Biomedical Research in Developing Countries - UNICRI

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EGYPT National specific legislation on ethics in biomedical research Guidelines and/or SOPs concerning ethics in research National/Institutional Bioethics Committees that review ethics of biomedical research with human participants NO N/A* YES *The research is based on International Ethics Guidelines, the EU Guidelines, the US Guidelines and others http://medschool.umaryland.edu/enrec/guidelines.asp Sources: 1) Arab Republic of Egypt, Constitution, Art. 43, 1971 (Accessed on 12 November 2008 at http://www.egypt.gov.eg/english/laws/constitution/default.aspx) 2) Arab Republic of Egypt, Minister of Health and Population, Egyptian Medical Syndicate, Profession Ethics Regulations issued by the Resolution of the Minister of Health and Population No. 238/2003, 2003 (Accessed on 17 December 2008 at http://www.ems.org.eg/images/leha_eng.doc) 3) Email from Dr. Shehata M., Member of the National Research Ethics Committee 4) Email from El-Setouhy M., MD, Professor, Department of Community, Environmental and Occupational Medicine,Vice Chair of the Research Ethics Committee, Faculty of Medicine,Ain Shams University,Abbasia, Cairo, Egypt, CO-Director of the Health Research Ethics Training Initiative in Egypt (HRETIE) 5) Kandeel N., Elnemer A., Kassem H., Moustafa N., El-Setouhy M. Silverman H., Developing Research Ethics Committees: Implications for Global Health, HRETIE - Health Research Ethics Training Initiative in Egypt, (Date unknown), (Accessed on 24 July 2008 at http://medschool.umaryland.edu/hretie/docs/Kandeel_2006_Forum_Paper.pdf) 6) Khalil S. S, Silverman H. J., Raafat M., El-Kamary S., El-Setouhy M., Attitudes, understanding, and concerns regarding medical research amongst Egyptians: A qualitative pilot study, BMC Medical Ethics, 2008,Vol. 8:9 (Accessed on 24 July 2008 at http://www.biomedcentral.com/content/pdf/1472-6939-8-9.pdf) 7) HRETIE – University of Maryland School of Medicine, Health Research Ethics Training Initiative in Egypt, Egyptian Enhancing Research Ethics Committees in Egypt, Guidelines for Standard Operating Procedures SOPs, (Date unknown), (Accessed on 27 August 2008 at http://medschool.umaryland.edu/enrec/docs/Standard%20Operating%20Procedures% 20(SOPs).pdf) 8) HRETIE – University of Maryland School of Medicine, Health Research Ethics Training Initiative in Egypt, Egyptian Network of Ethics Committees (ENREC), Directory, 164
Research Ethics Committees in Egypt, (Date unknown), (Accessed on 27 August 2008 at http://medschool.umaryland.edu/enrec/directory.asp) 9) HRETIE – University of Maryland School of Medicine, Health Research Ethics Training Initiative in Egypt, Egyptian Research Ethics Committees Standard Operating Procedures, (Date unknown), (Accessed on 27 August 2008 at http://medschool.umaryland.edu/enrec/docs/Best%20Practice%20SOPs%20for%20Egy pt.pdf) 10) UNESCO – United Nations Educational, Scientific and Cultural Organization, Global Ethics Observatory, (Accessed on 30 September 2008 at http://www.unesco.org/shs/ethics/geo/user/?action=select&lng=en&db=) 12) 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 (Accessed on 30 September 2008 at http://unesdoc.unesco.org/images/0015/00152805e.pdf) 13) WHO/EMRO - World Health Organization Regional Office for the Eastern Mediterranean, National Health Research System Mapping in the Eastern Mediterranean Region, A study of ten Countries, 2008 (Accessed on 17 December 2008 at http://www.emro.who.int/dsaf819.pdf) 165
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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
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
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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 148 and 149: The diffusion of GCP Inspectorates
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 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
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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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