Potential behavioural and psychological contributions to ethical HIV vaccine trials in South Africa

South African Journal of Psychology

Volumn 36, Issue 4, 2006, Pages 715-733

  Lindegger, G ^a   Milford, C ^a   Ranchod, C ^a   Slack, C ^a  

^a UNIVERSITY OF KWAZULU NATAL   (South Africa)

Author keywords

Adolescents; Ethics; HIV vaccine trials; Informed consent; Psychology; Social harms

Indexed keywords

EID: 33847728237     PISSN: 00812463     EISSN: None     Source Type: Journal    
DOI: 10.1177/008124630603600405     Document Type: Article

References (77)

1. Abdool Karim, S. (2002). Conducting HIV vaccine trials in South Africa. Continuing Medical Education, 20(9), 588-592.
2. Abramovitch, R., Freedman, J. L., Henry, K., & van Brunschot, M. (1995). Children's capacity to agree to psychological research: Knowledge of risks and benefits and voluntariness. Ethics & Behaviour, 5, 25-48.
3. AIDS Vaccine Advocacy Coalition (AVAC). (2004). AIDS vaccine trials: Getting the global house in order. New York: AVAC.
4. Allen, M. (2001). Trial-related discrimination in HIV vaccine clinical trials. AIDS Research and Human Retroviruses, 17, 667-668.
5. Baleta, A. (1999). South Africa faces an AIDS crisis as government health campaigns fail. Lancet, 353, 653.
6. Bartholow, B. N., Buchbinder, S., Celum, C., Goli, V., Koblin, B., Para, M., Marmor, M., Novak, R. M., Mayer, K., Creticos, C., Orozco-Cronin, P., Popovic, V., & Mastro, T. D. (2005). HIV sexual risk behaviour over 36 months of follow-up in the world's first HIV vaccine efficacy trial. Journal of Acquired Immune Deficiency Syndromes, 39, 90-101.
7. Bayer, R. (2000). Ethical challenges of HIV vaccine trials in less developed nations: Conflict and consensus in the international arena. AIDS, 14, 1051-1057.
8. Beauchamp, T., & Childress, J. (2001). Principles of biomedical ethics (4th ed.). New York: Oxford University Press.
9. Bednar, D. E., & Fisher, T. D. (2003). Peer referencing in adolescent decision-making as a function of perceived parenting style. Adolescence, 38, 1-11.
10. 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, 4, 93-97.
11. Belmont Report. (1979). Ethical principles and guidelines for the protection of human subjects of research. Retrieved May 5, 2006 from http://www.fda.gov/oc/ohrt/IRBS/belmont.html
12. Belshe, R. B., Stevens, C., Gorse, G. J., Buchbinder, S., Weinhold, K., Sheppard, H., Stablein, D., Self, S., McNamara, J., Frey, S., Flores, J., Excler, J. L., Klein, M., Habib, R. E., Duliege, A., Harro, C., Corey, L., Keefer, M., Mulligan, M., Wright, P., Celum, C., Judson, F., Mayer, K., McKirnan, D., Marmor, M., & Woody, G. (2001). Safety and immunogenicity of a canarypox-vectored HIV type 1 vaccine with or without GP 120. Journal of Infectious Diseases, 183, 1343-1352.
13. Bhutta, Z. (2004). Beyond informed consent. Bulletin of WHO, 82, 771-777.
14. Chesney, M. A., Chambers, D. B., & Kahn, J. O. (1997). Risk behavior for HIV infection in participants in preventive HIV vaccine trials: A cautionary note. Journal of Acquired Immune Deficiency Syndromes, 16, 266-271
15. Council for International Organizations of Medical Science (CIOMS) and World Health Organisation (WHO). (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS.
16. Declaration of Helsinki. (1983). Recommendations guiding physicians in biomedical research involving human subjects. Retrieved May 5, 2006 from http://www.fda.gov/oc/health/helsinki83.html
17. Department of Health. (2000). Guidelines for good practice in the conduct of clinical trials in human participants in South Africa. Pretoria: National Department of Health.
