Biomedical Research in Developing Countries - UNICRI

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Japan Pharmaceutical Manufacturers Association, PhRMA – Pharmaceutical Research and Manufacturers of America, Joint Position on the Disclosure of Sensitive Information via Clinical Trial Registries, 2005 Ijsselmuiden C., Clinical trials in developing countries: Ethical issues, COHRED-The Council on Health Research for Development, 2007 Ikingura J.K., Kruger M., Zeleke W., Health research ethics review and needs of institutional ethics committees in Tanzania, United Republic of Tanzania, NIMR - National Institute for Medical Research, (date unknown) Imasheva A., Seiter A., The Pharmaceutical Sector of the Western Balkan Countries, World Bank Health, Nutrition and Population (HNP), 2008 Infezione da HIV: Repertorio delle sperimentazioni terapeutiche, Ed. 2004, Suppl. Positifs, 2004, Anno X, No. 65 INSERM - Institut National de la Santé et de la Recherche Médicale, Ethique biomédicale de la recherche: Bilan d’un Partenariat constructif Europe-Afrique coordonné par l’INSERM, Communiqué de Presse, Paris 13 Décembre 2006 International Conference on Primary Health Care, Declaration of Alma-Ata, 1978 Irabor D.O., Omonzejele P., Country Report, Local attitudes, moral obligation, customary obedience and other cultural practices: their influence on the process of gaining informed consent for surgery in a tertiary institution in a developing country, Developing World Bioethics ISSN 1471-8731, 2007 ISESCO – Islamic Educational, Scientific and Cultural Organization, Basic Document on the Establishment of the Islamic Body on Ethics of Science and Technology (IBEST), (date unknown) Johansson K.A. et al., National HIV Treatment Guidelines in Tanzania and Ethiopia: are they legitimate rationing tools?, Journal of Medical Ethics, 2008, Vol. 34, Pages 478- 483 John Hopkins Bloomberg School of Public Health, NIH-Funded Case Study: Research Ethics Committees in Africa Report Inadequate Funding, Staffing and Training, 2007 Kagarise M.J., Sheldon G.F., Transnational Ethics. A perspective for the New Millennium, Archives of Surgery, 2000, Vol. 135, No. 1, Pages 39-45 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) Karbwang J., Pattou C., Standard Operating Procedures for Clinical Investigators, TDR – UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, 2001 Kass N.E., Hyder A.A., Ajuwon A., Appiah-Poku J., Barsdorf N., Elsayed D.E., Mokhachane M., Mupenda B., Ndebele P., Ndossi G., Sikateyo B., Tangwa G., Tindana P., The Structure and Function of Research Ethics Committees in Africa: a Case Study, PlosMed 2007, Vol. 4, No. 1, Pages 26-31 226
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, 2007, Vol. 8:9 Kennedy A., Khoja T.A.M., Abou-Zeid A.H., Ghannem H., Ijsselmuiden C., on behalf of the WHO-EMRO/COHRED/GCC NHRS Collaborative Group, National health research system mapping in 10 Eastern Mediterranean countries, La Révue de la Santé Orientale, 2008, Vol. 14, No. 3, Pages 502-517 Kent D.M., Mwamburi D.M., Bennish M.L., Kupelnick B., et al., Clinical Trials in Sub- Saharan Africa and Established Standards of Care: A Systematic of HIV, Tubercolosis, and Malaria Trials, The Journal of the American Medical Association, 2004, Vol. 292, No. 2, Pages 237-242 Kenyan science and technology system - a brief profile, Research-Africa.net, (date unknown) Kilama W.L., Equipping Africa’s researchers for global collaboration, SciDevNet – Science and Development Network, 2003 Killen J., Grady C., Folkers G.K., Fauci A.S., Ethics of Clinical Research in the Developing World, Nature, 2002, Vol. 2, Pages 210-215 Killien M., Bigby J.A., Champion V., Fernandez-Repollet E., Jackson R.D., Kagawa- Singer M., Kidd K., Naughton M.J., Prout M., The Millennium Series, Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women’s Health, Journal Of Women’s Health & Gender-Based Medicine, 2000, Vol. 9, No. 10, Pages 1061-1070 Kintampo Health Research Centre, Ghana Health Service, Ghana Health Service Annual Report For The Year 2006, 2007 Kirigia J.M., Wambebe C., Baba-Moussa A., Status of national research bioethics committees in the WHO African region, BMC Medical Ethics, 2005, Vol. 6:10 Kitua A.Y., Mashalla Y.J.S., Shija J.K., Coordinating health research to promote action: the Tanzanian experience, British Medical Journal, 2000, Vol. 321, Pages 821-823 Kokkonen P., Medicine, the Law and Medical Ethics in a Changing Society, World Medical Journal, 2004, Vol. 50, No. 1, Pages 5-8 Koski G., Nightingale S.L., Research involving human subjects in developing countries, New England Journal of Medicine, 2001, Vol. 345, No. 2, Pages 136-138 Kubar O., Ethical Review of Biomedical Research in the CIS Countries (Social and Cultural Aspects), 2007 Kumaranayake L., Lake S., Mujinja P., Hongoro C., Mpembeni R., How do countries regulate the health sector? Evidence from Tanzania and Zimbabwe, Health Policy and Planning, 2000, Vol. 15, No.4, Pages 357-367 Kuritzkes D.R., Ethical conduct of Research in Resource-Limited Settings, Journal of Infectious Diseases, 2004, Vol. 189, No. 5, Pages 764-765 227
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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
Page 45 and 46:
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
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
Page 102 and 103:
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
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
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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
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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
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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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 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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Biomedical Research in Developing Countries - UNICRI

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