Health research: The challenges related to ethical review and informed consent in developing countries

Giornale Italiano di Medicina Tropicale

Volumn 15, Issue 1-4, 2010, Pages 15-20

  Ravinetto, R ^a   Tinto, H ^b   Rouamba, N ^b   Talisuna, A ^c   Adoke, Y ^c   Kadima Ebeja, A ^d   Maketa, V ^e   Grietens, K P ^a   Buve A ^a   Crawley, F ^f  

^a INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^b CENTRE MURAZ   (Burkina Faso)

^c Uganda Malaria Surveillance Project   (Uganda)

^d Human African Trypanosomiasis Platform ^*  (Congo)

^e UNIVERSITY OF KINSHASA   (Congo)

^f Good Clinical Practice Alliance Europe   (Belgium)

Author keywords

Developing countries; Ethical review; Informed consent; Research ethics

Indexed keywords

ARTICLE; BIOETHICS; CLINICAL ASSESSMENT; CLINICAL PRACTICE; CONGO; DEVELOPING COUNTRY; GEOGRAPHY; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL CARE; MEDICAL DECISION MAKING; MEDICAL RESEARCH; PATIENT PARTICIPATION; PERU; RESEARCH ETHICS;

EID: 79851490047     PISSN: 03943445     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (31)

1. AMERICAN ANTHROPOLOGICAL ASSOCIATION (2004). Statement on Ethnography and Institutional Review Boards. Available at: http://www.aaanet.org/stmts/irb.htm.
2. BOMPART F. HIRSCH F., BERTOYE P.H AND VRAY M. (2008). Bonnes Pratiques Cliniques dans les pays en développement: recommandations en termes d'application. Thérapie, 63(2): 77-82.
3. CIOMS (2002). Council for International Organizations of Medical Sciences and World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva.
4. CRAWLEY F.P. (1997). Guidelines and Recommendations for European Ethics Committees. European forum for good clinical practice (EFGCP). Revised Edition. Kessel-Lo, Belgium.
5. EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES TO THE EUROPEAN COMMISSION (2003). Opinion on the Ethical Aspects of Clinical research in Developing Countries. Opinion No 17.
6. FITZGERALD D.W., MAROTTE C., VERDIER R.I, WARREN D.J., PAPE J. W. (2002). Comprehension during informed consent in a less-developed country. The Lancet, 360: 1301-02.
7. FLORY J., EMANUEL E. (2004). Interventions to Improve Research Participants' Understanding in Informed Consent for Research: A Systematic Review. Journal of the American Medical Association, 292(13): 1593-1601.
8. GLICKMAN S.W., McHUTCHISON J.G., PETERSON E.D., CAIRNS C.B., HARRINGTON R.A., CALIFF R.M., AND SCHULMAN K.A. (2009). Ethical and scientific implications of the globalization of clinical research. The New England Journal of Medicine, 360(8): 816-823.
9. GLOBAL MINISTERIAL FORUM ON RESEARCH FOR HEALTH (2008). Strengthening Research for Health, Development and Equity. 17-19 November 2008, Bamako, Mali.
10. HYDER A.A., WALI S.A, KHAN A.N., TEOH N.B., KASS N.E., DAWSON L. (2004). Ethical review of health research: a perspective from developing country researchers. Journal of Medical Ethics, 30: 68-72.
11. HYDER A.A, DAWSON L., BACHANI A.M., LAVERY J.V. (2009). Moving from research ethics review to research ethics systems in low-income and middle-income countries. The Lancet; 373: 862-5
12. th June 1996.
13. KASS N.E., HYDER A.A., AJUWON A., APPIAHPOKU J., BARSDORF N., ELSAYED D.E., MOKHACHANE M., MUPENDA B., NDEBELE P., NDOSSI G., SIKATEYO B., TANGWA G., TINDANA P. (2007). The structure and function of research ethics committees in Africa: A case study. PLoS Medicine, 4(1): e3. doi:10.1371/journal.
14. LANCET EDITORS (2007). Editorial: Strengthening clinical research in India. The Lancet, 369: 1233.
15. LENZER J. (2008). Nigerian judge orders arrests of Pfizer officials. British Medical Journal, 336: 11.
16. MAKETA V., EBEJA A., BOELAERT M., RAVINETTO R., UTUMBA P. (2009). Ethics and clinical research in Democratic Republic of Congo (DRC). European Journal of Tropical Medicine and International Health, 14(2): 48.
17. NAKKASH R. MAKHOUL J., AFIFI R. (2009). Obtaining informed consent: observations from community research with refugee and impoverished youth. Journal of Medical Ethics, 35: 638-643.
18. NUFFIELD COUNCIL ON BIOETHICS (2002). The ethics of research related to healthcare in developing countries. Nuffield Council on Bioethics, London.
19. NUREMBERG CODE (1947). Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.
20. RENQUIST J. (2001). The globalization of Clinical Trials: a growing challenge in protecting human subjects. US Department of Health and Human Services, Office of Inspector General. OEI-01-00-00190.
21. SCHIPPER I., WEYZIG F. (2008). Examples of unethical trials. SOMO briefing paper on ethics in clinical trials. SOMO, The Netherland. Available at: www.somo.nl.
22. SCHOPPER D., UPSHUR R., MATTHYS F., SINGH J.A., BANDEWAR S.S., AHMAD A., VAN DONGEN E. (2009). Research Ethics Review in Humanitarian Contexts: The Experience of the Independent Ethics Review Board of Médecins Sans Frontières. PLos Medicine, 6(7): 1-6.
23. TDR (2000). Special Programme for Research and Training in Tropical Diseases/World Health Organization. Operational Guidelines for Ethics Committees That Review Biomedical Research. TDR WHO, Geneva. Available at: www.who.int/tdr/publications/.
24. TDR (2007). Special Programme for Research and Training in Tropical Diseases/World Health Organization. Ethical challenges in study design and informed consent for health research in resource-poor settings. TDR/SDR/SEB/ST/07.1. Special topics No 5. WHO TDR.
25. UGANDA NATIONAL COUNCIL FOR SCIENCES AND TECHNOLOGY. Available at: http://www.uncst.go.ug/.
26. US NATIONAL BIOETHICS ADVISORY COMMISSION (2001). Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Volume I. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, Maryland.
27. US NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIOURAL RESEARCH (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education and Welfare, US.
28. WEMOS (2008). A bitter pill: The risks of carrying out clinical drug trials in developing countries. Wemos, The Netherlands. Available at: www.wemos.nl.
29. WORLD HEALTH ORGANIZATION (1995). Guidelines for Good Clinical Practices for trials on pharmaceutical products. WHO Technical Report Series No. 850, Annex 3. WHO, Geneva.
30. WORLD HEALTH ORGANIZATION (2008). Clinical Trials in India: ethical concerns. Transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform there. Patralekha Chatterjee reports. Bulletin of the World Health Organization, 86(8): 581-582.
31. th WMA General Assembly, Seoul, October 2008.