18. Department of Health. (2004). Ethics in health research: Principles, structures and processes. Pretoria: National Department of Health.
19. Dickey, S. B., & Deatrick, J. (2000). Autonomy and decision making for health promotion in adolescence. Journal of Pediatric Nursing, 26, 461-467.
20. Emanuel, E., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Journal of the American Medical Association, 283, 2701-2711.
21. Faden, R., & Beauchamp, T. (1986). A history and theory of informed consent. Oxford: Oxford University Press.
22. 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, 1593-1601.
23. Fuchs, J., Durham, M., McLellan-Lemal, E., Vittinghoff, E., Buchbinder, S., & Vax004 Study Team. (2004, July). Younger HIV vaccine trial participants report negative social impacts [ThPeC7444]. Paper presented at the XV International AIDS Conference, Bangkok.
24. Fundudis, T. (2003). Consent issues in medico-legal procedures: How competent are children to make their own decisions? Child and Adolescent Mental Health, 8, 18-22.
25. Gardner, M., & Steinberg, L. (2005). Peer influence on risk taking, risk preference and risky DM in adolescence and adulthood: An experimental study. Developmental Psychology, 41, 625-635.
26. Gasa, N. (1999). Cultural conceptions of informed consent. Unpublished master's thesis. University of Natal, Pietermaritzburg.
27. Global Campaign for Microbicides. (2005). Rethinking the ethical roadmap for clinical testing of microbicides: Report on an international consultation. Washington, DC: The Global Campaign for Microbicides.
28. Hart, N., & Lindegger, G. (2002, August). Culture and self. Paper presented at the 2nd International Biennial Conference of the Self Research Centre, Sydney.
29. Health Systems Development Unit. (1998). Adolescent sexuality and reproductive health in the Northern Province. Acornhoek, South Africa: Health Systems Development Unit.
30. Ijsselmuiden, C., & Faden, R. (1992). Research and informed consent in Africa: Another look. New England Journal of Medicine, 326, 830-834.
31. Jaspan, H. B., Gray, G. E., Robinson, A. K. L., Coovadia, H. M., & Bekker, L-G. (2005). Scientific justification for the participation of children and adolescents in HIV-1 vaccine trials in South Africa. South African Medical Journal, 95, 685-687.
32. Jaspan, H. B., Lawn, S. D., Safrit, J. T., & Bekker, L-G. (2006). The maturing immune system: Implications for development & testing HIV-1 vaccines for children and adolescents. AIDS, 20, 483-494.
33. Jenkins, R. A., Thapinta, D., Morgan, P. A., Wongkamhaeng, S., Sornsathapornkul, P., Bussaratid, V., Sontirat, A., Ruangyuttikarn, C., Pitisuttithum, P., Thongchareoen, P., Khamboonruang, C., Suriyanon, V., Nitayaphan, S., Brown, A. E., & Thai AIDS Vaccine Evaluation Group. (2005). Behavioural and social issues among volunteers in a preventive HIV vaccine trial in Thailand. Journal of Acquired Immune Deficiency Syndromes, 40, 592-599.
34. Jermano, J. (2000, August). Monitoring of social and behavioral harms in the phase III trial of AIDS VAX(r) B/B [ThOrD679]. Paper presented at the XIII International AIDS Conference, Durban.
35. Lind, C., Anderson, B., & Oberle, K. (2003). Ethical issues in adolescent consent for research. Nursing Ethics, 10, 504-511.
36. Lindegger, G. (2002). Cross-cultural perspectives on self construction. Unpublished research report for the Human Sciences Research Council. Pietermaritzburg.
37. Lindegger, G., & Bull, S. (2002). Ensuring valid consent in a developing country context. Retrieved November 2, 2002 from www.scidev.net/dossiers/ethics/erpolicy_lindegger_- bull.html
