Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries

Sahara J

Volumn 6, Issue 2, 2009, Pages 46-57

  Mystakidou, Kyriaki ^a   Panagiotou, Irene ^b   Katsaragakis, Stelios ^a   Tsilika, Eleni ^c   Parpa, Efi ^c  

^a UNIVERSITY OF ATHENS   (Greece)

^b UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^c UNIVERSITY OF ATHENS   (Greece)

Author keywords

Clinical trials; Developing world; HIV AID; Informed consent

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADOLESCENT; ADULT; ARTICLE; ATTITUDE; BREAST FEEDING; CHILD; CLINICAL TRIAL; COMMUNICATION DISORDER; CONFIDENTIALITY; CULTURAL ANTHROPOLOGY; DEVELOPING COUNTRY; EDUCATIONAL STATUS; ETHICS; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN RELATION; INFANT; INFORMED CONSENT; MALE; NEWBORN; PERSONAL AUTONOMY; POVERTY; PREGNANCY; PREGNANCY COMPLICATION; PRESCHOOL CHILD; PSYCHOLOGICAL ASPECT; SOCIAL PSYCHOLOGY;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADOLESCENT; ADULT; ANTI-HIV AGENTS; ATTITUDE; BREAST FEEDING; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; COMMUNICATION BARRIERS; CONFIDENTIALITY; CULTURE; DEVELOPING COUNTRIES; EDUCATIONAL STATUS; FEMALE; HIV INFECTIONS; HUMANS; INFANT; INFANT, NEWBORN; INFORMED CONSENT; INTERPERSONAL RELATIONS; MALE; PERSONAL AUTONOMY; POVERTY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREJUDICE; THIRD-PARTY CONSENT;

EID: 70350726313     PISSN: 17290376     EISSN: 18134424     Source Type: Journal    
DOI: 10.1080/17290376.2009.9724930     Document Type: Article

References (56)

