister of Health lauds organisation’s achievements, Research into Action, 2001, No. 23, Pages 8-9 COHRED - The Council on Health Research for Development, Priority Setting for Health Research: Toward a management process for low and middle income countries Country experiences Philippines, South Africa, Brazil, The Netherlands, Overview of existing tools and methods, 2006 COHRED - The Council on Health Research for Development, Research capacity strengthening: creating demand for research in Kenya, 2001 COHRED-The Council on Health Research for Development, Resource Flows for Health Research in Cameroon and Tanzania, Research into Action, 2003, No. 31, Pages 6-7 COHRED - The Council on Health Research for Development, Tanzania - re-orientation of the ENHR mechanism to reinforce partnership, 2000 COHRED - The Council on Health Research for Development, What factors influence health research agendas in developing countries?, 2006 Coleman C.H., Bouësseau M.C., Strengthening Local Review of Research in Africa: Is the IRB Model Relevant?, Bioethics Forum, 2006 217
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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
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
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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
Page 66 and 67:
societies. The Foundation also host
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annual, interdisciplinary and inter
Page 70 and 71:
project in the respect of internati
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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
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the trainees home countries. Based
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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
Page 88 and 89:
exchange in health research ethics
Page 90 and 91:
objectives of SIDCER are to foster
Page 92 and 93:
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
Page 108 and 109:
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
Page 122 and 123:
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
Page 162 and 163:
COTE D’IVOIRE National specific l
Page 164 and 165:
EGYPT National specific legislation
Page 166 and 167: EQUATORIAL GUINEA National specific
Page 168 and 169: 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 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 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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