Biomedical Research in Developing Countries - UNICRI

More documents

Recommendations

Info

c) We recommend the appropriate identification of resources for the training of research ethics committees and the training of judiciary and policy makers on the themes of ethics and legality of clinical research with human participants. d) We recommend the identification of priority actions or the designation of a global forum of experts that can work towards the establishment of an international instrument that can effectively: o o o Assist in the development of biomedical research policies that meet the needs of both the developed and the developing countries. Address the inequities in research priorities. Monitor on-going research to safeguard participants and communities from exploitation. 208
Agenzia Italiana del Farmaco Italian Medicines Agency GCP Promotion Unit, GCP and Pharmacovigilance Inspectorate International Round Table AIFA-UNICRI Biomedical Research in Developing Countries: the Promotion of Ethics, Human Rights and Justice Rome, 15-16 December 2008 Proposals and Recommendations The respect of the GCP principles in the clinical trials of medicines guarantees the ethics of the trials as well as the protection of the rights of the participants. This could be achieved through: a) Legislation authorizing Clinical Trials only if the protocol is in compliance with GCP principles, following the evaluation of Ethical Committees. b) Legislation authorizing the marketing of medicines only if their efficacy and safety is based on CTs performed in the respect of GCP principles. c) Implementation of CTs in compliance with GCP principles. d) GCP Inspectorates which verify the respect of GCP principles before, during and after CTs conduct. 209
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
Page 19:
3) the existence of centres or rese
Page 22 and 23:
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
Page 29 and 30:
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
Page 82 and 83:
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
Page 88 and 89:
exchange in health research ethics
Page 90 and 91:
objectives of SIDCER are to foster
Page 92 and 93:
national institutions, Tuskegee Uni
Page 94 and 95:
The Office for Human Research Prote
Page 96 and 97:
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 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 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
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 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 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
show all

Biomedical Research in Developing Countries - UNICRI

Create successful ePaper yourself

Delete template?

Save as template?