1. Abdool Karim, Q., Abdool Karim, S., Coovadia, H. M. & Susser, M. (1998). Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? American Journal of Public Health, 88: 637-640.
2. Abdool Karim, S. S. (2000). Globalization, ethics and AIDS vaccines. Science, 288: 2129.
3. Achrekar, A. & Gupta, R. (1998). Informed consent for a clinical trial in Thailand. New England Journal of Medicine, 339(18): 1331-1332.
4. Annas, G. J. & Grodin, M. A. (1998). Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal of Public Health, 88(4): 560-563.
5. Armstrong, R. (2008). Mandatory HIV testing in pregnancy: is there ever a time? Developing World Bioethics, 8(1): 1-10.
6. Bekker, L. G., Jaspan, H., McIntyre, J., Wood, R. & Gray, G. (2005). Adolescents and HIV vaccine trials. What are the clinical trial site issues? Journal of the International Association of Physicians in AIDS Care (Chicago, III), 4: 93-97.
7. Bhutta, Z. A. (2004). Beyond informed consent. Bulletin of the World Health Organization, 82: 771-777.
8. Council for International Organizations of Medical Sciences (CIOMS) (2002). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland.
9. Coutsoudis, A., Coovadia, H. M. & Wilfert, C. M., (2008). HIV, infant feeding and more perils for poor people: new WHO guidelines encourage review of formula milk policies. Bulletin of the World Health Organization, 86(3): 210-214.
10. Crigger, N. J., Holcomb, L. & Weiss, J. (2001). Fundamentalism, multiculturalism and problems of conducting research with populations in developing nations. Nursing Ethics, 8: 459-468.
11. Dawson, L. & Kass, N. E. (2005). Views of US researchers about informed consent in international collaborative research. Social Science & Medicine, 61: 1211-1222.
12. De Bruyn, M. & Paxton, S. (2005). HIV testing of pregnant women-what is needed to protect positive women’s needs and rights. Sexual Health, 2: 143-151.
13. del Rio, C. (1998). Is ethical research feasible in developed and developing countries? Bioethic, 12(4): 328-330.
14. Dickert, N. & Sugarman, J. (2005). Ethical goals of community consultation research. American Journal of Public Health, 95: 1123-1127.
15. Doherty, T., Chopra, M., Jackson, D., Goga, A., Colvin, M. & Persson, L. A. (2007). Effectiveness of the WHO/UNICEF guidelines on infant feeding for HIV-positive women: results from a prospective cohort study in South Africa. AIDS, 21(13): 1791-1797.
16. Faden, R. & Kass, N. (1998). HIV research, ethics and the developing world. American Journal of Public Health, 88(4): 548-550.
17. Fitzgerald, D. W., Marotte, C., Verdier, R. I., Johnson, W. D. & Pape, J. W. (2002). Comprehension during consent in a less-developed country. Lancet, 360: 1301-1302.
18. Homsy, J., King, R., Malamba, S. S., Opio, C., Kalamya, J. N., Mermin, J., Okallanyi A. & Obonyo, J. H. (2007). The need for partner consent is a main reason for opting out routine HIV testing for prevention of mother-to-child transmission in a rural Ugandan hospital. Journal of Acquired Immune Deficiency Syndrome, 44(3): 366-369.
19. Hyder, A. A. & Wali, S. A. (2006). Informed consent and collaborative research: perspectives from the developing world. Developing World Bioethics, 6: 33-40.
20. Jaspan, J. B., Cunningham, C. K., Tucker, J. P. T., Wright, P. F., Self, S. G., Sheets, R. L., Rogers, A. S., Bekker, L. G., Wilson, C. M., Duerr, A. & Wasserheit, J. N. (2008). Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads. Journal of Acquired Immune Deficiency Syndromes, 47: 86-92.
21. Joint United Nations Programme on HIV/AIDS (UNAIDS) (2004). Report on ethical considerations in HIV preventive vaccine research. Geneva, Switzerland.
22. Karamagi, C. A., Tumwine, J. K., Tylleskar, T. & Heggenhougen, K. (2006). Intimate partner violence against women in eastern Uganda: implications of HIV prevention. BMC Public Health, 6: 284.
23. Kass, N. & Hyder, A. (2001) Attitudes and experience of U. S and developing country investigators regarding U. S human subjects regulations. In: Ethical and Policy Issues in International Research: Clinical trials in developing countries. (Vol I-II) Bethesda, MD: National Bioethics Advisory Commission.
24. Kaufert, J. M., Putsch, R. W. & Lavallee, M. (1998). Experience of aboriginal health interpreters in mediation of conflicting values in end-of-life decision making. International Journal of Circumpolar Health, 57(Suppl 1): 43-48.
25. Keeton, C. (2007). South African study highlights importance of research involving children. Bulletin of the World Health Organisation, 85(10): 738-740.
26. Klitzman, R. (2008). Views of the process and content of ethical reviews of HIV vaccine trials among members of US institutional review boards and South African research ethics committees. Developing World Bioethics, 8(3): 207-218.
27. Kuczewski, M. G. & Marshall, P. (2002). The decision dynamics of clinical research: the context and process of informed consent. Medical Care, 40(Suppl 9): 45-54.