38. Lindegger, G., & Richter, L. (2000). HIV vaccine trials: Critical issues in informed consent. South African Journal of Science, 96, 1-6.
39. Lindegger, G., & van Loon, K. (2004, November). Informed consent experiences of South African researchers. Paper presented at the 7th World Congress of Bioethics, University of New South Wales, Sydney.
40. Lindegger, G., Milford, C., Slack, C., & Xaba, X. (2004, November). The development and comparison of methods to assess understanding for informed consent for phase I HIV vaccine trials. Paper presented at the 7th World Congress of Bioethics, University of New South Wales, Sydney.
41. Maduna-Butshe, A. C. Z. (1997). Women sex workers and the pandemic: Stigma and blame in context. South African AIDS News, 5, 8-11.
42. Maek-A-Nantawat, W., Pitisuttithum, P., Phonrat, B., Bussaratid, V., Naksrisook, S., Peonim, W., Thantamnu, N., & Muanaum, R. (2003). Evaluation of attitude, risk behaviour and expectations among Thai participants in Phase I/II HIV/AIDS vaccine trials. Journal of the Medical Association of Thailand, 86, 299-307.
43. Mann, L., Harmoni, R., & Power, C. (1989). Adolescent decision-making: The development of competence. Journal of Adolescence, 12, 265-278.
44. Markel, H. (2005). The search for effective HIV vaccines. New England Journal of Medicine, 353, 753-758.
45. Markus, H. R., & Kitayama, S. (1991). Culture and self: Implications for cognition, emotion, and motivation. Psychological Review, 98, 224-253.
46. McClure, C. A., Gray, G., Rybczyk, G. K., & Wright, P. F. (2004). Challenges to conducting HIV preventative vaccine trials with adolescents. Journal of Acquired Immune Deficiency Syndromes, 36, 726-733.
47. Medical Research Council (MRC). (2000). Guidelines on ethics for medical research: General principles. Cape Town: MRC.
48. Medical Research Council (MRC). (2003). Guidelines on ethics for medical research: HIV preventative vaccine trials. Cape Town: MRC.
49. Moodley, K. (2002). HIV vaccine trial participation in South Africa: An ethical assessment. Journal of Medicine and Philosophy, 27, 197-215.
50. Muyinda, H., Seeley, J., Pickering, H., & Barton, J. (1997). Social aspects of AIDS-related stigma in rural Uganda. Health and Place, 3, 143-147.
51. Northoff, G. (2006). Neuroscience of decision making and informed consent: An investigation in neuroethics. Journal of Medical Ethics, 32, 70-73.
52. Nuffield Council on Bioethics. (2002). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics.
53. Olivier, S. (1995). Informed consent and transcultural research. South African Medical Journal, 85, 984-985.
54. Pitisuttithum, P. (2000, August). Social harm monitoring among injecting drug users in a phase III HIV vaccine trial in Bangkok, Thailand: Preliminary results [TuOrD448]. Paper presented at the XIII International AIDS Conference, Durban.
55. Republic of South Africa. (2003). National Health Act (No. 61 of 2003). Retrieved November 30, 2004 from http://www.info.gov.za/documents/acts/ 2003.htm
56. Richter, L., Lindegger, G., Abdool-Karim, Q., & Gasa, N. (1999). Guidelines for the development of culturally sensitive approaches to obtaining informed consent for participation for HIV vaccine trials. Geneva: UNAIDS.
57. Rogers, A. S. (2005). Adolescents and AIDS vaccine research in the United States. In P. Kahn (Ed.), AIDS vaccine handbook: Global perspectives (2nd ed.) (pp. 199-203). New York: AIDS Vaccine Advocacy Coalition.
58. Schachter, D., Kleinman, I., & Harvey, W. (2005). Informed consent and adolescents. Canadian Journal of Psychiatry, 50, 534-541.
