Biomedical Research in Developing Countries - UNICRI

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The diffusion of GCP Inspectorates and Ethical Review Boards, in developing countries would help in promoting the respect of international ethical and legal standards in the research trials with human participants, aligned with the adoption of strategies to verify the accuracy of clinical trial results and to confront related ethical, juridical and penal aspects as described above. The promotion of the international harmonization in the application of the Good Clinical Practices is important to facilitate the process of their inclusion in the national legislations; this would also contribute to increase knowledge and foster awareness of the phenomenon and assist developing countries in strengthening capacity in dealing with ethical and legal issues of clinical research. Finally, it is important to increase knowledge and diffusion of the United Nations and international legal and ethical instruments concerning the harmonization of the technical, administrative and legislative procedures, for the correct application of the guidelines and the good practices in the conduct of clinical trials with human participants through trainings, conferences and awareness campaigns. 148
Table 4 - Summary of the analyzed country information sheets Country National specific legislation on ethics in biomedical research Guidelines and/or SOPs concerning ethics in biomedical research National/Institutional Bioethics Committees that review ethics of biomedical research with human participants Algeria NO NO YES Angola NO NO YES Benin N/A N/A YES Botswana N/A NO YES Burkina Faso N/A N/A YES Burundi N/A N/A NO Cameroon N/A N/A YES Cape Verde N/A N/A NO Chad N/A N/A NO Congo N/A N/A NO Côte d'Ivoire N/A N/A YES Democratic Republic of Congo N/A N/A YES Egypt NO N/A YES Equatorial Guinea N/A N/A NO Ethiopia NO YES YES Gabon N/A N/A YES Gambia N/A N/A YES Ghana NO NO YES Guinea N/A N/A YES Guinea Bissau N/A N/A NO Kenya YES YES YES Lybia N/A N/A YES Malawi * N/A N/A YES Mali N/A N/A YES Mauritania N/A N/A NO Mauritius ** N/A N/A N/A Morocco NO N/A YES Mozambique N/A N/A YES Nigeria YES YES YES Rwanda N/A N/A YES Sao Tome and Principe N/A N/A NO Senegal YES YES YES Seychelles N/A N/A YES South Africa YES YES YES Sudan NO NO YES Swaziland N/A N/A NO Tanzania NO YES YES Togo N/A N/A NO Tunisia NO N/A YES Uganda N/A YES YES Zambia N/A N/A YES Zimbabwe N/A YES YES YES 4 YES 8 YES 31 Tot. 42 NO 9 NO 5 NO 10 NOT AVAILABLE 29 NOT AVAILABLE 29 NOT AVAILABLE 1 * According to direct information from a country expert, Malawi is currently preparing a Draft Law regulating clinical trials. ** Based on governmental information, Mauritius is currently undergoing Parliamentary discussions on a Draft Bill on clinical trials and on the establishment of a National Ethics Review Committee. 149
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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
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
Page 106 and 107: 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”
Page 112 and 113: 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
Page 120 and 121: States agreed to increase funding f
Page 122 and 123: very critical and difficult to ensu
Page 124 and 125: The Botswana study was terminated a
Page 126 and 127: THE CAPACITY FOR EDUCATION AND RESE
Page 128 and 129: THE AFRICAN DIASPORA The need for A
Page 130 and 131: with South Africa and Egypt account
Page 132 and 133: Political and social instability, a
Page 134 and 135: 2) Promoting independence from poli
Page 136 and 137: 136
Page 138 and 139: health care become critical issues.
Page 140 and 141: not yet developed a uniform model f
Page 142 and 143: In order to calculate the percentag
Page 144 and 145: Finally, the analysis was performed
Page 146 and 147: there can be considerable differenc
Page 150 and 151: Table 5 - List of not analyzed coun
Page 152 and 153: ANGOLA National specific legislatio
Page 154 and 155: BOTSWANA National specific legislat
Page 156 and 157: BURUNDI National specific legislati
Page 158 and 159: 10) République du Cameroun, Minist
Page 160 and 161: 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
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TOGO National specific legislation
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Conférence Annuelle, 2005 (Accesse
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8) Republic of Uganda, National Hea
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ZIMBABWE National specific legislat
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ANNEXES INTERNATIONAL ROUND TABLE
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c) We recommend the appropriate ide
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AIFA INVITES 1) International and r
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212
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Arab Republic of Egypt, Minister of
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Chong W., China sets up rules to co
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Collier J., Confusion over use of p
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Dramé B., Becker C., Samba Cor Sar
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Federal Democratic Republic of Ethi
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Hamza B., Spécificités et Rôle d
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Japan Pharmaceutical Manufacturers
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Repère Médical, La bioéthique da
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Molyneux C.S., Peshu N., Marsh K.,
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Petrini C. (Ed.), Informed consent
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Republic of South Africa, Medical R
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République Tunisienne, Ministère
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Struble K.A., Toigo T.A., Behrman R
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UNESCO - United Nations Educational
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Varmus H., Satcher D., Ethical Comp
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WHO - World Health Organization, Na
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246
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REC R&D RMTC RBM SARETI SEAICRN TDR
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Biomedical Research in Developing Countries - UNICRI

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