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Biomedical Research in Developing Countries

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Biomedical Research in Developing Countries Agenzia Italiana del Farmaco GCP INSPECTORATE Biomedical Research in Developing Countries: The Promotion of Ethics, Human Rights and Justice A. P. Brizi, U. Filibeck, K. Kangaspunta, A. Liquori O’Neil The views expressed are those of the authors and do not necessarily reflect the views of UNICRI and AIFA. The Authors are not responsible for the use that might be made of the information contained in this Report. Contents of this Report may be quoted or reproduced, provided that the source of information is acknowledged. UNICRI and AIFA would like to receive a copy of the document in which this Report is used or quoted. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations, UNICRI and of AIFA concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific institutions, companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by UNICRI and AIFA in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. ©UNICRI and AIFA, 2009 Printed in Italy The results of this Report were presented at an international Round Table, organized by UNICRI and AIFA, which was held in Rome on 15-16 December 2008. Further information is available in the UNICRI website at: http://www.unicri.it e-mail: Clinical Trials Ethics Project <[email protected]> Cover Illustration: M. Di Pane, M. Flamini, Information Technology, UNICRI Editing and Printing: Novegrafie, Vicolo Margana, 12 - 00186 Rome, Italy UNICRI Publication No. 92, Rome, March, 2009 Table of Contents Authorship and Acknowledgments . .9 Report Summary . .11 Forewords, by Sandro Calvani, Director UNICRI . .13 Presentation, by Guido Rasi, Executive Director, AIFA . .17 Introduction, by Umberto Filibeck, Head of GCP Promotion Unit and GCP and Pharmacovigilance Inspectorate, AIFA Italian Medicines Agency . .21 Chapter I - The International Guidance . .27 The Ethics of Clinical Research . .27 The Guidance . .29 European Union . .35 Council of Europe . .39 Other Relevant Documents in the Field of Research Ethics . .43 Publication Ethics . .52 The Role of Professional Medical Writers . .56 The Need to Establish a Clinical Trials Registry . .57 Conclusions . .58 Chapter II - Global Training Initiatives and Programmes on Bioethics . .61 African Health Research Forum - AHRF . .61 African Malaria Network Trust - AMANET . .62 Aga Khan University - Master on Bioethics . .63 Arab League Educational, Cultural and Scientific Organization - ALECSO . .64 Bill and Melinda Gates Foundation - Global Health Program . .65 Brocher Foundation . .65 Centre for the AIDS Programme of Research in South Africa - CAPRISA . .66 Collaborative Institutional Training Initiative - CITI . .67 Communication, Medicines and Ethics - COMET . .67 Council on Health Research for Development - COHRED . .68 Council of Europe - COE . .69 Critical Research Ethics Issues in the Era of HIV in Tanzania . .69 Days of Ethics and Bioethics for West and Central Africa . .70 East African Community Health and Scientific Conference . .70 3 European and Developing Countries Clinical Trials Partnership - EDCTP . .71 European Forum for Good Clinical Practice - EFGCP . .72 Evidence Informed Policy Network - EVIPnet Africa . .72 Fogarty African Bioethics Training Programme . .73 Fogarty International Center for Advanced Studies in Health Sciences . .74 Georgetown University, Kennedy Institute of Ethics . .74 Global Forum for Health Research – GFHR . .75 Global Forum on Bioethics in Research - GFBR . .76 Global Ministerial Forum on Research for Health Bamako . .76 Good Clinical Practices (GCP) Inspection Training Course . .77 Health Research Ethics Training Initiative in Egypt - HRETIE . .77 International Association of Bioethics - IAB . .78 International Research Ethics Network for Southern Africa – IRENSA . .79 Islamic Educational, Scientific and Educational Organization - ISESCO Islamic Body on Ethics of Science and New Technology - IBEST . .79 Islamic Medical Association of Northern America - IMANA . .80 Islamic Organization for Medical Sciences - IOMS . .81 Kintampo Health Research Center, Ghana - KHRC . .81 Middle East Research Ethics Training Initiative - MERETI . .82 New Partnership for Africa’s Development - NEPAD . .82 Pan-African Bioethics Initiative - PABIN . .83 Research Center on Health, Cultures and Societies - CReCSS . .84 Research Methodology Training Course - RMTC . .84 Roll Back Malaria Partnership - RBM . .85 Science with Africa . .86 South African Research Ethics Training Initiative -SARETI . .87 South East Asia Infectious Disease Clinical Research Network - SEAICRN . .88 Special Programme for Research and Training in Tropical Diseases - TDR . .88 Strategic Initiative for Developing Capacity in Ethical Review - SIDCER . .89 Training for Scholarship in Research Ethics University . .90 TRREE for Africa . .91 Tuskegee University, USA - National Center for Bioethics in Research and Health Care . .91 United Nations Educational, Scientific and Cultural Organization - UNESCO . .92 Ethics Education Programme . .92 ABC Project - Assisting Bioethics Committees . .93 US National Institute of Health Bioethics Resources on the Web . .93 US Office for Human Research Protections - OHRP . .94 Wellcome Trust . .94 West African Bioethics Training Programme - WAB . .95 4 World Health Organization - WHO . .96 Ethics and Health . .96 Department of Research Policy and Cooperation . .96 Research Ethics Training Course . .97 Initiative for Vaccine Research . .97 Developing Countries Vaccine Regulators Network - DCVRN . .98 Afro Vaccine Regulatory Forum - AVAREF . .99 World Medical Association - WMA . .102 Chapter III - Health Research in Developing Countries . .105 Poverty, Corruption and the Right to Health . .105 The Health Care Scenario in the Developing World . .108 The International Health Research Scenario . .111 The Pharmaceutical Market Scenario . .113 Patenting Issues and Access to Essential Medicines . .114 The Size and Type of Clinical Research in Africa . .120 The Capacity for Education and Research on Health in Africa . .126 The African Diaspora . .128 The Capacity for the Ethical Review of Research in Africa . .130 Chapter IV - The State of Legislation regarding Ethics in Biomedicine and Ethical Review Capacity in Africa, end of 2008 . .137 Introduction . ..
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