Hidden risks associated with clinical trials in developing countries

Journal of Medical Ethics

Volumn 36, Issue 2, 2010, Pages 111-115

  Lorenzo, Cláudio ^a   Garrafa, Volnei ^a   Solbakk, Jan Helge ^b,c   Vidal, Susana ^d  

^a UNIVERSITY OF BRASILIA   (Brazil)

^b UNIVERSITY OF OSLO   (Norway)

^c UNIVERSITY OF BERGEN   (Norway)

^d SHS Sector   (Uruguay)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DEVELOPING COUNTRY; ETHICS; HUMAN; MEDICAL RESEARCH; PATIENT SELECTION; PROFESSIONAL STANDARD; RISK ASSESSMENT;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DEVELOPING COUNTRIES; ETHICS COMMITTEES, RESEARCH; HUMANS; PATIENT SELECTION; RISK ASSESSMENT;

EID: 77952534170     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2009.031708     Document Type: Article

References (46)

1. Angell M. The ethics of clinical research in the third world. N Engl J Med 1997;337:847-9.
2. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997;337:1003-5.
3. Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988;319:1081-3.
4. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997;337:853-6.
5. Cleaton-Jones PE. An ethical dilemma: availability of anti-retroviral therapy after clinical trials with HIV infected patients are ended. BMJ 1997;314:887-8.
6. Wilmshurst P. Scientific imperialism: if they won't benefit from the findings, poor people in the developing world shouldn't be used in research. BMJ 1997;314:840-1.
7. Glantz LH, Annas GJ, Grodin MA, et al. Research in developing countries: taking "benefit" seriously. Hastings Cent Rep 1998;28:38-42.
8. Annas GJ, Grodin MA. Human rights and maternalefetal HIV transmission prevention trials in Africa. Am J Public Health 1998;88:560-2.
9. Karim Q, Karim SS, Coovadia HM, et al. Informed consent for HIV testing in a South African hospital: Is it truly informed and truly voluntary? Am J Public Health 1998;88:637-40.
10. Angell M. Investigators' responsibilities for human subjects in developing countries [Editorial]. N Engl J Med 2000,342:967-9.
11. Shapiro H, Meslin E. The ethics of international research. N Engl J Med 2001;314:139-42.
12. Luna F. Research in developing countries. In: Steinbock B, ed. The Oxford Handbook of Bioethics. New York: Oxford University Press, 2007:621-47.
13. Fabio A, Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature reviews. Drug Discov 2008;7:13-14.
14. Chirac P, Torreele E. Global framework on essential health R&D. Lancet 2006;367:1560-1.
15. Glickman SW, McHutchison J, et al. Ethical and scientific implications of the globalization of clinical research. New Engl J Med 2009;360:816-23.
16. World Trade Organization. Trade related aspects of intellectual property rights. http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm (accessed 7 Feb 2009).
17. Brody BA. When are placebo-controlled trials no longer appropriate? Controlled Clin Trials 1997;18:602-12.
18. Lallemant M, McIntosh K, Jourdain G, et al. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the third world. N Engl J Med 1998,338:839-40.
19. Schüklenk U. Unethical perinatal HIV transmission trials establish bad precedent. Bioethics 1998;12:312-19.
20. Levine C. Placebos and HIV. Lessons learned. Hastings Cent Rep 1998:43-8.
21. Lie RK. Ethics of placebo-controlled trials in developing countries. Bioethics 1998;12:307-11.
22. Lie RK. Justice and international research. In: Levine RJ, Gorovitz S, Gallagher J, eds. Biomedical research ethics: updating international guidelines. Geneva: A consultation, 2000:27-39.
23. Weijer C, Anderson JA. The ethics wars. Disputes over international research. Hastings Cent Rep 2001;31:18-20.
24. Emanuel EJ, Miller FK. The ethics of placebo-controlled trialsda middle ground. N Engl J Med 2001;345:915-19.
25. de Zulueta P. Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitations? Bioethics 2001;15:289-311.
26. Lie RK. The HIV perinatal transmission studies. In: Lie RK, Schotsmans PT, eds. Healthy thoughts. European perspectives on health care ethics. Leuven, Paris, Sterling, Virginia: Peeters, 2002:189-206.
27. Solbakk JH. Use and abuse of empirical knowledge in contemporary bioethics. A critical analysis of empirical arguments employed in the controversy surrounding studies of maternalefetal HIV-transmission and HIV-prevention in developing countries. Med Health Care Philos 2004;7:5-16.
28. Solbakk JH. Uses and abuses of biomedical research. In: Ethical eye: biomedical research. Strasbourg Cedex: Council of Europe Publishing, 2004:35-50.
29. Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saúde Pública 2008;24:2219-26.
30. Allemand S. Les paradoxes d'une "société du risque". Sciences humaines 2002;124:24-5.
31. Van Ness P. (2001). The concept of risk in biomedical research involving human subjects. Bioethics 2001;4:364-70.
32. Tri-Council Policy Statement. Ethical conduct for research involving humans. 1998. http://www.pre.gc.ca/English/policystatement (accessed 2 Feb 2009).
33. Office of Human Subjects e USA. Title 45 CFR Part 46 Protection of human subjects. 2001. http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html (accessed 2 Feb 2009).
34. World Medical Association. Ethical principles for medical research involving human subjects. Seoul: 59th WMA General Assembly, 2008. http://www.wma.net/e/policy/b3.htm (accessed 2 Apr 2009).
35. King NMP, Churchill LR. Assessing and comparing potential benefits and risks of harm. In: Emmanuel EJ, eds. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press, 2008:514-26.
36. UNESCO Universal Declaration of Bioethics and Human Rights 2005, Article 3.2, http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html (accessed 5 May 2009).
37. Wisner B. Disaster vulnerability: Scale, power and daily life. Geojournal 1993;30:127-40.
38. Cutter L, Mitchell J, Scott M. Revealing the vulnerability of peoples and places: A case study of Geogetown County, South Carolina. Ann Assoc Am Geogr 2000;90:713-37.
39. Alleyne G, Castilo-Salgado C, Schneider M, et al. Overview of social inequalities in health in the region of the Americas, using various methodological approaches. Rev Panam Salud Publica 2002;12:388-97.
40. Santos MA. Urbanização desigual. Petrópolis: Vozes, 1990.
41. Hydder A, Wali S, Khan A, et al. Ethical review in health research: A perspective from developing country researchers. J Med Ethics 2004;30:68-72.
42. Vidal S. Ethics or market, an urgent decision. Guidelines for the design of ethics norms in biomedical research in Latin America. In: Keyeux G, Penchaszadeh V, Saada A, eds. Bogotá: Investigación en seres Humanos. UNIBIBLOS-UNESCO, 2006:191-232.
43. Lorenzo C. Sistemas de revisiónética. In: Tealdi J, ed. Diccionario latinoamericano de bioética. Bogotá: Unibiblos/UNESCO, 2008:363-6.
44. World Health Organization. International Clinical Trials Registry Platform (ICTRP). http://www.who.int/ictrp/en/ (accessed 26 Jan 2009).
45. Kirigia J, Wambebe C, Baba-Moussa A. Status of clinical research bioethics committees in the WHO african region. BMC Med Ethics 2005;6:1472-9.
46. Ugalde A, Homedes N. Discrepancies around Helsinki 2008: Are we missing the point? Clinical Trials Magnifier 2009;2:107e11 http://www.clinicaltrialmagnifier.com/ (accessed 3 Aug 2009).