Biomedical Research in Developing Countries - UNICRI

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Petrini C. (Ed.), Informed consent to treatment of persons with dementia: ethical, deontological, juridical aspects, Rapporto ICTISAN 08/03, 2008 Petros B., Biomedical Research and Ethics in Ethiopia, A Keynote Address, (date unknown) Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2006 Pich J. et al., Role of a Research Ethics Committee in follow up and publication of results, The Lancet, 2003, Vol. 361, No. 9376, Page 2246 PIC/S – Pharmaceutical Inspection Convention Co-operation Scheme, Press release: PIC/S Committee Meeting, Geneva, Switzerland 23 May 2007 Positifs, 2007, Anno XVI, No. 81-82 Poncin J., Des essais cliniques dans les pays du Sud? Oui, mais…, IRCM Centre de Bioéthique, L’Observatoire de la Génétique, No. 7, 2002 Public Health Fact Sheet, Barriers to Access: Medication-Assisted Treatment and Injection- Driven HIV Epidemics, 2008, No. 4 Rachier A., Legislative and administrative measures for the implementation of the Universal Declaration on Bioethics and Human Rights in Africa, (date unknown) Ramahi I., Silverman H., Clinical Research Law in Jordan: an Ethical Analysis, Developing World Bioethics, 12 December 2007 Ramasubbu K., Gurm H., Litaker D., Gender Bias in Clinical Trials: Do Double Standards Still Apply?, Journal Of Women’s Health & Gender-Based Medicine, 2001, Vol. 10, No. 8, Pages 757-764 Ramsay S., African health researchers unite, The Lancet, 2002, Vol. 360, No. 9346, Pages 1665-1666 Rehnquist J., Clinical Trial Web Site, A Promising Tool To Foster Informed Consent, US Department of Health and Human Services, Office of Inspector General, 2002 Rehnquist J., The Globalization of Clinical Trials, A Growing Challenge in Protecting Human Subjects, US Department of Health and Human Services, Office of Inspector General, 2001 Repubblica Italiana, Decreto Legislativo n. 211 del 24 Giugno 2003, Attuazione della direttiva 2001/20/CE relativa all’applicazione della buona pratica clinica nell’esecuzione delle sperimentazioni cliniche di medicinali per uso clinico, Gazzetta Ufficiale n. 184 del 9 Agosto 2003 Repubblica Italiana, Decreto Legislativo n. 200 del 6 novembre 2007, Attuazione della direttiva 2005/28/CE recante principi e linee guida dettagliate per la buona pratica clinica relativa ai medicinali in fase di sperimentazione a uso umano, nonché requisiti per l'autorizzazione alla fabbricazione o importazione di tali medicinali, Gazzetta Ufficiale n. 261 del 09 Novembre 2007 232
Repubblica Italiana, Ministero della Sanità, Decreto Ministeriale de 15 Luglio 1997, Recepimento delle linee guida della UE di Buona Pratica Clinica per l’esecuzione delle sperimentazioni cliniche dei medicinali, 1997 Republic of Ghana, Food and Drugs Board, Guidelines for the registration of vaccines in Ghana, (date unknown) Republic of Ghana, Ghana Health Service, Annual Report 2007, (date unknown) Republic of Ghana, Ghana Health Service, Code of Ethics, (date unknown) Republic of Ghana, Ghana Health Service, Health Research Unit Annual Report 2003, (date unknown) Republic of Ghana, Ghana National Drug Policy, 2004 Republic of Ghana, The Constitution of the Republic of Ghana, 1992 Republic of Kenya, Ministry of Health, Kenya National Guidelines for Research & Development of HIV/AIDS Vaccine, 2005 Republic of Kenya, Ministry of Health, Pharmacy and Poisons Board, Guideline for the national pharmacovigilance system in Kenya, 2007 Republic of Sierra Leone, Minister of Health, Regulatory Authorities: Pharmacy Board, (date unknown) Republic of South Africa, Department of Health, Ethics in health research principles, structures and processes, Research Ethics Guidelines, 2004 Republic of South Africa, Department of Health, Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa, 2000 Republic of South Africa, Department of Health, Health Act No. 61/2004, Government Gazette, 23 July 2004, Vol. 469, No. 26595 Republic of South Africa, Department of Health, Law audit applicable to child participation in research and clinical trials, (date unknown) Republic of South Africa, Department of Health, South African Good Clinical Practice Guidelines Second Edition, 2006 Republic of South Africa, Department of Health, South African National Clinical Trials Register, Research Ethics Committees, (date unknown) Republic of South Africa, Department of Health, The Patient’s Rights Charter, (date unknown) Republic of South Africa, Department of Health, What you should know when deciding to take part in a clinical trial as a research participant, 2002 Republic of South Africa, Department of Health, White Paper for the Transformation of the Health System in South Africa, 1997 233
Page 1 and 2:
Agenzia Italiana del Farmaco GCP IN
Page 3 and 4:
Table of Contents Authorship and Ac
Page 5 and 6:
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
Page 14 and 15:
UNICRI facilitates global partnersh
Page 17 and 18:
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
Page 31 and 32:
therapeutic methods identified by t
Page 33 and 34:
to conduct large-scale trials for v
Page 35 and 36:
preparatory work on a declaration o
Page 37 and 38:
Consequently, these authorities rar
Page 39 and 40:
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
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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
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”
Page 112 and 113:
about 2,075 molecules were in devel
Page 114 and 115:
PATENTING ISSUES AND ACCESS TO ESSE
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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
Page 150 and 151:
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
Page 176 and 177:
(Accessed on 9 July 2008 at http://
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MALAWI National specific legislatio
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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 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 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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