Login

Join for Free!
117015 members
table of contents table of contents

This article outlines likely complexities for researchers and research ethics committees, including …


Biology Articles » Bioethics » Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa » References

References
- Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

  1. IAVI:

    IAVI Report 7(1) Feb 2003–April 2003. New York. 2003.

  2. Villa LL, Costa RL, Petta CA, Andrade R, Ault K, Giuliano A, Wheeler C, Koutsky L, Malm C, Lehtinen M: Phrophylactic quadrivalent human papillomavirus (types 6, 11, 16 and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial.

    Lancet Oncol 2005, 6:271-278.

  3. Cunningham CK, Wara DW, Kang M, Kang M, Fenton T, Hawkins K, McNamara J, Mofenson L, Duliege AM, Francis D, McFarland EJ, Borkowsky W, Pediatric AIDS Clinical Trials Group 230 Collaborators: Safety of two recombinant HIV-1 envelope vaccines in neonates born to HIV-1 infected women.

    Clin Infect Dis 2001, 32:801-807.

  4. Johnson DC, McFarland EJ, Muresan P, Fenton T, McNamara J, Read JS, Hawkins E, Bouquin PL, Estep SG, Tomaras GD, Vincent CA, Rathore M, Melvin AJ, Gurunathan S, Lambert J: Safety and immunogenicity of an HIV-1 recombinant canarypox vaccine in newborns and infants of HIV-1-infected women.

    J Infect Dis 2005, 192:2129-2133.

  5. Pettifor AE, Rees HV, Kleinschmidt I, Steffenson AE, MacPhail C, Hlongwa-Madikizela L, Vermaak K, Padian NS: Young people's sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey.

    AIDS 2005, 19:1525-1534.

  6. Shisana O, Simbayi L: Nelson Mandela/Human Sciences Research Council study of HIV/AIDS. South African national HIV prevalence, behavioural risks and mass media household survey. Cape Town: HSRC Publishers; 2002.

  7. UNAIDS:

    Report on the global HIV/AIDS epidemic. Geneva. 2004.

  8. Alonsa PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, Sigauque B, Milman J, Mandomando I, Bassat Q: Duration of protection with RTS, S/AS02A malaria vaccine in prevention of plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial.

    Lancet 2005, 366:2012-2018.

  9. Moorthy VS, Imoukhuede EB, Milligan P, Bojang K, Keating S, Kaye P, Pinder M, Gilbert SC, Walraven G, Brian M, Greenwood BM, Hill ASV: Randomised, double-blind, controlled vaccine efficacy trial of DNA/MVA ME-TRAP against malaria infection in Gambian adults.

    PLoS Med 2004, 1:e33.

  10. Centers for Disease Control and Prevention: Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP).

    MMWR 1991, 40(RR-13):1-19.

  11. Child Care Act 1983, no 74

  12. Constitution of the Republic of South Africa 1996, No.108

  13. Age of Majority Act 1972, No.57

  14. Children's Act 2005, No. 38 [http://ci.org.za/depts/ci/plr/pdf/bills/childrensAct38-2005.pdf] 

  15. Institute of Child Health: Topic E 11: clinical investigation of medicinal products in the paediatric population. [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf] 2000.

  16. Levine RJ: Ethics and regulation of clinical research. London: Yale University Press; 1988.

  17. National Health Act No. 61, of 2003, Government Gazette No. 27503, 18 April 2005

  18. Department of Health: Ethics in health research: principles, structures and processes. Pretoria; 2004.

  19. South African Medical Research Council: Guidelines on ethics of medical research: HIV preventative vaccine trials. [http://www.sahealthinfo.org/ethics/ethicsbook5.pdf] 

    Cape Town 2003.

  20. Department of Health: Guidelines for good practice in the conduct of clinical trials in human participants in South Africa. Pretoria; 2000.

  21. South African Medical Research Council: Guidelines onethics of medical research: general principles. [http://www.sahealthinfo.org/ethics/ethicsbook1.pdf] 

    Cape Town 2001.

  22. Republic of South Africa, Government Gazette: Regulations relating to research on human subjects.

    Gazette No 8629, 23 February, 2007, Regulation No. 29637, regulations 10–16

  23. Strode A, Slack C, Grant K, Mushariwa M: Ethical and legal challenges in enrolling adolescents in medical research in South Africa: implications for HIV vaccine trials.

    South African Journal of Science 2005, 101:224-228.

  24. Van Wyk C: HIV preventative vaccine research on children. Is it possible in terms of South African law and research guidelines?

    Tydskrif vir Hedendaagse Romeins Hollandse Reg 2005, 68:35-50.

  25. Singh J: The impact on ethics. In HIV/AIDS in South Africa. Edited by: Abdool Karim SS, Abdool Karim Q. Pretoria: Cambridge Press; 2005:346-366.

  26. Van Oosten F: The law and ethics of information and consent in medical research.

    Tydskrif vir Hedendaagse Romeins-Hollandse 2000, 63:5-31.

  27. Strode A, Grant C, Slack C, Mushariwa M: How well does the South Africa's National Health Act regulate research involving children.

    S Afr Med J 2005, 95:265-268.

  28. Lind C, Anderson B, Oberle K: Ethical issues in adolescent consent for research.

    Nursing Ethics 2003, 10:504-511.

  29. Agre P, Rapkin B: Improving informed consent: a comparison of four consent tools.

    IRB 2003, 25:1-7.

  30. Lindegger G, Richter L: HIV vaccine trials: critical issues in informed consent.

    South African Journal of Science 2000, 96:1-6.