59. Sheon, A. R., Wagner, L., McElrath, M. J., Keefer, M. C., Zimmermann, E., Israel, H., Berger, D., & Fast, P. (1998). Preventing discrimination against volunteers in prophylactic HIV vaccine trials: Lessons from a phase II trial. Journal of Acquired Immune Deficiency Syndromes, 19, 519-526.
60. Slack, C., Stobie, M., Milford, C., Lindegger, G., Wassenaar, D., Strode, A., & Ijsselmuiden, C. (2005). Provision of HIV treatment in HIV preventive vaccine trials: A developing country perspective. Social Science and Medicine, 60(6), 1197-1208.
61. Smit, J., Middelkoop, K., Myer, L., Lindegger, G., Swartz, L., Seedat, S., Tucker, T., Wood, R., Bekker, L. G., & Stein. D. (2005). Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa. African Health Sciences 5(3), 198-206.
62. Society for Adolescent Medicine. (2003). Guidelines for adolescent health research: A position paper of the society for adolescent medicine. Journal of Adolescent Health, 33, 396-409.
63. Solomon, V., van Rooyen, H., Griesel, R., Gray, D., Stein, J., & Nott, V. (2004). Critical review and analysis of voluntary counselling and testing literature in Africa. Health Systems Trust, Durban. Retrieved August 17, 2006 from http://www.hst.org.za/publications/629
64. South African Children's Bill. (2003). (B 70). Retrieved October 23, 2005 from http://www.uct.ac.za/depts/ci/plr/cbill.htm
65. Spiro, M. (2000). Is the western conception of the self peculiar within the context of world cultures? Ethos, 21, 107-153.
66. Stam, H. J. (2004). A sound mind in a sound body: A critical historical analysis of health psychology. In M. Murray (Ed.), Critical Health Psychology (pp. 15-30). London: Palgrave.
67. Steinberg, L., & Scott, E. S. (2003). Less guilty by reason of adolescence: Developmental immaturity, diminished responsibility and the juvenile death penalty. American Psychologist, 58, 1009-1018.
68. Swartz, L., Kagee, A., Kafaar, Z., Smit, J., Bhana, A., Gray, G., Lesch, A., Lindegger, G., Milford, C., Richter, L., Seedat, S., Skhosana, N., & Stein, D. J. (2005). Social and behavioural aspects of child and adolescent participation in HIV vaccine trials. Journal of the International Association of Physicians in AIDS Care, 4, 89-92.
69. Thapinta, D., Jenkins, R. A., Celentano, D. D., Nitayaphan, S., Buapunth, P., Triampon, A., Morgan, P. A., & Khamboornruang, C. (1999). Evaluation of behavioral and social issues among Thai HIV vaccine trial volunteers. Journal of Acquired Immune Deficiency Syndromes, 20, 308-315.
70. Udemezue, O. (2005). Informed consent in clinical trials: Participants' experiences of various aspects of informed consent. Unpublished master's thesis in Public Health. University of Pretoria.
71. UNAIDS. (2000). Ethical considerations in HIV preventive vaccine research. Geneva: UNAIDS.
72. UNAIDS. (2005). AIDS epidemic update. Geneva: UNAIDS.
73. Veatch, R. M. (1995). Abandoning informed consent. Hastings Centre Report, March/April, 5-12.
74. Villafana, T. L., Phaladze, N., Stegling, C., Hambira, R., Thumbi, P., & Makhema, J. (2005). Adolescents in HIV vaccine trials: Perspective from Botswana. In P. Kahn (Ed.), AIDS vaccine handbook: Global perspectives (2nd ed.) (pp. 205-210). New York: AIDS Vaccine Advocacy Coalition
75. Wendler, D., & Shah, S. (2003). Should cm.uren decide whether they are enrolled in non beneficial research? The American Journal of Bioethics, 3, 1-7.
76. Wendler, D. (2005). Human subjects research: Unit on vulnerable populations: Children in research. Retrieved December 3, 2005 from http://www.bioethics.nih.gov/research/humanres/Children.pdf
77. Wood, K., & Jewkes, R. (1997). Violence, rape and sexual coercion: Everyday love in a South African township. Gender and Development, 5, 41-46.