Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa

被引：22
作者：
Slack C. [1 ]
Strode A. [1 ]
Fleischer T. [2 ]
Gray G. [3 ]
Ranchod C. [1 ]
机构：
[1] HIV AIDS Vaccines Ethics Group, School of Psychology, University of KwaZulu-Natal, Scottsville, 3209, Pietermaritzburg
[2] Bioethics Centre, Department of Medicine, Groote Schuur Hospital, Observatory 7925, Cape Town, Anzia Road
[3] HIV AIDS Vaccine Division, Faculty of Health Sciences, University of the Witwatersrand, Diepkloof, 1864, Gauteng
来源：
BMC Medical Ethics | / 8卷 / 1期
关键词：
Legal Obligation; Human Papilloma Virus Vaccine; Procedural Requirement; Child Research; National Regulatory Authority;
D O I：
10.1186/1472-6939-8-5
中图分类号：
学科分类号：
摘要：
Background. South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary. This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance. © 2007 Slack et al; licensee BioMed Central Ltd.
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  • [1] Iavi, IAVI Report 7(1) Feb 2003-April 2003. New York, (2003)
  • [2] Villa L.L., Costa R.L., Petta C.A., 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, 6, pp. 271-278, (2005)
  • [3] Cunningham C.K., Wara D.W., Kang M., Kang M., Fenton T., Hawkins K., McNamara J., Mofenson L., Duliege A.M., Francis D., McFarland E.J., Borkowsky W., Safety of two recombinant HIV-1 envelope vaccines in neonates born to HIV-1 infected women, Clin Infect Dis, 32, pp. 801-807, (2001)
  • [4] Johnson D.C., McFarland E.J., Muresan P., Fenton T., McNamara J., Read J.S., Hawkins E., Bouquin P.L., Estep S.G., Tomaras G.D., Vincent C.A., Rathore M., Melvin A.J., 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, 192, pp. 2129-2133, (2005)
  • [5] Pettifor A.E., Rees H.V., Kleinschmidt I., Steffenson A.E., MacPhail C., Hlongwa-Madikizela L., Vermaak K., Padian N.S., Young people's sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey, AIDS, 19, pp. 1525-1534, (2005)
  • [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, (2002)
  • [7] Unaids, Report on the Global HIV/AIDS Epidemic. Geneva, (2004)
  • [8] Alonsa P.L., Sacarlal J., Aponte J.J., 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, 366, pp. 2012-2018, (2005)
  • [9] Moorthy V.S., Imoukhuede E.B., Milligan P., Bojang K., Keating S., Kaye P., Pinder M., Gilbert S.C., Walraven G., Brian M., Greenwood B.M., Hill A.S.V., Randomised, double-blind, controlled vaccine efficacy trial of DNA/MVA ME-TRAP against malaria infection in Gambian adults, PLoS Med, 1, (2004)
  • [10] For Disease Control C., 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, 40, RR-13, pp. 1-19, (1991)
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