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Clinical trials in developing countries: ethical issues

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References

  1. Gilman RH, Garcia HH (2004) Ethics review procedures for research in developing countries: a basic presumption of guilt. Can Med Ass J 171: 248–249

    Google Scholar 

  2. Bhutta ZA (2002) Ethics in international health research: a perspective from the developing world. Bull WHO 80: 114–120

    PubMed  Google Scholar 

  3. Nuffield Council on Bioethics (2002) The ethics of research related to health care in developing countries. Nuffield Council on Bioethics, London, p. 76

    Google Scholar 

  4. National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants. Vol 1. Reports and Recommendations of the National Bioethics Advisory Commission, NBAC, Bethesda, Maryland

    Google Scholar 

  5. Hyder AA, Wali SA, Khan AN, Teoh, NB, Kass, NE, Dawson L (2004) Ethical review of health research: a perspective from developing country researchers. J Med Ethics 30: 68–72

    Article  PubMed  CAS  Google Scholar 

  6. Anonymous. Clinical trials without ethical review under the spotlight. In Focus: 26 March 2004. Accessed from: www.who.int/bulletin/volumes/82/4/feature0404/en. Accessed on October 15, 2004

    Google Scholar 

  7. Emmanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical. J Am Med Ass 283: 2701–2711

    Google Scholar 

  8. World Medical Association (2000) Declaration of Helsinki. Edinburg

    Google Scholar 

  9. Vastag B (2000) Helsinki discord? A controversial declaration. JAMA 284: 2983–2985

    PubMed  CAS  Google Scholar 

  10. World Health Organization (2000) Operational guidelines for ethics committees that review biomedical research. Geneva

    Google Scholar 

  11. Strauss RP, Sengupta, S, Quinn SC, Goepingger J, Spaulding C, Kegeles SM, Millett G (2001) The role of community advisory boards: involving communities in the informed consent process. Am J Publ Health 91: 1938–1943

    Article  CAS  Google Scholar 

  12. Shalala D (2000) Protecting research subjects: what must be done. New Engl J Med 343: 808–810

    Article  PubMed  CAS  Google Scholar 

  13. Council for International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Geneva

    Google Scholar 

  14. National Health and Medical Research Council (1991) Guidelines on ethical matters in aboriginal and Torres Strait islander health research. Wellington

    Google Scholar 

  15. Health Research Council of New Zealand (1998) Guidelines for researchers on health research involving Maori. Wellington

    Google Scholar 

  16. Indian Council of Medical Research (2000) Ethical guidelines for biomedical research on human beings. New Delhi

    Google Scholar 

  17. Weijer C (1999) Protecting communities in research: philosophical and pragmatic challenges. Cambridge Quart Healthcare Ethics 8: 501–513

    CAS  Google Scholar 

  18. Anonymous (1995) Note for guidance on good clinical practice (CPMP/ICH/135/1995). ICH harmonized tripartite guideline. ICH Secretariat/CPMP/World Medical Association

    Google Scholar 

  19. Hochhauser M (2000) The informed consent form: document development and evaluation. Drug Inform J 34: 1309–1317

    Google Scholar 

  20. Paasche-Orlow MK, Taylor HA, Brancat FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348: 721–726

    Article  PubMed  Google Scholar 

  21. Hochhauser M (2004) Informed consent: reading and understanding are not the same. Appl Clin Trials 13: April. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=90594

    Google Scholar 

  22. Stiffler H (2003) Guidelines for obtaining informed consent for clinical research. Appl Clin Trials 12: Nov 2. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=77704

    Google Scholar 

  23. Brady JS (2003) Multimedia delivery can enhance the consent process. Appl Clin Trials 12: Jan 1 www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=80369

    Google Scholar 

  24. Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP, Desormeau J, Davis H, Boulos R, Halsey NA (1998) Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. AIDS Educ Prev 10: 46–62

    PubMed  CAS  Google Scholar 

  25. Leach A, Hilton S, Greenwood BM, Manneh E, Dibba B, Wilikns A, Mulholland EK (1999) An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type b conjugate vaccine undertaken in the Gambia, West Africa. Soc Sci Med 48: 139–148

    Article  PubMed  CAS  Google Scholar 

  26. Kuczewski MG, Marshall P (2002) The decision dynamics of clinical research: the context and process of informed consent. Med Care 40: 45–54

    Article  Google Scholar 

  27. Preziozi MP, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak SGF (1997) Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med 336: 370–373

    Google Scholar 

  28. Stapleton H, Kirkham M, Thomas G (2002) Qualitative study of evidence based leaflets in maternity care. Br Med J 323: 1464–1466

    Google Scholar 

  29. Benitez O, Devauz D, Dausset J (2002) Audio-visual documentation of oral consent: a new method of informed consent for illiterate populations. Lancet 359: 1407–1407

    Article  Google Scholar 

  30. Tallo V (2003) Evaluating comprehension of informed consent: how should it be done? Oral Presentation at the 3rd African Conference on Ethical Aspects of Clinical Research in Developing Countries. Kampala, Uganda, March 19–21, 2003.

    Google Scholar 

  31. Stober M (2003) Multinational clinical trials: breaking language and cultural barriers. Appl Clin Trials 12 Sept 1. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=79882

    Google Scholar 

  32. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD, Pape JW (2002) Comprehension during informed consent in a less developed country. Lancet 360: 1301–1302

    Article  PubMed  Google Scholar 

  33. Slack C, Lindegger G, Vardas E, Richter L, Strode A, Wassernaar D (2000) Ethical issues in HIV vaccine trials in South Africa. S Afr J Sci 96: 291–295

    PubMed  CAS  Google Scholar 

  34. Weijer, C (2000) The future of research into rotavirus vaccine. Br Med J 321: 525–526

    CAS  Google Scholar 

  35. Knudsen KM, Aaby P, Whittle H, Rowe M, Samb B, Simondon F, Fine P (1996) Child mortality following standard, medium or high titre measles immunization in West Africa. Int J Epidemiol 25: 665–673

    PubMed  CAS  Google Scholar 

  36. Anonymous (2002) A dwindling set of manufacturers. GAVI Immunization Focus March 2002, page 4

    Google Scholar 

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Tallo, V.L., Nohynek, H.M. (2005). Clinical trials in developing countries: ethical issues. In: Kaufmann, S.H., Lambert, PH. (eds) The Grand Challenge for the Future. Birkhäuser Advances in Infectious Diseases BAID. Birkhäuser Basel. https://doi.org/10.1007/3-7643-7381-4_9

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  • DOI: https://doi.org/10.1007/3-7643-7381-4_9

  • Publisher Name: Birkhäuser Basel

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  • Online ISBN: 978-3-7643-7381-8

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