28. Lau, C. Y., Cardinali, M., Sato, P. A., Fix, A., & Flores, J. (2008). Broadening inclusion of vulnerable populations in HIV vaccine trials. Expert Review of Vaccines, 7: 259-268.
29. Lindegger, G. & Richter, L. M. (2000). HIV vaccine trials: critical issues in informed consent. South African Journal of Science, 96: 313-317.
30. Little, K. E., Bland, R. M. & Newell, M. L. (2008). Vertically acquired paediatric HIV infection: the challenges of providing comprehensive packages of care in resource-limited settings. Tropical Medicine & International Health, 13(9): 1098-1110.
31. Loue, S. & Okello, D. (2000). Research bioethics in the Ugandan context. II: Procedural and substantive reform. The Journal of Law, Medicine & Ethics 28: 165-173.
32. Macklin, R. (1999). International research: ethical imperialism or ethical pluralism? Accountability in Research, 7(1): 59-83.
33. MacQueen, K. M., Shapiro, K., Karim, Q. A. & Sugarman, J. (2004). Ethical challenges in international HIV prevention research. Accountability in Research, 11: 49-61.
34. Macrae, D. J. (2007) The Council for International Organizations and Medical Sciences (CIOMS) Guidelines on Ethics of Clinical Trials. The Proceedings of the American Thoracic Society, 4(2): 176-178.
35. Makgoba, M. W. (2002). Politics, the media and science in HIV/AIDS: the peril of pseudoscience. Vaccine, 20: 1899-1904.
36. Marshall, P. A. & Rotimi, C. (2001). Ethical challenges in community based research. The American Journal of the Medical Sciences, 322: 259-263.
37. Mayss, A. (2000). Drug-testing on seropositive pregnant women in the developing world: moral and legal implications. Medical Law International, 4(3-4): 183-210.
38. Mc Clure, C. A., Gray, G., Rybczyk, K. & Wright, P. F. (2008). Challenges to conducting HIV preventive vaccine trials with adolescents. Journal of Acquired Immune Deficiency Syndromes, 36: 726-732.
39. Mills, E, Nixon, S., Singh, S., Dolma, S., Nayyar, A. & Kapoor, S. (2006). Enrolling women into HIV preventive vaccine trials: An ethical imperative but a logistic challenge. PLoS Medicine, 3: e94.
40. Moodley, K. (2002). HIV vaccine trial participation in South Africa: An ethical assessment. The Journal of Medicine and Philosophy 27: 197-215.
41. Muthuswamy, V. (2005). Ethical issues in HIV/AIDS research. The Indian Journal of Medical Research, 121: 601-610.
42. Pace, C., Emanuel, E. J., Chuenyam, T., Duncombe, C., Bebchuk, J. D., Wendler, D., Tavel, J. A., McNay, L. A., Phanuphak, P., Forter, H. P. & Grady, C. (2005). The quality of informed consent for a clinical research study in Thailand. IRB, 27(1): 9-17.
43. Pettifor, A. E., Rees, H. V., Kleinschmidt, I., Steffenson, A. E., MacPhail, C., Hlongwa-Madikizela, L., Vermaak, K., Padian, N. S. (2005). Young people’s sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey. AIDS, 19: 1525-1534.
44. Resnik, D. B. (1998). The ethics of HIV research in developing nations. Bioethics, 12(4): 286-306.
45. Salvi, V. & Damania, K. (2006). HIV, research, ethics and women. Journal of Postgraduate Medicine, 52: 161-162.
46. Shaibu, S. (2007). Ethical and cultural considerations in informed consent in Botswana. Nursing Ethics, 14: 503-509.
47. Shapiro, H. T. & Meslin, E. M. (2001). Ethical issues in the design and conduct of clinical trials in developing countries. New England Journal of Medicine, 345: 139-142.
48. Shisana, O. & Simbayi, L. (2002). Nelson Mandela/Human Sciences Research Council Study of HIV/AIDS. South African national HIV prevalence, behavioral risks and mass media house-hold survey. Cape Town: HSRC Publishers.
49. Slack, C., Strode, A., Fleischer, T., Gray, G. & Ranchod, C. (2007). Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. BMC Medical Ethics, 8: 1-8.
50. Slaughter, S., Cole, D., Jennings, E. & Reimer, M. A. (2007). Consent and assent to participate in research from people with dementia. Nursing Ethics, 14: 27-40.
51. Strauss, R. P., Sengupta, S., Quinn, S. C. & Goeppinger, J. (2001). The role of community advisory boards involving communities in the informed consent process. American Journal of Public Health, 91: 1938-1943.
52. Taylor, C. C. (1991). The harp that plays by itself. Medical Anthropology, 13: 99-119.
53. Upvall, M. & Hashwani, S. (2001). Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan. International Nursing Review, 48: 188-192.
54. Woodsong, C. & Karim, Q. A. (2005). A model designed to enhance informed consent: experience from HIV Prevention Trials Network. American Journal of Public Health, 95: 412-419.
55. Zion, D. (2005a). Community without communitarianism: HIV/AIDS research, prevention and treatment in Australia and the developing world. Monash Bioethics Review, 24(2): 20-31.
56. Zion, D. (2005b). Does autonomy require freedom? The importance of options in international HIV/AIDS research. Health Care Analysis, 13(3): 189-202.