  31. Murphy D, Hoffman D, Seage G, Belzer M, Xu J, Durako SJ, Geiger M: The Adolescent Trials Network for HIV/AIDS Interventions: Geiger M. Improving comprehension for HIV vaccine trial information among adolescents at risk of HIV.

    AIDS Care 2007, 19(1):41-51.

  32. Fitzgerald D, Marotte C, Verdier I, Johnson WD, Pape JW: Comprehension during informed consent in a less-developed country.

    Lancet 2002, 360:1301-1302.

  33. Lindegger G, Milford C, Slack C, Quayle M, Xaba X, Vardas E: Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa.

    JAIDS 2006, 43(5):560-566.

  34. Flory J, Emanuel E: Interventions to improve research participants' understanding in informed consent for research: a systematic review.

    JAMA 2004, 292:1503-1601.

  35. Investigating Directorate: Serious EconomicOffences v Hyundai Motor Distributors (Pty) Ltd: In re Hyundai Motor Distributors (Pty) Ltd v Smit NO 2001 (1) SA 545 (CC) paras 16 at 557.

  36. Currie I, De Waal J: The human rights handbook. 5th edition. Lansdowne: Juta; 2005.

  37. Halpern-Felsher BL, Cauffman E: Costs and benefits of a decision-making competence in adolescents and adults.

    Applied Developmental Psychology 2001, 22:257-273.

  38. Greene K, Krcmar M, Walters LH, Rubin DL, Hale J, Hale L: Targeting adolescent risk-taking behaviors: the contribution of ego-centrism and sensation-seeking.

    Journal of Adolescence 2000, 23:439-461.

  39. Irwin CE: Adolescence and risk taking: how are they related? In Adolescent risk taking. Edited by: Bell NJ, Bell WB. Newbury Park: Sage Publications; 1993:7-28.

  40. Tonkin RS, Cox DN, Blackman AR, Sheps S: Risk taking behaviour in adolescence. In Behaviour disorders of adolescence: research, intervention and policy in clinical and school settings. Edited by: MacMohan RJ, Dev Peters R. New York: Plenum Press; 1990:27-37.

  41. Steinberg L, Scott ES: Less guilty by reason of adolescence: developmental immaturity, diminished responsibility and the juvenile death penalty.

    American Psychologist 2003, 58:1009-1018.

  42. Cohn LD, Macfarlane S, Yanez C: Risk-perception: differences between adolescents and adults.

    Health Psychology 1995, 14:217-222.

  43. Ruck MD, Abramovitch R, Keating DP: Children's and adolescents, understanding of rights: balancing nurturance and self-determination.

    Child Development 1998, 69:404-417.

  44. Gardner M, Steinberg L: Peer influence on risk taking, risk preference and risky decision-making in adolescence and adulthood: an experimental study.

    Developmental Psychology 2005, 41:625-635. 

  45. Kuther TL: Medical decision-making and minors: issues of consent and assent.

    Adolescence 2003, 38:343-359. 

  46. Nelson RM: Children as research subjects. In Beyond consent: towards justice in healthcare. Edited by: Kahn J. New York: Oxford University Press; 1998:47-66.

  47. Miller VA, Drotar D, Kodish E: Children's competence for assent and consent: a review of empirical findings.

    Ethics & Behaviour 2004, 14:255-295.

  48. Wendler D, Shah S: A response to commentators on 'Should children decide whether they are enrolled in nonbeneficial research.

    The American Journal of Bioethics 2003, 4:W37. 

  49. Quieroz da Fonseca O, Lie RK: Informed consent to AIDS-Vaccine trials in Brazil.

    AIDS and Public Policy Journal 1995, 10:22-26.

  50. McClure CA, Gray G, Rybczyk GK, Wright PF: Challenges to conducting HIV preventative vaccine trials with adolescents.

    JAIDS 2004, 36:726-733. 

  51. Neethling J, Potgieter JM, Visser PJ: Law of Delict. 4th edition. Durban: Butterworths; 2001.

  52. Stobie ML, Strode A, Slack C: The dilemma of enrolling children in HIV vaccine research in South Africa: what is in a child's best interest? In AIDS in Africa. Edited by: Van Niekerk AA, Kopelman LM. Cape Town: David Philip/New Africa Books; 2005:190-207.

  53. Slack C, Kruger M: The South African Medical Research Council's guidelines on ethics for medical research – implications for HIV-preventive vaccine trials with children.

    S Afr Med J 2005, 95:269-271. 

  54. Shah S, Whittle A, Wifond B, Gensler G, Wendler D: How do institutional review boards apply the federal risk and benefit standards for pediatric research?

    JAMA 2004, 291:476-482. 

  55. Weijer C: The ethical analysis of risk.

    Journal of Law, Medicine & Ethics 2000, 28:344-360. 

  56. Universal Declaration of Human Rights [http://www.un.org/Overview/rights.html] 

    Adopted by UN General Assembly Resolution 217A (III) of 10 December 1948)

  57. Sexual Offences Act 1957, No.23

  58. Snyman CR: Criminal Law. Durban: Butterworths; 2002.

  59. Family Violence Act 1992, No. 133, s4

  60. Genetically Modified Organisms Act 1997, No. 15, s4 and s5

  61. Medicines and Related Substances Act 1965, No. 101, s35(1) (xxxix)

  62. Regulations 34(4) No. R 510, Government Gazette No.24727, 10 April 2003

  63. Medicines Control Council:

    Guide to completing a clinical trial application of HIV vaccine. Pretoria. 2003.


rating: 0.00 from 0 votes | updated on: 21 Oct 2008 | views: 6223 |

Rate article:







excellent!bad…